Coping after breast cancer (CABC-trial): Testing two digital stress-management interventions in a randomized controlled trial at 6 months

doi:10.21203/rs.3.rs-4915515/v1

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Research Article

Coping after breast cancer (CABC-trial): Testing two digital stress-management interventions in a randomized controlled trial at 6 months

https://doi.org/10.21203/rs.3.rs-4915515/v1

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Purpose

The digital stress-management intervention StressProffen has been shown to be associated with improved well-being and quality of life for cancer survivors. In the Coping After Breast Cancer (CABC) trial, effects of 6 months access to modified versions of StressProffen, delivered through a digital download-only model, were examined.

Methods

Women with breast cancer were invited to participate in the trial 6–9 months following diagnosis. Eligible participants were randomized to either: 1) digital cognitive behavioral therapy stress-management intervention (CBI), n = 140, 2) digital mindfulness-based stress-management intervention (MBI), n = 143, or 3) usual-care (control group), n = 147. Primary outcome was change in perceived stress level (PSS-10), while secondary outcomes included changes in health-related quality of life (HRQoL), anxiety and depression, fatigue, mindfulness, sleep and coping.

Results

Perceived stress level at baseline was low for all groups. No statistically significant mean differences (MD) were detected between either of the intervention groups and the control group from baseline to 6-month follow-up for perceived stress level (MBI: MD -0.28 [95%CI: -1.75, 1.19], CBI: MD -0.42 [95%CI: -1.89, 1.06]), nor for the majority of the secondary outcomes.

Conclusion

After 6 months of access, the CBI and MBI stress-management interventions did not yield significantly improved outcomes for women with breast cancer compared with usual-care controls. Further explorations of which delivery models may optimize use and effect, best timing for delivery, and individual preferences, are needed.

ClinicalTrials.gov identifier NCT04480203.

breast cancer

psychosocial

stress-management

mindfulness

cognitive behavioral

late effects

Progress in diagnostics and treatment have raised the 5-year relative survival rate for early detected breast cancer to above 90% in many Western countries [1, 2]. Although improvements in supportive therapies have alleviated the immediate side-effects of adjuvant systemic therapies, receiving a breast cancer diagnosis and undergoing subsequent treatment is associated with high levels of stress [3] that can persist long after the person is considered cancer-free [3, 4]. Stress can induce psychosocial and physical challenges that may impact overall psychological well-being and ability to cope [3–8], as well as health-related quality of life (HRQoL) [9–11].

Psychosocial stress-management interventions have been shown to be effective in women with breast cancer for decades, being associated with reduced stress, anxiety and depression, fatigue, insomnia, pain and enhanced HRQoL [3, 12–17]. These interventions often incorporate cognitive-behavioral and mindfulness techniques [6, 8], that are, separately and combined, known to be effective in reducing stress and cancer-related side effects, as well as having positive effects on HRQoL [3, 16, 18, 19] [20–23]. While the aim of cognitive-behavioral therapy (CBT) is to modify cognitions and behavior with brief- and goal oriented interventions [3], one aim of mindfulness-based interventions is to learn to tolerate and change ones relationship to stressful thoughts, feelings or sensations, which over time can lead to reduced physiological over-arousal [24]. Some reviews exist comparing the effect of various intervention types in support of stress-management in cancer development [25–28], but few studies have sought to directly compare CBT and mindfulness effects in randomized controlled trials (RCTs) [8, 29].

The use of electronic health (eHealth) solutions to deliver psychosocial stress-management interventions to breast cancer patients is increasing [30, 31]. In a two-arm 12-month RCT, StressProffen [32, 33], an evidence-based, user-centered application (app)-based stress-management program, delivered in a simple blended care model, has shown to be associated with reduced stress and symptoms of anxiety and depression and improved capacity for self-regulation and HRQoL in cancer survivors (majority breast cancer) [32–35]. As StressProffen is primarily CBT-based with elements of mindfulness [32–35], and studies comparing recognized psychosocial treatment methods is lacking [8], the Coping After Breast Cancer (CABC) project developed two distinct adaptations of the original StressProffen app, with either CBT content; the cognitive behavioral intervention (CBI) or mindfulness content; the mindfulness-based intervention (MBI), seeking to test both against usual care in a new delivery format (i.e., entirely self-administered). Participants receiving either StressProffen CBI or MBI over 6 months, compared to participants receiving usual-care (i.e., control group) were hypothesized to experience decreased perceived stress level, anxiety and depression and fatigue, and improvements in HRQoL, mindfulness, coping and sleep.

Study design and participants

The protocol and study design of the CABC trial has been fully described previously [36].

Women diagnosed with either ductal carcinoma in situ, or breast cancer stage I-III, human epidermal growth factor receptor 2–positive (HER2-positive) or estrogen receptor–negative tumor(s)) (ER-negative) registered in the Cancer Registry of Norway (CRN), aged 21–69 years who had completed the digital CRN patient reported outcome measures (CRN PROMs) survey sent to all breast cancer patients at least 21 days following diagnosis [37] were eligible for trial inclusion.

In total 1123 potentially eligible breast cancer patients were identified from the CRN PROMs survey and received the CABC trial specific survey 6–9 months following their diagnosis and in the period January 2021 and May 2023. In total 467 completed the CABC survey which constituted consent and were randomized 1:1:1 to CBI, MBI or usual-care controls. The randomization was concealed, and we employed a block randomization variant without stratification, with block sizes varying between 12 and 27. Twenty-three participants were included in a pilot study and thus excluded from the current study [36].

In an initial, introductory call to participants in the intervention groups, three additional eligibility criteria were assessed: Whether the participants; 1) understood Norwegian, 2) had access to a smartphone or tablet, and 3) had/ were willing to enable phone locks on their devices (a necessity for accessing the app). In total 430 satisfied the eligibility criteria and participants randomized to CBI (n = 140) or MBI (n = 143) accessed the interventions (downloaded the StressProffen app with intervention specific content on their phones with guidance from study staff), whereas participants randomized to controls (n = 147) received no more follow-up (Fig. 1).

CRN PROMs; Cancer Registry of Norway (CRN) patient reported outcome measures (survey sent to all digitally active breast cancer patients after diagnosis). CABC; Coping After Breast Cancer. CBI; cognitive behavioral therapy intervention. MBI; mindfulness-based intervention.

Intervention arms and delivery model

The CBI and MBI interventions, originating from the original StressProffen program (i.e., primarily CBT based but with aspects of mindfulness), were developed to be almost identical in length, design, format and layout, for details see [38]. Each intervention consisted of 10 modules with 9–16 brief steps containing various stress-management related educational material and exercises (i.e., diaphragmatic breathing, visualization, focus) available through text, audio, video, and illustrations. The interventions are self-guided with a 3-day mandatory pause between modules to encourage reflection and practice. The titles of the 10 modules in both interventions are displayed in Supplementary file 1. Examples of CBI and MBI content are displayed in Supplementary file 2 and 3, respectively.

The original StressProffen program was delivered in a simple blended care model (i.e., one in-person introduction session providing rationale for the stress-management concept and guidance in downloading the app, followed by two follow-up phone calls) [33, 34]. Most “health apps” are however downloaded individually from online stores, and are rarely delivered with additional support [39]. The current CABC trial therefore opted to deliver the StressProffen CBI and MBI versions in a digital download-only delivery model. To add a follow-up aspect for the intervention (i.e., to encourage use and adherence), participants were contacted by phone three times during the intervention period (about 1-, 3- and 6-weeks post app access). These follow-up phone calls, although brief, were conducted to ask about status, help resolve any potential technical issues or barriers for use, and through such help motivate continued usage of the app.

Data collection and outcome measures

All outcomes were assessed with the CABC 1 survey at baseline (6–9 months after diagnosis) and with the CABC 2 survey 6 months after baseline (about 13 months after diagnosis). However, since fatigue was already scheduled to be assessed with the ongoing CRN PROMs 2 survey 14 months after diagnosis, this outcome was not included in the CABC 2 survey [36] (Supplementary file 4).

Outcome measures

Primary outcome

The primary outcome, perceived stress, was assessed using Cohen’s 10-item Perceived Stress Scale [40]. Items were rated on a 5-point Likert scale ranging from “never” (0) to “very often (5)” over the last month, and a total score was calculated (0–40). Score 0–13 represents low perceived stress level, 14–26 moderate, and 27–40 high perceived stress level [40].

Secondary outcomes

An anxiety and depression score was generated from four individual items in the brief version of the Patient Health Questionnaire for Depression and Anxiety (PHQ4)[41]. Fatigue was measured using Chalder’s Fatigue Scale (13 items) and presented as a summary score [42]. HRQoL was measured by the RAND Corporation 36-Item Short Form Health Survey (RAND-36). RAND-36 assesses 8 health domains: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions [43]. Mindfulness was assessed using the 15 items from Baer’s 5 Facet Mindfulness Questionnaire (FFMQ-15) and presented as a total score [44, 45]. Coping, helplessness and hopelessness were measured by the Theoretically Originated Measure of the Cognitive Activation Theory of Stress [46]. Sleep (duration and quality) was measured by items from the Norwegian Shift Work, Sleep and Health survey [47]. Rationale and more details on outcome measures are provided in the protocol paper[36]

Sociodemographic and medical data

Sociodemographic data (i.e., age, educational level, relationship and family status, income, physical activity level, smoking and alcohol habits, height, and weight) were obtained from the CRN PROMs 1 survey (administered ≥ 21 days following diagnosis). Medical data on breast cancer diagnosis were obtained from the CRN.

App use

Data related to program use (i.e., such as app progress/activity, time spent using the app, days from first to last use, number of completed modules, etc.) were automatically extracted from user logs that were collected and stored on a secure research server at the Services for Sensitive Data, University of Oslo.

Statistical analysis

All analysis followed a statistical analysis plan that was evaluated by the CABC main project group prior to analysis.

The study was powered to find significant differences in the primary outcome (i.e., 6-month between-group difference in perceived stress) using independent sample t tests. Presumed effect size and variance were based on previous results from the StressProffen study [33, 48]. Originally, we used an alpha level of 5%, but since we had two intervention groups, we needed to adjust for multiple comparisons (two intervention groups) and reduced the alpha level to 2.5% in February 2022. Simultaneously, we downgraded one of the two primary outcomes (HRQoL) to a secondary outcome. Assuming a completion rate of 70%, we needed minimum 335 participants [36], and ended up including 430 participants.

Results for all outcomes were presented as the mean change from baseline to 6-month follow-up, adjusted for baseline values. Between-group differences were calculated as the intervention group changes from baseline minus control group change from baseline. Analyses were performed according to the intention-to-treat principle, with all participants included regardless of app use and loss to follow-up. Missing data on outcomes at baseline and follow-up were imputed using fully conditional specification. In addition, the results from the complete case analysis are presented in Supplementary file 5. Groups were also compared after controlling for the a-priori defined potential confounders of age (grouped as 18–44, 45–54, 55–69), educational level (low and high), having children < 18 years (yes/no), BMI (under- and normal weight, overweight or obese), cancer stage (DCIS + stage 1, stage 2 and 3 or missing) and alcohol use in multivariable regression analyses. Results from these analyses are presented in Supplementary file 6.

For the primary outcome, exploratory subgroup analyses were performed by app completion (completed 0–6 modules vs. 7–10 modules) [34], and perceived stress at baseline[(low vs. moderate/high (due to few individuals in the high group)] and below vs. above median baseline level). P-values are reported for the interactions between subgroup and intervention group to assess whether intervention effects varied by subgroup.

Multiple imputations

Missing data (including due to deaths [n = 2]) on all primary and secondary outcomes at baseline and at follow-up were addressed using multiple imputation by chained equations under the missing-at-random assumption. Each outcome was imputed separately, stratified by randomized group, with all the variables in the multivariable regression model included in the conditional models. Additionally, the EORTC QLQ-C30 emotional functioning scale [49] from CRN PROMs survey 1 and 2 were included as auxiliary variables due to strong association with non-response on CABC survey 2. This was done to satisfy the missing-at-random assumption and reduce the variance of the imputations [50]. To reduce the complexity of the imputation models, the cross-lagged predictors from the surveys were not included in the conditional distributions [51].

For the primary outcome, the imputation models were validated by comparing observed and imputed data, and performing posterior predictive checking of the estimated intervention effect [52]. Since the pattern of missingness was similar for all outcomes, this was not repeated for the secondary outcomes. A total of 100 imputed datasets were created, and the estimates of the intervention effect were combined using Rubin’s rules.

Sample description

The sociodemographic characteristics were similar between participants in all three groups. Mean age was 53.1 (SD 9.5) in CBI, 51.5 (SD 9.5) in MBI, and 52.6 (SD 9.2) in controls, respectively. There was a higher proportion of individuals in the MBI group who were living with children < 18 years (39.2%) compared to in the control group (29.3%), and a lower proportion of women in the CBI group than in the control group who reported drinking (any) alcohol (57.9% vs 69.4%) (Table 1).

The groups were comparable across breast cancer characteristics. However, there were fewer participants in the MBI group with breast cancer stage III (4.9%) than in the control group (13.6%) and CBI (10.9%). Participants in all three groups were enrolled in the trial about 8 months following diagnosis. Most of the participants had undergone breast conserving therapy or mastectomy or radiation therapy before responding to the baseline survey. The control group had the lowest proportion with breast conserving therapy at survey response of 18.4%, compared to 25.9% in MBI and 24.3% in CBI (Table 2).

Mean (with 95% CI) baseline levels of all outcomes are presented in Table 3. Mean perceived stress levels were 16.3 (15.0, 17.6) in CBI, 15.5 (14.2, 16.7) in MBI and 15.4 (14.1, 16.7) in controls.

Table 1

Sociodemographic background data for participants in all three groups.
	Interventions
Variables	CBI (n = 140)	MBI (n = 143)	Controls (n = 147)	P (CBI vs. Controls)	P (MBI vs. Controls)
Age (years)				0.59	0.32
Mean (SD)	53.1 (9.5)	51.5 (9.5)	52.6 (9.2)
Median (min-max)	53.0 (30.0–69.0)	52.0 (26.0–68.0)	53.0 (31.0–70.0)
BMI (kg/m²)				0.05	0.72
Mean (SD)	26.4 (5.2)	25.4 (4.2)	25.2 (4.5)
Median (min-max)	26.0 (16.0–41.0)	25.0 (17.0–35.0)	24.0 (16.0–39.0)
Relationship status, n (%)				0.19	0.34
In a relationship	117 (83.6)	115 (80.4)	113 (76.9)
Not in a relationship	19 (13.6)	21 (14.7)	28 (19.0)
Missing	4 (2.9)	7 (4.9)	6 (4.1)
Children < 18^a, n (%)				0.40	0.06
No	88 (62.9)	80 (55.9)	98 (66.7)
Yes	48 (34.3)	56 (39.2)	43 (29.3)
Missing	4 (2.9)	7 (4.9)	6 (4.1)
Educational level, n (%)				0.85	0.42
Primary school	6 (4.3)	5 (3.5)	4 (2.7)
Secondary school	43 (30.7)	37 (25.9)	41 (27.9)
College/university ≤ 4 years	48 (34.3)	41 (28.7)	53 (36.1)
College/university > 4 years	39 (27.9)	53 (37.1)	43 (29.3)
Missing	4 (2.9)	7 (4.9)	6 (4.1)
Employed, n (%)				0.32	0.32
Employed (without sick leave/benefits)	27 (19.3)	29 (20.3)	21 (14.3)
Employed (with sick leave/disability benefits)	84 (60.0)	88 (61.5)	94 (63.9)
Unemployed (including 100% disability benefits)	16 (11.4)	12 (8.4)	11 (7.5)
Retired	7 (5.0)	6 (4.2)	12 (8.2)
Missing	6 (4.3)	8 (5.6)	9 (6.1)
Weekly physical activity level, n (%)				0.81	0.87
No exercise, light activity ≤ 3h	16 (11.4)	16 (11.2)	14 (9.5)
No exercise, light activity > 3h	47 (33.6)	44 (30.8)	54 (36.7)
Exercise 0–1 h	31 (22.1)	37 (25.9)	37 (25.2)
Exercise 2–3 h	29 (20.7)	29 (20.3)	26 (17.7)
Exercise 4 + h	13 (9.3)	10 (7.0)	10 (6.8)
Missing	4 (2.9)	7 (4.9)	6 (4.1)
Smoking, n (%)				0.58	0.55
Never smoker	67 (47.9)	81 (56.6)	78 (53.1)
Former smoker	58 (41.4)	44 (30.8)	54 (36.7)
Current smoker	11 (7.9)	11 (7.7)	9 (6.1)
Missing	4 (2.9)	7 (4.9)	6 (4.1)
Drinking alcohol, n (%)				0.03	0.28
No (zero)	54 (38.6)	30 (21.0)	39 (26.5)
Yes (at least one unit)	81 (57.9)	106 (74.1)	102 (69.4)
Missing	5 (3.6)	7 (4.9)	6 (4.1)
BMI group (kg/m²), n (%)				0.34	0.56
< 25	59 (42.1)	62 (43.4)	71 (48.3)
25–29	43 (30.7)	52 (36.4)	45 (30.6)
≥ 30	32 (22.9)	22 (15.4)	24 (16.3)
Missing	6 (4.3)	7 (4.9)	7 (4.8)
^aLiving with children under 18 years. CBI; cognitive behavioral therapy intervention. MBI; mindfulness-based intervention. Data obtained about 1 month after diagnosis (5–8 months prior to randomization) from the Cancer Registry of Norway patient reported outcome measures survey (CRN PROMs survey 1). h; hours and w; week.

Table 2

Breast cancer related background data for participants in all three groups.
Interventions
Variables	CBI (N = 140)	MBI (N = 143)	Controls (N = 147)	P (CBI vs. Controls)	P (MBI vs. Controls)
Breast cancer stage, n (%)				0.67	0.27
DCIS	47 (33.6)	52 (36.4)	52 (35.4)
Stage I	29 (20.7)	33 (23.1)	31 (21.1)
Stage II	23 (16.4)	26 (18.2)	22 (15.0)
Stage III	9 (6.4)	7 (4.9)	16 (10.9)
Missing/neoadjuvantly treated	32 (22.9)	25 (17.5)	26 (17.7)
cTNM, n (%)				0.69	0.06
Localised	112 (80.0)	116 (81.1)	108 (73.5)
Locally advanced	18 (12.9)	10 (7.0)	20 (13.6)
Missing	10 (7.1)	17 (11.9)	19 (12.9)
HER2 status, n (%)				0.39	0.28
Negative	48 (34.3)	47 (32.9)	42 (28.6)
Positive	49 (35.0)	45 (31.5)	55 (37.4)
DCIS/Missing^a	43 (30.7)	51 (35.7)	50 (34.0)
ER status, n (%)				0.73	0.68
Negative	61 (43.6)	57 (39.9)	61 (41.5)
Positive	43 (30.7)	41 (28.7)	39 (26.5)
DCIS/Missing^a	36 (25.7)	45 (31.5)	47 (32.0)
PR status, n (%)				0.25	0.92
Negative	67 (47.9)	73 (51.0)	74 (50.3)
Positive	29 (20.7)	21 (14.7)	22 (15.0)
DCIS/Missing^a	44 (31.4)	49 (34.3)	51 (34.7)
Treatment status at survey response, n (%)				0.63	0.53
Surgery unknown	2 (1.4)	4 (2.8)	5 (3.4)
BCT	34 (24.3)	37 (25.9)	27 (18.4)
BCT + radiation therapy	69 (49.3)	63 (44.1)	74 (50.3)
Masectomy	25 (17.9)	31 (21.7)	30 (20.4)
Masectomy + radiation therapy	10 (7.1)	8 (5.6)	11 (7.5)
Months from diagnosis to response				0.72	0.85
Mean (SD)	8.2 (1.3)	8.1 (1.2)	8.1 (1.3)
Median (min-max)	7.8 (6.9–14.5)	7.9 (6.9–11.3)	7.7 (6.9–11.9)
Time from diagnosis to response, n (%)				0.35	0.65
< 7 months	12 (8.6)	11 (7.7)	11 (7.5)
7–8 months	74 (52.9)	77 (53.8)	86 (58.5)
8–10 months	40 (28.6)	38 (26.6)	30 (20.4)
>=10 months	14 (10.0)	17 (11.9)	20 (13.6)
CBI: cognitive behavioral therapy intervention. MBI: mindfulness-based intervention. cTNM: Clinical Stage Group. HER2; human epidermal growth factor receptor 2 ER; Estrogen receptor PR; progesterone receptors. BCT; breast conserving therapy. Medical data were obtained from time of diagnosis or at screening about 6–9 months prior to baseline. ^aOnly 1 invasive breast cancer case missing information on receptors.

Table 3

Baseline levels and between-group changes in primary and secondary outcomes between those randomized to the cognitive behavioral therapy intervention (CBI) or the mindfulness-based intervention (MBI) compared to the treatment as usual control group.
	CBI (n = 140)		MBI (n = 143)		Control group (n = 147)		CBI vs. control group difference		MBI vs. control group difference
Primary outcome	M	95% CI	M	95% CI	M	95% CI	MD	95% CI	MD	95% CI
Perceived stress (PSS-10)
Baseline	16.31	15.02, 17.60	15.46	14.19, 16.73	15.40	14.14, 16.67	0.91	-0.90, 2.71	0.06	-1.74, 1.85
6 month follow-up	14.92	13.49, 16.35	14.44	13.07, 15.82	14.68	13.33, 16.03	0.24	-1.71, 2.19	-0.24	-2.17, 1.70
Change adjusted for baseline	-1.23	-2.32, -0.13	-1.09	-2.13, -0.04	-0.81	-1.84, 0.22	-0.42	-1.89, 1.06	-0.28	-1.75, 1.19
Secondary outcomes
HRQoL (RAND-36)
General health
Baseline	59.18	55.69, 62.67	62.05	58.61, 65.48	62.14	58.76, 65.52	-2.96	-7.82, 1.89	-0.10	-4.91, 4.72
6 month follow-up	61.22	57.22, 65.21	64.33	60.27, 68.38	60.36	56.56, 64.17	0.85	-4.57, 6.28	3.97	-1.58, 9.51
Change adjusted for baseline	1.56	-1.48, 4.60	2.50	-0.69, 5.69	-1.54	-4.41, 1.33	3.10	-0.94, 7.14	4.04	-0.18, 8.26
Physical functioning
Baseline	74.77	71.32, 78.22	78.74	75.32, 82.16	77.67	74.32, 81.02	-2.90	-7.71, 1.90	1.07	-3.70, 5.85
6 month follow-up	77.52	73.76, 81.27	81.06	77.27, 84.84	78.29	74.71, 81.88	-0.78	-6.00, 4.45	2.76	-2.44, 7.96
Change adjusted for baseline	2.21	-0.55, 4.97	2.70	-0.10, 5.51	0.76	-1.82, 3.35	1.44	-2.37, 5.26	1.94	-1.84, 5.72
Role-physical
Baseline	32.30	25.13, 39.48	36.87	29.81, 43.93	34.51	27.60, 41.43	-2.21	-12.17, 7.75	2.36	-7.53, 12.25
6 month follow-up	45.14	37.01, 53.27	46.78	38.29, 55.28	47.69	39.67, 55.71	-2.55	-13.87, 8.78	-0.91	-12.83, 11.01
Change adjusted for baseline	11.95	4.99, 18.91	10.81	3.39, 18.22	13.15	6.30, 20.01	-1.20	-10.82, 8.41	-2.34	-12.71, 8.02
Role-emotional
Baseline	56.97	49.60, 64.34	62.40	55.16, 69.64	61.30	54.22, 68.38	-4.33	-14.57, 5.91	1.10	-9.03, 11.23
6 month follow-up	63.84	55.39, 72.29	67.52	59.28, 75.76	71.00	63.27, 78.73	-7.16	-18.68, 4.36	-3.48	-14.78, 7.82
Change adjusted for baseline	4.87	-3.08, 12.83	6.42	-1.35, 14.19	10.33	3.08, 17.59	-5.46	-16.24, 5.31	-3.91	-14.48, 6.66
Vitality
Baseline	43.42	39.46, 47.39	46.30	42.41, 50.19	45.40	41.56, 49.23	-1.97	-7.49, 3.54	0.90	-4.56, 6.37
6 month follow-up	48.92	44.48, 53.35	51.03	46.65, 55.40	47.40	43.26, 51.53	1.52	-4.52, 7.56	3.63	-2.47, 9.73
Change adjusted for baseline	5.06	1.58, 8.53	5.06	1.68, 8.44	2.09	-0.96, 5.14	2.97	-1.59, 7.52	2.97	-1.67, 7.61
Mental health
Baseline	69.21	66.12, 72.29	71.65	68.62, 74.69	71.22	68.22, 74.21	-2.01	-6.31, 2.28	0.43	-3.83, 4.70
6 month follow-up	72.35	69.25, 75.45	73.99	70.92, 77.05	74.14	71.17, 77.10	-1.79	-6.02, 2.44	-0.15	-4.39, 4.09
Change adjusted for baseline	2.63	0.26, 5.01	2.66	0.28, 5.03	3.09	0.84, 5.34	-0.46	-3.62, 2.71	-0.43	-3.62, 2.76
Social functioning
Baseline	61.57	57.17, 65.96	67.45	63.12, 71.78	64.61	60.34, 68.88	-3.04	-9.16, 3.08	2.84	-3.23, 8.92
6 month follow-up	68.92	64.34, 73.51	72.88	68.19, 77.56	70.99	66.59, 75.39	-2.07	-8.31, 4.18	1.89	-4.52, 8.30
Change adjusted for baseline	6.29	2.62, 9.96	6.46	2.58, 10.33	6.40	2.89, 9.90	-0.11	-4.99, 4.78	0.06	-5.07, 5.19
Bodily pain
Baseline	60.04	55.92, 64.16	63.60	59.55, 67.64	62.68	58.70, 66.66	-2.64	-8.37, 3.09	0.91	-4.76, 6.59
6 month follow-up	63.66	58.69, 68.63	64.79	59.97, 69.61	63.81	59.10, 68.51	-0.14	-7.05, 6.77	0.99	-5.75, 7.72
Change adjusted for baseline	2.95	-1.20, 7.10	1.67	-2.34, 5.67	1.30	-2.55, 5.16	1.65	-4.05, 7.35	0.37	-5.20, 5.93
Mindfulness (FFMQ-15)
Baseline	12.34	11.86, 12.81	12.88	12.41, 13.35	12.78	12.32, 13.24	-0.45	-1.11, 0.22	0.10	-0.56, 0.75
6 month follow-up	12.77	12.24, 13.30	13.41	12.89, 13.92	12.84	12.33, 13.36	-0.08	-0.82, 0.66	0.56	-0.16, 1.29
Change adjusted for baseline	0.35	-0.05, 0.75	0.58	0.20, 0.97	0.09	-0.30, 0.48	0.26	-0.30, 0.82	0.49	-0.05, 1.03
TOMCATS
Coping
Baseline	3.11	3.02, 3.20	3.17	3.08, 3.26	3.04	2.95, 3.13	0.07	-0.06, 0.20	0.14	0.01, 0.26
6 month follow-up	3.01	2.91, 3.12	3.17	3.06, 3.27	3.10	3.00, 3.20	-0.09	-0.23, 0.06	0.07	-0.08, 0.22
Change adjusted for baseline	-0.09	-0.19, 0.00	0.03	-0.06, 0.13	0.02	-0.07, 0.11	-0.12	-0.25, 0.02	0.01	-0.12, 0.15
Helplessness
Baseline	2.07	1.95, 2.19	1.95	1.83, 2.07	1.99	1.87, 2.11	0.08	-0.09, 0.25	-0.04	-0.21, 0.13
6 month follow-up	2.06	1.93, 2.20	1.97	1.83, 2.11	1.97	1.84, 2.10	0.09	-0.10, 0.29	-0.00	-0.19, 0.19
Change adjusted for baseline	0.02	-0.10, 0.13	0.00	-0.12, 0.12	-0.02	-0.13, 0.09	0.04	-0.12, 0.20	0.03	-0.14, 0.19
Hopelessness
Baseline	1.67	1.56, 1.78	1.56	1.45, 1.67	1.56	1.46, 1.67	0.10	-0.05, 0.26	-0.00	-0.16, 0.15
6 month follow-up	1.58	1.47, 1.70	1.52	1.40, 1.63	1.59	1.47, 1.71	-0.00	-0.17, 0.17	-0.07	-0.24, 0.09
Change adjusted for baseline	-0.05	-0.15, 0.05	-0.06	-0.16, 0.04	0.01	-0.09, 0.12	-0.06	-0.21, 0.08	-0.07	-0.21, 0.07
Global Fatigue (CFQ-11)
Baseline	20.38	19.43, 21.33	19.50	18.57, 20.44	20.00	19.08, 20.92	0.38	-0.94, 1.70	-0.50	-1.81, 0.81
6 month follow-up	18.77	17.69, 19.85	17.35	16.21, 18.49	18.57	17.52, 19.62	0.20	-1.31, 1.70	-1.22	-2.77, 0.33
Change adjusted for baseline	-1.51	-2.33, -0.69	-2.27	-3.18, -1.35	-1.42	-2.21, -0.64	-0.09	-1.24, 1.06	-0.84	-2.06, 0.37
Anxiety and depression (PHQ-4)
Baseline	3.40	2.92, 3.87	3.04	2.57, 3.50	3.18	2.72, 3.64	0.22	-0.44, 0.88	-0.14	-0.80, 0.51
6 month follow-up	3.08	2.62, 3.55	2.72	2.26, 3.18	2.84	2.39, 3.29	0.24	-0.40, 0.89	-0.12	-0.76, 0.52
Change adjusted for baseline	-0.24	-0.59, 0.11	-0.38	-0.74, -0.02	-0.35	-0.69, -0.00	0.11	-0.40, 0.61	-0.03	-0.52, 0.46
Sleep (hours)
Baseline	7.04	6.81, 7.27	7.09	6.87, 7.32	7.16	6.94, 7.38	-0.12	-0.43, 0.20	-0.07	-0.38, 0.25
6 month follow-up	7.33	6.80, 7.85	7.20	6.80, 7.60	7.22	6.84, 7.61	0.10	-0.55, 0.75	-0.02	-0.58, 0.54
Change adjusted for baseline	0.27	-0.23, 0.77	0.11	-0.25, 0.47	0.07	-0.27, 0.42	0.20	-0.40, 0.79	0.03	-0.47, 0.53
Sleep (summary score)
Baseline	19.08	17.20, 20.95	17.73	15.88, 19.57	17.62	15.81, 19.44	1.45	-1.16, 4.06	0.10	-2.48, 2.69
6 month follow-up	17.48	15.42, 19.53	16.86	14.88, 18.84	16.20	14.20, 18.19	1.28	-1.59, 4.14	0.66	-2.17, 3.50
Change adjusted for baseline	-1.33	-2.91, 0.26	-0.98	-2.48, 0.52	-1.57	-3.10, -0.04	0.24	-1.95, 2.44	0.59	-1.59, 2.77
Missing data handled by multiple imputation
M; mean
MD; mean difference
PSS; perceived stress scale.
HRQoL; Health- related quality of life
RAND-36; RAND corporation 36-item Short Form health Survey
FFMQ; Five Facet Mindfulness Questionnaire
TOMCATS; Theoretically Originated Measure of the Cognitive Activation Theory of Stress
CFQ-11: Chalder fatigues questionnaire 11 items
PHQ; Patient health questionnaire

Between group differences

After 6 months of access to the interventions, there was no statistically significant difference in perceived stress levels between either of the intervention groups and the control group. Similarly, there were no significant differences in HRQoL subscales, levels of anxiety and depression, mindfulness, fatigue, coping or sleep between the three groups. When combining the intervention groups, the HRQoL general health scale improved significantly more in the intervention groups combined vs. the control group (3.58 [95% CI: 0.06–7.09]) (Table 3).

All outcomes yielded similar results in the complete case analysis (Supplementary file 5) and in the multivariable regression analysis (Supplementary file 6).

Subgroup (interaction) analyses

Perceived stress level

Individuals with highest perceived stress level at baseline, especially in the MBI group, had a somewhat larger reduction in perceived stress after 6 months compared to individuals with lower mean levels at baseline, although this interaction was not statistically significant (Fig. 2).

Use of the intervention (app use)

In total, 43% completed at least 7 of the 10 modules of any intervention (i.e., defined as completers in accordance with Børøsund and colleagues [34]) whereas 19% completed all 10 modules. Fourteen (5%) of the 238 participants did not appear to have used the app at all. For MBI, completers had a higher reduction of perceived stress level than those completing fewer modules, but this interaction was not statistically significant and was not observed for CBI (Fig. 2).

Participants assigned to MBI had a higher median (min-max) frequency of use of 8 (1-144) active days, compared to 5 (1–63) active days in CBI, whereas participants assigned to CBI completed more modules (6 vs. 4) and had a higher number of completers (46% vs. 40%) (Table 4).

CBI; cognitive behavioral therapy intervention. MBI; mindfulness-based intervention.

Table 4

Intervention (app) use among participants randomized to the CBI and MBI interventions.
Variables	CBI (n = 140)	MBI (n = 143)	Intervention groups combined (n = 283)	P^a
Number of active days of use				0.03
Mean (SD)	9.7 (12.3)	13.7 (18.4)	11.8 (15.8)
Median (min-max)	5.0 (1.0–63.0)	8.0 (1.0-144.0)	7.0 (1.0-144.0)
Days from first to last use				0.75
Mean (SD)	97.2 (59.0)	103.7 (55.6)	100.5 (57.3)
Median (min-max)	86.5 (1.0-182.0)	100.0 (1.0-185.0)	97.0 (1.0-185.0)
Number of completed modules				0.34
Mean (SD)	5.4 (3.7)	5.0 (3.7)	5.2 (3.7)
Median (min-max)	6.0 (0.0–10.0)	4.0 (0.0–10.0)	5.0 (0.0–10.0)
Completed 7–10 modules				0.32
n (%)	64 (45.7)	57 (39.9)	121 (42.8)
Completed all modules				0.59
n (%)	29 (20.7)	26 (18.2)	55 (19.4)
No registered app use				0.56
n (%)	8 (5.7)	6 (4.2)	14 (4.9)

CBI; Cognitive Behavioral Therapy Intervention. MBI; mindfulness-based intervention.

^aP for MBI vs CBI.

The current CABC trial with early breast cancer survivors was initiated to enable comparison of the effects of different digital stress-management interventions (cognitive behavioral [i.e., CBI] or mindfulness-based content [i.e., MBI]) compared to usual-care controls. Results after 6-months of intervention access showed no statistically significant differences between either intervention group and the control group in terms of the selected outcome measures.

The lack of significant findings when comparing the CBI and MBI interventions and the control group was somewhat surprising, given that access to the original StressProffen intervention program (combining CBI and MBI content) previously had been associated with reduced perceived stress, anxiety and depression, as well as improved self-regulatory fatigue and HRQoL for cancer survivors after 6 and 12 months [34]. There are several possible explanations for the apparent lack of intervention effects after 6 months in the CABC trial. First, baseline perceived stress levels were on average low for all groups, corresponding to those of healthy female populations at similar ages [53–55]. This creates a floor effect and leaves less room for further reductions [31, 56, 57], which was also evident in the subgroup analysis where those with the highest perceived stress level at baseline displayed larger reductions in perceived stress levels than those with lower baseline stress level, though these were non-significant. This notion is supported by other digital stress-management interventions, where a certain level of stress or distress has been part of the inclusion criteria [58, 59]. Nevertheless, there are several methods to assess stress, and it is possible that other effects could have been detected if different outcome measures were applied [60].

Second, the digital download-only delivery method employed in the current study may have acted as a barrier to use, and hence reduced the effect of the interventions. In total 43% of participants were defined as intervention completers [34] at 6 months in this study, and the intervention use in the CABC trial therefore falls below an average of 50% adherence in eHealth interventions [61]. In comparison, completion rates in the original StressProffen trials were 58% at 3 months [33] and 68% at 12 months [34]. There was also a lower frequency of app use in the CABC trial compared to the original StressProffen trial(s), with participants using the apps a median of 7 times (range 1-144) in this study, and 17.5 times (range 3-170) in the StressProffen trial [34, 38]. Intended benefit from interventions can only be achieved through actual use of the interventions, and if digital download-only, as used in this trial, introduces a barrier to use, this will also indicate a barrier to intended effect [57]. It is possible that a similar in-person introduction session as used in the original StressProffen trial, or perhaps a less resource requiring introduction and follow-up via secure video link, could have improved intervention adherence and subsequently intervention effects.

Another factor potentially impacting motivation for use could have been the recruitment methods used. In the CABC trial, only responders of the digital, ongoing CRN PROMs survey sent to all breast cancer patients in Norway [37] were invited, while participants in the original StressProffen trials were broadly recruited through social media (i.e., self-motivation) and local cancer treatment institutions (i.e., through familiar hospital settings/providers) [34]. There is also the aspect of timing of intervention delivery and access. For example, since anxiety and depression may peak around the time of diagnosis, whereas sleep disturbances, fatigue and pain may occur at later stages or persist long-term [6, 8], there may have been potential intervention effects prior to the 6-month assessment that were not captured, and potential interventions effects after 6 months has yet to be evaluated. It is also possible the CABC interventions could have been more effective if used during active cancer treatment [3, 62]. Introducing new activities such as psychosocial interventions during the early days following diagnosis can however be challenging, and in the current study, avoiding interference with surgery or medical breast cancer treatment was considered important [63].

There is also a potential issue related to power. When combining the intervention groups, improved general health on the HRQoL scale was detected in favor of the intervention groups compared to controls, within the range of a minimally important difference [43, 64, 65] and in line with other digital intervention studies [57]. This could suggest that including a larger number of participants in the trial might have enabled identification of a weaker impact. There were some differences in terms of app use, with participants in the CBI group completing the most modules, but participants in the MBI group using the app more frequently. Given the lack of other types of significant findings, these findings should nevertheless be interpreted with caution.

Strengths and limitations

The CABC trial has several strengths. First, with 430 breast cancer patients, it is one of the largest sampled population-based RCTs of digital stress-management intervention [66], with robust trial design and a planned long-term follow-up with survey data to 36 months after diagnosis. The outcome measure completion rate, ≥ 71% at 6-months, was only slightly lower than in the original StressProffen (77%) [34], and acceptable in comparison to other eHealth interventions [57]. The study also has several limitations. First, there is a lack of diversity in participant demographic characteristics [8], as participants were predominantly highly educated, and also, according to national Norwegian data on the same sample, predominantly Caucasian/White. Second, as this study relied on participation through the ongoing CRN PROMs survey (i.e., response to written invitations), the sample was in many ways self-selected. Thirdly, the study did not control for activities within the control group. Participants in the control group may have participated in other types of stress-management activities during the study period without the research team being able to control for such activities.

Future Directions

Acquiring psychoeducational knowledge and incorporating such knowledge into daily use and practice takes time. Future studies should therefore explore whether longer term access to digital health interventions such as CBI and MBI can yield more significant indications of effect. Post-study qualitative interviews with participants to understand pattern of use or non-use could also shed light on what works for whom and when in such settings. As the original StressProffen intervention [34] was not included in the current trial, future research might also consider comparing the original version (i.e., primarily CBT-based but with aspects of mindfulness) with the two developed CBI and MBI versions, as we do not yet know if a combination of CBI and MBI is superior to both interventions separately. Intervention preferences may also play a role, and future research should explore whether having the option to choose between the two types of stress-management interventions presented in this trial may enhance motivation, use and subsequently potential effects [67–70]. Incorporating aspects from persuasive design, motivational interviewing, behavior change theories and techniques might facilitate engagement and adherence to eHealth interventions [71–75]. The StressProffen app contains some individualized options (e.g., option to read or listen, and mark own favorites), but not other potentially adherence-promoting features such as gamification and option to connect to a community, or join group sessions [62, 76]. Future research may explore additional options for improving adherence to digital interventions, potentially also incorporating follow-up contact either by phone, chat or video at later timepoints than conducted in the current study.

In the CABC trial, women with breast cancer receiving either a digital stress-management intervention with cognitive behavioral or mindfulness-based content did not show significantly greater improvements in perceived stress, anxiety, depression, fatigue, HRQoL, mindfulness, coping, or sleep after 6 months of intervention access compared to usual-care controls. Perceived stress at baseline was however low in all groups, which may have impacted the outcome. This was a digital download-only intervention trial, and further research is needed to determine the best way to deliver digital health interventions to facilitate use and subsequent intended effect. Timing of delivery during the cancer trajectory to achieve impact, types of stress-management interventions, and what works best for whom and when, should also be explored.

Competing Interests

LSN is an unpaid board member of dHealth AS, which seeks to commercialize the original StressProffen program, but does not have any financial interest in the company or application TC is Co-chief investigator on a National Institute for Health and Care Research (NIHR) program grant in the UK testing a modified acceptance and commitment therapy intervention to improve quality of life for people with a range of cancers in the posttreatment phase. MHA is a consultant for Blue Note Therapeutics and Atlantis Healthcare, both digital health software companies. LEC receives royalties for 2 mindfulness book titles, and from eMindful for an online mindfulness-based cancer recovery program. HRE is a co-founder and a shareholder of a company offering lectures, education, and supervision about stress and coping (Stressprofessorene AS). HRE has no commercial interest in the StressProffen program.

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. The trial was approved by The Regional Committee for Medical Research Ethics Southeast Norway (32637), assessed by the Data Protection Officer (Oslo University Hospital) and registered at ClinicalTrials.gov (NCT04480203). Reporting of this trial follows the CONSORT 2010 checklist.

Consent to participate
Submitting the initial digital survey implies consent: Participants have to read the informed consent and actively confirm that they “consent to participate by filling out and return this survey”.

Consent to publish
Not applicable.

Funding

This trial was supported by the Norwegian Breast Cancer Society and Norwegian Cancer Society (Brystkreftforeningen og Kreftforeningen; Grant #197409 Principal Investigator, Giske Ursin), as well as internal expertise from the Norwegian Cancer Registry and Oslo University Hospital.

Author Contribution

GU, HRE, AM, EB, LSN conceptualized the study and study method and led the development of the StressProffen intervention arms (CBI and MBI). MHA, LEC, TC contributed to developing the content of the intervention arms and the study design used. Material preparation and data collection were performed by IML, YMG, AB, CB, EB, SB, TÅM. Statistical considerations and statistical analysis were performed by SL and TÅM. IM, CEK contributed to material preparation.The first draft of the manuscript was written by KS and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Acknowledgement

The authors would like to thank Birte Helene Moen for her contribution to the trial as user representative from the Norwegian Breast Cancer Association and women with breast cancer that volunteered for the pilot study and parts of the pilot study. Thank you to The Cancer registry of Norway employees Tanja Nygård and Ingunn Aune for contacting trial participants, and Jan Nygård for handling the app use data. Finally, the authors would also like to thank the content editor and design and development teams at the Department of Digital Health Research, including Elise Flak Nordang and Per Tømmer for facilitation and quality assurance of system app use data collection.

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Competing interest reported. LSN is an unpaid board member of dHealth AS, which seeks to commercialize the original StressProffen program, but does not have any financial interest in the company or application TC is Co-chief investigator on a National Institute for Health and Care Research (NIHR) program grant in the UK testing a modified acceptance and commitment therapy intervention to improve quality of life for people with a range of cancers in the posttreatment phase. MHA is a consultant for Blue Note Therapeutics and Atlantis Healthcare, both digital health software companies. LEC receives royalties for 2 mindfulness book titles, and from eMindful for an online mindfulness-based cancer recovery program. HRE is a co-founder and a shareholder of a company offering lectures, education, and supervision about stress and coping (Stressprofessorene AS). HRE has no commercial interest in the StressProffen program.

Supplementaryfile1.pdf
Supplementary file 1. Titles of modules (translated from Norwegian) in the StressProffen CBI and MBI apps.
Supplementaryfile2.tif
Supplementary file 2. Examples of content in one intervention arm: the cognitive behavioral therapy intervention (CBI).
Supplementaryfile3.tif
Supplementary file 3. Examples of content in one intervention arm: the mindfulness-based intervention (MBI).
Supplementaryfile4.png
Supplementary file 4. Timeline for the Coping After Breast Cancer (CABC) trial. The Cancer registry of Norway patient reported outcome measures survey (CRN PROMs survey) is an ongoing survey sent to all breast cancer patients in Norway whereas the CABC survey is a CABC trial-specific survey covering the outcomes not assessed with the CRN PROMs survey.
Supplementaryfile5.docx
Supplementary file 5. Results from complete case analysis.
Supplementaryfile6.docx
Supplementary file 6. Results from multi-adjusted model.

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Coping after breast cancer (CABC-trial): Testing two digital stress-management interventions in a randomized controlled trial at 6 months

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Coping after breast cancer (CABC-trial): Testing two digital stress-management interventions in a randomized controlled trial at 6 months

Status:

Version 1

Abstract

Figures

Background

Methods

Statistical analysis

Results

Discussion

Conclusion

Declarations

Competing Interests

Ethics approval

Consent to participate Submitting the initial digital survey implies consent: Participants have to read the informed consent and actively confirm that they “consent to participate by filling out and return this survey”.

Consent to publish Not applicable.

Funding

Author Contribution

Acknowledgement

References

Additional Declarations

Supplementary Files

Status:

Version 1

Consent to participate
Submitting the initial digital survey implies consent: Participants have to read the informed consent and actively confirm that they “consent to participate by filling out and return this survey”.

Consent to publish
Not applicable.