Aim and Design
This pilot study aimed to assess the feasibility and acceptability of a gratitude journaling intervention and to evaluate its preliminary efficacy on dispositional gratitude, spiritual well-being, perceived stress, dimensions of the Superwoman Schema, exercise self-efficacy, and inflammatory biomarkers among Black women with breast cancer. We employed a two-group, parallel random-assignment experimental design to compare a gratitude journaling intervention with a general memory journaling (attention control) group. The study followed a pre-post design, with outcomes measured at baseline and after eight weeks of intervention.
Setting
Participants' surveys and biospecimen collection were performed at the University of Florida (UF) Clinical and Translational Science Institute's Clinical Research Center (CRC). The CRC offers comprehensive services for research studies encompassing a wide range of diseases and age groups and provides essential resources and support for data management and execution. The CRC includes a team of experienced research professionals, including registered nurses, research coordinators, dietitians, investigational pharmacists, and administrative personnel.
Participants
The participants for the study were screened for eligibility via telephone. Eligible participants were English-speaking, self-reported African American or Black women with a history of breast cancer (Stage I–IV). Women on hormonal therapies and anti-human epithelial receptor 2 (HER-2) therapy were included. Exclusion criteria included self-reported regular meditation or gratitude practices (more than once a week for at least a month) or meeting the Centers for Disease Control and Prevention's physical activity guidelines. Participants were compensated $100 within two time points for their participation.
Sample Size
Following Julious' (24) recommendation to have 12 participants per group for a pilot study, 26 Black female participants were recruited to account for attrition.
Approval and consent
The pilot study (Protocol ID: 202201483) was approved by the Institutional Review Board (IRB) at the University of Florida. IRB approval was obtained before participant recruitment. Potential participants underwent a brief phone screening to assess their suitability for the study. During this screening process, they were provided with a concise overview of the study procedures, which included information regarding the nature of the questionnaires, blood-draw collection, and any associated risks. Upon signifying their understanding of the study procedures and risks, participants provided informed consent before enrollment.
Recruitment
Participants were recruited using organic social media recruitment, flyers, and multiple specialized strategies from various resources, including the OAIC Pepper Center Clinical Research Core - Claude D. Pepper Center Participant Registry (IRB201601352), UF Health Cancer Center Community-Partnered Cancer Disparities Research Collaborative, UF Health Cancer Center Community Outreach and Engagement, UF Healthstreet, Integrated Data Repository, and UF Consent2Share Registries. Potential participants were screened for eligibility via telephone.
Gratitude journaling intervention group
The proposed study was built on the McCullough, Emmons (17) original gratitude journaling intervention to reduce the burden of journaling for breast cancer survivors. Participants received a gratitude journal and were instructed to journal at least twice weekly over an eight-week period. They were instructed to complete the following journaling prompt at least twice a week for 10–15 minutes: "There are many things in our lives, both large and small, that we might be grateful about. Think back over the day and write down on the line below all that you are grateful for today" (maximum six reasons). The educational goal-setting component was drawn from the American Cancer Society's Diet and Physical Activity Guideline. Participants were allowed to choose the order in which they completed the goal-setting modules.
General memory journaling control group
For the attention control arm, the participants engaged in general memory journaling and documented their daily activities and reflections to be a neutral comparison against the intervention group. Participants received the following general journaling prompt at least twice a week for no more than 15 minutes: "What are some memorable events that happened to you today, big or small (maximum six memories)? Write a brief statement about it." At the end of the intervention, at week 8, both groups collected the journals for treatment fidelity.
Data and Biomarker Collection
After screening for eligibility and obtaining verbal consent, participants were scheduled for an in-person appointment to collect baseline and post-intervention survey data, including collecting a blood sample over two-time points. Participants completed demographic and cancer history questionnaires and self-report instruments at each appointment. Informed written consent was obtained during the baseline appointment. Before the appointment, participants were randomized to either the gratitude journaling intervention or attention control group in a 1:1 ratio, with a permuted block randomization method. The participants received concealed bags that informed them of their group assignment and intervention details. The research assistant and biostatistician were unaware of group allocation throughout the study to maintain blinding.
Inflammatory Biomarker Collection
The collected blood samples were processed and stored in collaboration with the OAIC Metabolism and Translational Science Core at the UF Clinical Research Center. After blood sample collection, the plasma was separated, aliquoted, and stored at − 80°C for later assay. A custom multiplex immunoassay panel for TNF-α, IL-6, and GDF15 (R&D Systems, Minneapolis, MN) was analyzed using a MILLIPLEX® Analyzer 4.3 xPONENT System (Luminex Corp, Austin, TX). CRP levels were measured via ELISA (R&D Systems) utilizing BioTek Instruments (Winooski, VT) Synergy™ HTX Multi-Mode Microplate Reader and analyzed via Gen5 Microplate Reader Software (Bio-Tek Instruments). Analyses demonstrated a minimal interassay coefficient of variation < 14%.
Assessment of feasibility and acceptability
The research assistant inputted various metrics using spreadsheet software to assess the feasibility and acceptability of the intervention, including recruitment and retention rates, participant adherence, and satisfaction measures. Recruitment and retention rates were tracked by monitoring the number of potential participants screened and enrolled in the study. The enrollment rate was calculated as the number enrolled relative to the total number of individuals screened to indicate the effectiveness of the recruitment process.
Participant adherence to the intervention was evaluated by analyzing journal logs to determine the frequency and consistency of engagement with the assigned journaling tasks. Adherence rates were calculated based on the number of completed journal entries relative to the expected frequency, indicating participants' compliance with the intervention protocol. The proportions of women meeting the inclusion criteria relative to the number approached was calculated, with feasibility defined as > 75% of women approaching meeting the criteria. Additionally, the percentage of participants completing baseline assessment measures was computed, with feasibility defined as > 80% of participants completing these measures. Furthermore, the percentage of participants completing both baseline and post-intervention assessments was determined, with feasibility defined as > 80% of those completing baseline assessments completing post-intervention assessments.
Feasibility and acceptability were further assessed through exit interviews and the Client Satisfaction Questionnaire (CSQ) administered at the end of the study. The CSQ is a standard measure widely used in healthcare delivery settings to evaluate the acceptability of interventions (25). The CSQ provided additional insights into the gratitude exercises. The exit interview comprised structured and open-ended questions to explore participants' perceptions of the intervention's content, value, structure, and potential burden.
Demographic, Psychosocial, and Inflammatory Biomarker Measures
Demographic, psychosocial variables, and inflammatory biomarkers were measured at baseline (T1) and postintervention at eight weeks (T2).
Demographics (T1)
Demographic information, including age, sex, education, marital status, and body mass index was collected from participants at baseline (T1). Additional variables related to cancer and its treatment were recorded, such as time since diagnosis, cancer stage, grade, hormonal and HER2 + status, surgical type, chemotherapy, radiotherapy, and other relevant treatment modalities.
Psychosocial Variables (T1, T2)
Dispositional gratitude. Dispositional gratitude was assessed using the Gratitude Questionnaire-6 (GQ-6) at baseline (T1) and follow-up (T2). The GQ-6 is a well-validated, self-administered 6-item scale that measures four facets of dispositional gratitude, including intensity, frequency, span, and density. Participants rated each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree) (17). Scores range from 6 to 42, with higher scores implying a greater level of dispositional gratitude and lower scores indicating a decreased disposition in gratitude.
Spiritual well-being. Spiritual well-being was evaluated using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACITsp12) at both baseline (T1) and follow-up (T2). The FACITsp12 consists of 12 items rated on a Likert-type scale ranging from 0 (not at all) to 4 (very much), that assesses spiritual well-being over the past seven days among individuals with chronic illness (26). Higher scores indicate enhanced spiritual well-being.
Perceived stress. Perceived stress levels were measured using the Perceived Stress Scale (PSS) at baseline (T1) and follow-up (T2). The PSS comprises ten items rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often), reflecting perceived stress experienced during the last month (27). Higher scores indicate more perceived stress during the last month.
Superwoman Schema. The Giscombe Superwoman Schema Questionnaire (G-SWS-Q) was utilized to assess the superwoman schema, including racial and gender identity, at both baseline (T1) and follow-up (T2). The G-SWS-Q consists of 35 statements rated from 0 (not true) to 4 (true all the time) across five subscales: (1) obligation to present an image of strength, (2) obligation to suppress emotions, (3) resistance to being vulnerable, (4) intense motivation to succeed, and (5) obligation to help others (23). Higher scores indicate higher agreement with the identity.
Exercise self-efficacy. Exercise self-efficacy was assessed using the Stage of Motivational Readiness for Physical Activity questionnaire at baseline (T1) and follow-up (T2). This highly reliable instrument comprises five items and classifies individuals into the pre-contemplation, contemplation, preparation, action, or maintenance stage of exercise behavior change based on the selection by the participant (28).
Inflammatory Biomarkers (T1, T2)
Levels of tumor necrosis factor alpha (TNF-α), interleukin 6 (IL-6), growth/differentiation Factor-15 (GDF15), and C-reactive Protein (CRP) were measured at baseline (T1) and follow-up (T2) using a Luminex panel for TNF-α, IL-6, and GDF15, and an enzyme-linked immunosorbent assay (ELISA) kit for CRP.
Data analysis
The statistical analysis was conducted using R software (Version 4.3.2). Results were reported as mean (standard deviation, SD) for continuous variables and as frequencies and percentages for categorical variables. Demographic characteristics were examined by groups at baseline. Participant satisfaction was assessed using mean CSQ scores post-intervention.
The Wilcoxon rank sum test and Fisher's exact test were used to calculate p-values and estimate effect sizes (ES) for group comparisons on changes between the baseline and post-test for the secondary psychosocial and inflammatory biomarker measures. Cohen's (29) guidelines were used to interpret ES as follows: small (ES = .10), medium (ES = .24), and large (ES = .37).