The analysis protocol was written by using Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)-2020 [19] guideline to assess and compare quality of life of cancer caregivers. (Fig. 1)
Data sources and selection criteria
Online published research studies from PubMed, PubMed Central, Clinical Key, Google Scholar, and Cochrane from January 2010 and April 2021. The quest was limited to peer-reviewed publications, papers written in English and research concerning human subjects. The search strategy followed the PICO (population, intervention, control, and outcomes) format, P = Caregiver, I = Cancer, C = Patients, O = Quality of life. Medical Subject Headings (MeSH) terms used for population were “Caregiver”, “Family caregiver”, “Spouse”, “Partner”, with intervention were “Cancer”, “Oncology”, with control were “Patient”, “Cancer patient” and with outcome were “Quality of life”, “QOL” were used to search the literature.
Selection of study
Two reviewers (KKR and CVK) screened titles and abstracts separately to find published studies. The research design included reported randomized controlled trials conducted in English from January 2010 to April 2021. Caregivers who are providing care to adult cancer patients were included. Exclusion criteria included studies involving children cancer patients and studies with qualitative methodology were excluded.
Outcome measures
Both independent authors (KKR and CVK) looked at the primary outcomes of the studies that were included, such as study characteristics and participant profiles. The main goal is to evaluate the quality of life of cancer patients' caregivers.
Data extraction
Data was extracted from the selected studies by two separate authors (KKR and CVK). Any differences in inclusion eligibility were resolved through discussion among the authors. Following the selection of each study, the data was tabulated in the form of author name, publication year, study design, study population, study characteristics, source of data collection, research tools and statistical methods used. Any necessary clarifications were obtained by emailing the correspondence author.
Risk Bias and Quality Assessment
The probability of bias was assessed separately by the writers KKR and CVK. Cochrane risk of bias assessment guidelines by Higgins et al were used. [20] Selection, performance, detection, attrition, reporting and other biases are included in the risk of bias graph and risk of bias overview for each selected RCT. (Figs. 2 & 3)
For each variable, all studies were categorised as low, high, or unclear risk. Any disagreements between the two independent authors were settled by consensus. The Chi-square test was used to evaluate heterogeneity using I2 statistics of treatment effects among selected trials. Table 1 lists all of the data collected from the studies that were included.
Seven studies i.e. Fegg (2013) [21], Belgacem (2013) [22], Bahrami (2014) [23], Susan (2015) [24], Joanne (2015) [25], Virginia (2015) [26] and Lapid (2016) [27] had low risk of bias followed by one study i.e. Mabel (2015) [28] with moderate risk of bias.
Table 3
Characteristics of Included Studies (n = 8)
Author & Year
|
Exp Group/ Control Group
|
Exp Group/ Control Group Age (SD)
|
Exp Group/ Control Group Male & Female
|
Treatment Group
|
Research tool
|
Control Group
|
Setting
|
Fegg et al [21] (2013)
|
67/62
|
54.3 (13.5)/ 54.7 (12.9)
|
M-17 (28%),
F- 50 (72%)/ M-19 (23%), F- 43 (67%)
|
EBT (Existential Behaviour Therapy) treatment for six sessions
|
WHOQOL-BREF i.e. WHO Quality of Life-BREF
|
Placebo
|
Germany
|
Belgacem et al [22] (2013)
|
33/34
|
56.6 (20.4)/ 62.5 (18.1)
|
M-40.6%, F- 59.4%/ M-42.4%,F-57.6 %
|
Caregiver Educational Program
|
SF36 Health Survey comprises 36 items score from 0 (worst quality of life) to 100 (highest quality of life)
|
Placebo
|
France
|
Bahrami and Farzi [23] (2014)
|
32/32
|
36.94 (11.3)/ 38.97 (10.2)
|
M-43.8%, F-56.2%/ M-28.1%, F-71.9 %
|
Supportive educational program based on COPE model
|
Caregiver Quality of Life Index-Cancer (CQOL-C)
|
Placebo
|
Iran
|
Mabel Leow et al [28] (2015)
|
40/40
|
NA
|
NA
|
Caring for Caregiver Programme (CCP)
|
EORTC Quality of life (QOL)
|
Placebo
|
Singapore
|
Susan C. McMillan et al [24](2006)
|
111/109
|
63.06 (13.58)/ 59.98 (15.27)
|
M-24%, F-76%/ M-20%, F-80%
|
Coping skills intervention for Caregivers
|
Caregiver Quality of Life Index-Cancer (CQOL-C), which is 35 items scored by using a five point Likert-type scale
|
Placebo
|
South Florida
|
Joanne M. Shaw et al [29](2015)
|
64/64
|
55.7 (14.9)/ 52.7 (11.8)
|
M-27%, F-73%/ M-28%, F-72%
|
Family Connect intervention
|
Caregiver QOL using the Short Form (SF)-12v2, a 12-item QOL questionnaires with two subscales that assess physical and mental well-being
|
Placebo
|
Australia
|
Virginia Sun et al [26](2015)
|
197/157
|
57.54 (14.31)/ 57.23 (13.16)
|
M-39.4%, F-60.6% /M-36.2%, F-63.8%
|
Palliative care intervention
|
Caregiver QOL tool
|
Placebo
|
California
|
Lapid, M. I. et al [27] (2016)
|
47/53
|
Mean age & SD = NA
|
Male and Female = NA
|
QOL intervention for caregivers
|
Caregiver Quality of Life Index-Cancer Scale (CQOLC) with 35 items on 5-point Likert scales
|
Placebo
|
Rochester, USA
|
Data analysis
The final statistical study was carried out using RevMan Manager version 5.4 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen) and the protocol from the current edition of the Cochrane Handbook for Systematic Reviews of RCT.
Continuous data on caregivers' quality of life outcomes was presented as a mean difference (MD) with a 95% confidence interval. Chi-square test was used to evaluate heterogeneity using I2 statistics of treatment effects among selected trials. I2 of 0% indicates no heterogeneity, 50% indicates minimal heterogeneity, and > 50% indicates substantial heterogeneity, according to the researchers. For the final meta-analysis, the researchers used a fixed-effect model with a significant p-value of 0.05 and an I2 statistic of 50% (with non-overlapping of CI in forest plot suggesting heterogeneity). All p-values were two-sided, with 0.05 indicating statistical significance. The funnel graph for the mean difference with standard error was plotted to analyse the caregiver quality of life to evaluate possible publication bias.