Abstract
Purpose
This study aimed to test the feasibility and acceptability of a digital health promotion intervention for family caregivers of patients with advanced colorectal cancer and explore the intervention’s preliminary efficacy for mitigating the impact of caregiving on health and well-being.
Methods
We conducted a single-arm pilot feasibility trial of C-PRIME (Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life), an 8-week digital health-promotion behavioral intervention involving monitoring and visualizing health-promoting behaviors (e.g., objective sleep and physical activity data) and health coaching (NCT05379933). A priori benchmarks were established for feasibility (≥ 50% recruitment and objective data collection; ≥ 75% session engagement, measure completion, and retention) and patient satisfaction (> 3 on a 1–5 scale). Preliminary efficacy was explored with pre- to post-intervention changes in quality of life (QOL), sleep quality, social engagement, and self-efficacy.
Results
Participants (N = 13) were M = 52 years old (SD = 14). Rates of recruitment (72%), session attendance (87%), assessment completion (87%), objective data collection (80%), and retention (100%) all indicated feasibility. All participants rated the intervention as acceptable (M = 4.7; SD = 0.8). Most participants showed improvement or maintenance of QOL (15% and 62%), sleep quality (23% and 62%), social engagement (23% and 69%), and general self-efficacy (23% and 62%).
Conclusion
The C-PRIME digital health promotion intervention demonstrated feasibility and acceptability among family caregivers of patients with advanced colorectal cancer. A fully powered randomized controlled trial is needed to test C-PRIME efficacy, mechanisms, and implementation outcomes, barriers, and facilitators in a divserse sample of family caregivers.
Trial registration
The Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life (C-PRIME) study was registered on clinicaltrials.gov, NCT05379933, in May 2022.
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Data availability
Data are available from the corresponding author upon reasonable request. The data are not publicly available due to privacy restrictions.
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Funding
Dr. Brian Gonzalez received funding for this work from Moffitt Cancer Center.
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Contributions
L.G.: methodology, formal analysis and investigation, writing—original draft preparation, writing–review, and editing; X.L.: data collection, formal analysis and investigation, writing—original draft preparation, writing—review and editing; A.H.: writing—review and editing; LO.: writing—review and editing; I.l: writing—review and editing; B.S.: writing—review and editing; H.J.: writing—review and editing; Y.R.: data collection, writing—review, and editing; C.B.: regulatory support, writing—review, and editing; K.Z.: data collection, writing—review, and editing; K.W.: data collection, writing—review, and editing; M.R.: conceptualization, methodology, data collection, writing—original draft preparation, writing—review and editing, funding acquisition, resources, supervision; B.G.: conceptualization, methodology, data collection, formal analysis, writing—original draft preparation, writing—review and editing, funding acquisition, resources, supervision.
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C-PRIME: Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life – Advarra Institutional Review Board (Pro00062245) / Moffitt MCC21751. All participants provided informed consent to participate in the current study.
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Not applicable.
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The authors declare no competing interests.
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Gudenkauf, L.M., Li, X., Hoogland, A.I. et al. Feasibility and acceptability of C-PRIME: A health promotion intervention for family caregivers of patients with colorectal cancer. Support Care Cancer 32, 198 (2024). https://doi.org/10.1007/s00520-024-08395-5
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DOI: https://doi.org/10.1007/s00520-024-08395-5