Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 5, 2023
Date Accepted: May 26, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients with Colorectal Cancer and Their Caregivers: A Study Protocol
ABSTRACT
Background:
Patients with colorectal cancer (CRC) receiving chemotherapy often experience psychoneurological symptoms (PNS, i.e., fatigue, depression, anxiety, sleep disturbance, pain, and cognitive dysfunction) that negatively impact both patients’ and their caregivers’ health outcomes. Limited information is available on PNS management for CRC patient and caregiver dyads.
Objective:
The purposes of this study are to: 1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their caregivers (CRCweb); and 2) evaluate the feasibility, acceptability, and preliminary effects of CRCweb among patient-caregiver dyads in a cancer clinic.
Methods:
A mixed methods approach will be used. Semi-structured interviews among eight dyads will be conducted to develop CRCweb. A single-group pre- and post-test clinical trial will be employed to examine the feasibility, acceptability, and preliminary effects of the intervention (CRCweb) among 20 dyads. Study assessments will be conducted pre- (T1) and post-intervention (T2). Content analysis will be performed for semi-structured interviews. Descriptive statistics will be calculated separately for patients and caregivers, and pre-post paired t-tests will be used to evaluate treatment effects.
Results:
This study was funded in November 2022. As of April 2023, we have completed the Institutional Review Board approval and clinical trial registration and are currently recruiting patient-caregiver dyads in a cancer clinic. The study is expected to be completed in October 2024.
Conclusions:
Developing a web-based dyadic intervention holds great promise to reduce PNS burden for patients with CRC receiving chemotherapy and their caregivers. The findings from this study will advance intervention development and implementation of symptom management and palliative care for cancer patients and their caregivers. Clinical Trial: ClinicalTrials.gov identifier, NCT05663203
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