A Web-Based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients With Colorectal Cancer and Their Caregivers: Protocol for a Mixed Methods Study.
Yufen Lin, Laura S Porter, Wonshik Chee...
https://pubmed.ncbi.nlm.nih.gov/37379055/Actively Recruiting
Led by Emory University · Updated on 2025-12-19
56
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating a web-based dyadic intervention designed to help manage psychoneurological symptoms such as fatigue, depression, sleep problems, pain, and cognitive difficulties in patients with colorectal cancer who are receiving chemotherapy, along with support for their caregivers. These symptoms can severely affect both patient and caregiver quality of life and health outcomes. The study aims to develop and test this novel intervention to reduce symptom burden and improve well-being in cancer care. The intervention, called CRCweb, is developed through interviews and feedback from patient-caregiver pairs to tailor its content. The study includes a prototype usability test and then a pilot clinical trial where 20 patient-caregiver dyads participate in the web-based program over 8 weeks. Throughout this period, patients and caregivers engage with the intervention and complete interviews and surveys. Participants will be involved in surveys and interviews during the 8-week intervention to assess factors such as adherence, acceptability, and symptom changes. Researchers will measure fatigue, depression, sleep quality, pain, cognitive function, and overall quality of life. Health records will also be reviewed. This approach helps understand how feasible and helpful the CRCweb program may be for patients and caregivers managing colorectal cancer symptoms.
CONDITIONS
A Web-Based Dyadic Intervention for Colorectal Cancer
Y
Yufen Lin, PhD, RN
C
Canhua Xiao, PhD, RN
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Emory University
Lead Sponsor
Oncology Nursing Society
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CRCWeb Intervention (patients + caregivers) | Standard Supportive Care (context) |
|---|---|---|
| What reaction or therapy is being offered | A web‑based dyadic supportive care program (CRCWeb) delivered to colorectal cancer patients on chemotherapy and their primary caregivers | Usual supportive care often includes symptom monitoring, general education, psychosocial support, and caregiver guidance via standard clinical encounters or printed materials |
| Role in trial | Participants attend CRCWeb intervention as the single trial arm | Not evaluated in trial, serves as contextual comparator |
| Purpose of the program | To manage psychoneurological symptoms (fatigue, depression, sleep disturbance, pain, cognitive dysfunction) in patients and support caregivers through a web‑based dyadic format | General symptom management and supportive care delivered through usual clinical pathways without a structured dyadic web component |
| How it is delivered | Web‑based modules completed by patient and caregiver dyads, with interviews and surveys over up to 8 weeks | Delivered via standard clinical visits, education materials, and usual psychosocial support methods |
| Evidence supporting effect | Feasibility, acceptability, and preliminary effectiveness being tested in this early‑phase trial; results pending | Standard supportive care effectiveness is generally accepted but lacks structured dyadic digital delivery; systematic review evidence shows dyadic interventions improve quality of life compared to usual care |
| Known risks or harms | Minimal physical risk as a web‑based behavioral program; potential for emotional discomfort or technology access challenges | Standard supportive care poses minimal risk and is routinely delivered |
| Key limitations | Single‑group design without control arm limits comparative efficacy conclusions; small pilot sample limits generalizability | Lacks structured dyadic web delivery and may not directly address psychoneurological symptoms in both patients and caregivers concurrently |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 8 weeks
Participants attend a web-based dyadic intervention (CRCWeb) alongside their caregivers to manage psychoneurological symptoms during chemotherapy.
Participants complete interviews and surveys throughout the 8 weeks
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Yufen Lin, Laura S Porter, Wonshik Chee...
https://pubmed.ncbi.nlm.nih.gov/37379055/Emory University
Lead Sponsor
Oncology Nursing Society
Collaborating Sponsor