A Web-based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients with Colorectal Cancer and Their Caregivers

Active:	Yes
Cancer Type:	Colon/Rectal Cancer	NCT ID:	NCT05663203
Trial Phases:		Protocol IDs:	STUDY00004750 (primary) NCI-2022-08788 EU5733-22
Eligibility:	18 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05663203

Summary

This clinical trial studies how well a web-based dyadic intervention works to manage psychoneurological symptoms for patients with colorectal cancer and their caregivers. Patients with colorectal cancer receiving chemotherapy experience severe and distressing psychoneurological symptoms that include fatigue, depression, sleep disturbance, pain, and cognitive dysfunction. When these co-occurring symptoms are undertreated, they negatively affect functional status, survival rates, and quality of life of patients as well as decrease health outcomes of their family caregiver. A critical need exists to develop an effective and novel intervention that focuses on patients with colorectal cancer receiving chemotherapy and their caregivers. A web-based dyadic intervention holds great promise to reduce psychoneurological symptoms burden and improve quality of life for patients with colorectal cancer receiving chemotherapy and advance intervention development and implementation in cancer supportive care and health equity.

Objectives

PRIMARY OBJECTIVES:
I. To develop a web-based dyadic intervention (CRCweb) for patients with colorectal cancer (CRC) receiving chemotherapy and their caregivers.
Ia. Determine tailored contents by identifying needs and supports for a web-based dyadic intervention using interviews with patient-caregiver dyads (n=8);
Ib. Develop a prototype of a web-based dyadic intervention program (CRCweb);
Ic. Test the usability (e.g., design, language) of CRCweb prototype using interviews with 4 dyads (in Aim 1a).
II. Evaluate the feasibility and acceptability of CRCweb for patients with CRC receiving chemotherapy and their caregivers in 20 dyads in a pilot clinical trial.
III. Evaluate the preliminary effects of CRCweb on the primary outcome (i.e., psychoneurological symptoms) and secondary outcomes (i.e., quality of life, self-efficacy) for patients with CRC receiving chemotherapy and their caregivers in 20 dyads in a pilot clinical trial.

OUTLINE:
Patients and caregivers attend a CRCweb intervention over 8 weeks. Patients and caregivers complete interviews and surveys throughout the trial.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.