A Web-Based Dyadic Intervention for Colorectal Cancer

Phase

N/A

Condition

Cancer/tumors

Carcinoma

Colorectal Cancer

Treatment

Interview

Electronic Health Record Review

Internet-Based Intervention

Clinical Study ID

NCT05663203

STUDY00004750

2022RE03

EU5733-22

Ages > 18
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA

Patients:

Age >= 18 years
Diagnosed with colorectal cancer
Life expectancy > 12 months
Receiving active chemotherapy
Self-reported at least two psychoneurological symptoms (based on the symptom measures' cutoff scores)
Identified primary caregiver (i.e., family members or significant others identified by the patients as their primary source of emotional and physical support)
Access to the Internet
Fluent in English

Caregivers:

Age >= 18 years
Primary caregiver
Access to the Internet
Fluent in English

EXCLUSION CRITERIA

Patients:

• Karnofsky Performance Scale < 50

Caregivers:

• Have severe diseases (e.g., cancer, heart disease)

Study Design

Interview

May 01, 2023

October 01, 2026

Study Description

PRIMARY OBJECTIVES:

I. To develop a web-based dyadic intervention for patients with colorectal cancer receiving chemotherapy and their caregivers (CRCweb).

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, navigation, structure, language) of CRCweb prototype using interviews with 4 dyads (in Aim Ia).

II. Evaluate the feasibility and acceptability of CRCweb for patients with colorectal cancer 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., attrition, adherence, acceptability, fatigue, depression, sleep disturbance, pain, and cognitive dysfunction) and secondary outcomes (i.e., quality of life) for patients with colorectal cancer 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.

Connect with a study center

Emory University/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Active - Recruiting

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