A Web-Based Dyadic Intervention for Colorectal Cancer (CRCweb)

Emory University

Status: Enrolling

Conditions: Colorectal Carcinoma

Treatments: Other: Internet-Based Intervention; Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review

Study type: Interventional

Funder types: Other

Identifiers

NCT05663203

EU5733-22 (Other Identifier)

STUDY00004750

2022RE03 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Supportive care (CRCWeb intervention)

Experimental group

Description:

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

Treatment:

Other: Electronic Health Record Review

Other: Interview

Other: Survey Administration

Other: Internet-Based Intervention