A Web-based Dyadic Intervention to Manage Psychoneurological Symptoms for Patients with Colorectal Cancer and Their Caregivers
18 Years and older, Male and Female
STUDY00004750 (primary)
NCI-2022-08788
EU5733-22
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.
Eligibility
- PATIENTS: Age >= 18 years.
- PATIENTS: Diagnosed with CRC.
- PATIENTS: Life expectancy > 12 months.
- PATIENTS: Currently undergoing active chemotherapy or within two years post-treatment.
- PATIENTS: Scheduled to receive at least two additional cycles of chemotherapy.
- PATIENTS: Self-reported at least two psychoneurological symptoms (PNS) (based on the symptom measures’ cutoff scores).
- PATIENTS: Identified caregiver.
- PATIENTS: Access to the internet.
- PATIENTS: Fluent in English.
- CAREGIVERS: Age >= 18 years.
- CAREGIVERS: Primary caregiver.
- CAREGIVERS: Access to internet.
- CAREGIVERS: Fluent in English.
Treatment Sites in Georgia
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