This clinical trial studies how well a web-based dyadic intervention (CRCweb) 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. In addition, this clinical trial compares the effects of CRCweb to another web-based dyadic intervention, CanBeWell. CanBeWell includes educational content, digital lessons and personalized recommendations. CRCweb may be more effective than CanBeWell in managing psychoneurological symptoms for patients with colorectal cancer and their caregivers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05663203.
Locations matching your search criteria
United States
Georgia
Atlanta
Grady Health SystemStatus: Active
Contact: Yufen Lin
Phone: 919-808-6106
Emory University Hospital/Winship Cancer InstituteStatus: Active
Contact: Yufen Lin
Phone: 919-808-6106
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.
IV. Compare the preliminary effects of the CRCweb intervention with another web-based dyadic intervention, CanBeWell, among patients with CRC and their caregivers.
V. Test the effect of the CRCweb intervention through a randomized controlled trial (RCT) among patients with CRC.
OUTLINE:
AIM 1: Patients and caregivers complete semi-structured interviews on study.
AIMS 2 and 3: Patients and caregivers attend a CRCweb intervention over 8 weeks.
AIM 4 (PILOT TRIAL): Patients are assigned to 1 of 2 arms.
ARM I (CANBEWELL): Patients and caregivers attend a CanBeWell intervention over 6 months. Patients participate in an exercise program, as well as an anti-inflammatory diet program over the 6 months. Patients also wear a Fitbit activity tracker continuously and upload food images three times weekly throughout the study. In addition, patients receive coaching sessions once weekly (QW) on weeks 1-6 then every 2 weeks of weeks 7-24.
ARM II (CRCWEB): Patients and caregivers attend a CRCweb intervention over 8 weeks.
AIM 5: Patients are randomized to 1 of 2 groups.
GROUP I (WAITLIST CONTROL GROUP): Patients continue to maintain their regular activities on study. After completion of the study, patients receive access to the CRCweb tool.
GROUP II (CRCWEB GROUP): Patients participate in CRCweb mobile application (app) components for 12 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorYufen Lin
