This clinical trial examines training and resources in improving quality of life in stage II-III colon cancer patients and their caregivers. Studies have shown that providing caregiving for cancer patients reduces stress, anxiety, and provides patients with the information they need to handle difficult situations. However, few studies have offered resources to help informal caregivers to provide this type of care. Providing training or resources to help caregivers in their role may improve the quality of life for cancer patients, and their caregivers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04713007.
PRIMARY OBJECTIVES:
I. To compare quality of life (QOL) scores of patient and caregivers at 90 days post-randomization between the intervention arm and the attention control arm.
II. To assess patient and caregiver perception of care coordination as measured by the care coordination instruments (CCI) for caregivers and patients.
SECONDARY OBJECTIVES:
I. To assess study feasibility, adherence, and retention.
II. To assess the acceptability of the supportive cancer training curriculum.
III. To measure the acceptability of the computer tablet platform.
IV. To explore variation in primary and exploratory study outcomes according to sex, and to investigate whether intervention effects on the primary outcome differ across subgroups defined by sex.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients and caregivers watch TED-talk style training videos over 18 minutes. Patients and caregivers also complete questionnaires over 30-45 minutes at baseline and at 3 months.
GROUP 1: Patients and caregivers receive supportive materials and resources. Patients and caregivers also complete questionnaires over 30-45 minutes at baseline and at 3 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Hawaii Cancer Center
Principal InvestigatorKevin Cassel
