This clinical trial evaluates a symptom management and survivorship handbook (SMSH) intervention alone, compared to SMSH in combination with health coaching, for reducing symptom severity and improving quality of life in patients with breast cancer, gastrointestinal cancer, or melanoma that has spread from where it first started (primary site) to other places in the body (metastatic) and their caregivers. The SMSH intervention is designed to address informational needs for the management of physical and psychological symptoms. It includes both symptom assessment and management. Health coaching is an interactive technique for providing consultation, direction, and feedback to participants seeking to make behavior changes to achieve a health-related goal. Combining the SMSH intervention with health coaching may be more effective at helping patients and caregivers manage their symptoms and quality of life, compared to SMSH alone.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07415564.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - TucsonStatus: Active
Contact: Terry A. Badger
Phone: 520-626-6058
PRIMARY OBJECTIVES:
I. Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers.
II. Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone.
III. Examine the enactment of self-management strategies in SMSH + health coaching versus SMSH alone.
OUTLINE: Patient and caregiver dyads are randomized to 1 of 2 groups.
GROUP A: Participants receive a printed SMSH containing information on over 26 common cancer symptoms and strategies to manage them, survivorship guidelines, lifestyle and behavior information, and resources. Participants receive phone calls with a trained health professional, over 10-15 minutes each, once per week for 10 weeks. During each call, the trained health professional assesses the participant's symptoms and refers them to the appropriate SMSH chapter(s), based on their reported symptom(s).
GROUP B: Participants receive a printed SMSH containing information on over 26 common cancer symptoms and strategies to manage them, survivorship guidelines, lifestyle and behavior information, and resources. Participants receive phone calls with a health coach, over 20-30 minutes each, once per week for 10 weeks. During each call, the health coach assesses the participant's symptoms and refers them to the appropriate SMSH chapter(s), based on their reported symptom(s). Additionally, the health coach works with the participants to prioritize the symptoms they wish to address and set a goal of potential strategies to support symptom management. Coaches review relevant handbook recommendations and provide coaching to facilitate uptake of symptom management strategies for the identified goal.
After completion of study intervention, participants are followed up in week 11.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorTerry A. Badger
