Clinical Trials Directory

Trials / Completed

CompletedNCT05128838

RISE (Reinvent, Integrate, Strengthen, Expand) Self-Management Program for Cancer Survivors: A Feasibility Study

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Arash Asher, MD · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a prospective feasibility study using a convenience sample of cancer survivors from Cedars-Sinai and its surrounding catchment area. As this study will be primarily focused on optimization of the RISE (Re-invent, Integrate, Strengthen, Expand) protocol, there will be no control group or randomization of participants. The RISE intervention is informed by the principles of Lifestyle Redesign, an occupational therapy-based therapeutic technique focused on measurable, individually-tailored, health-related goals. All participants will complete the 13-session RISE intervention. Sessions will occur weekly or biweekly. Measures will be completed at baseline (session #0) and post-intervention (session #12), with repeat survey measures at midpoint (session #6). There will also be a follow-up timepoint 12 weeks after the final session, at which time some measures will be completed to assess long-term maintenance of self-efficacy improvement.

Conditions

Interventions

TypeNameDescription
OTHERRISE (Reinvent, Integrate, Strengthen, Expand) InterventionWorking one-on-one with the PI (a licensed occupational therapist (OT) and behavior change expert), participants will set goals and develop practical strategies in order to establish sustainable positive habits around lifestyle areas such as physical activity, nutrition, stress management, sleep, self-efficacy, and spiritual well-being. Motivational interviewing, cognitive behavioral therapy, and patient education will accompany intensive collaborative problem-solving and creation of accountability structures to create increased self-efficacy for health self-management. In summary, the RISE intervention includes three components: patient education, internalization of self-determination, and habit formation.

Timeline

Start date
2022-05-25
Primary completion
2024-10-09
Completion
2024-10-09
First posted
2021-11-22
Last updated
2025-02-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05128838. Inclusion in this directory is not an endorsement.