Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
NCT Number: NCT05128838
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Los Angeles, California, 90048, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Working 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.
Time frame: Up to 38 weeks.
All participants will complete the 13-session RISE intervention. RISE program will be considered feasible if ≥80% of study participants complete ≥10 RISE sessions of the total 13 sessions.
Time frame: Up to 24 weeks.
The RISE Satisfaction Survey will use a Likert scale to ask to what extent participants found that the program improved their confidence in their ability to manage their own health, as well as how much it improved their overall well-being. Two questions are measured on a scale of 0-4, where higher scores indicate higher satisfaction rate. The remaining questions are measured on a scale of 0-10, where higher scores indicate more positive feedback and higher acceptability of the program. Participants will also have the opportunity to rate the RISE instructor (on a scale of 0-10, 10 being the best possible rating) and will include an open text box for suggestions for future iterations of the program.
Time frame: Up to 24 weeks.
he PROMIS General Self-Efficacy Short Form questionnaire consists of 4 questions that asks the subject to rate their confidence levels in managing various situations, problems, and events. Each question is answered on a scale of 1-5, where higher scores indicate the highest level of confidence. The questionnaire responses at baseline and end of study will be compared.
Arash Asher, MD
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06184256
Behavior, Body Weight
Aurora, Colorado, United States
View Trial DetailsNCT07165600
Cancer, Neoplasms
San Francisco, California, United States
View Trial DetailsNCT04547634
COVID-19, Cancer
Málaga, Spain
View Trial DetailsNCT05490641
Cancer, Neoplasms
Arlington, Texas, United States
View Trial Details