Clinical trial NCT05128838: RISE (Reinvent, Integrate, Strengthen, Expand) Self-Management Program for Cancer Survivors: A Feasibility Study
Official title: RISE (Reinvent, Integrate, Strengthen, Expand) Self-Management Program for Cancer Survivors: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cancer
Survivorship
Keywords: Cancer Survivor
Self-management
Lifestyle
Survivorship
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. History of cancer diagnosis within two years prior to enrollment
2. Completed all primary cancer treatment (surgery, radiation, and/or chemotherapy) at least 12 weeks before initial RISE session. Long-term hormonal/biologic therapy is acceptable.
3. Identified by oncologist, by medical record, or by self-report as having at least one lifestyle-related risk factor for cancer recurrence. Lifestyle-related risk factors include:

   * BMI of 25 or higher;
   * Sedentary lifestyle, defined as physical activity of less than 150 minutes per week of moderate-intensity aerobic activity OR less than 75 minutes per week of vigorous aerobic activity;
   * Non-adherence to dietary recommendations, including intake of less than five portions or servings (at least 400g or 15oz in total) of fruit/vegetables per day; consumption of ultra-processed foods more than once a week, defined as foods high in fat, starches or sugars (including "fast foods", pre-prepared dishes, bakery foods, and desserts); consumption of red/processed meats above 500g or 18oz cooked weight per week, and/or intake of more than 3 alcoholic beverages a week, per patient report;
   * Smoking cigarettes or e-cigarettes;
   * Patient self-report of high unmanaged stress, as measured by a score of 1, 2, or 3 out of 5 (responses indicating a clinically relevant level of emotional/mental stress) on at least one of two items from the PROMIS Global 10: "How often have you been bothered by emotional problems such as feeling anxious, depressed or irritable?" and "In general, how would you rate your mental health, including your mood and your ability to think?
   * Patient self-report of fatigue (either due to too little sleep, too much sleep, or any other cause), as measured by a score of 1, 2, or 3 out of 5 (responses indicating a clinically relevant level of fatigue) on a single item from the PROMIS Global 10: "How would you rate your fatigue on average?".
4. Treating and/or study physician clearance to participate in this study's program and to work toward World Cancer Research Fund and American Institute for Cancer Research (WCRF/AICR) lifestyle recommendation-related goals.
5. Age \>18 years
6. Ability to read, write, and understand English.
7. Written informed consent obtained from participant and ability for participant to comply with the requirements of the study.

Exclusion Criteria:

1. Cognitive issues substantially affecting patient's ability to participate in the study, as determined by the PI or study physician.
2. Planning to have active anti-cancer treatment (including radiation, chemo, and/or major surgery) within 6 months after initial RISE session. Long-term hormonal/biologic therapy is acceptable.
3. Known metastatic disease (stage IV cancers).

Primary outcomes:
measure: RISE program feasibility will be measured by tracking participant attrition rate. RISE program will be considered feasible if ≥80% of study participants complete ≥10 RISE sessions.
timeFrame: Up to 38 weeks.
Secondary outcomes:
measure: To measure participant acceptability of the RISE program through a survey at the final RISE session.
timeFrame: Up to 24 weeks.
measure: To test the impact of the RISE intervention on participant self-efficacy, as measured by the PROMIS General Self-Efficacy Short Form questionnaire.
timeFrame: Up to 24 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Arash Asher, MD
role: PRINCIPAL_INVESTIGATOR
References: