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RISE Intervention for Cancer Survivorship

Phase < 1
Recruiting
Led By Alix G Sleight, PhD, OTD, MPH, OTR/L
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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?".
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 38 weeks.
Awards & highlights

Study Summary

This trial will study how well the RISE intervention works in cancer survivors. There is no control group, and participants will all complete the 13-session intervention. Measurements will be taken at different points to see how well the intervention works long-term.

Who is the study for?
This trial is for adults over 18 who've had a cancer diagnosis within the last two years, finished primary treatment at least 12 weeks ago, and have a BMI of 25 or higher. Participants should have lifestyle-related risk factors for cancer recurrence like poor diet, physical inactivity, smoking, or high stress. They must be able to read and understand English and commit to the study requirements.Check my eligibility
What is being tested?
The RISE Self-Management Program aims to help cancer survivors improve their health through tailored sessions based on Lifestyle Redesign principles. The program includes 13 sessions focusing on individual health goals related to diet, exercise, stress management etc., with measures taken before, during (midpoint), after intervention (session #12), and at a follow-up after three months.See study design
What are the potential side effects?
Since this is not a drug trial but an intervention focused on lifestyle changes there are no direct side effects as one would expect from medication. However participants may experience discomfort adjusting to new habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I often feel tired for various reasons.
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I finished my main cancer treatments over 12 weeks ago, but may still be on long-term medication.
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I am older than 18 years.
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I was diagnosed with cancer within the last two years.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 38 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 38 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
To measure participant acceptability of the RISE program through a survey at the final RISE session.
To test the impact of the RISE intervention on participant self-efficacy, as measured by the PROMIS General Self-Efficacy Short Form questionnaire.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RISE InterventionExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
497 Previous Clinical Trials
164,534 Total Patients Enrolled
Alix G Sleight, PhD, OTD, MPH, OTR/LPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

RISE (Reinvent, Integrate, Strengthen, Expand) Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05128838 — Phase < 1
Cancer Research Study Groups: RISE Intervention
Cancer Clinical Trial 2023: RISE (Reinvent, Integrate, Strengthen, Expand) Intervention Highlights & Side Effects. Trial Name: NCT05128838 — Phase < 1
RISE (Reinvent, Integrate, Strengthen, Expand) Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128838 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participation in this scientific experiment?

"According to clinicaltrials.gov, this research study is currently searching for suitable participants, with the initial posting of trial information occurring on May 25th 2022 and an update made one day later."

Answered by AI

How many participants has the trial recruited thus far?

"Correct. Clinicaltrials.gov confirms that this research is actively seeking participants, which was initially posted on May 25th 2022 and updated the following day. The project requires 25 people from a single medical site to be enrolled in the trial."

Answered by AI
~15 spots leftby Nov 2026