RISE Intervention for Cancer Survivorship

Overseen By Mehrnoosh Nassaj, MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Arash Asher, MD

Disqualifiers: Cognitive issues, Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help cancer survivors make positive lifestyle changes to improve health and well-being. The study examines the RISE (Reinvent, Integrate, Strengthen, Expand) program, which focuses on creating personalized health goals in areas like exercise, diet, stress management, and sleep. Participants collaborate with an expert to build sustainable habits that may help prevent cancer recurrence. This trial suits individuals who have completed primary cancer treatments and face lifestyle-related risk factors, such as low physical activity or high stress. As an Early Phase 1 trial, participants will be among the first to explore the impact of this innovative program on health and well-being.

Do I need to stop my current medications for the RISE trial?

The trial does not specify if you need to stop your current medications. However, long-term hormonal or biologic therapy is allowed, so you may not need to stop those. It's best to discuss your specific medications with the study team.

What prior data suggests that the RISE protocol is safe for cancer survivors?

Research shows that the RISE Intervention remains in the early stages of testing, so complete safety information is not yet available. However, this early phase study focuses more on assessing the intervention's practicality than on safety.

The RISE Intervention is based on Lifestyle Redesign, a method commonly used in occupational therapy to help individuals achieve health goals. This approach is generally well-received, as it involves personalized plans to improve areas such as exercise, diet, stress, and sleep. While no specific negative effects have been reported, the emphasis on habit and lifestyle changes suggests it is likely safe.

In summary, although detailed safety data is lacking, the RISE Intervention is expected to be well-tolerated. Participants work closely with a therapist, which helps address any potential issues that might arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RISE Intervention is unique because it combines personalized goal-setting with cutting-edge behavioral techniques like motivational interviewing and cognitive behavioral therapy. Unlike standard cancer survivorship care, which often focuses on medical follow-up and generalized advice, RISE provides a tailored approach that empowers individuals to manage their health proactively. Researchers are excited about this intervention as it emphasizes creating sustainable positive habits in critical lifestyle areas, potentially leading to enhanced long-term well-being for cancer survivors.

What evidence suggests that the RISE protocol is effective for cancer survivorship?

Research has shown that personalized programs like the RISE Intervention, which participants in this trial will receive, can improve the quality of life for cancer survivors. These programs focus on personal goals and lifestyle changes, enhancing overall health and well-being. Studies have found that similar programs support better physical activity, stress management, and nutrition. The goal is to boost self-efficacy, meaning increased confidence in managing one's own health. Early results suggest that these personalized approaches can lead to lasting positive habits and improved health outcomes. ^{3 6 7 8 9}

Who Is on the Research Team?

Arash Asher, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have not been following specific dietary guidelines, such as eating at least five servings of fruits and vegetables a day, limiting your intake of processed and high-fat foods, consuming more than 18 ounces of red or processed meat per week, or drinking more than three alcoholic beverages per week.

I often feel tired for various reasons.

You are moderately overweight or obese.

Exclusion Criteria

You have trouble thinking or remembering things that could make it difficult for you to take part in the study, as determined by the study doctor.

I plan to start cancer treatment within 6 months after the RISE session.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

RISE Intervention

Participants complete the 13-session RISE intervention focusing on lifestyle redesign and self-management

13-26 weeks

13 sessions (weekly or biweekly)

Follow-up

Participants are monitored for long-term maintenance of self-efficacy improvement

12 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• RISE (Reinvent, Integrate, Strengthen, Expand) Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: RISE Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Arash Asher, MD

Lead Sponsor

Trials

6

Recruited

220+

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05128838

RISE (Reinvent, Integrate, Strengthen, Expand) Intervention in ... This is a prospective feasibility study using a convenience sample of cancer survivors from Cedars-Sinai and its surrounding catchment area.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12242455/

Evidence-based digital health interventions for breast ... We conducted an umbrella review to summarize the evidence on digital health interventions aimed at improving health-related outcomes for BCS.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223334/

Cancer treatment and survivorship statistics, 2025 The number of people living in the United States with a history of cancer is rising because of advances in detection and treatment that have improved survival.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125000412

Effectiveness of tailored interventions on quality of life in ... Tailored interventions can improve social and physical quality of life and general health in cancer survivors. •. Remote, iterative tailored interventions ...

5. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30563-0/abstract

Evaluation of effectiveness of survivorship programmes Survivorship programmes tend to evaluate their effectiveness by assessing changes in patient-reported outcomes, symptoms and health status, knowledge, and ...

6. withpower.com withpower.com/trial/early-phase-1-2022-cf9d8

RISE Intervention for Cancer Survivorship 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 ...

7. ctv.veeva.com ctv.veeva.com/study/rise-reinvent-integrate-strengthen-expand-self-management-program-for-cancer-survivors-a-feasi

RISE (Reinvent, Integrate, Strengthen, Expand) Self ... This is a prospective feasibility study using a convenience sample of cancer survivors from Cedars-Sinai and its surrounding catchment area.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06799481?cond=brain%20cancer%20&start=2024-11-01_2025-06-30&aggFilters=ages:child%20adult%20older,status:rec,studyType:int&locStr=United%20States&country=United%20States&rank=5

Virtual Home-based Exercise Intervention (RISE) to ... This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment ...

9. withpower.com withpower.com/trial/phase-syndrome-2-2021-37e0a

AYA-RISE Program for Cancer Syndromes There is no specific safety data available for the AYA-RISE Program for Cancer Syndromes in the provided research articles. Show more.