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CancerEarly Phase 1NCT05128838

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

A Early Phase 1 study testing RISE (Reinvent, Integrate, Strengthen, Expand) Intervention in people with Cancer and Survivorship, run by Arash Asher, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Survivorship
What is being tested?
RISE (Reinvent, Integrate, Strengthen, Expand) Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
25 May 2022to 9 Oct 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of cancer diagnosis within two years prior to enrollment
  • 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.
  • 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;
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  • 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?".
  • 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.
  • Age >18 years
  • Ability to read, write, and understand English.
  • Written informed consent obtained from participant and ability for participant to comply with the requirements of the study.

Who cannot join

  • Cognitive issues substantially affecting patient's ability to participate in the study, as determined by the PI or study physician.
  • 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.
  • Known metastatic disease (stage IV cancers).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

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
Cancer, Survivorship
Being tested
RISE (Reinvent, Integrate, Strengthen, Expand) Intervention
Keywords
Cancer Survivor, Self-management, Lifestyle, Survivorship
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT05128838
Study groupRoleWhat they receive
RISE InterventionExperimentalWorking 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.
Receives: Other: RISE (Reinvent, Integrate, Strengthen, Expand) Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: Up to 38 weeks.

Secondary outcomes (2)

  1. To measure participant acceptability of the RISE program through a survey at the final RISE session.

    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.

    Measured: Up to 24 weeks.

  2. To test the impact of the RISE intervention on participant self-efficacy, as measured by the PROMIS General Self-Efficacy Short Form questionnaire.

    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.

    Measured: Up to 24 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start25 May 2022
  3. Primary completion9 Oct 2024
  4. Study completion9 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128838
Sponsor's protocol ID
IIT2020-28-SLEIGHT-RISE
Status last verified
Feb 2025
First submitted
10 Nov 2021
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing RISE (Reinvent, Integrate, Strengthen, Expand) Intervention in people with Cancer and Survivorship, run by Arash Asher, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Up to 38 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128838.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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