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RISE Intervention for Cancer Survivorship
Phase < 1
Waitlist Available
Led By Alix G Sleight, PhD, OTD, MPH, OTR/L
Research Sponsored by Arash Asher, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18 years
Be older than 18 years old
Must not have
Known metastatic disease (stage IV cancers).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 38 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help cancer survivors improve their health through the RISE program, which involves setting and working towards personal health goals over several sessions.
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.
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.
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 belowSelect...
I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 38 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 38 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Arash Asher, MDLead Sponsor
5 Previous Clinical Trials
197 Total Patients Enrolled
Cedars-Sinai Medical CenterLead Sponsor
510 Previous Clinical Trials
163,154 Total Patients Enrolled
Alix G Sleight, PhD, OTD, MPH, OTR/LPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
120 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You are not physically active enough and do not meet the recommended amount of exercise per week.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.You do not engage in regular physical activity that gets your heart pumping and your body moving for at least 150 minutes per week.You have reported high levels of emotional and mental stress during a survey, which includes feeling anxious, depressed, or irritable.Your doctor needs to approve your participation in this study and support your efforts to follow healthy lifestyle recommendations from the World Cancer Research Fund and American Institute for Cancer Research (WCRF/AICR).I often feel anxious, depressed, or irritable.You do not follow the recommended diet, which includes eating at least 5 servings of fruits and vegetables every day, avoiding foods high in fat, starch, or sugar, and limiting your intake of red/processed meat and alcohol.You smoke cigarettes or e-cigarettes.I often feel tired, rating my fatigue between 1 to 3 out of 5.You are not allowed to smoke either traditional cigarettes or e-cigarettes during the trial.I finished my main cancer treatments over 12 weeks ago, but may still be on long-term medication.I plan to start cancer treatment within 6 months after the RISE session.I am older than 18 years.I was diagnosed with cancer within the last two years.You have at least one lifestyle-related risk factor for cancer recurrence, which was identified by your doctor, medical records, or your own report. These risk factors may include:My cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: RISE Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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