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Behavioral Intervention for Childhood Cancer Survivors (SALSA Trial)

Q: Does the age limit for this research study extend past 65 years old?

<p>In order to be included in this particular study, patients must be between 18-54 years old. There are 321 other studies available for people below the age of 18 and 2296 for those over 65.</p>

Q: Which type of patient would be the best candidate for this clinical trial?

<p>This clinical trial is looking for 403 participants aged 18 to 54 who have lymphoid cells. The most important criteria for participants are as follows: a Healthy Eating Index (HEI)-2015 score of less than 60 per study food frequency questionnaire (FFQ), a Body mass index (BMI) of 25 kg/m^2 or more per self-reported height and weight, internet access (can be via smartphone or computer; if neither device is available, the study can loan participants a Wi-Fi enabled device, but participant will need to have access to the internet), no known (self-reported) ischemic heart</p>

N/A

Waitlist Available

Led By Eric J. Chow

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Childhood Cancer Survivor Study (CCSS) participant who is between age 18 to < 55 years at time of initial consent

Moderate to high CV risk status based on CCSS risk prediction models for cardiomyopathy and ischemic heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

SALSA Trial Summary

This trial is testing whether a motivational intervention can help cancer patients be more physically active and improve their diet.

Who is the study for?

This trial is for childhood cancer survivors aged 18-54 with moderate to high cardiovascular risk, no active cancer treatment or heart disease, a BMI of 25 or higher, poor diet quality, and low physical activity. Participants must speak English and have internet access.Check my eligibility

What is being tested?

The study tests if counseling and mobile health interventions based on self-determination theory can boost physical activity and improve diet in young adult cancer survivors. It involves surveys to track progress.See study design

What are the potential side effects?

Since the interventions are behavioral involving counseling and use of mobile health tools, there may not be direct side effects like with medication; however, increased physical activity could cause muscle soreness or fatigue.

SALSA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a childhood cancer survivor aged 18 to 54.

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I am at moderate to high risk for heart disease according to a specific risk assessment.

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I do not have any heart diseases like blocked arteries or weak heart muscles.

SALSA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Healthy Eating Index (HEI)-2015 score

Sedentary time

Secondary outcome measures

Health-related self-efficacy scale

Multidimensional Health Locus of Control Scale

Participant engagement

Side effects data

From 2013 Phase 1 & 2 trial • 16 Patients • NCT01923896

13%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Behavioral Intervention & DCS

Behavioral Intervention & Placebo

SALSA Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm 4 (remote sessions with a health coach)Experimental Treatment2 Interventions

Patients receive remote sessions with a health coach every 1-2 weeks for 6 months. Patients may continue to receive remote sessions once a month after 12 months.

Group II: Arm 2 (personalized goal setting)Experimental Treatment2 Interventions

Patients receive personalized goal setting for daily steps and activity (updated weekly) and 3 dietary goals (updated monthly) with social media peer support for 6 months. Patients with poor response at 3 months are randomized to Arms 1 or 4. Patients may receive personalized goal setting for daily steps and activity (updated monthly) and dietary goals (updated every 2 months) after 12 months.

Group III: Arm 1 (personalized clinician-led self-management telehealth)Experimental Treatment2 Interventions

Patients receive a personalized clinician-led self-management telehealth session at baseline and 2 months. Patients with poor response at 3 months are randomized to Arm 2 or 4, otherwise patients receive the same telehealth session at months 4 and 6. Patients may receive 2 additional telehealth sessions after 12 months.

Group IV: Arm 3 (waitlist)Active Control1 Intervention

Patients receive no intervention for 12 months, and then receive their choice of intervention for up to 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention

2021

Completed Phase 4

~3740

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,342,865 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,750 Total Patients Enrolled

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

147,842 Total Patients Enrolled

Media Library

Tailored Intervention based on Self-Determination Theory Clinical Trial Eligibility Overview. Trial Name: NCT05075759 — N/A

Cancer Research Study Groups: Arm 1 (personalized clinician-led self-management telehealth), Arm 2 (personalized goal setting), Arm 3 (waitlist), Arm 4 (remote sessions with a health coach)

Cancer Clinical Trial 2023: Tailored Intervention based on Self-Determination Theory Highlights & Side Effects. Trial Name: NCT05075759 — N/A

Tailored Intervention based on Self-Determination Theory 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075759 — N/A

Frequently Asked Questions

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

Does the age limit for this research study extend past 65 years old?

"In order to be included in this particular study, patients must be between 18-54 years old. There are 321 other studies available for people below the age of 18 and 2296 for those over 65."

Answered by AI

Which type of patient would be the best candidate for this clinical trial?

"This clinical trial is looking for 403 participants aged 18 to 54 who have lymphoid cells. The most important criteria for participants are as follows: a Healthy Eating Index (HEI)-2015 score of less than 60 per study food frequency questionnaire (FFQ), a Body mass index (BMI) of 25 kg/m^2 or more per self-reported height and weight, internet access (can be via smartphone or computer; if neither device is available, the study can loan participants a Wi-Fi enabled device, but participant will need to have access to the internet), no known (self-reported) ischemic heart"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality in Survivors of Childhood Cancer

2022. "Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality in Survivors of Childhood Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05075759.