Behavioral Intervention for Childhood Cancer Survivors

(SALSA Trial)

Recruiting at 1 trial location

Overseen By Eric J. Chow

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Cardiomyopathy, Ischemic heart disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

403 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates several behavioral interventions for the improvement of physical activity in cancer patients. Childhood and adolescent/young adult cancer survivors have been reported to have poor diet quality and rarely meet recommended physical activity guidelines. This trial aims to see whether a tailored intervention based on self-determination theory may help to improve physical activity and dietary change.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving physical activity and diet for cancer survivors.

What data supports the effectiveness of the treatment Tailored Intervention based on Self-Determination Theory for childhood cancer survivors?

Research on similar interventions for cancer survivors, like those for breast and gynecological cancer, shows that using self-determination theory can improve quality of life and help patients set and achieve personal goals. This suggests that the tailored intervention could be effective for childhood cancer survivors as well. ^{1 2 3 4 5}

Is the behavioral intervention for childhood cancer survivors safe?

The research articles do not provide specific safety data for the behavioral intervention, but they focus on promoting healthy behaviors and reducing risky behaviors, which generally suggests a focus on safe practices. ^{5 6 7 8 9}

How is the Tailored Intervention based on Self-Determination Theory different from other treatments for childhood cancer survivors?

This treatment is unique because it focuses on enhancing motivation and personal growth by addressing basic psychological needs, which is different from traditional medical treatments. It uses principles from Self-Determination Theory to encourage behavior change, such as increasing physical activity, through personalized support and motivation. ^{1 5 10 11 12}

Research Team

Eric J. Chow

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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.

Inclusion Criteria

Healthy Eating Index (HEI)-2015 score < 60 per study food frequency questionnaire (FFQ)

Less than 30 minutes/day of moderate to vigorous physical activity (MVPA) based on validated self-report instrument (Godin)

I am a childhood cancer survivor aged 18 to 54.

Exclusion Criteria

Not currently known to be pregnant; individuals known to be pregnant and otherwise eligible for the study can be enrolled once no longer known to be pregnant. Participants who report being pregnant after randomization can remain in the study

I cannot walk or be active due to health reasons.

I am currently undergoing treatment for cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various interventions including telehealth sessions, personalized goal setting, and remote health coaching depending on the assigned arm

6 months

Telehealth sessions at baseline, 2, 4, and 6 months; weekly updates for goals; remote sessions every 1-2 weeks

Follow-up

Participants are monitored for sedentary time, self-efficacy, health locus of control, and engagement

6 months

Optional Extension

Participants may opt into additional interventions or continued sessions after the main treatment phase

Up to 6 months

Treatment Details

Interventions

• Tailored Intervention based on Self-Determination Theory

Trial Overview 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.

Participant Groups

Group I: Arm 4 (remote sessions with a health coach) Experimental Treatment 2 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 6 months.

Group II: Arm 2 (personalized goal setting) Experimental Treatment 3 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 monthly) after 6 months.

Group III: Arm 1 (personalized clinician-led self-management telehealth) Experimental Treatment 3 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 6 months.

Group IV: Arm 3 (waitlist) Active Control 2 Interventions

Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A randomized clinical trial involving 202 cervical cancer survivors is evaluating the efficacy of the MAPS approach for smoking cessation, which includes proactive counseling and standard treatment components over 12 months.

The study aims to determine if the MAPS intervention is more effective than standard treatment in helping these women quit smoking, with significant public health implications if proven successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial. Jones, SR., Vidrine, DJ., Wetter, DW., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Mediating processes of two communication interventions for breast cancer patients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Self-determination theory and physical activity among breast cancer survivors. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A person-centered intervention targeting the psychosocial needs of gynecological cancer survivors: a randomized clinical trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A Content Analysis of Functional Recovery Strategies of Breast Cancer Survivors. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Adherence and contamination in a 1-year physical activity program in childhood cancer survivors: A report from the SURfit study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Multi-component behavioral intervention to promote health protective behaviors in childhood cancer survivors: the protect study. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Adolescent survivors: a secondary analysis of a clinical trial targeting behavior change. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Predicting and modifying substance use in childhood cancer survivors: application of a conceptual model. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Survivor typologies predict medical surveillance participation: the childhood cancer survivor study. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Gamified Text Messaging Contingent on Device-Measured Steps: Randomized Feasibility Study of a Physical Activity Intervention for Cancer Survivors. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Understanding rural-living young adult cancer survivors' motivation during a telehealth behavior change intervention within a single-arm feasibility trial. [2022]