Behavioral Intervention for Childhood Cancer Survivors

(SALSA Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help cancer survivors become more active and eat healthier. It tests various approaches, such as setting personal goals and having remote sessions with a health coach, to determine which is most effective at boosting physical activity and improving diet. The trial includes a tailored intervention based on Self-Determination Theory, focusing on enhancing motivation and personal growth. It seeks participants who survived childhood cancer, have a moderate to high risk of heart issues, and struggle to meet daily exercise and healthy eating goals. Those who do not get much exercise or have a poor diet may find this trial a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies for improving health and well-being among childhood cancer survivors.

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 prior data suggests that these behavioral interventions are safe for childhood cancer survivors?

Research has shown that programs based on self-determination theory can safely and effectively improve lifestyle habits. Previous studies found that these programs enhance quality of life by focusing on individual motivations and personal goals. They typically include personalized guidance and support, which most people find easy to follow.

In this trial, participants will access personalized telehealth sessions, set goals for physical activity and diet, and meet remotely with a health coach. These non-invasive methods focus on behavior change, usually posing a low risk of side effects. Reports of serious safety issues are absent, as these programs primarily involve counseling and encouragement rather than medical treatment.

Overall, the programs are designed to be supportive and adaptable to each person's needs, ensuring safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative behavioral interventions for childhood cancer survivors, focusing on self-determination theory to enhance self-management and goal setting. Unlike standard care options that typically involve routine follow-ups and general lifestyle advice, this trial offers personalized telehealth sessions and goal-setting plans tailored to each patient's needs. It also integrates remote health coaching and social media peer support to maintain motivation and engagement, setting it apart from traditional approaches. By offering flexible, patient-centered interventions, this trial aims to empower survivors with better tools for long-term health and well-being.

What evidence suggests that this trial's behavioral interventions could be effective for improving physical activity in childhood cancer survivors?

Research has shown that personalized programs based on self-determination theory can help childhood cancer survivors improve their lifestyle habits. In this trial, participants may join different treatment arms, such as personalized clinician-led self-management telehealth, personalized goal setting, or remote sessions with a health coach. These programs focus on personal motivation and readiness to change, enhancing quality of life. They encourage survivors to become more active and eat healthier. Other studies on similar programs have demonstrated improvements in body mass index (BMI) and overall health habits. This evidence suggests that the programs tested in this trial may effectively support cancer survivors in leading healthier lives. ^{2 3 4 6 7}

Who Is on the Research Team?

Eric J. Chow

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Arm 1 and 2 patients with poor response after 3 months can be re-randomized to Arm 4. Patients receive remote sessions with a health coach every 1-2 weeks for 3 months. Patients may continue to receive remote sessions once a month after 3 months, during the maintenance phase (months 6-12).

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772696725000134

'Making Moves': Protocol for a hybrid effectiveness- ... This protocol describes the development and planned evaluation of 'Making Moves', a co-designed online physical activity program for childhood cancer survivors ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39879873/

Effectiveness of tailored interventions on quality of life in ... Interventions incorporating theoretical determinants such as readiness to change and self-efficacy were notably effective in enhancing quality of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11868983/

Efficacy of the PanCareFollowUp eHealth Lifestyle ... This intervention was designed to support CAYA cancer survivors in achieving a personal lifestyle goal and improve body mass index (BMI), ...

4. withpower.com withpower.com/trial/phase-neoplasms-2-2022-9bb40

Behavioral Intervention for Childhood Cancer Survivors ... This trial aims to see whether a tailored intervention based on self-determination theory may help to improve physical activity and dietary change. Show more.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ecc.13063

Tailored education enhances healthy behaviour self ... The intervention was acceptable and effective in promoting HBSE in childhood cancer survivors. Further empirical work is needed to reveal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05075759?term=NCT05075759&rank=1

Study Details | NCT05075759 | Testing Counseling and ... This trial aims to see whether a tailored intervention based on self-determination theory may help to improve physical activity and dietary change.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11473175/

Design and methods of the StepByStep randomized trial of a ... Children and adolescents with cancer have 5-year overall survival rates exceeding 86% due to advances in treatment [1]. Unfortunately, survivors of childhood ...