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

SALSA: Study of Active LifeStyle Activation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention

Detailed Description

OUTLINE: Patients are randomized to Arms 1, 2, or 3.

ARM 1: 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.

ARM 2: 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 6 months.

ARM 3: Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.

ARM 4: If Arms 1 or 2 patients have poor response after 3 months, patients may 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).

• Study Type: Interventional
• Enrollment (Actual): 374
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Childhood Cancer Survivor Study (CCSS) participant who is between age 18 to < 55 years at time of initial approach
• Moderate to high CV risk status based on CCSS risk prediction models for cardiomyopathy and ischemic heart disease
• Able to read, write, and speak English
• Ability to understand and the willingness to provide informed consent

• At least one of the following:

  • Less than 30 minutes/day of moderate to vigorous physical activity (MVPA) based on validated self-report instrument (Godin)
  • Healthy Eating Index (HEI)-2015 score < 60 per study food frequency questionnaire (FFQ)
  • Body mass index (BMI) >= 25 kg/m^2 per self-reported height and weight
• Be free of any known (self-reported) ischemic heart disease or cardiomyopathy
• Have 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)

Exclusion Criteria:

• Individuals with known cardiomyopathy or ischemic heart disease based on prior CCSS surveys are excluded. While not likely to be common, participants who newly report in our study's screening questionnaire that they have newly diagnosed cardiomyopathy or ischemic heart disease will also be excluded
• Having any self-reported contraindication to walking or being physically active
• 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
• Individuals receiving active cancer treatment. Participants who report starting active cancer treatment after randomization can remain in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 (personalized clinician-led self-management telehealth); 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.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Behavioral: Behavioral Intervention; Receive personalized clinician-led self-management telehealth sessions; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Receive personalized goal setting for daily steps and activity and dietary goals; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Remote sessions with a health coach; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments
Experimental: Arm 2 (personalized goal setting); 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.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Behavioral: Behavioral Intervention; Receive personalized clinician-led self-management telehealth sessions; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Receive personalized goal setting for daily steps and activity and dietary goals; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Remote sessions with a health coach; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments
Active Comparator: Arm 3 (waitlist); Patients receive no intervention for 12 months. After 12 months, they may optionally receive their choice of intervention for up to 6 months.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies
Experimental: Arm 4 (remote sessions with a health coach); 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).	Other: Survey Administration; Ancillary studies; Behavioral: Behavioral Intervention; Receive personalized clinician-led self-management telehealth sessions; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Receive personalized goal setting for daily steps and activity and dietary goals; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Remote sessions with a health coach; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary time	<100 counts/minute as measured by research-grade accelerometry	Up to 12 months
Healthy Eating Index (HEI)-2015 score	On a scale of 100 (perfect score) as measured by Food Frequency Questionnaire	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant engagement	As measured by: 1) response to clinician action plans [score of 0-10; 10 being most engaged]; 2) use of mHealth apps [e.g., number of days with daily steps ≥500; number of days with recorded calories ≥500; social media interactions counting viewing, liking, or posting comments]; and 3) number of sessions completed with lifestyle health coach and coach's rating of engagement [score of 0-10; 10 being most engaged]	Up to 12 months
Health-related self-efficacy scale	Per Schwarzer R, et al. and converted to T-score (higher equaling greater self-efficacy)	Up to 12 months
Multidimensional Health Locus of Control Scale	Per Wallston KA, et al. with 3 subscales: internal, chance, and powerful others (each scored from 6-36, with higher values indicating greater agreement with that subscale's locus on control beliefs)	Up to 12 months

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eric J. Chow, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Psychotherapy; Behavioral Disciplines and Activities; Interviews as Topic; Behavior Therapy
• Other Study ID Numbers: RG1121690; 10784 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2021-09186 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA263144 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No