Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05075759

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

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

Survey Administration

Other

Ancillary studies

interview

Other

Ancillary studies

Primary outcomes

  1. Sedentary time

    Time frame: Up to 12 months

    <100 counts/minute as measured by research-grade accelerometry

  2. Healthy Eating Index (HEI)-2015 score

    Time frame: Up to 12 months

    On a scale of 100 (perfect score) as measured by Food Frequency Questionnaire

Secondary outcomes

  1. Participant engagement

    Time frame: Up to 12 months

    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]

  2. Health-related self-efficacy scale

    Time frame: Up to 12 months

    Per Schwarzer R, et al. and converted to T-score (higher equaling greater self-efficacy)

  3. Multidimensional Health Locus of Control Scale

    Time frame: Up to 12 months

    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)

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

SALSA: Study of Active LifeStyle Activation

Acronym: SALSA

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2021
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.