Clinical trial NCT05075759: Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality in Survivors of Childhood Cancer
Official title: SALSA: Study of Active LifeStyle Activation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-13
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: 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.

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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sedentary time
timeFrame: Up to 12 months
measure: Healthy Eating Index (HEI)-2015 score
timeFrame: Up to 12 months
Secondary outcomes:
measure: Participant engagement
timeFrame: Up to 12 months
measure: Health-related self-efficacy scale
timeFrame: Up to 12 months
measure: Multidimensional Health Locus of Control Scale
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Eric J. Chow
role: PRINCIPAL_INVESTIGATOR
References: