NCT05075759

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

SALSA: Study of Active LifeStyle Activation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Not accepted

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: 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).

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Receive personalized clinician-led self-management telehealth sessions
BEHAVIORAL	Behavioral Intervention	Receive personalized goal setting for daily steps and activity and dietary goals
BEHAVIORAL	Behavioral Intervention	Remote sessions with a health coach
OTHER	Survey Administration	Ancillary studies
OTHER	Interview	Ancillary studies

Timeline

• Start date: 2022-06-06
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-10-13
• Last updated: 2026-04-16

Locations

2 sites across 1 country: United States