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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
374
Receive personalized clinician-led self-management telehealth sessions
Receive personalized goal setting for daily steps and activity and dietary goals
Remote sessions with a health coach
Ancillary studies
Ancillary studies
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Sedentary time
\<100 counts/minute as measured by research-grade accelerometry
Time frame: Up to 12 months
Healthy Eating Index (HEI)-2015 score
On a scale of 100 (perfect score) as measured by Food Frequency Questionnaire
Time frame: Up to 12 months
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 \[score of 0-10; 10 being most engaged\]
Time frame: Up to 12 months
Health-related self-efficacy scale
Per Schwarzer R, et al. and converted to T-score (higher equaling greater self-efficacy)
Time frame: 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)
Time frame: Up to 12 months
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