Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors

PRIMARY OBJECTIVES:

I. Develop and evaluate the usability of cancer-specific and motivational tools in the mobile
application (app). (Phase 1) II. Evaluate the feasibility of the technology-enhanced
(electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot
randomized clinical trial. (Phase 2)

SECONDARY OBJECTIVES:

I. Determine the effectiveness of the technology-enhanced fitness program on participants'
cardiorespiratory fitness and muscular fitness.

II. Examine the effects of the program on secondary outcomes of health related quality of
life (HRQOL) and fatigue.

OUTLINE:

PHASE I: Participants attend individual or small group interviews and provide input about
desired features for the app. After a usable app is developed, participants wear an
electronic accelerometer, use the mobile app, and may engage in private social support
messaging between individuals in the study. Participants may undergo an individual one time
interview, perform an usability test over 1-2 hours, or perform a field trial using the app
for up to 1 week.

PHASE II: Participants are randomized to 1 of 2 arms.

ARM I (TEENS LIVING WITH CANCER - FITNESS IMPROVEMENT TRAINING [TLC FIT]): Participants
attend 8 group meetings over 90 minutes weekly, wear an electronic accelerometer, engage in
private social support messaging within the app and Facebook private groups, and use the
mobile app for up to 4 weeks without in-person groups.

ARM II (WAIT-LIST CONTROL [WLC]): After the 6 month assessment, participants receive the TLC
FIT intervention as in arm I.

Inclusion Criteria:

- PHASE I: Any diagnosis of cancer prior to age 21

- PHASE I: Off treatment

- PHASE I: For patients < 18 years, parents must give informed consent and patient must
give assent; patients >= 18 must give informed consent

- PHASE II: Any diagnosis of cancer prior to age 21

- PHASE II: Off treatment for at least 6 months

- PHASE II: For patients < 18 years, parents must give informed consent and patient must
give assent; patients >= 18 must give informed consent

Exclusion Criteria:

- PHASE I: Non-English speaking

- PHASE I: Significant developmental delay per patient, parent, or physician report

- PHASE I: Pregnant (per patient report)

- PHASE II: Any medical contraindication to exercise according to a physician or
physician's designee

- PHASE II: Non-English speaking

- PHASE II: Current physical activity level exceeding Centers for Disease Control and
Prevention (CDC) guidelines for activity (60 min of moderate-vigorous exercise/day for
5+ days/week (wk) including 3+ days of vigorous intensity activities and
muscle-strengthening exercises on 3+ days/wk and bone strengthening exercises on 3+
days/wk for children < 18 and 150 min of moderate vigorous exercise or 75 min of
vigorous exercise/wk and 2+ days of muscle strengthening activities for adults >= 18);
the CDC guidelines are used to determine exercise prescription in our intervention;
individuals already exceeding the guidelines would be unlikely to benefit from
participating

- PHASE II: Significant developmental delay per patient, parent, or physician report

- PHASE II: Pregnant (per patient report); if participant becomes pregnant during the
course of the study, she will be removed from further participation