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

Rutgers The State University of New Jersey

Status: Completed

Conditions: Survivorship; Fatigue

Treatments: Behavioral: Internet-Based Intervention; Other: Quality-of-Life Assessment; Behavioral: Exercise Intervention; Device: Monitoring Device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02688192

Pro2013003658

P30CA072720 (U.S. NIH Grant/Contract)

K07CA174728 (U.S. NIH Grant/Contract)

131323 (Other Identifier)

NCI-2015-01841 (Registry Identifier)

Details and patient eligibility

About

This clinical trial studies a mobile health fitness program for adolescent and young adult childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at risk to have negative late effects from treatment and to develop chronic health conditions. A sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early mortality. Physical activity reduces the risk for cardiovascular disease and early mortality, improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and it is also positively associated with quality of life. Programs and technologies that promote physical activity are important because health behaviors adopted by adolescent and young adult childhood cancer survivors are likely to continue into adulthood. A mobile health fitness application may motivate adolescent and young adult childhood cancer survivors to engage and maintain physical activity.

Full description

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial.

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:

Participants are randomized to 1 of 2 arms.

ARM I (Intervention): Participants attend 8 group meetings weekly, wear an electronic accelerometer, engage in private social support messaging within the app and Facebook private groups, and then use the mobile app for 4 weeks without in-person groups.

ARM II (WAITLIST CONTROL [WLC]): After the 6 month assessment, participants receive the FitSurvivor intervention as in arm I.

Enrollment: 49 patients

Sex: All

Ages: 13 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any diagnosis of cancer prior to age 21
• Off treatment for at least 6 months
• For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consent

Exclusion criteria

• Any medical contraindication to exercise according to a physician or physician's designee
• Non-English speaking
• 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
• Significant developmental delay per patient, parent, or physician report
• Pregnant (per patient report); if participant becomes pregnant during the course of the study, she will be removed from further participation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Arm I (Intervention)

Active Comparator group

Description:

Assessment including 1. Wear an electronic accelerometer 2. Quality of life assessment 3. Physical fitness evaluation 4. Participate in a fitness program which includes: * 8 group meetings of 90 minutes weekly * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app

Treatment:

Device: Monitoring Device

Behavioral: Exercise Intervention

Other: Quality-of-Life Assessment

Behavioral: Internet-Based Intervention

Arm II (Waitlist Control [WLC])

Active Comparator group

Description:

Assessment including 1. Wear an electronic accelerometer 2. Quality of life assessment 3. Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I

Treatment:

Device: Monitoring Device

Behavioral: Exercise Intervention

Other: Quality-of-Life Assessment

Behavioral: Internet-Based Intervention