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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-02

Study Completion Date

2018-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Survivorship Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (Intervention)

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

Group Type ACTIVE_COMPARATOR

Exercise Intervention

Intervention Type BEHAVIORAL

Participate in fitness program

Internet-Based Intervention

Intervention Type BEHAVIORAL

Engage in private social support messaging and Use the mobile app

Monitoring Device

Intervention Type DEVICE

Wear an electronic accelerometer

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm II (Waitlist Control [WLC])

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

Group Type ACTIVE_COMPARATOR

Exercise Intervention

Intervention Type BEHAVIORAL

Participate in fitness program

Internet-Based Intervention

Intervention Type BEHAVIORAL

Engage in private social support messaging and Use the mobile app

Monitoring Device

Intervention Type DEVICE

Wear an electronic accelerometer

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Exercise Intervention

Participate in fitness program

Intervention Type BEHAVIORAL

Internet-Based Intervention

Engage in private social support messaging and Use the mobile app

Intervention Type BEHAVIORAL

Monitoring Device

Wear an electronic accelerometer

Intervention Type DEVICE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Monitor Quality of Life Assessment

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No