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

NCT02688192 | Completed Results

• 5 other identifiers: Pro2013003658NCI-2015-01841131323K07CA174728P30CA072720
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Survivorship; Fatigue

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Technology-enhanced Fitness Program

  Feasibility will be evaluated by the number of participants who enroll and complete baseline assessment for the randomized trial. In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).

  Baseline

Secondary Outcomes (6)

• Feasibility - Retention

  Baseline to post-intervention (3 months)

• Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale

  Baseline to post-intervention (3 months)

• Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale

  Baseline to post-intervention (3 months)

• Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test

  Baseline to post-intervention (3 months)

• Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)

  Baseline to post-intervention (3 months)

Study Arms (2)

Arm I (Intervention)

ACTIVE COMPARATOR

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

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

Arm II (Waitlist Control [WLC])

ACTIVE COMPARATOR

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

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

Interventions

Exercise Intervention BEHAVIORAL

Participate in fitness program

Arm I (Intervention); Arm II (Waitlist Control [WLC])

Internet-Based Intervention BEHAVIORAL

Engage in private social support messaging and Use the mobile app

Arm I (Intervention); Arm II (Waitlist Control [WLC])

Monitoring Device DEVICE

Wear an electronic accelerometer

Also known as: Monitor

Arm I (Intervention); Arm II (Waitlist Control [WLC])

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (Intervention); Arm II (Waitlist Control [WLC])

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (2)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Katie Devine
• Organization: Rutgers Cancer Inst. of NJ

katie.devine@rutgers.edu

7322357549

Study Officials

• Katie Devine

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: February 23, 2016
• Study Start: January 2, 2014
• Primary Completion: May 22, 2018
• Study Completion: July 30, 2018
• Last Updated: April 9, 2021
• Results First Posted: March 26, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)