Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors - Clinical Trial for Survivorship | NCT02688192

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Intervention

Internet-Based Intervention

Monitoring Device

Quality-of-Life Assessment

About this trial

This is an interventional supportive care trial for Survivorship

Eligibility Criteria

13 Years - 25 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Hackensack University Medical Center
Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm I (Intervention)

Arm II (Waitlist Control [WLC])

Arm Description

Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation 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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Feasibility - Retention

Percentage of participants who compete the 3 month assessment

Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale

Fatigue measured using the PedsQL Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale yields three subscales: general, sleep/rest, and cognitive fatigue. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.

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

The PedsQL Generic Core Scale is a well-validated measure of HRQOL with physical, emotional, social, and cognitive functioning domains. The PedsQL Generic Core yields two summary scores - Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.

Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test

Cardiorespiratory fitness was measured via submaximal treadmill testing using a modified Bruce protocol. This standardized graded treadmill test adds two warm-up stages, with the first performed at a 1.7 mph and 0% grade and the second at 1.7 mph and 5% grade. Participants performed the graded exercise test until they reached 85% of their age-predicted maximum heart rate, which was measured using a chest-worn Polar heart rate monitor. Estimated VO2 max was calculated for each participant using the multi-stage model and American College of Sports Medicine metabolic equations.

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

Lower and upper body muscular strength/endurance were measured via 10-repetition maximum (10-RM) tests following National Strength and Conditioning Association guidelines (leg press machine for lower body and barbell bench press for upper body). Weight was increased until participants executed 10 repetitions in good form for both exercises. Estimates of 1-RM leg and bench press were made using a linear prediction equation. Higher scores indicate greater muscular strength/endurance.

Feasibility - Engagement With the App

Engagement with the app was measured by 1) number of in-app exercises completed; 2) points earned (more active = more points); 3) achievements unlocked; and 4) number of likes and comments posted within the social feed. These are count data. Achievements unlocked has possible range of 0 to 20. Number of in-app exercises completed, points earned, and number of likes and comments posted within the social feed have a possible lower limit of 0 and no upper limit; higher numbers indicate more instances of each. The full range of participant data are: number of in-app exercises completed = 0-44; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8.

Full Information

NCT ID

NCT02688192

First Posted

November 30, 2015

Last Updated

April 7, 2021

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT02688192

Brief Title

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

Acronym

TLCFIT

Official Title

Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

January 2, 2014 (Actual)

Primary Completion Date

May 22, 2018 (Actual)

Study Completion Date

July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Survivorship, Fatigue

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (Intervention)

Arm Type

Active Comparator

Arm Description

Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation 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

Arm Title

Arm II (Waitlist Control [WLC])

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise Intervention

Intervention Description

Participate in fitness program

Intervention Type

Behavioral

Intervention Name(s)

Internet-Based Intervention

Intervention Description

Engage in private social support messaging and Use the mobile app

Intervention Type

Device

Intervention Name(s)

Monitoring Device

Other Intervention Name(s)

Monitor

Intervention Description

Wear an electronic accelerometer

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Feasibility of the Technology-enhanced Fitness Program

Description

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).

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Feasibility - Retention

Description

Percentage of participants who compete the 3 month assessment

Time Frame