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Clinical Trials/NCT03386383
NCT03386383
Completed
N/A

mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers

UNC Lineberger Comprehensive Cancer Center3 sites in 1 country64 target enrollmentFebruary 28, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
64
Locations
3
Primary Endpoint
Accrual rate
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote physical activity among adolescent and young adult (AYA) cancer survivors compared to a delayed intervention control group.

Detailed Description

Adolescent and young adult (AYA) survivors are not meeting recommended physical activity guidelines for cancer survivors, and few interventions to date have focused specifically on promoting physical activity among AYAs or capitalized on new technologies to deliver them. This is a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote PA among AYA survivors compared to a delayed intervention control group. This project will focus on how to best integrate self-monitoring with wearable trackers, increase self-efficacy, enhance autonomous motivation, and promote social support in a mobile health behavioral intervention that promotes moderate-to-vigorous intensity physical activity (MVPA) among AYA survivors. Participants will be AYA cancer survivors (N=60), diagnosed at age 15 or older and currently age 18-39. AYA cancer survivors will be recruited from the three comprehensive cancer centers in North Carolina to participate in this study. The behavioral intervention will consist of an activity tracker, Facebook group, weekly email lessons, and weekly tailored feedback emails. Assessments of objectively-measured physical activity and other outcomes will be completed at baseline, 3, and 6 months.

Registry
clinicaltrials.gov
Start Date
February 28, 2018
End Date
March 25, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with cancer (excluding basal cell skin cancer) at age 15 or older
  • Currently age 18-39
  • Are 0 to 10 years post active cancer treatment (i.e., current hormonal treatments or maintenance therapies are permissible)
  • Able to speak, read and write English
  • Have access to the Internet and computer on at least a weekly basis
  • Possession and usage of an Internet e-mail address or willingness to sign up for a free email account
  • Have active Facebook account
  • Willing to be randomized to either arm

Exclusion Criteria

  • History of heart attack or stroke within past 6 months
  • Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
  • Have a pre-existing medical condition(s) or contraindications that preclude adherence to an unsupervised exercise program, including cardiovascular disease, heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
  • Are already adhering to the American Cancer Society's recommendation of ≥150 minutes of moderate-intensity exercise per week (\<150 minutes/week)
  • Current participation in another physical activity or weight control program
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
  • Plans for major surgery (e.g., breast reconstruction) during the study time frame

Outcomes

Primary Outcomes

Accrual rate

Time Frame: Through completion of study enrollment, an average of 6 months.

Number of participants who agreed to participate divided by the number of months of recruitment.

Participation rate

Time Frame: Through completion of study enrollment, an average of 6 months.

Percentage of eligible participants who agreed to participate.

Retention rate at 3 months

Time Frame: 3 months

Number of intervention participants who completed 3-month measures divided by the number who consented to participate.

Secondary Outcomes

  • Satisfaction with intervention(6 months)
  • Intrinsic motivation(Baseline, 3 months, 6 months)
  • Retention rate at 6 months(6 months)
  • Weight(Baseline, 3 months, 6 months)
  • Adherence to physical activity monitoring(Through study completion, 6 months)
  • Physical activity: objective(Baseline, 3 months, 6 months)
  • Physical activity: self-report(Baseline, 3 months, 6 months)
  • Sedentary behavior: self-report(Baseline, 3 months, 6 months)
  • Social support for exercise(Baseline, 3 months, 6 months)
  • Self-efficacy for exercise(Baseline, 3 months, 6 months)

Study Sites (3)

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