Clinical trial NCT03386383: mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers
Official title: mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Physical Activity
Keywords: adolescent and young adult
cancer survivor
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2017-12-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Accrual rate
timeFrame: Through completion of study enrollment, an average of 6 months.
measure: Participation rate
timeFrame: Through completion of study enrollment, an average of 6 months.
measure: Retention rate at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Retention rate at 6 months
timeFrame: 6 months
measure: Satisfaction with intervention
timeFrame: 6 months
measure: Adherence to physical activity monitoring
timeFrame: Through study completion, 6 months
measure: Physical activity: objective
timeFrame: Baseline, 3 months, 6 months
measure: Physical activity: self-report
timeFrame: Baseline, 3 months, 6 months
measure: Sedentary behavior: self-report
timeFrame: Baseline, 3 months, 6 months
measure: Weight
timeFrame: Baseline, 3 months, 6 months
measure: Intrinsic motivation
timeFrame: Baseline, 3 months, 6 months
measure: Self-efficacy for exercise
timeFrame: Baseline, 3 months, 6 months
measure: Social support for exercise
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Posttraumatic growth
timeFrame: Baseline, 3 months, 6 months
measure: Positive psychosocial illness impact
timeFrame: Baseline, 3 months, 6 months
measure: Negative psychosocial illness impact
timeFrame: Baseline, 3 months, 6 months
measure: Positive affect
timeFrame: Baseline, 3 months, 6 months
measure: Social network orientation
timeFrame: Baseline, 3 months, 6 months
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmina G. Valle, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: John M. Salsman, PhD
role: PRINCIPAL_INVESTIGATOR
References: