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

NCT03386383 | Completed DMC

• 1 other identifier: LCCC1709
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer; Physical Activity

Keywords

adolescent and young adult; cancer survivor

Outcome Measures

Primary Outcomes (3)

• Accrual rate

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

  Through completion of study enrollment, an average of 6 months.

• Participation rate

  Percentage of eligible participants who agreed to participate.

  Through completion of study enrollment, an average of 6 months.

• Retention rate at 3 months

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

  3 months

Secondary Outcomes (10)

• Retention rate at 6 months

  6 months

• Satisfaction with intervention

  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

Other Outcomes (5)

• Posttraumatic growth

  Baseline, 3 months, 6 months

• Positive psychosocial illness impact

  Baseline, 3 months, 6 months

• Negative psychosocial illness impact

  Baseline, 3 months, 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive an initial individual session, physical activity tracker, weekly behavioral lessons, tailored feedback summaries, and access to a Facebook group immediately after baseline assessments.

Behavioral: Intervention

Wait List Control

NO INTERVENTION

Participants will receive a physical activity tracker and be advised to maintain their current activity. After 3 months, participants will receive an initial individual session, weekly behavioral lessons, tailored feedback summaries, and access to a Facebook group.

Interventions

Intervention BEHAVIORAL

Individual session, physical activity tracker, online intervention

Intervention

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (3)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Carmina G. Valle, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• John M. Salsman, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 4
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: December 29, 2017
• Study Start: February 28, 2018
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)