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Completed

NCT Number: NCT03386383

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

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

Individual session, physical activity tracker, online intervention

Primary outcomes

  1. 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.

  2. Participation rate

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

    Percentage of eligible participants who agreed to participate.

  3. 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

  1. Retention rate at 6 months

    Time frame: 6 months

    Number of intervention participants who completed 6-month measures divided by the number randomized to the intervention group.

  2. Satisfaction with intervention

    Time frame: 6 months

    Ratings of satisfaction with the intervention, as measured by satisfaction questionnaire.

  3. Adherence to physical activity monitoring

    Time frame: Through study completion, 6 months

    Number of days physical activity tracked, as measured by Fitbit.

  4. Physical activity: objective

    Time frame: Baseline, 3 months, 6 months

    Change in objective levels of physical activity, as measured by accelerometry (Actigraph), from baseline to 3 months, and 3 months to 6 months.

  5. Physical activity: self-report

    Time frame: Baseline, 3 months, 6 months

    Change in self-report levels of physical activity, as measured by the Godin Leisure Time Exercise Questionnaire, from baseline to 3 months, and 3 months to 6 months.

  6. Sedentary behavior: self-report

    Time frame: Baseline, 3 months, 6 months

    Change in self-report levels of sedentary behavior, as measured by the Marshall Sitting Time Questionnaire, from baseline to 3 months, and 3 months to 6 months.

  7. Weight

    Time frame: Baseline, 3 months, 6 months

    Change in self-reported weight, from baseline to 3 months, and 3 months to 6 months.

  8. Intrinsic motivation

    Time frame: Baseline, 3 months, 6 months

    Change in intrinsic motivation, as measured by the intrinsic motivation subscale of the Treatment Self-Regulation Questionnaire for Exercise, from baseline to 3 months, and 3 months to 6 months. Responses to four items comprising intrinsic motivation subscale are averaged to yield a score from 1 to 7, with higher values representing higher intrinsic motivation.

  9. Self-efficacy for exercise

    Time frame: Baseline, 3 months, 6 months

    Change in self-efficacy for exercise, as measured by the Self-Efficacy and Exercise Habits Survey, from baseline to 3 months, and 3 months to 6 months. Responses for two subscales (Sticking to it, Making time for exercise) are averaged to yield a score from 1 to 5, with higher values representing higher self-efficacy for exercise.

  10. Social support for exercise

    Time frame: Baseline, 3 months, 6 months

    Change in social support for exercise, as measured by the Social Support for Exercise Survey, from baseline to 3 months, and 3 months to 6 months. Responses for three factors (Family participation, Friend participation, Friends on social networking sites participation), ranging from 1 to 5, are summed, with higher values representing higher social support for exercise.

Other outcomes

  1. Posttraumatic growth

    Time frame: Baseline, 3 months, 6 months

    Change in posttraumatic growth, as measured by the Short Form of the Posttraumatic Growth Inventory, from baseline to 3 months, and 3 months to 6 months. Responses range from 0 to 5 and yield an overall score and subscale scores for relating to others, new possibilities, personal strength, spiritual change, and appreciation of life. Items are summed, with higher scores reflecting more positive change (i.e., posttraumatic growth).

  2. Positive psychosocial illness impact

    Time frame: Baseline, 3 months, 6 months

    Changes in positive psychosocial impact of illness, as measured by the PROMIS Psychosocial Illness Impact - Positive (4a), from baseline to 3 months, and 3 months to 6 months. Responses to the 4-item short from range from 1 to 5. Items are summed, with higher scores reflecting more positive psychosocial impact.

  3. Negative psychosocial illness impact

    Time frame: Baseline, 3 months, 6 months

    Changes in positive psychosocial impact of illness, as measured by the PROMIS Psychosocial Illness Impact - Negative (4a), from baseline to 3 months, and 3 months to 6 months. Responses to the 4-item short from range from 1 to 5. Items are summed, with higher scores reflecting more negative psychosocial impact.

  4. Positive affect

    Time frame: Baseline, 3 months, 6 months

    Changes in positive affect, as measured by the NIH Toolbox Positive Affect Short Form, from baseline to 3 months, and 3 months to 6 months.

  5. Social network orientation

    Time frame: Baseline, 3 months, 6 months

    Changes in positive affect, as measured by the Network Orientation Scale, from baseline to 3 months, and 3 months to 6 months. Responses to 20 items range from 1 to 4. Items are summed (range: 20 to 80), with higher scores representing a more negative social network orientation.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Wake Forest University Health Sciences

Registry information

Acronym: THRIVE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2017
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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