AzTrials
AzTrials

CancerTHRIVENCT03386383

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

A study testing Intervention in people with Cancer and Physical Activity, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Cancer, Physical Activity
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesUnited States
Study dates
28 Feb 2018to 25 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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.

Being tested
Intervention
Keywords
adolescent and young adult, cancer survivor
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    Individual session, physical activity tracker, online intervention

Study groups in NCT03386383
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: Intervention
Wait List ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accrual rate

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

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

  2. Participation rate

    Percentage of eligible participants who agreed to participate.

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

  3. Retention rate at 3 months

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

    Measured: 3 months

Secondary outcomes (10)

  1. Retention rate at 6 months

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

    Measured: 6 months

  2. Satisfaction with intervention

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

    Measured: 6 months

  3. Adherence to physical activity monitoring

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

    Measured: Through study completion, 6 months

  4. Physical activity: objective

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

    Measured: Baseline, 3 months, 6 months

  5. Physical activity: self-report

    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.

    Measured: Baseline, 3 months, 6 months

  6. Sedentary behavior: self-report

    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.

    Measured: Baseline, 3 months, 6 months

  7. Weight

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

    Measured: Baseline, 3 months, 6 months

  8. Intrinsic motivation

    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.

    Measured: Baseline, 3 months, 6 months

  9. Self-efficacy for exercise

    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.

    Measured: Baseline, 3 months, 6 months

  10. Social support for exercise

    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.

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2017
  2. Study start28 Feb 2018
  3. Primary completion25 Mar 2019
  4. Study completion25 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03386383
Sponsor's protocol ID
LCCC1709
Acronym
THRIVE
Status last verified
May 2023
First submitted
13 Nov 2017
Last updated
31 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Cancer and Physical Activity, run by UNC Lineberger Comprehensive Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accrual rate (time frame: Through completion of study enrollment, an average of 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03386383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in