Promoting Physical Activity in Young Adult Cancer Survivors Using mHealth and Adaptive Tailored Feedback Strategies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2021-01-29

Brief Summary

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To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to PA. The purpose of this randomized controlled trial is to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing physical activity among young adult cancer survivors.

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Detailed Description

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There are over half a million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk over time for obesity and chronic diseases such as diabetes and cardiovascular disease. Increasing physical activity is a promising behavioral intervention that has positive effects on physical function, body composition, cardiovascular fitness, health-related quality of life, and depression, and may prevent cancer recurrence, new cancers and improve survival. To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to physical activity. This is a randomized controlled trial to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing PA among young adult cancer survivors. Young adult cancer survivors (n=280), diagnosed between ages 18-39, will be recruited and randomized into one of two conditions: 1) activity tracker + Facebook group (Self-help) or 2) activity tracker + Facebook group + adaptive goal-setting and tailored feedback (Intervention). Young adult cancer survivors will receive a 6-month intervention followed by an additional 6 months of tapered contacts. Assessments of objectively-measured physical activity and other outcomes will be conducted at baseline, 3, 6, and 12 months.

Conditions

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Physical Activity Neoplasms Neoplasms by Site Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After completing informed consent, 7-day PA assessment, weight measurement, and baseline questionnaires, participants will be randomly assigned with equal probability to 1 of 2 treatment groups: 1) self-help or 2) intervention. Future treatment assignments will be concealed from study staff who are recruiting and enrolling participants.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Self-help

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.

Group Type ACTIVE_COMPARATOR

Intervention

Intervention Type BEHAVIORAL

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group with the addition of behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.

Intervention

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group, behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.

Group Type EXPERIMENTAL

Self-help

Intervention Type BEHAVIORAL

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.

Interventions

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Self-help

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.

Intervention Type BEHAVIORAL

Intervention

Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group with the addition of behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.

Intervention Type BEHAVIORAL

Other Intervention Names

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Digital tools Digital tools plus

Eligibility Criteria

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Inclusion Criteria

* Currently age 18-39
* Diagnosed with invasive malignancy between the ages of 18-39 years
* Diagnosed with invasive malignancy in the last 10 years with no evidence of progressive disease or second primary cancers
* Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
* Have the ability to read, write and speak English
* No pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
* Not adhering to the American College of Sports Medicine recommendation of at least 150 moderate-to-vigorous physical activity minutes/week
* Have access to the Internet 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 (e.g., gmail)
* Have mobile phone with text messaging plan
* Willing to be randomized to either arm
* Successful completion of accelerometer-assessed activity (i.e., at least 10 hours/day on 4 of 7 days) and return of the accelerometer in a pre-paid envelope at baseline

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
* Health problems which preclude ability to walk for physical activity
* Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency.
* Report a past diagnosis of or treatment for a DSM-IV-TR eating disorder (anorexia nervosa or bulimia nervosa)
* Current participation in another physical activity or weight control program
* Currently using prescription weight loss medications
* Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
* Currently exercising \> 150 minutes/week of moderate-to-vigorous intensity physical activity

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No