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

Cancer Clinical Trial

— THRIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386383
• Other study ID #: LCCC1709
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: March 25, 2019

Study information

• Verified date: May 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Physical Activity

Intervention

Behavioral:
• Intervention
Individual session, physical activity tracker, online intervention

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Posttraumatic growth	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).	Baseline, 3 months, 6 months
Other	Positive psychosocial illness impact	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.	Baseline, 3 months, 6 months
Other	Negative psychosocial illness impact	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.	Baseline, 3 months, 6 months
Other	Positive affect	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.	Baseline, 3 months, 6 months
Other	Social network orientation	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.	Baseline, 3 months, 6 months
Primary	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.
Primary	Participation rate	Percentage of eligible participants who agreed to participate.	Through completion of study enrollment, an average of 6 months.
Primary	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	Retention rate at 6 months	Number of intervention participants who completed 6-month measures divided by the number randomized to the intervention group.	6 months
Secondary	Satisfaction with intervention	Ratings of satisfaction with the intervention, as measured by satisfaction questionnaire.	6 months
Secondary	Adherence to physical activity monitoring	Number of days physical activity tracked, as measured by Fitbit.	Through study completion, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	Weight	Change in self-reported weight, from baseline to 3 months, and 3 months to 6 months.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months