Intervention
BehavioralIndividual session, physical activity tracker, online intervention
NCT Number: NCT03386383
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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Notify Me18 year–39 year
All sexes
Interventional
Not applicable
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individual session, physical activity tracker, online intervention
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.
Time frame: Through completion of study enrollment, an average of 6 months.
Percentage of eligible participants who agreed to participate.
Time frame: 3 months
Number of intervention participants who completed 3-month measures divided by the number who consented to participate.
Time frame: 6 months
Number of intervention participants who completed 6-month measures divided by the number randomized to the intervention group.
Time frame: 6 months
Ratings of satisfaction with the intervention, as measured by satisfaction questionnaire.
Time frame: Through study completion, 6 months
Number of days physical activity tracked, as measured by Fitbit.
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.
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.
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.
Time frame: Baseline, 3 months, 6 months
Change in self-reported weight, from baseline to 3 months, and 3 months to 6 months.
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.
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.
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.
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).
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.
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.
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.
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.
UNC Lineberger Comprehensive Cancer Center
Other
Acronym: THRIVE
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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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