An interventional study of Intervention in Cancer and Physical Activity, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 3 sites in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 64 is close to the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Behavioral: Intervention
Participants 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.
Individual session, physical activity tracker, online intervention
Accrual rate
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.
Participation rate
Percentage of eligible participants who agreed to participate.
Time frame: Through completion of study enrollment, an average of 6 months.
Retention rate at 3 months
Number of intervention participants who completed 3-month measures divided by the number who consented to participate.
Time frame: 3 months
Retention rate at 6 months
Number of intervention participants who completed 6-month measures divided by the number randomized to the intervention group.
Time frame: 6 months
Satisfaction with intervention
Ratings of satisfaction with the intervention, as measured by satisfaction questionnaire.
Time frame: 6 months
Adherence to physical activity monitoring
Number of days physical activity tracked, as measured by Fitbit.
Time frame: Through study completion, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
Weight
Change in self-reported weight, from baseline to 3 months, and 3 months to 6 months.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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).
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Mar 2019, 12 months.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 12 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UNC Lineberger Comprehensive Cancer Center →