Physical Activity Intervention for Young Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT04064892|
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Quality of Life Physical Activity||Behavioral: Exercise Intervention||Not Applicable|
Young breast cancer survivors (i.e. those < 50 years old) have lower survival rates than their older counterparts and experience unique physical and mental challenges associated with their cancer treatments. Depression, anxiety, and poor body image are common in young breast cancer survivors. Research in older breast cancer survivors has shown that physical activity can decrease cancer recurrence and mortality, and improve many aspects of quality of life. Few physical activity intervention studies have been conducted in young breast cancer survivors, despite the fact that young survivors would be best served by age-specific interventions designed to target their needs. Remotely-delivered, technology-based interventions may be important to help young breast cancer survivors overcome unique barriers to increasing physical activity and improving quality of life.
The study aims are: 1) Explore the feasibility and acceptability of a technology-based, remotely-delivered, peer-moderated physical activity intervention for young breast cancer survivors; 2a) Assess the invention's impact on change in physical activity; and 2b) Measure the intervention's effect on multiple aspects of quality of life
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Physical Activity Interventions for Young Cancer Survivors|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Exercise Intervention
Participants will receive a 12-week, individually-tailored, video conference-based physical activity intervention
Behavioral: Exercise Intervention
The intervention will use peer mentors, motivational interviewing, and technology (Fitbit, Fitbit Coach App, & Fitbit message board) to support behavior change. All participants will receive phone or video calls from their peer mentors every other week, and interact with their peer mentor and other participants through a private Fitbit message board at least weekly. Peer mentors will use Fitbit data to identify participants who need additional support to increase their activity.
- Physical Activity [ Time Frame: Baseline to 12 weeks ]The ActiGraph GT3X+ accelerometer will be used to measure change in minutes of moderate to vigorous physical activity from baseline to 12 weeks. For 7 days around each assessment time point, participants will wear the accelerometer.
- Body Image Scale [ Time Frame: Baseline to 12 weeks ]The Body Image Scale will be used to measure changes in perceptions of body image from baseline to 12 weeks. Scores range from 0 to 30. A higher score indicates more distress.
- Female Sexual Function Index [ Time Frame: Baseline to 12 weeks ]The Female Sexual Function Index will be used to measure change in self-reported sexual functioning from baseline to 12 weeks. Scores range from 2 to 36. A higher score indicates fewer problems with sexual functioning.
- PROMIS Cancer - Fatigue [ Time Frame: Baseline to 12 weeks ]Change in fatigue from baseline to 12 weeks will be assessed via a Patient-Reported Outcome Measurement Information System (PROMIS) computer adaptive test (CAT), PROMIS Cancer- Fatigue. CAT items are dynamically selected for administration from an item bank based upon the respondent's previous answers. Participants will complete 4-12 items. This measure yields a T-Score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of fatigue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064892
|Contact: Sheri J Hartman, PhDemail@example.com|
|Contact: Lauren S Weiner, BAfirstname.lastname@example.org|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Sheri J Hartman, PhD 858-534-9235 email@example.com|
|Principal Investigator: Sheri J Hartman, PhD|