Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Physical Activity Intervention for Young Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064892
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Haus of Volta
Information provided by (Responsible Party):
Sheri Hartman, University of California, San Diego

Brief Summary:
The proposed mixed methods pilot study will enroll 20 young breast cancer survivors into a 12-week technology-based, remotely-delivered, peer-moderated physical activity program to examine the effects of the intervention on objectively measured physical activity and multiple aspects of quality of life; and conduct qualitative analyses to refine the intervention for a future randomized controlled trial.

Condition or disease Intervention/treatment Phase
Breast Cancer Quality of Life Physical Activity Behavioral: Exercise Intervention Not Applicable

Detailed Description:

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


Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with breast cancer between 18-49 years old
  • Completed active treatment (chemotherapy, radiation) at least 6 months prior to enrollment
  • Self-report low levels of moderate to vigorous physical activity each week
  • Accessible by phone or video chat
  • Have a Fitbit compatible cellphone, tablet, or laptop with Internet

Exclusion Criteria:

  • medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
  • currently pregnant
  • unable to commit to intervention schedule
  • prisoner

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Sheri J Hartman, PhD 8585349235 sjhartman@ucsd.edu
Contact: Lauren S Weiner, BA 8585346224 lsweiner@ucsd.edu

Locations
Layout table for location information
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Sheri J Hartman, PhD    858-534-9235    sjhartman@ucsd.edu   
Principal Investigator: Sheri J Hartman, PhD         
Sponsors and Collaborators
University of California, San Diego
Haus of Volta

Layout table for additonal information
Responsible Party: Sheri Hartman, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04064892     History of Changes
Other Study ID Numbers: 181367
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No