Physical Activity Intervention for Young Cancer Survivors

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT04064892
Collaborator
Haus of Volta (Other)
34
1
1
13
2.6

Study Details

Study Description

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
  • Behavioral: Exercise Intervention
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
N/A
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 :
Sep 1, 2019
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Physical Activity [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Diego La Jolla California United States 92093

Sponsors and Collaborators

  • University of California, San Diego
  • Haus of Volta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheri Hartman, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT04064892
Other Study ID Numbers:
  • 181367
First Posted:
Aug 22, 2019
Last Update Posted:
Nov 3, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 3, 2020