Physical Activity Intervention for Young Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Physical Activity Interventions for Young Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064892
• Other study ID #: 181367
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Physical Activity
• Quality of Life

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.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Haus of Volta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity	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.	Baseline to 12 weeks
Secondary	Body Image Scale	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.	Baseline to 12 weeks
Secondary	Female Sexual Function Index	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.	Baseline to 12 weeks
Secondary	PROMIS Cancer - Fatigue	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.	Baseline to 12 weeks