RISE - Reduce Sitting Time Among Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

RISE - A Pilot Study to Reduce Sitting Time Among Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260723
• Other study ID #: PILOT 171548
• Status: Completed
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: May 7, 2023

Study information

• Verified date: May 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life.

Description:

Many cancer survivors experience long-term physical problems following their cancer treatments and can often seem much older than same age peers who were never treated for cancer. This is known as accelerated aging. One way to improve accelerated aging is to increase moderate to vigorous intensity exercise; however, for many cancer survivors, especially those with physical limitations, increasing exercise levels is not possible. Another potential way to improve accelerated aging may be to decrease the amount of time spent sitting. Long periods of sitting are related to many physical and health problems. Cancer survivors spend more than 9 hours a day sitting and often increase the amount they sit after their cancer treatments. This study could help identify realistic intervention targets for many cancer survivors and be used to guide recommendations for improving physical function and quality of life after cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 7, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer survivors (stages I-IV) at least 1 year post active treatment (e.g., chemotherapy, radiotherapy)

• Breast cancer was treated with chemotherapy, radiation, immunotherapy, and/or endocrine therapy

• self-report difficulties with physical function

• self-report low levels of moderate to vigorous physical activity

• self-report high levels of sitting time

Exclusion Criteria:

• medical condition that interferes with ability to safely stand or stay balanced

• other cancer diagnoses that occurred after their breast cancer diagnosis

• Stage IV breast cancer with brain metastases or less than 12 months life-expectancy

• unable to commit to a 3-month study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sedentary Behavior
• Sedentary Time

Intervention

Behavioral:
• Behavioral: Sit Less
The Sit Less arm uses habit formation, social cognitive theory, and motivational interviewing techniques to support behavior change and includes: 1) 7 health coaching sessions to set personalized goals and review progress; 2) wearing an activPAL (thigh worn accelerometer that measures sitting time); 3) intervention tools to support behavior change (e.g., standing desk, wrist worn monitor).

Locations

Country	Name	City	State
United States	Moores UCSD Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate of enrolled participants	Percent of participants returning for the 3 month measures	3 months
Secondary	4 meter walk test	Measure of physical functioning	3 months
Secondary	30-second Sit-to-Stand Test	Measure of physical functioning	3 months
Secondary	Timed Up and Go (TUG)	Measure of physical functioning	3 months
Secondary	Patient Reported Measurement Information System - Physical Function	Measure of Self-Report Physical Function, standardized T-score, higher scores indicated better functioning	3 months