RISE - Reduce Sitting Time Among Breast Cancer Survivors

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Sedentary Behavior; Sedentary Time
• Intervention / Treatment: Behavioral: Behavioral: Sit Less

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Moores UCSD Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sit Less; The primary goal of the Sit Less arm is to reduce the total amount of time spent sitting each day and break up prolonged bouts of sitting.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate of enrolled participants	Percent of participants returning for the 3 month measures	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4 meter walk test	Measure of physical functioning	3 months
30-second Sit-to-Stand Test	Measure of physical functioning	3 months
Timed Up and Go (TUG)	Measure of physical functioning	3 months
Patient Reported Measurement Information System - Physical Function	Measure of Self-Report Physical Function, standardized T-score, higher scores indicated better functioning	3 months

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): May 7, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Physical Function; Cognitive Function
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PILOT 171548

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No