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RISE - Reduce Sitting Time Among Breast Cancer Survivors

Primary Purpose

Sedentary Behavior, Sedentary Time, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: Sit Less
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sedentary Behavior focused on measuring Physical Function, Cognitive Function, Quality of Life

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Moores UCSD Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sit Less

Arm Description

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.

Outcomes

Primary Outcome Measures

Retention rate of enrolled participants
Percent of participants returning for the 3 month measures

Secondary Outcome Measures

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

Full Information

First Posted
February 9, 2022
Last Updated
May 11, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05260723
Brief Title
RISE - Reduce Sitting Time Among Breast Cancer Survivors
Official Title
RISE - A Pilot Study to Reduce Sitting Time Among Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
April 7, 2023 (Actual)
Study Completion Date
May 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Behavior, Sedentary Time, Breast Cancer
Keywords
Physical Function, Cognitive Function, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sit Less
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Sit Less
Intervention Description
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).
Primary Outcome Measure Information:
Title
Retention rate of enrolled participants
Description
Percent of participants returning for the 3 month measures
Time Frame
3 months
Secondary Outcome Measure Information:
Title
4 meter walk test
Description
Measure of physical functioning
Time Frame
3 months
Title
30-second Sit-to-Stand Test
Description
Measure of physical functioning
Time Frame
3 months
Title
Timed Up and Go (TUG)
Description
Measure of physical functioning
Time Frame
3 months
Title
Patient Reported Measurement Information System - Physical Function
Description
Measure of Self-Report Physical Function, standardized T-score, higher scores indicated better functioning
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

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RISE - Reduce Sitting Time Among Breast Cancer Survivors

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