NCT05260723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

March 29, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

February 9, 2022

Last Update Submit

May 11, 2023

Conditions

Keywords

Physical FunctionCognitive FunctionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Retention rate of enrolled participants

    Percent of participants returning for the 3 month measures

    3 months

Secondary Outcomes (4)

  • 4 meter walk test

    3 months

  • 30-second Sit-to-Stand Test

    3 months

  • Timed Up and Go (TUG)

    3 months

  • Patient Reported Measurement Information System - Physical Function

    3 months

Study Arms (1)

Sit Less

EXPERIMENTAL

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

Interventions

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).

Sit Less

Eligibility Criteria

Age50 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 2, 2022

Study Start

March 29, 2022

Primary Completion

April 7, 2023

Study Completion

May 7, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations