The Plan and Stand Study: Reducing Sitting Time in Breast Cancer Survivors

July 5, 2018 updated by: University of Wisconsin, Madison

Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors

Excessive sitting time (sedentary time) has been associated with risk of insulin resistance and other factors which may be relevant to breast cancer prognosis. This 8-week study tests different strategies for helping breast cancer survivors to modify their levels of sitting time. Participants will be assigned with equal likelihood to one of three groups (1) overall reduction in sitting time, (2) interruption of sitting time with standing breaks, and (3) usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States
        • UW Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. diagnosed with Stage 0-III breast cancer. Bilateral or multiple primary breast cancers are permitted.
  2. Completed primary treatment defined as definitive surgery, (neo)adjuvant chemotherapy and/or (neo)adjuvant radiation. Participants still receiving adjuvant endocrine or HER2 targeted therapies are eligible.
  3. Report sitting for ≥8 accumulated waking hours on a typical day,
  4. Willing and able to attend 3 study visits at the UW,
  5. Willing to attempt reduction of sitting time,
  6. Use the internet on a regular basis,
  7. Willing and able to complete study requirements, and
  8. Currently considered postmenopausal (no menstrual periods in past 12 months), even if pre-menopausal at diagnosis.

Exclusion Criteria:

  1. Evidence of recurrence or metastatic disease,
  2. Unable to move from sitting to standing without difficulty and to walk 1 block.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Reducing Sitting Time Group
This group will be asked to reduce overall accumulated sitting time by 2 hours per day.
Behavioral: Reducing Sitting Time Group
This is a behavioral intervention to help women reduce their overall accumulated sitting time by 2 hours per day.
EXPERIMENTAL: Re-Patterning Sitting Time Group
This group will be asked to use standing breaks to interrupt long bouts of sitting time.
Behavioral: Re-Patterning Sitting Time Group
This is a behavioral intervention to help women interrupt long bouts of sitting time by incorporating standing breaks into their lifestyle.
PLACEBO_COMPARATOR: Usual Care
This is an attention control group and is not asked to make changes to sitting time.
Behavioral: Usual Care
This intervention consists solely of follow-up contact to control for attention effects and reduce attrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as measured by recruitment and retention rates
Time Frame: 12 months
Feasibility of recruiting participants to the study
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedentary behavior as measured by ActivPal
Time Frame: 7 days
Sedentary time as measured by the ActivPAL inclinometer
7 days
Physical activity as measured by ActiGraph
Time Frame: 7 days
Physical activity as measured by the ActiGraph accelerometer
7 days
Sedentary time as measured by ActiGraph
Time Frame: 7 days
Sedentary time as measured by the ActiGraph accelerometer
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Lisa A Cadmus-Bertram, Ph.D., University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 30, 2015

Primary Completion (ACTUAL)

January 24, 2018

Study Completion (ACTUAL)

January 24, 2018

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (ESTIMATE)

July 29, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0449
  • UW14101 (OTHER: UWCCC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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