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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Re-Patterning Sitting Time Group
Reducing Sitting Time Group
Usual Care
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms

Eligibility Criteria

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

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.

Sites / Locations

  • UW Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Reducing Sitting Time Group

Re-Patterning Sitting Time Group

Usual Care

Arm Description

This group will be asked to reduce overall accumulated sitting time by 2 hours per day.

This group will be asked to use standing breaks to interrupt long bouts of sitting time.

This is an attention control group and is not asked to make changes to sitting time.

Outcomes

Primary Outcome Measures

Feasibility as measured by recruitment and retention rates
Feasibility of recruiting participants to the study

Secondary Outcome Measures

Sedentary behavior as measured by ActivPal
Sedentary time as measured by the ActivPAL inclinometer
Physical activity as measured by ActiGraph
Physical activity as measured by the ActiGraph accelerometer
Sedentary time as measured by ActiGraph
Sedentary time as measured by the ActiGraph accelerometer

Full Information

First Posted
July 24, 2015
Last Updated
July 5, 2018
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02510430
Brief Title
The Plan and Stand Study: Reducing Sitting Time in Breast Cancer Survivors
Official Title
Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 30, 2015 (undefined)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reducing Sitting Time Group
Arm Type
Experimental
Arm Description
This group will be asked to reduce overall accumulated sitting time by 2 hours per day.
Arm Title
Re-Patterning Sitting Time Group
Arm Type
Experimental
Arm Description
This group will be asked to use standing breaks to interrupt long bouts of sitting time.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
This is an attention control group and is not asked to make changes to sitting time.
Intervention Type
Behavioral
Intervention Name(s)
Re-Patterning Sitting Time Group
Intervention Description
This is a behavioral intervention to help women interrupt long bouts of sitting time by incorporating standing breaks into their lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
Reducing Sitting Time Group
Intervention Description
This is a behavioral intervention to help women reduce their overall accumulated sitting time by 2 hours per day.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
This intervention consists solely of follow-up contact to control for attention effects and reduce attrition.
Primary Outcome Measure Information:
Title
Feasibility as measured by recruitment and retention rates
Description
Feasibility of recruiting participants to the study
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Sedentary behavior as measured by ActivPal
Description
Sedentary time as measured by the ActivPAL inclinometer
Time Frame
7 days
Title
Physical activity as measured by ActiGraph
Description
Physical activity as measured by the ActiGraph accelerometer
Time Frame
7 days
Title
Sedentary time as measured by ActiGraph
Description
Sedentary time as measured by the ActiGraph accelerometer
Time Frame
7 days

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with Stage 0-III breast cancer. Bilateral or multiple primary breast cancers are permitted. 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. Report sitting for ≥8 accumulated waking hours on a typical day, Willing and able to attend 3 study visits at the UW, Willing to attempt reduction of sitting time, Use the internet on a regular basis, Willing and able to complete study requirements, and Currently considered postmenopausal (no menstrual periods in past 12 months), even if pre-menopausal at diagnosis. Exclusion Criteria: Evidence of recurrence or metastatic disease, Unable to move from sitting to standing without difficulty and to walk 1 block.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A Cadmus-Bertram, Ph.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Hospital
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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

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