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Clinical Trials/NCT02510430
NCT02510430
Completed
Not Applicable

Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors

University of Wisconsin, Madison1 site in 1 country59 target enrollmentNovember 30, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
University of Wisconsin, Madison
Enrollment
59
Locations
1
Primary Endpoint
Feasibility as measured by recruitment and retention rates
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 30, 2015
End Date
January 24, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Feasibility as measured by recruitment and retention rates

Time Frame: 12 months

Feasibility of recruiting participants to the study

Secondary Outcomes

  • Sedentary behavior as measured by ActivPal(7 days)
  • Physical activity as measured by ActiGraph(7 days)
  • Sedentary time as measured by ActiGraph(7 days)

Study Sites (1)

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