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OpenTrials
Completed

NCT Number: NCT02510430

The Plan and Stand Study: Reducing Sitting Time 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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UW Hospital

Madison, Wisconsin, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Re-Patterning Sitting Time Group

Behavioral

This is a behavioral intervention to help women interrupt long bouts of sitting time by incorporating standing breaks into their lifestyle.

Reducing Sitting Time Group

Behavioral

This is a behavioral intervention to help women reduce their overall accumulated sitting time by 2 hours per day.

Usual Care

Behavioral

This intervention consists solely of follow-up contact to control for attention effects and reduce attrition.

Primary outcomes

  1. Feasibility as measured by recruitment and retention rates

    Time frame: 12 months

    Feasibility of recruiting participants to the study

Secondary outcomes

  1. Sedentary behavior as measured by ActivPal

    Time frame: 7 days

    Sedentary time as measured by the ActivPAL inclinometer

  2. Physical activity as measured by ActiGraph

    Time frame: 7 days

    Physical activity as measured by the ActiGraph accelerometer

  3. Sedentary time as measured by ActiGraph

    Time frame: 7 days

    Sedentary time as measured by the ActiGraph accelerometer

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2015
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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