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

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Behavioral: Re-Patterning Sitting Time Group; Behavioral: Reducing Sitting Time Group; Behavioral: Usual Care

• Registration Number: NCT02510430
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-29
• Study Start: 2015-11-30
• Primary Completion: 2018-01-24
• Study Completion: 2018-01-24
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Re-Patterning Sitting Time Group	Re-Patterning Sitting Time Group	This group will be asked to use standing breaks to interrupt long bouts of sitting time.
Reducing Sitting Time Group	Reducing Sitting Time Group	This group will be asked to reduce overall accumulated sitting time by 2 hours per day.
Usual Care	Usual Care	This is an attention control group and is not asked to make changes to sitting time.

Primary Outcome Measures

Name	Time	Method
Feasibility as measured by recruitment and retention rates	12 months	Feasibility of recruiting participants to the study

Secondary Outcome Measures

Name	Time	Method
Sedentary behavior as measured by ActivPal	7 days	Sedentary time as measured by the ActivPAL inclinometer
Physical activity as measured by ActiGraph	7 days	Physical activity as measured by the ActiGraph accelerometer
Sedentary time as measured by ActiGraph	7 days	Sedentary time as measured by the ActiGraph accelerometer

Trial Locations

Locations (1)

UW Hospital; 🇺🇸 Madison, Wisconsin, United States