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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Behavioral: Re-Patterning Sitting Time Group
* Behavioral: Reducing Sitting Time Group
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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