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

Breast Neoplasms Clinical Trial

Official title:

Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510430
• Other study ID #: 2015-0449
• Secondary ID: UW14101
• Status: Completed
• Phase: N/A
• Start date: November 30, 2015
• Est. completion date: January 24, 2018

Study information

• Verified date: July 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• Re-Patterning Sitting Time Group
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
This is a behavioral intervention to help women reduce their overall accumulated sitting time by 2 hours per day.
• Usual Care
This intervention consists solely of follow-up contact to control for attention effects and reduce attrition.

Locations

Country	Name	City	State
United States	UW Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as measured by recruitment and retention rates	Feasibility of recruiting participants to the study	12 months
Secondary	Sedentary behavior as measured by ActivPal	Sedentary time as measured by the ActivPAL inclinometer	7 days
Secondary	Physical activity as measured by ActiGraph	Physical activity as measured by the ActiGraph accelerometer	7 days
Secondary	Sedentary time as measured by ActiGraph	Sedentary time as measured by the ActiGraph accelerometer	7 days