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

University of Wisconsin (UW)

Status: Completed

Conditions: Breast Neoplasms

Treatments: Behavioral: Re-Patterning Sitting Time Group; Behavioral: Usual Care; Behavioral: Reducing Sitting Time Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02510430

2015-0449

UW14101 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups, including a placebo group

Reducing Sitting Time Group

Experimental group

Description:

This group will be asked to reduce overall accumulated sitting time by 2 hours per day.

Treatment:

Behavioral: Reducing Sitting Time Group

Re-Patterning Sitting Time Group

Experimental group

Description:

This group will be asked to use standing breaks to interrupt long bouts of sitting time.

Treatment:

Behavioral: Re-Patterning Sitting Time Group

Usual Care

Placebo Comparator group

Description:

This is an attention control group and is not asked to make changes to sitting time.

Treatment:

Behavioral: Usual Care