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

NCT ID: NCT02510430

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-01-24

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.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Reducing Sitting Time Group

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

Group Type EXPERIMENTAL

Reducing Sitting Time Group

Intervention Type BEHAVIORAL

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

Re-Patterning Sitting Time Group

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

Group Type EXPERIMENTAL

Re-Patterning Sitting Time Group

Intervention Type BEHAVIORAL

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

Usual Care

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

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Reducing Sitting Time Group

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

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa A Cadmus-Bertram, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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UW Hospital

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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UW14101

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0449

Identifier Type: -

Identifier Source: org_study_id

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