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

NCT02510430 | Completed

• 2 other identifiers: 2015-0449UW14101
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Feasibility as measured by recruitment and retention rates

  Feasibility of recruiting participants to the study

  12 months

Secondary Outcomes (3)

• Sedentary behavior as measured by ActivPal

  7 days

• Physical activity as measured by ActiGraph

  7 days

• Sedentary time as measured by ActiGraph

  7 days

Study Arms (3)

Reducing Sitting Time Group

EXPERIMENTAL

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

Behavioral: Reducing Sitting Time Group

Re-Patterning Sitting Time Group

EXPERIMENTAL

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

Behavioral: Re-Patterning Sitting Time Group

Usual Care

PLACEBO COMPARATOR

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

Behavioral: Usual Care

Interventions

Re-Patterning Sitting Time Group BEHAVIORAL

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

Re-Patterning Sitting Time Group

Reducing Sitting Time Group BEHAVIORAL

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

Reducing Sitting Time Group

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Evidence of recurrence or metastatic disease,
• Unable to move from sitting to standing without difficulty and to walk 1 block.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Hospital

Madison, Wisconsin, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lisa A Cadmus-Bertram, Ph.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 29, 2015
• Study Start: November 30, 2015
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Locations

US (1)