NCT02969291

Brief Summary

There is a well-documented association between physical activity \& risk for breast cancer development and recurrence. It is known that exercise interventions have been effective at increasing physical activity levels in breast cancer survivors. Knowing that breast cancer survivors are less active than non-cancer patients, a less active lifestyle places them at risk of obesity and poor overall health, which in turn also increases risk of cancer and cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known that hormones and other inflammatory markers play a role. This study has three goals:

  1. 1.To investigate the feasibility of a home intervention designed to reduce sedentary behavior.
  2. 2.Describe the effects of the intervention on levels of sedentary behavior, physical activity, and symptoms.
  3. 3.Assess cost of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

November 2, 2016

Last Update Submit

July 16, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Sedentary Time

    Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention.

    8 weeks

Secondary Outcomes (15)

  • Activity Level

    8 weeks

  • Glucose

    8 weeks

  • Insulin

    8 weeks

  • Total cholesterol

    8 weeks

  • High density lipoprotien cholesterol

    8 weeks

  • +10 more secondary outcomes

Study Arms (1)

Reduced Sedentary Time Intervention

OTHER

Reduced Sedentary Time Intervention (RSTI)

Behavioral: Reduced Sedentary Time Intervention (RSTI)

Interventions

Reduced Sedentary Time Intervention (RSTI)BEHAVIORAL

Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant. For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time. This program has been successful in sedentary overweight office workers and investigators will use similar techniques.

Reduced Sedentary Time Intervention

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage I-III breast cancer survivors 20-80 who have completed primary treatment (surgery, radiation and/or chemotherapy) greater than 6 months but less than 5 years ago. Patients may be on adjuvant hormonal therapy
  • BMI \> 25 (overweight or class I/II obese)
  • Not meeting current guidelines for regular exercise as defined by less than 150 minutes a week of moderate to vigorous physical activity
  • No gain or loss of \>10% body weight over the prior 6 months.

You may not qualify if:

  • Known diabetes
  • Known coronary artery disease
  • Pregnancy
  • Any injury that would limit mobility or require use of assisted mobility devices
  • Weight gain or loss of \>10% body weight over the prior 6 months
  • Greater than 150 minutes a week of moderate to vigorous physical activity
  • Inability to provide informed consent
  • Non-english speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Grace Makari-Judson, MD

    Baystate Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 21, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations

US(1)