Feasibility Study of the Addition of a Personal Trainer to the Post-Treatment Regimen of Breast Cancer Survivors

April 5, 2019 updated by: Van Londen, Gijsberta, University of Pittsburgh
The purpose is to examine the feasibility and preliminary effectiveness of the role of a personal trainer for non-metastatic breast cancer survivors to improve physical activity and well-being (in terms of quality of life).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After breast cancer treatment, many women are faced with effects of treatment such as changes in appearance, fatigue, and reduced quality of life as compared to the pre-disease state. An intervention to increase physical activity may be helpful to improve well-being and outcomes for women treated for breast cancer.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh, Department of Medicine.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Post active breast cancer therapy (e.g. surgery and/or chemotherapy and/or radiation therapy), but may still be undergoing maintenance cancer therapy.
  • Free of macro-metastatic disease
  • Sedentary pre-cancer diagnosis: Those individuals not participating in a regular exercise program or not meeting the minimal physical activity recommendations from the General Surgeon which is accumulating 30 minutes or more of moderate physical activity on most days of the week
  • Ability to provide informed consent
  • Ability to provide a written physician's clearance
  • Patients must be new to the Survivorship Clinic (within first 12 months).

Exclusion Criteria:

  • Medical conditions that would preclude participation in a weight-training program.
  • Those who plan on relocating outside the Greater Pittsburgh Area in the next 3 months of intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personal Trainer
All subjects will meet a set amount of times with a personal trainer over the course of the study to participate in an exercise regimen.
Other: Exercise regimen
Subjects will receive a personal exercise regimen based on their health history and individual capability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study recruitment ability
Time Frame: Baseline through ~ 6 months of follow-up.
Pilot study
Baseline through ~ 6 months of follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical fitness
Time Frame: Baseline through ~ 6 months of follow-up.
Measured by pedometer.
Baseline through ~ 6 months of follow-up.
Change in Paffenberger Exercise habits questionnaire
Time Frame: Baseline and ~ 6 months
This questionnaire asks about exercise habits.
Baseline and ~ 6 months
Change in physical activity self-efficacy questionnaire
Time Frame: Baseline and ~ 6 months
This questionnaire will measure a person's perceived competence to engage in an activity
Baseline and ~ 6 months
Functional Assessment of Cancer Therapy - Endocrine Symptoms
Time Frame: Baseline and ~ 6 months
This is a quality of life questionnaire
Baseline and ~ 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: G van Londen, MD, MS, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

July 11, 2018

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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