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

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: Breast Cancer
• Intervention / Treatment: Other: Exercise regimen

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Pilot study	Baseline through ~ 6 months of follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical fitness	Measured by pedometer.	Baseline through ~ 6 months of follow-up.
Change in Paffenberger Exercise habits questionnaire	This questionnaire asks about exercise habits.	Baseline and ~ 6 months
Change in physical activity self-efficacy questionnaire	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	This is a quality of life questionnaire	Baseline and ~ 6 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Qiao Y, van Londen GJ, Brufsky JW, Poppenberg JT, Cohen RW, Boudreau RM, Glynn NW. Perceived physical fatigability improves after an exercise intervention among breast cancer survivors: a randomized clinical trial. Breast Cancer. 2022 Jan;29(1):30-37. doi: 10.1007/s12282-021-01278-1. Epub 2021 Jul 30.

Study record dates

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: physical fitness; survivors
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 15-064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED