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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Exercise regimen

• Registration Number: NCT02770781
• Lead Sponsor: University of Pittsburgh

Brief Summary

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).

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 Timeline

• Study First Submitted: 2015-06-03
• Study Start: 2015-10
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2018-04
• Study Completion: 2018-07-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Personal Trainer	Exercise regimen	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.

Primary Outcome Measures

Name	Time	Method
Study recruitment ability	Baseline through ~ 6 months of follow-up.	Pilot study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pittsburgh, Department of Medicine.; 🇺🇸 Pittsburgh, Pennsylvania, United States