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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770781
• Other study ID #: 15-064
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 11, 2018

Study information

• Verified date: April 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 11, 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Exercise regimen
Subjects will receive a personal exercise regimen based on their health history and individual capability.

Locations

Country	Name	City	State
United States	University of Pittsburgh, Department of Medicine.	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study recruitment ability	Pilot study	Baseline through ~ 6 months of follow-up.
Secondary	Physical fitness	Measured by pedometer.	Baseline through ~ 6 months of follow-up.
Secondary	Change in Paffenberger Exercise habits questionnaire	This questionnaire asks about exercise habits.	Baseline and ~ 6 months
Secondary	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
Secondary	Functional Assessment of Cancer Therapy - Endocrine Symptoms	This is a quality of life questionnaire	Baseline and ~ 6 months