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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise regimen

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring survivors, physical fitness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Pittsburgh, Department of Medicine.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Personal Trainer

Arm Description

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.

Outcomes

Primary Outcome Measures

Study recruitment ability

Pilot study

Secondary Outcome Measures

Physical fitness

Measured by pedometer.

Change in Paffenberger Exercise habits questionnaire

This questionnaire asks about exercise habits.

Change in physical activity self-efficacy questionnaire

This questionnaire will measure a person's perceived competence to engage in an activity

Functional Assessment of Cancer Therapy - Endocrine Symptoms

This is a quality of life questionnaire

Full Information

NCT ID

NCT02770781

First Posted

June 3, 2015

Last Updated

April 5, 2019

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT02770781

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

July 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

survivors, physical fitness

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Personal Trainer

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Exercise regimen

Intervention Description

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

Primary Outcome Measure Information:

Title

Study recruitment ability

Description

Pilot study

Time Frame

Baseline through ~ 6 months of follow-up.

Secondary Outcome Measure Information:

Title

Physical fitness

Description

Measured by pedometer.

Time Frame

Baseline through ~ 6 months of follow-up.

Title

Change in Paffenberger Exercise habits questionnaire

Description

This questionnaire asks about exercise habits.

Time Frame

Baseline and ~ 6 months

Title

Change in physical activity self-efficacy questionnaire

Description

This questionnaire will measure a person's perceived competence to engage in an activity

Time Frame

Baseline and ~ 6 months

Title

Functional Assessment of Cancer Therapy - Endocrine Symptoms

Description

This is a quality of life questionnaire

Time Frame

Baseline and ~ 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

G van Londen, MD, MS

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh, Department of Medicine.

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34328623

Citation

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.

Results Reference

derived

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

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