NCT02770781

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2018

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

June 3, 2015

Last Update Submit

April 5, 2019

Conditions

Keywords

survivorsphysical fitness

Outcome Measures

Primary Outcomes (1)

  • Study recruitment ability

    Pilot study

    Baseline through ~ 6 months of follow-up.

Secondary Outcomes (4)

  • Physical fitness

    Baseline through ~ 6 months of follow-up.

  • Change in Paffenberger Exercise habits questionnaire

    Baseline and ~ 6 months

  • Change in physical activity self-efficacy questionnaire

    Baseline and ~ 6 months

  • Functional Assessment of Cancer Therapy - Endocrine Symptoms

    Baseline and ~ 6 months

Study Arms (1)

Personal Trainer

EXPERIMENTAL

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

Interventions

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

Personal Trainer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh, Department of Medicine.

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • G van Londen, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2015

First Posted

May 12, 2016

Study Start

October 1, 2015

Primary Completion

April 1, 2018

Study Completion

July 11, 2018

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations