Feasibility Study of the Addition of a Personal Trainer to the Post-Treatment Regimen of Breast Cancer Survivors
1 other identifier
interventional
68
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2018
CompletedApril 9, 2019
April 1, 2019
2.5 years
June 3, 2015
April 5, 2019
Conditions
Keywords
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
EXPERIMENTALAll subjects will meet a set amount of times with a personal trainer over the course of the study to participate in an exercise regimen.
Interventions
Subjects will receive a personal exercise regimen based on their health history and individual capability.
Eligibility Criteria
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
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.
PMID: 34328623DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
G van Londen, MD, MS
University of Pittsburgh
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