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OpenTrials
Completed

NCT Number: NCT02770781

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh, Department of Medicine.

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise regimen

Other

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

Primary outcomes

  1. Study recruitment ability

    Time frame: Baseline through ~ 6 months of follow-up.

    Pilot study

Secondary outcomes

  1. Physical fitness

    Time frame: Baseline through ~ 6 months of follow-up.

    Measured by pedometer.

  2. Change in Paffenberger Exercise habits questionnaire

    Time frame: Baseline and ~ 6 months

    This questionnaire asks about exercise habits.

  3. Change in physical activity self-efficacy questionnaire

    Time frame: Baseline and ~ 6 months

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

  4. Functional Assessment of Cancer Therapy - Endocrine Symptoms

    Time frame: Baseline and ~ 6 months

    This is a quality of life questionnaire

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 12, 2016
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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