Clinical trial NCT02770781: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: survivors
physical fitness
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Study recruitment ability
timeFrame: Baseline through ~ 6 months of follow-up.
Secondary outcomes:
measure: Physical fitness
timeFrame: Baseline through ~ 6 months of follow-up.
measure: Change in Paffenberger Exercise habits questionnaire
timeFrame: Baseline and ~ 6 months
measure: Change in physical activity self-efficacy questionnaire
timeFrame: Baseline and ~ 6 months
measure: Functional Assessment of Cancer Therapy - Endocrine Symptoms
timeFrame: Baseline and ~ 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Department of Medicine.
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: G van Londen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.