IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer (IMPROVE-B)

January 7, 2020 updated by: Kathryn Schmitz, Milton S. Hershey Medical Center

The purpose of this study is to determine whether patients are able to participate in a so called prehabilitation program (prior to the beginning of cancer treatment) which includes (1) a supervised and home-based exercise program plus one educational session or (2) just home-based exercise plus one educational session or (3) just one educational session.

Breast cancer surgery may have potential for several side effects, including functional (e.g. flexibility in the affected arm, lymphedema [swelling that generally occurs in the arms or legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer treatment], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue) aspects.

Evidence shows that exercise is considered to be an effective treatment approach in breast cancer patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exits with regard to prehabilitation exercise in breast cancer patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
  • Not metastatic (stage <4)
  • Females and males ≥18 years of age
  • Fluent in written and spoken English
  • Must be able to provide and understand informed consent
  • Must have an ECOG PS of ≤ 2
  • Scheduled for lump- or mastectomy at Penn State Cancer Institute
  • ≥ 2 weeks till primary treatment
  • Primary attending surgeon approval

Exclusion Criteria:

  • Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy
  • Not fluent in written and spoken English
  • Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL; reduced standing or walking ability) for exercise
  • Pregnant women
  • Engaging in systematic intense exercise training (at least 1h twice per week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Partly Supervised Prehabilitation
Will be offered an initial one week (5 days for 3 hours each) supervised exercise prehabilitation program including a two hour group-based prehabilitation class at Penn State Rehabilitation Hospital, Hummelstown. The following weeks till surgery the learned exercise program should be done home-based for 5 times a week. A weekly phone call during this period will help to support and adapt the exercise program.
Behavioral: Exercise
The exercise intervention is an at least 2 weeks lasting (till the day surgery is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).
Behavioral: Prehabilitation Education
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
ACTIVE_COMPARATOR: Home-based Prehabilitation
Will be offered an individual one-on-one appointment for an exercise introduction session with an exercise and cancer specialist and weekly phone calls to support and adapt the exercise program. The exercises should be done home-based for 5 times a week until the time of surgery. Furthermore, a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute will be offered.
Behavioral: Exercise
The exercise intervention is an at least 2 weeks lasting (till the day surgery is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).
Behavioral: Prehabilitation Education
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
ACTIVE_COMPARATOR: Control Group
Will be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute.
Behavioral: Prehabilitation Education
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
NO_INTERVENTION: Comparison group- women too active
Added comparison group: Women who are ineligible on the basis of 'engaging in systematic intense exercise training (at least 1h twice a week) will be recruited to complete measures only, with no randomization

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of the exercise intervention (assessed by standardized questionnaire)
Time Frame: Through study intervention, an average of 3 weeks
Within the questionnaire we will assess whether musculoskeletal occur (yes/no; ongoing; location; severity (mild-life threatening); daily activities affected). The intervention will be considered as safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).
Through study intervention, an average of 3 weeks
Feasibility of the exercise intervention (assessed via exercise logs)
Time Frame: Through study intervention, an average of 3 weeks
The exercise intervention will be considered feasible if 50% of included patients actually do at least half of the exercise sessions prescribed for 2 weeks or more.
Through study intervention, an average of 3 weeks
Acceptability of the exercise intervention (assessed via patient flow diagram)
Time Frame: During Recruitment till first intervention is delivered (with one week after enrolment)
The intervention will be considered acceptable if more than 50% of the patients randomized to the control group agree to receive at least the first exercise session.
During Recruitment till first intervention is delivered (with one week after enrolment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life: EORTC QLQ-C30, version 3.0
Time Frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
QoL will be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0).
Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Breast cancer-related symptoms and quality of Life
Time Frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
In addition to the EORTC-QLQ-C30 specific breast cancer-related symptoms will be assessed with the validated 23-item breast cancer specific module (EORTC QLQ-BR23). It will assess common problems of breast cancer patients, e.g. with the affected breast or arm
Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Fatigue
Time Frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire.
Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Sleep
Time Frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI)
Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Depression
Time Frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Depressive symptoms will be assessed with the 20-item Center for Epidemiological Studies Depression Scale (CES-D).
Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Shoulder Problems
Time Frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
The Penn Shoulder Score (PSS) is a 100-point shoulder-specific self-report questionnaire consisting of 3 subscales of pain, satisfaction, and function.
Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Physical activity behavior
Time Frame: Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Physical activity behavior in the domains of commuting activity, leisure time activities such as cycling, walking, and sports, household and occupational activity will be assessed via a standardized and validated questionnaire, the Short QUestionnaire to ASsess Health-enhancing Physical Activity
Through study intervention, an average of 3 weeks; 6 weeks after surgery; and after the end of primary treatment, an average of 6 month after surgery
Symptoms
Time Frame: Weekly from baseline to 6 weeks after Surgery
The revised Edmonton symptom assessment scale is a 10-item patient-rated symptom visual numeric scale developed for use in assessing symptoms of patients receiving palliative care/cancer treatment.
Weekly from baseline to 6 weeks after Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathryn M Schmitz, PhD, Penn State College of Medicine Hershey
  • Principal Investigator: Joachim Wiskemann, PhD, National Center for Tumor Diseases, Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSCI # 17-051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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