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

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ClinicalTrials.gov Identifier: NCT03498157
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Kathryn Schmitz, Milton S. Hershey Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Prehabilitation Physical Activity Surgery Behavioral: Exercise Behavioral: Prehabilitation Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : August 8, 2019
Estimated Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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)

  5. 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).

  6. 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.

  7. 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

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498157


Contacts
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Contact: Shawna Doersken, PhD 717-531-7678 sdoerksen@phs.psu.edu
Contact: Melanie Potiaumpai, PhD 717-531-0003 ext 287621 mpotiaumpai@phs.psu.edu

Locations
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United States, Pennsylvania
Penn State Cancer Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Shawna Doersken, PhD    717-531-7678    sdoersken@phs.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Kathryn M Schmitz, PhD Penn State College of Medicine Hershey
Principal Investigator: Joachim Wiskemann, PhD National Center for Tumor Diseases, Heidelberg

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Responsible Party: Kathryn Schmitz, Professor, Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03498157     History of Changes
Other Study ID Numbers: PSCI # 17-051
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathryn Schmitz, Milton S. Hershey Medical Center:
Prehabilitation
Exercise
Breast Cancer
Physical Activity
Surgery

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases