IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
IMPROVE-B
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Oct 2017
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
Study Start
First participant enrolled
October 15, 2017
CompletedFirst Submitted
Initial submission to the registry
February 21, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJanuary 9, 2020
January 1, 2020
1.7 years
February 21, 2018
January 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Safety of the exercise intervention (assessed by standardized questionnaire)
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)
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)
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 Outcomes (8)
Health-Related Quality of Life: 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
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
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
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
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
- +3 more secondary outcomes
Study Arms (4)
Partly Supervised Prehabilitation
EXPERIMENTALWill 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.
Home-based Prehabilitation
ACTIVE COMPARATORWill 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.
Control Group
ACTIVE COMPARATORWill be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute.
Comparison group- women too active
NO INTERVENTIONAdded 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
Interventions
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).
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Cancer Institute
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn M Schmitz, PhD
Penn State College of Medicine Hershey
- PRINCIPAL INVESTIGATOR
Joachim Wiskemann, PhD
National Center for Tumor Diseases, Heidelberg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Public Health Sciences
Study Record Dates
First Submitted
February 21, 2018
First Posted
April 13, 2018
Study Start
October 15, 2017
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
January 9, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share