Breast CancerIMPROVE-BNCT03498157
IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
A study testing Exercise and Prehabilitation Education in people with Breast Cancer and Prehabilitation, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prehabilitation, Physical Activity
- What is being tested?
- Exercise and Prehabilitation Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Scheduled for lump- or mastectomy at Penn State Cancer Institute
- ≥ 2 weeks till primary treatment
- Primary attending surgeon approval
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
About this study
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.
- Conditions
- Breast Cancer, Prehabilitation, Physical Activity, Surgery
- Being tested
- Exercise, Prehabilitation Education
- Keywords
- Prehabilitation, Exercise, Breast Cancer, Physical Activity, Surgery
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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).
Prehabilitation EducationBehavioural
Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
| Study group | Role | What they receive |
|---|---|---|
| Partly Supervised Prehabilitation | Experimental | 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. Receives: Behavioral: Exercise; Behavioral: Prehabilitation Education |
| Home-based Prehabilitation | Active comparator | 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. Receives: Behavioral: Exercise; Behavioral: Prehabilitation Education |
| Control Group | Active comparator | Will be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute. Receives: Behavioral: Prehabilitation Education |
| Comparison group- women too active | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: 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
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
Measured: 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
Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire.
Measured: 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
Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI)
Measured: 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
Depressive symptoms will be assessed with the 20-item Center for Epidemiological Studies Depression Scale (CES-D).
Measured: 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
The Penn Shoulder Score (PSS) is a 100-point shoulder-specific self-report questionnaire consisting of 3 subscales of pain, satisfaction, and function.
Measured: 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
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
Measured: 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
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.
Measured: Weekly from baseline to 6 weeks after Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start15 Oct 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Schmitz, Milton S. Hershey Medical Center
- Investigators
- Kathryn M Schmitz, PhD, Principal investigator, Penn State College of Medicine HersheyJoachim Wiskemann, PhD, Principal investigator, National Center for Tumor Diseases, Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498157
- Sponsor's protocol ID
- PSCI # 17-051
- Acronym
- IMPROVE-B
- Status last verified
- Jan 2020
- First submitted
- 21 Feb 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
- ClinicalTrials.gov ID
- NCT03498157
- Acronym / sponsor ID
- IMPROVE-B / PSCI # 17-051
- Conditions
- Breast Cancer, Prehabilitation, Physical Activity, Surgery
- Keywords
- Prehabilitation, Exercise, Breast Cancer, Physical Activity, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Partly Supervised Prehabilitation | Experimental | Behavioral: Exercise, Behavioral: Prehabilitation EducationWill 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 comparator | Behavioral: Exercise, Behavioral: Prehabilitation EducationWill 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 comparator | Behavioral: Prehabilitation EducationWill be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute. |
| Comparison group- women too active | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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). | Behavioural | Home-based Prehabilitation, Partly Supervised Prehabilitation |
| Prehabilitation EducationParticipate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey | Behavioural | Control Group, Home-based Prehabilitation, Partly Supervised Prehabilitation |
Primary outcome
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).
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.
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.
8 secondary outcomes
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
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
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
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
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
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
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
Symptoms
Time frame: Weekly from baseline to 6 weeks after Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn M Schmitz, PhD principal investigator
Penn State College of Medicine Hershey
Joachim Wiskemann, PhD principal investigator
National Center for Tumor Diseases, Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Prehabilitation Education in people with Breast Cancer and Prehabilitation, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the exercise intervention (assessed by standardized questionnaire) (time frame: Through study intervention, an average of 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.