Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-30 @ 9:03 PM
Study NCT ID:
NCT03498157
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2018-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-04-06', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of the exercise intervention (assessed by standardized questionnaire)', 'timeFrame': 'Through study intervention, an average of 3 weeks', 'description': '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).'}, {'measure': 'Feasibility of the exercise intervention (assessed via exercise logs)', 'timeFrame': 'Through study intervention, an average of 3 weeks', 'description': '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.'}, {'measure': 'Acceptability of the exercise intervention (assessed via patient flow diagram)', 'timeFrame': 'During Recruitment till first intervention is delivered (with one week after enrolment)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Health-Related Quality of Life: EORTC QLQ-C30, version 3.0', 'timeFrame': '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', 'description': '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).'}, {'measure': 'Breast cancer-related symptoms and quality of Life', 'timeFrame': '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', 'description': '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'}, {'measure': 'Fatigue', 'timeFrame': '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', 'description': 'Fatigue will be assessed with the Multidimensional Fatigue Inventory (MFI) which is a 20-item, multidimensional self-assessment questionnaire.'}, {'measure': 'Sleep', 'timeFrame': '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', 'description': 'Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Depression', 'timeFrame': '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', 'description': 'Depressive symptoms will be assessed with the 20-item Center for Epidemiological Studies Depression Scale (CES-D).'}, {'measure': 'Shoulder Problems', 'timeFrame': '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', 'description': 'The Penn Shoulder Score (PSS) is a 100-point shoulder-specific self-report questionnaire consisting of 3 subscales of pain, satisfaction, and function.'}, {'measure': 'Physical activity behavior', 'timeFrame': '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', 'description': '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'}, {'measure': 'Symptoms', 'timeFrame': 'Weekly from baseline to 6 weeks after Surgery', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehabilitation', 'Exercise', 'Breast Cancer', 'Physical Activity', 'Surgery'], 'conditions': ['Breast Cancer', 'Prehabilitation', 'Physical Activity', 'Surgery']}, 'descriptionModule': {'briefSummary': '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.\n\nBreast 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.\n\nEvidence 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy\n* Not metastatic (stage \\<4)\n* Females and males ≥18 years of age\n* Fluent in written and spoken English\n* Must be able to provide and understand informed consent\n* Must have an ECOG PS of ≤ 2\n* Scheduled for lump- or mastectomy at Penn State Cancer Institute\n* ≥ 2 weeks till primary treatment\n* Primary attending surgeon approval\n\nExclusion Criteria:\n\n* Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy\n* Not fluent in written and spoken English\n* 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\n* Pregnant women\n* Engaging in systematic intense exercise training (at least 1h twice per week)'}, 'identificationModule': {'nctId': 'NCT03498157', 'acronym': 'IMPROVE-B', 'briefTitle': 'IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'IMpact of PRehabilitation in Oncology Via Exercise - Breast Cancer', 'orgStudyIdInfo': {'id': 'PSCI # 17-051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Partly Supervised Prehabilitation', 'description': '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.', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Prehabilitation Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Home-based Prehabilitation', 'description': '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.', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Prehabilitation Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Will be offered a two hour group-based prehabilitation class at the Penn State Hershey Cancer Institute.', 'interventionNames': ['Behavioral: Prehabilitation Education']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison group- women too active', 'description': "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"}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '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).', 'armGroupLabels': ['Home-based Prehabilitation', 'Partly Supervised Prehabilitation']}, {'name': 'Prehabilitation Education', 'type': 'BEHAVIORAL', 'description': 'Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey', 'armGroupLabels': ['Control Group', 'Home-based Prehabilitation', 'Partly Supervised Prehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Cancer Institute', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Kathryn M Schmitz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine Hershey'}, {'name': 'Joachim Wiskemann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Tumor Diseases, Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Public Health Sciences', 'investigatorFullName': 'Kathryn Schmitz', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}