Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT04478851
Status:
RECRUITING
Last Update Posted:
2022-03-31
First Post:
2020-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EXCEL: Exercise for Cancer to Enhance Living Well
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Hybrid implementation effectiveness study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Minutes Per Week', 'timeFrame': 'Baseline to one-year', 'description': 'Change in number of participants meeting Guidelines for Physical Activity of 150 minutes per week of moderate intensity exercise, based on accelerometer data from commercially-available activity tracker.'}], 'secondaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'Baseline to post 12-week exercise intervention', 'description': 'Change in body mass index (BMI)'}, {'measure': 'Aerobic Endurance', 'timeFrame': 'Baseline to post 12-week exercise intervention', 'description': 'Change in 6-minute walk test (m) or 2 minute step test (steps) results'}, {'measure': 'Upper extremity grip strength', 'timeFrame': 'Baseline to post 12-week exercise intervention', 'description': 'Change in hand-grip dynamometry (kg)'}, {'measure': 'Functional performance test', 'timeFrame': 'Baseline to post 12-week exercise intervention', 'description': 'Change in sit-to-stand (number of repetitions in 30 seconds)'}, {'measure': 'Upper extremity flexibility', 'timeFrame': 'Baseline to post 12-week exercise intervention', 'description': 'Change in active shoulder flexion range of motion (degrees)'}, {'measure': 'Lower extremity flexibility', 'timeFrame': 'Baseline to post 12-week exercise intervention', 'description': 'Change in sit-and-reach test (cm)'}, {'measure': 'Balance', 'timeFrame': 'Baseline to post 12-week exercise intervention', 'description': 'Change in one legged stance test (seconds)'}, {'measure': 'Symptom tracking', 'timeFrame': 'Baseline to one year', 'description': 'Change in fatigue, mood, and QOL, recorded via m-Health app'}, {'measure': 'Cancer related symptoms', 'timeFrame': 'Baseline to one year', 'description': 'Change in Edmonton Symptom Assessment Scale.\n\n\\- scale is from 0-10, where 0 means the symptom is absent and 10 means the worst possible severity of the symptom is being experienced.'}, {'measure': 'Subjective reporting of average weekly physical activity', 'timeFrame': 'Baseline to one year', 'description': 'Change in Godin Leisure Time Exercise Questionnaire'}, {'measure': 'General Health-related Quality of Life', 'timeFrame': 'Baseline to one year', 'description': 'Change in EuroQual - 5Dimensions (EQ-5D) tool\n\n\\- first section is a questionniare; last section uses a scale from 0-100, where 0 means the worst health imaginable and 100 means the best health imaginable.'}, {'measure': 'Fatigue', 'timeFrame': 'Baseline to one year', 'description': 'Change in Functional Assessment of Chronic Illness Therapy - Fatigue subscale\n\n\\- scale is from 0-4, where 0 means "not at all" and 4 means "very much".'}, {'measure': 'General well-being', 'timeFrame': 'Baseline to one year', 'description': 'Change in Functional Assessment of Cancer Therapy - General subscale\n\n\\- scale is from 0-4, where 0 means "not at all" and 4 means "very much".'}, {'measure': 'Cognition', 'timeFrame': 'Baseline to one year', 'description': 'Change in Functional Assessment of Cancer Therapy - Cognitive subscale\n\n\\- scale is from 0-4, where 0 means "never" and 4 means "several times a day" (experiencing symptoms).'}, {'measure': 'Barriers and facilitators to exercise participation', 'timeFrame': 'Baseline to one year', 'description': 'Change in Exercise Barriers and Facilitators questionnaire'}, {'measure': 'Exercise adherence', 'timeFrame': 'Baseline to one year', 'description': 'Adherence to exercise programming (attendance at sessions)'}, {'measure': 'Program implementation and evaluation', 'timeFrame': 'Baseline to one year', 'description': 'RE-AIM: program reach, effectiveness, adoption, implementation and maintenance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical activity', 'Exercise', 'Community programs', 'Online resources', 'Quality of life', 'Cancer survivor', 'mobile health', 'telehealth'], 'conditions': ['Cancer', 'Head and Neck Cancer', 'Colon Cancer', 'Breast Cancer', 'Prostate Cancer', 'Cancer Caregivers']}, 'referencesModule': {'references': [{'pmid': '36581419', 'type': 'DERIVED', 'citation': 'Culos-Reed N, Wagoner CW, Dreger J, McNeely ML, Keats M, Santa Mina D, Cuthbert C, Capozzi LC, Francis GJ, Chen G, Ester M, McLaughlin E, Eisele M, Sibley D, Langley J, Chiekwe J, Christensen T; EXCEL Project Team. Implementing an exercise oncology model to reach rural and remote individuals living with and beyond cancer: a hybrid effectiveness-implementation protocol for project EXCEL (EXercise for Cancer to Enhance Living Well). BMJ Open. 2022 Dec 29;12(12):e063953. doi: 10.1136/bmjopen-2022-063953.'}]}, 'descriptionModule': {'briefSummary': "Project EXCEL will provide community or online exercise programs to rural and remote and under-served cancer survivors, as well as encourage participants to become life-long exercisers. Exercise is an evidence-based self-management strategy that benefits all cancer survivors. However, most cancer survivors who live in remote or rural places don't have adequate opportunities to be involved in exercise programs that are tailored to their needs.", 'detailedDescription': 'As cancer survivorship numbers grow, a focus on positive health in survivorship is essential. Exercise is an evidence-based effective self-management strategy that benefits all cancer survivors (CS). However, the majority of research and the limited development of evidence-based clinical or community programs in exercise and cancer has been conducted almost exclusively in urban academic and clinical settings, with very limited implementation outreach to "hard to reach" CS.\n\nIn this proposed cancer exercise hybrid implementation effectiveness research, over 5 years we will use an integrated knowledge translation approach to move the current evidence-base that clearly supports the role of exercise in cancer survivorship, into sustainable and effective community-based or online settings that will optimize the delivery of exercise to rural/remote and underserved CS (RCS). Implementing and evaluating the proposed Exercise Oncology Survivorship (EOS) partnership model will result in a sustainable resource to support the implementation and delivery of exercise oncology programs in rural Canadian communities.\n\nInvestigators will work to develop lasting referral pathways between cancer care clinics and local fitness professionals. These fitness professionals will have additional cancer specific training to ensure they can effectively and safely deliver the program. Eligible and consenting participants will be screened for exercise safety, and following fitness testing will be triaged to appropriate exercise programming. If, due to COVID-19 public health restrictions, community based programming cannot occur, the exercise sessions will be delivered online by fitness professionals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have a diagnosis of cancer\n* are over the age of 18 years\n* are able to participate in mild levels of activity\n* are about to have treatment, are currently having treatment, or have had cancer treatment within the last 5 years\n* can read/write in English\n* can access online programs, if necessary, to participate in the exercise programs.\n\nExclusion Criteria:\n\n* unable to read/write in English\n* are unable to participate in exercise\n* for online programs, do not have internet or computer access'}, 'identificationModule': {'nctId': 'NCT04478851', 'acronym': 'EXCEL', 'briefTitle': 'EXCEL: Exercise for Cancer to Enhance Living Well', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Project EXCEL: Dissemination, Implementation, and Effectiveness of the Exercise Oncology Survivorship Partnership Model - Reaching Rural Cancer Survivors to Enhance Quality of Life', 'orgStudyIdInfo': {'id': 'HREBA.CC-20-0098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'All participants will be involved in group exercise classes, twice a week for 12 weeks.', 'interventionNames': ['Behavioral: Group Exercise Classes']}], 'interventions': [{'name': 'Group Exercise Classes', 'type': 'BEHAVIORAL', 'description': 'The exercise program to be implemented for rural cancer survivors will combine aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for a 12-week period. If public health restrictions require closure of fitness facilities due to COVID-19, the program will be delivered online. If facilities are open, the sessions will be integrated in the community, delivered in-person. Whether delivered in-class or remotely, the program follows exercise progression principles (ie, frequency, intensity, time, type, overload and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 1N4', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nicole Culos-Reed, PhD', 'role': 'CONTACT', 'email': 'wellnesslab@ucalgary.ca', 'phone': '+1 403-210-8482'}, {'name': 'Julianna Dreger, M.ClinExPhys', 'role': 'CONTACT', 'email': 'wellnesslab@ucalgary.ca', 'phone': '+1 403-210-8482'}], 'facility': 'Health and Wellness Lab, University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2G4', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Margaret L McNeely, PhD', 'role': 'CONTACT'}], 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'B3H 4R2', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Melanie Keats, PhD', 'role': 'CONTACT'}], 'facility': 'Dalhousie University', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'centralContacts': [{'name': 'Nicole Culos-Reed, PhD', 'role': 'CONTACT', 'email': 'nculosre@ucalgary.ca', 'phone': '+1 (403) 220-7540'}, {'name': 'Julianna Dreger, M.ClinExPhys', 'role': 'CONTACT', 'email': 'jdreger@ucalgary.ca', 'phone': '+1 (403) 210-8482'}], 'overallOfficials': [{'name': 'Nicole Culos-Reed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Margaret L McNeely, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}, {'name': 'Melanie Keats, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dalhousie University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan at this time to share IPD outside of the research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alberta', 'class': 'OTHER'}, {'name': 'Dalhousie University', 'class': 'OTHER'}, {'name': 'Alberta Health services', 'class': 'OTHER'}, {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}, {'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'University of Prince Edward Island', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}