Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-06-13 @ 8:08 PM
Study NCT ID:
NCT02751892
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2016-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2016-04-21', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version', 'timeFrame': '0, 3, 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2', 'timeFrame': '0, 3, 6 months'}, {'measure': 'Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale', 'timeFrame': '0, 3, 6 months'}, {'measure': 'Change in quality of life measure with the Functional Assessment of Cancer Therapy general', 'timeFrame': '0, 3, 6 months'}, {'measure': 'Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal', 'timeFrame': '0, 3, 6 months'}, {'measure': 'Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue', 'timeFrame': '0, 3, 6 months'}, {'measure': 'Change in intention to exercise', 'timeFrame': '0, 3, 6 months', 'description': 'assessed with Intention to exercise scale'}, {'measure': 'Change in barriers to exercise', 'timeFrame': '0, 3, 6 months', 'description': 'assessed with Barriers to Exercise scale'}, {'measure': 'Change in physical fitness', 'timeFrame': '0, 3, and 6 months', 'description': 'assessed with the modified Bruce treadmill test'}, {'measure': 'Change in upper body strength-grip strength', 'timeFrame': '0, 3, 6 months', 'description': 'Assessed with grip dynanometer'}, {'measure': 'Change in upper body strength-upper arm strength', 'timeFrame': '0, 3, 6 months', 'description': 'Assessed with biceps curl test'}, {'measure': 'Change in lower body strength', 'timeFrame': '0, 3, 6 months', 'description': 'Assessed with 30 sec sit-to-stand test'}, {'measure': 'Changes in body composition (% body fat) assessed with bioelectrical impedance analysis', 'timeFrame': '0, 3, 6 months'}, {'measure': 'Change in antropometric measures (waist circumference, hip circumference', 'timeFrame': '0, 3, 6 months', 'description': 'Waist and hip circumference will be used to calculate the waist-to-hip ratio'}, {'measure': 'Changes in anthropometric measures (height, weight, BMI)', 'timeFrame': '0, 3, 6 months', 'description': 'Body weight and body height will be used to calculate BMI'}, {'measure': 'Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry', 'timeFrame': '0, 3, 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Long-term maintenance of physical activity behaviour change post-intervention remains challenging. This study is investigating the feasibility of a behaviour change intervention based on Self-Determination Theory in people recovering from colorectal cancer and its effects on behaviour change 6 months post-intervention.', 'detailedDescription': 'This study was a randomized controlled feasibility trial consisting of a 3-months active lifestyle intervention and a 3-months follow-up period. Participants were allocated to an active lifestyle programme (ALP) or the standard (SC) care group. ALP was offered 12 supervised exercise sessions over 3 months and six supportive behaviour change workshops. SC was encouraged to continue with their usual lifestyle. The intervention was informed by Self-Determination Theory.\n\nThe supervised exercise sessions took place in small groups of maximum 7 participants and lasted approximately 1 hour. Exercise included aerobic and resistance exercises. The behaviour change workshops were delivered in a motivational interviewing style, also in small groups of maximum 7 participants.\n\nParticipants were followed-up at 6 months. There was no contact with participants during the post-intervention and follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a histologically confirmed diagnosis of colorectal cancer with Dukes stages A-C\n* completed cancer treatment within the last 24 months,\n* be able to understand spoken and written English\n* score of 80 or more on the Karnofsky Performance Status Scale\n\nExclusion Criteria:\n\n* already meeting general PA guidelines of 150 min of moderate PA or 75 min of vigorous intensity PA per week,\n* recent myocardial infarction\n* uncontrolled hypertension\n* a pacemaker\n* or unstable angina.'}, 'identificationModule': {'nctId': 'NCT02751892', 'acronym': 'MOVE', 'briefTitle': 'The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of East Anglia'}, 'officialTitle': 'Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer', 'orgStudyIdInfo': {'id': '13/EE/0060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Lifestyle Programme', 'description': 'Supervised exercises for 3 months and motivational interviewing to facilitate physical activity behaviour change. Supervised exercise sessions took place twice per week for the first four weeks. This was tapered off to once per week for the second four weeks. During the last month of the intervention participants continued with the exercise at home and were encouraged to achieve 150min of moderate to vigorous PA per week.', 'interventionNames': ['Behavioral: Active lifestyle programme']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Received usual care. Was offered the intervention after the completion of the study.'}], 'interventions': [{'name': 'Active lifestyle programme', 'type': 'BEHAVIORAL', 'otherNames': ['MOVE'], 'description': 'The intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention.', 'armGroupLabels': ['Active Lifestyle Programme']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'John M Saxton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University, Newcastle, United Kingdom'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of East Anglia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}