Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01512069
Status:
COMPLETED
Last Update Posted:
2014-04-24
First Post:
2012-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Web-based Tailored Self-management Program
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'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-23', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-13', 'lastUpdatePostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in numbers of goal behaviors at 3 months', 'timeFrame': 'Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)', 'description': 'The primary outcomes of the study are to achieve goals of healthy behaviors as followed:\n\ni) exercising≥12.5kcal/kg/week; ii) eating vegetables≥5serv/day and fruits 1-2 serv/day; iii) healthy weight (18.5kg/m2 ≤ BMI \\< 25kg/m2) The primary outcome of the study is the increased number of goal behaviors.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Stage of Change at 3 months', 'timeFrame': 'Baseline, 1month, 2 month, 3 month after starting the intervention', 'description': 'Stage of motivational readiness for exercise and diet based on the established TTM'}, {'measure': 'Change from baseline in self-efficacy at 3 months', 'timeFrame': 'Baseline, 1month, 2 month, 3 month after starting the intervention', 'description': 'The self-efficacy for exercising≥12.5kcal/kg/week, eating vegetables≥5serv/day and fruits 1-2 serv/day'}, {'measure': 'Change from baseline in psychosocial outcomes at 3 months', 'timeFrame': 'Baseline, 1month, 2 month, 3 month after starting the intervention', 'description': 'The psychosocial outcomes are HRQOL, fatigue, anxiety and depression'}, {'measure': 'Change from baseline in Diet quality at 3 months', 'timeFrame': 'Baseline, 1month, 2 month, 3 month after starting the intervention', 'description': 'Diet quality based on a three-day diet recall and the Diet Quality Index (DQI) revised for the Korean population'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['randomized controlled trial', 'internet', 'diet', 'exercise', 'health planning', 'the TTM'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24856854', 'type': 'DERIVED', 'citation': 'Lee MK, Yun YH, Park HA, Lee ES, Jung KH, Noh DY. A Web-based self-management exercise and diet intervention for breast cancer survivors: pilot randomized controlled trial. Int J Nurs Stud. 2014 Dec;51(12):1557-67. doi: 10.1016/j.ijnurstu.2014.04.012. Epub 2014 May 1.'}]}, 'descriptionModule': {'briefSummary': "Life style interventions that promote exercise and a healthy diet, which have the potential to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer survivors. The previous studies suggested that a key strategy to implement sustainable healthy behavior and improve health was providing appropriate feedback and promoting self-efficacy. Web-based program enables to provide the feedback in a timely manner on a daily basis, to continue the healthy behaviors.\n\nTherefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning program, and whether the program can promote significantly greater changes in behavioral outcomes \\[goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)\\], stage of changes for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and self-efficacy in implementing goal of exercise and diet among breast cancer survivors in Korea was examined.\n\nHypotheses were following:\n\n1. Survivors of a group participating in a web-based, stage-matched Exercise and Diet Planning program (hereinafter called the 'intervention group') will show a more advanced stage of change for exercise and diet compared to survivors in the control group.\n2. The intervention group will show a higher proportion of attaining goal of exercise (or higher level of energy expenditure of aerobic exercise) compared to the control group.\n3. The intervention group will show a higher proportion of attaining goal of diet (or higher level of diet quality) compared to the control group.\n4. The intervention group will show a better HRQOL level compared to the control group.\n5. The intervention group will show a better self-efficacy level compared to the control group.\n6. The intervention group will show a lower fatigue level compared to the control group.\n7. The intervention group will show less anxiety compared to the control group.\n8. The intervention group will show less depression compared to the control group.", 'detailedDescription': 'The purpose of the study was to develop a web-based, stage-matched Exercise and Diet Planning program and to examine effects of the program on implementation of exercise and diet, self-efficacy, HRQOL, fatigue, anxiety and depression among breast cancer survivors.\n\nAll participants were recruited from two tertiary university hospitals and the National Cancer Center in Korea.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged 20 years and older\n2. Histologically confirmed stage 0 to III breast cancer who received curative breast cancer surgery within 12 months since completion of primary cancer treatment and 2 years since diagnosis\n3. Serum platelet ≥ 100,000/mm3\n4. Serum hemoglobin ≥ 10g/dl\n5. Not met one or more behavior goals: i) energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week; ii) intake of vegetables except kimchi ≥ 5 serv/day and intake of fruit 1-2 serv/day; iii) maintenance of healthy weight (18.5 kg/m2 ≤ BMI \\< 23 kg/m2)\n6. Ability to use internet, and being accessible internet at home\n7. Mobile phone user\n8. Consent form to participate in the study\n\nExclusion Criteria:\n\n1. Currently receiving any cancer treatment\n2. Conditions that could limit adherence to an unsupervised exercise program such as uncontrolled congestive heart failure or angina, recent myocardial infarction, or breathing difficulties requiring oxygen use or hospitalization; walker or wheelchair use; or plans to have hip or knee replacement\n3. Conditions that could interfere with a high vegetable and fruit diet, such as kidney failure or chronic warfarin use\n4. Progressive malignant disease or additional primary cancers\n5. Infectious condition (body temperature ≥ 37.2℃ or WBC ≥ 11,000mm3)\n6. Inability to use computer or internet\n7. Visual and motor dysfunction'}, 'identificationModule': {'nctId': 'NCT01512069', 'briefTitle': 'Efficacy of a Web-based Tailored Self-management Program', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Efficacy of a Web-based Self-management Exercise and Diet Intervention Program With Tailored Motivation and Action Planning for Breast Cancer Survivors: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NCCNCS-11-501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Web-based, Stage-matched Exercise and Diet Planning program', 'description': 'The experimental arm is a group that assigned to use web-based, stage-matched exercise and diet planning program.', 'interventionNames': ['Behavioral: Web-based Health Planner on diet and exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-tailored booklet on exercise and diet', 'description': "The control group is provided a booklet containing same information on exercise and diet as in the experimental group's web-based program, but the information on a booklet is not tailored to participants' stage of motivational readiness for exercise and diet based on the TTM.", 'interventionNames': ['Behavioral: Non-tailored booklet on exercise and diet']}], 'interventions': [{'name': 'Web-based Health Planner on diet and exercise', 'type': 'BEHAVIORAL', 'otherNames': ['English name: Health Planner', 'Korean name: 건강플래너'], 'description': "URL is closed\n\nThe program is 12-week program, provides tailored information on the exercise and diet based on the stage of motivational readiness of TTM. The program is designed to allow to plan a regular exercise of 12.5 MET per week and to recommend to eat number of portions from six food groups for balanced diet tailored to individual's BMI, ideal body weight, and calories needed per day. The program provide the feedback based on the achievement of goals of the behaviors.", 'armGroupLabels': ['Web-based, Stage-matched Exercise and Diet Planning program']}, {'name': 'Non-tailored booklet on exercise and diet', 'type': 'BEHAVIORAL', 'description': 'The active control group is provided non-tailored booklet on exercise and diet, whose information is same as web-based program except stage-matching.', 'armGroupLabels': ['Non-tailored booklet on exercise and diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Gyenggi-do', 'state': 'Goyang-si', 'country': 'South Korea', 'facility': 'National Cancer Center'}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'YoungSung Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Seoul National University', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head', 'investigatorFullName': 'YoungSung Lee', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}