Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-02 @ 4:02 AM
Study NCT ID:
NCT00756795
Status:
WITHDRAWN
Last Update Posted:
2024-09-23
First Post:
2008-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI chose not to continue with this unfunded study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2010-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2008-09-18', 'studyFirstSubmitQcDate': '2008-09-19', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-report of physical activity behavior (duration, intensity and frequency)', 'timeFrame': 'Baseline and Post Intervention', 'description': 'Participants will be taught how to keep the Activity diary to record walking and physical activities.'}], 'secondaryOutcomes': [{'measure': 'Plasma IL-6 Concentration', 'timeFrame': 'Baseline and Post Intervention', 'description': '5ml of blood will be collected from each blood draw at baseline and post-intervention to assay for Interleukin-6 level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'Generally, patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Regular physical activity improves emotional well-being, increases immunological response, improves wound healing, lessens fatigue and improves general functionality and quality of life.\n\nThis study will determine effectiveness of the 12-week exercise intervention program, determine if physically active patients differ in quality of life, depression and fatigue during the course of the study, and determine if the change in physical activity levels is related to changes in immune responses.', 'detailedDescription': 'The general hypothesis of this research is that patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Increasing and sustaining physical activity of these patients will improve their emotional well-beings, increase their immunological response, improve wound healing, lessen fatigue and improve their general functionality and quality of life.\n\nThe purposes of this study are to: (1) determine the effectiveness of the 12-week exercise intervention program in increasing physical activity in head and neck cancer patients; (2) determine if physically active patients differ in quality of life, depression and fatigue during the course of the study; and (3) determine if the change in physical activity levels is related to changes in the immune responses in human.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients 19 years of age or above (Nebraska legal age).\n2. Patients diagnosed with HNC who are seen at the University of Nebraska Medical Center.\n3. Patients who have undergone chemotherapy, radiation and/or surgery for their cancer.\n4. Patients who have completed their cancer treatment at least 3 months prior.\n5. Patients who have consented to participate in this study with approval by their physicians.\n6. Patients who have no significant mental impairment.\n\nExclusion Criteria:\n\n1. Patients who are on enteral feeding.\n2. Patients who are not able to walk or whose surgeons report that walking is not advisable.\n3. Patients diagnosed with Lymphoma, Thyroid cancer or Melanoma.\n4. Patients who are on antidepressant medications.\n5. Patients who are unwilling to return to the clinic at the end of the study - after 12 weeks of intervention.\n6. Patients participating in another research study involving a therapeutic intervention.\n7. Patients with chronic medical and orthopedic conditions that would preclude physical activity (e.g., congestive heart failure, recent knee or hip replacements).\n8. Patients who are at 18 months or more after the start of cancer treatment.'}, 'identificationModule': {'nctId': 'NCT00756795', 'acronym': 'I-PAP', 'briefTitle': 'Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)', 'orgStudyIdInfo': {'id': '0053-08-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attention Control', 'description': '5ml of blood will be collected from each blood draw at baseline and post-intervention to assay for Interleukin-6 level.\n\nPatient will be taught how to keep the Activity diary to record walking and physical activities.\n\nStructured Interview will be conducted at baseline and post-intervention. All patients will receive 3 reminder phone calls during the first week of study and 10 minutes social visits in the following weeks by study coordinator on a weekly basis', 'interventionNames': ['Behavioral: Intervention group']}], 'interventions': [{'name': 'Intervention group', 'type': 'BEHAVIORAL', 'otherNames': ['Digi-Walker ™ Pedometer: SW-701'], 'description': '5ml of blood will be collected from each blood draw at baseline and post-intervention to assay for Interleukin-6 level.\n\nStructured Interview will be conducted at baseline and post-intervention.\n\nPatients assigned to the Intervention group will be given pedometers to obtain distance walked. In addition, patient will be taught how to keep the Exercise diary to record walking and physical activities.\n\nAll patients will receive 3 reminder phone calls during the first week of study and 10 minutes social visits in the following weeks by study coordinator on a weekly basis.', 'armGroupLabels': ['Attention Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alvin G Wee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}