Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02444195
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2015-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019018', 'term': 'Imagery, Psychotherapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2015-05-11', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.', 'timeFrame': 'postoperative day 1'}, {'measure': 'Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.', 'timeFrame': '6-8 week postoperative exam'}], 'secondaryOutcomes': [{'measure': 'Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).', 'timeFrame': 'postoperative day 1 and 6-8 week postoperative exam'}, {'measure': 'Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).', 'timeFrame': 'postoperative day 1 and 6-8 week postoperative exam'}, {'measure': 'Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain', 'timeFrame': 'postoperative day 1 and 6-8 week postoperative exam'}, {'measure': 'Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.', 'timeFrame': 'postoperative day 1 and 6-8 week postoperative exam'}, {'measure': 'Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.', 'timeFrame': 'postoperative day 1 and 6-8 week postoperative exam'}, {'measure': 'Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.', 'timeFrame': '6-8 week postoperative visit'}, {'measure': 'Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire.', 'timeFrame': 'postoperative day 1 and 6-8 week postoperative exam'}, {'measure': 'The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.', 'timeFrame': 'postoperative day 1 and 6-8 week postoperative exam'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gynecologic cancer', 'guided imagery', 'postoperative distress', 'perioperative distress'], 'conditions': ['Uterine Cervical Neoplasms', 'Uterine Neoplasms', 'Ovarian Neoplasms', 'Urogenital Neoplasms', 'Fallopian Tube Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)\n* Age 18 or greater\n* Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center\n* Able to understand and read English\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Patients must have working telephone, mobile or land line\n\nExclusion Criteria:\n\n* Severe hearing impairment that limits the ability to use audio-based guided imagery modules\n* Current documented alcohol abuse or illicit drug substance abuse\n* Planned outpatient surgery\n* Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.'}, 'identificationModule': {'nctId': 'NCT02444195', 'briefTitle': 'Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'HUM00095520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guided Imagery', 'description': 'Guided Imagery With Audio Media', 'interventionNames': ['Behavioral: Guided Imagery With Audio Media']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Postoperative Care', 'description': 'Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis.'}], 'interventions': [{'name': 'Guided Imagery With Audio Media', 'type': 'BEHAVIORAL', 'description': 'Subjects assigned to the experimental arm will be asked to participate in meditation daily using the audio media provided for the 7 days prior to surgery, in the preoperative holding area, for the 7 days following surgery, and are encouraged to engage in affirmations module use at least weekly in the 6-8 week postoperative period.', 'armGroupLabels': ['Guided Imagery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Brandy Michaels, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'J. Rebecca Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecologic Oncology Fellow', 'investigatorFullName': 'Brandy Michaels', 'investigatorAffiliation': 'University of Michigan'}}}}