Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-25 @ 12:11 PM
Study NCT ID:
NCT02918461
Status:
COMPLETED
Last Update Posted:
2019-01-04
First Post:
2016-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emerging From the Haze for Gynecologic Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2016-09-21', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of trainee-taught vs non-trainee taught class', 'timeFrame': 'First day of class (baseline), last day of class (6 weeks)', 'description': "To compare the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self report of cognitive changes based on change of the FACT-Cog compared to the impact of an ongoing non-trainee-taught Emerging from the Haze course on breast cancer survivors' self report of cognitive changes based on the change in FACT-Cog score from first day of class (baseline) to last day of class (6 weeks) in these two groups"}], 'primaryOutcomes': [{'measure': 'The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey', 'timeFrame': 'First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class', 'description': 'Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey', 'timeFrame': 'First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class', 'description': 'Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class'}, {'measure': 'UCLA Loneliness Scale Survey', 'timeFrame': 'First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class', 'description': 'Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Neoplasms', 'Cognition Disorders']}, 'descriptionModule': {'briefSummary': "At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for a 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.\n\nThe objective of this study is to quantify the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the change of FACT-Cog score."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of any stage gynecologic cancer including ovarian, uterine/endometrial, cervical, vulvar, and vaginal cancer\n* Treated with chemotherapy solely or in combination with surgery, radiation, and/or hormonal therapy\n* Female, age ≥ 18 years.\n* FACT-Cog score \\< 59 on the PCI sub scale\n* Eligible after 2 months (60 ±5 days) of completing all their active cancer treatment with the exception of long-term hormonal treatments\n* Subjective complaint of cognitive concerns at time of enrollment\n* Must be able to understand and communicate proficiently in English\n* Ability to understand and the willingness to sign a written informed consent.\n* Agree to complete study surveys\n\nExclusion Criteria:\n\n* Patients who have significant personality disorders or unstable psychiatric disorders (including active major depression, substance abuse, psychosis or bipolar disorder) as assessed by the interviewing clinician\n* Patients with known brain metastases, history of brain metastases or radiation to the brain.\n* Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction.\n* Non-English speakers\n* Receiving treatment for another malignancy other than breast cancer\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, chronic anemia, uncontrolled hypothyroidism, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.'}, 'identificationModule': {'nctId': 'NCT02918461', 'briefTitle': 'Emerging From the Haze for Gynecologic Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Pilot Study of Emerging From the Haze Evaluating a Trainee-taught Psycho-educational Program to Improve Cancer-related Cognitive Complaints in Gynecologic Cancer Survivors', 'orgStudyIdInfo': {'id': 'Pro00046105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emerging from the Haze class', 'description': 'A 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.', 'interventionNames': ['Behavioral: Emerging from the Haze class']}], 'interventions': [{'name': 'Emerging from the Haze class', 'type': 'BEHAVIORAL', 'description': 'A 6-week class designed to combat chemotherapy-induced cognitive dysfunction. Patients will report symptoms at 6 months and 1 year after the end of their Haze class.', 'armGroupLabels': ['Emerging from the Haze class']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Arash Asher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cancer Rehabilitation and Survivorship', 'investigatorFullName': 'Arash Asher, MD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}