Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-02-25 @ 7:49 PM
Study NCT ID:
NCT03097458
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized wait-list control design (cross-over).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-02', 'studyFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change of children's quality of life on the health-related quality of life questionnaire (KINDL)", 'timeFrame': '6 weeks (change between baseline and week 6)', 'description': "Enhancement of children's quality of life from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group."}, {'measure': "Change of children's behavioral-emotional functioning on the Strengths and Difficulties Questionnaire (SDQ)", 'timeFrame': '6 weeks (change between baseline and week 6)', 'description': "Enhancement of children's behavioral-emotional functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group."}, {'measure': "Change of parent's mental health on the Hospital Anxiety and Depression Scale (HADS)", 'timeFrame': '6 weeks (change between baseline and week 6)', 'description': "Enhancement of parent's mental health from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group."}, {'measure': 'Change of family functioning on the Family Adaptability and Cohesion Evaluation Scale (FACES IV)', 'timeFrame': '6 weeks (change between baseline and week 6)', 'description': 'Enhancement of family functioning from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.'}, {'measure': 'Change of relationship quality on the relationship questionnaire (Partnerschaftsfragebogen PFB)', 'timeFrame': '6 weeks (change between baseline and week 6)', 'description': 'Enhancement of relationship quality from T1 (baseline) to T2 (6 weeks) compared to the wait-list control group.'}], 'secondaryOutcomes': [{'measure': 'Number of participants willing to participate in the counselling', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Secondary outcome will be to determine whether a short-term counselling intervention is feasible in the Swiss medical setting by collecting the number of participants willing to participate.'}, {'measure': 'Sociodemographic characteristics (i.e. age, gender, education) of the participants willing to participate in the counselling with the sociodemographic questionnaire', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Collecting sociodemographic characteristics of the population willing to participate with the sociodemographic questionnaire'}, {'measure': 'Medical history characteristics (i.e. cancer diagnosis, cancer treatment) of the participants willing to participate in the counselling with the medical history questionnaire', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Collecting medical history of the population willing to participate with the medical history questionnaire'}, {'measure': 'Dropout rate during the recruitment and intervention procedure', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Secondary outcome will be to determine whether a short-term counselling intervention is feasible in the Swiss medical setting by collecting dropout rate during the recruitment and intervention procedure.'}, {'measure': 'Client satisfaction on the Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'Measures assessed after 6 weeks', 'description': "German Version of the Client Satisfaction Questionnaire: Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8) will be used to measure client's intervention satisfaction."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Counselling for Families', 'Parental cancer', 'Psychological distress and adjustment'], 'conditions': ['Psychological Adjustment', 'Cancer']}, 'descriptionModule': {'briefSummary': "A parental cancer diagnosis challenges the family's stability and the parent-child relationship. It may impact the children's well-being, so that about one third of them develop clinically relevant levels of psychological distress. Psycho-oncological family-based counselling programs have been shown to elevate children's and parents' well-being. However, there is still a dearth of familial health services in Switzerland, which has also been recognized by the Swiss National Cancer Program (2011-2017).\n\nThis study aims to implement and evaluate a short-term family counselling intervention at the Cancer Center of the University Hospital Basel. The primary objective of the study is the enhancement of adjustment to the parental cancer diagnosis. The study seeks secondary to determine the feasibility of the short-term counselling Intervention.", 'detailedDescription': 'This study ist designed as a randomized controlled wait-list Intervention study, which aims to implement and evaluate a short-term family counselling intervention at the Cancer Center of the University Hospital Basel. The study will be divided into two stages: Stage 1 serves as the preparatory work phase, where the intervention manual will be developed as well as the implementation strategy into the hospital. In stage 2 the intervention will be evaluated, with an interim analysis to test for feasibility. The primary objective of the study is the enhancement of adjustment (family, parents and children) to the parental cancer diagnosis. The study seeks secondary to determine the feasibility of the short-term counselling intervention in the Swiss medical setting and to identify predictors for families with continuing psychosocial adjustment problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Diagnosis of any kind of cancer, inclusive relapse, within the last year with an expected survival of at least 8 months\n* Married, cohabiting or single parent\n* At least one child between 1-5 - 18 years\n* German speaking\n\nExclusion Criteria:\n\n* The diagnosis is more than 1 year ago\n* Diagnosed patients (parent) not living with their children\n* Diagnosed patients without custody of their children'}, 'identificationModule': {'nctId': 'NCT03097458', 'briefTitle': 'Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Enhancing Adjustment to Parental Cancer: Short-term Counselling for Families. A Randomized, Wait-list Controlled Intervention Study', 'orgStudyIdInfo': {'id': 'PP-16-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Counselling', 'description': 'short-term counselling for families', 'interventionNames': ['Behavioral: Short-term Counselling for Families']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control group', 'description': 'Wait-list control group'}], 'interventions': [{'name': 'Short-term Counselling for Families', 'type': 'BEHAVIORAL', 'description': 'Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist.', 'armGroupLabels': ['Counselling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Corinne Urech, Dr. phil.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'propatient Forschungsstiftung', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}