- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00685256
Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
Parent Communication Study II - Randomized Controlled Trial of Decision Support vs. Education for Parent Communication of BRCA 1/2 Cancer Genetic Test Results to Children
RATIONALE: A study that evaluates the support of a decision guide used together with genetic counseling may improve communication between mothers undergoing BRCA1/2 testing and their minor-age children.
PURPOSE: This randomized phase III trial is studying standard genetic counseling given together with a decision guide to see how well it works compared with genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.
Panoramica dello studio
Stato
Descrizione dettagliata
OBJECTIVES:
Primary
- To evaluate the efficacy of a decision support intervention delivered in conjunction with standard genetic counseling compared to standard genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.
Secondary
- To understand the mechanisms by which decision support impacts on decision outcomes.
- To identify mothers who are most and least likely to benefit from decision support.
- To explore the potential impact of decision support on disclosure and parent-child psychosocial well-being.
OUTLINE: This is a multicenter study. Mothers are stratified according to their child's age (< 13 vs ≥ 13 years old), child's gender (female vs male), and trial site. Mothers are randomized to 1 of 2 arms.
- Arm I (standard genetic counseling with communication aid): Mothers undergo standard pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers also receive a copy of "My Children, My Test Results," a detailed decision guide developed to promote quality and informed decision making and outcomes, and provide support to mothers regardless of whether or not they choose to communicate their BRCA1/2 test results to their children.
- Arm II (standard genetic counseling alone): Mothers undergo standard pre-test genetic counseling and provide a blood sample for mutation analysis. Mothers also receive a copy of "Genetic Testing for Breast and Ovarian Cancer Risk: It's Your Choice" containing information regarding family history of breast and ovarian cancer risks, BRCA1/2 genes, risks and benefits of genetic testing, medical management options for carriers, and considerations including family communication.
All mothers complete extensive family history assessments during their baseline interviews and disclose if they have been diagnosed with cancer, length and type of treatments, and the number of other relatives with a history of cancer. Mothers are assessed at baseline (pre-test genetic counseling), post-genetic counseling after learning test results, and at 1 and 6 months post-genetic counseling by a 30-45 minute multi-item and multi-scale self-report telephone survey. Genetic testing results are also submitted to this study. The frequency (number), intensity (length in minutes), and content of participant-initiated telephone contacts to genetic counselors to assess intervention reactivity; participants' self-reported use of educational guides; and their satisfaction with the intervention will be assessed.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
-
-
District of Columbia
-
Washington, D.C., District of Columbia, Stati Uniti, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
- Mothers self-identified as primary caregivers to minor-age children (ages 8-21 years-old)
- Mothers must be undergoing genetic counseling and have provided a blood sample for analysis for BRCA1/2 mutations
- Mothers must have resided in the same home as the child(ren) for the past 6 months and intend to continue to reside with the child(ren) for the next 6 months
PATIENT CHARACTERISTICS:
- At least 21 years old (mothers)
- No serious mental illness (e.g., cognitive and psychotic disorders) or developmental disability that would limit participation or preclude informed consent
- Must be able to adequately understand, speak, and read English
- Must have ready and consistent access to a telephone
PRIOR CONCURRENT THERAPY:
- Not specified
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Self-reported outcomes at 1-and 6-months
Lasso di tempo: 6 months
|
6 months
|
Decision conflict, as assessed by the Decisional Conflict Scale
Lasso di tempo: 6 months
|
6 months
|
Parents' decision satisfaction with their communication decision, as assessed by the Satisfaction With Decision Scale
Lasso di tempo: 6 months
|
6 months
|
Decision quality
Lasso di tempo: 6 months
|
6 months
|
Disclosure of genetic testing results by parents
Lasso di tempo: 6 months
|
6 months
|
Child-rearing alliance between parents, as measured by the Parenting Alliance Measure at baseline, after learning test results, and at 1 and 6 months after genetic counseling
Lasso di tempo: 6 months
|
6 months
|
Parent-child communication, as assessed by the Parent-Adolescent Communication Scale at baseline, after learning test results, and at 1 and 6 months after genetic counseling
Lasso di tempo: 6 months
|
6 months
|
Family functioning, as assessed by the Family Relationship Index at baseline, after learning test results, and at 1 and 6 months after genetic counseling
Lasso di tempo: 6 months
|
6 months
|
Children's stress and worry, as assessed by the Child Behavior Checklist at baseline, after learning test results, and at 1 and 6 months after genetic counseling
Lasso di tempo: 6 months
|
6 months
|
Parents' knowledge and awareness of the advantages and disadvantages of disclosing maternal BRCA1/2 test results to their children
Lasso di tempo: 6 months
|
6 months
|
Parents' preferences and values regarding family communication of genetic test results
Lasso di tempo: 6 months
|
6 months
|
Decision self-efficacy, as assessed by the Decision Self-Efficacy Scale
Lasso di tempo: 6 months
|
6 months
|
Cognitive appraisals
Lasso di tempo: 6 months
|
6 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Kenneth Tercyak, PhD, Lombardi Comprehensive Cancer Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDR0000592726
- P30CA051008 (Sovvenzione/contratto NIH degli Stati Uniti)
- R01HG002686 (Sovvenzione/contratto NIH degli Stati Uniti)
- GUMC-2007-444
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro al seno
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University e altri collaboratoriCompletatoLa guida all'applicazione clinica di Conebeam Breast CTCina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Canada, Stati Uniti, Singapore
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)
Prove cliniche su counseling intervention
-
Duke UniversityCompletatoCessazione dell'uso del tabaccoStati Uniti
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletatoFemmina di cancro al seno
-
Tonia CarrRitiratoAderenza ai farmaci | Evento avverso da farmaci | Non aderenza ai farmaciStati Uniti
-
Centers for Disease Control and PreventionState University of New York - Downstate Medical CenterCompletatoClamidia Trachomatis | Neisseria gonorrhoeaeStati Uniti
-
Swiss Tropical & Public Health InstituteUniversity of Basel; Ministry of Health, Lesotho; SolidarMedCompletatoHIV/AIDS | Aderenza, FarmacoLesoto
-
Sarah MorrowLawson Health Research InstituteCompletato
-
University of TulsaTerminatoSuicidio, tentatoStati Uniti
-
University of PittsburghReclutamentoDistrofia muscolare di DuchenneStati Uniti
-
UKK InstituteCity of NokiaIscrizione su invitoQualità della vita | Dolore muscoloscheletrico | Attività fisica | Funzionamento fisicoFinlandia
-
Lisbon Institute of Global Mental Health - LIGMHColumbia UniversityReclutamentoDisturbi psicotici | Schizofrenia | Disordine bipolare | Disturbo affettivo schizoidePortogallo