- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00020553
Video Support Program For Families With a Parent Newly Diagnosed With Cancer
We Can Cope: Family Support When A Parent Has Cancer
RATIONALE: A videotape support program may help families improve communication and coping skills when a parent is diagnosed with cancer.
PURPOSE: Randomized trial to study the effectiveness of a video support program for families who have a parent who has been newly diagnosed with cancer.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES: I. Determine if families who participate in a video support program function better as a family in the areas of communication, togetherness, and overall increased ability to cope when a parent is newly diagnosed with cancer. II. Determine if participation in this program decreases stress-related illness in the well members of the family. III. Determine the safety of this program. IV. Determine patient/family and medical provider satisfaction with this program.
OUTLINE: This a randomized study. Adult parent participants and spouses undergo a baseline assessment over approximately 1 hour comprising completion of a self-assessment form followed by an interview. Families are then randomized to one of two arms. Arm I: Adult parent participants receive a video support program comprising 3 videotapes (parent tape, adolescent tape, and child tape) and a parent guidebook. The parents are encouraged to screen the videotapes and decide whether to have their child and/or adolescent view the program. Arm II: Adult parent participants receive no video support material. Families may view the video program after study completion. Adult parent participants in both arms complete follow-up assessments at 6 and 12 weeks. This clinical trial is being conducted at the locations listed below. If you are interested in this clinical trial but unable to visit these locations, please call #1-800-848-3895 ext. 226 and ask for more information about the We Can Cope study.
PROJECTED ACCRUAL: A total of 230 families will be accrued for this study.
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Maine
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Scarborough, Maine, Stati Uniti, 04074
- Maine Center for Cancer Medicine and Blood Disorders
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Massachusetts
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Newton, Massachusetts, Stati Uniti, 02464-1594
- Inflexxion
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New York
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Bronx, New York, Stati Uniti, 10461
- Albert Einstein Comprehensive Cancer Center
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28207
- Buddy Kemp Caring House
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Texas
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Dallas, Texas, Stati Uniti, 75246
- Baylor University Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS: Parent with a first diagnosis of cancer within the past 5 years No recurrence of a previously diagnosed cancer Must have at least 1 child between the ages of 6 and 18 Ill parent must live with child/children at least 50% of the time No plans to move out-of-state within the next 3 months
PATIENT CHARACTERISTICS: Age: See Disease Characteristics Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No psychotic disorder (such as schizophrenia) or a brain/psychiatric disorder due to disease/illness
PRIOR CONCURRENT THERAPY: Not specified
Piano di studio
Come è strutturato lo studio?
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Jonas I. Bromberg, Inflexxion, Inc.
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Inizio studio
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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CDR0000068602
- INFLEXXION-000080
- ITS-000080
- NCI-V01-1659
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 .