- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Maine
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Scarborough, Maine, Spojené státy, 04074
- Maine Center for Cancer Medicine and Blood Disorders
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Massachusetts
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Newton, Massachusetts, Spojené státy, 02464-1594
- Inflexxion
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New York
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Bronx, New York, Spojené státy, 10461
- Albert Einstein Comprehensive Cancer Center
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28207
- Buddy Kemp Caring House
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Texas
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Dallas, Texas, Spojené státy, 75246
- Baylor University Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Jonas I. Bromberg, Inflexxion, Inc.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- CDR0000068602
- INFLEXXION-000080
- ITS-000080
- NCI-V01-1659
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