- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maine
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Scarborough, Maine, United States, 04074
- Maine Center for Cancer Medicine and Blood Disorders
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Massachusetts
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Newton, Massachusetts, United States, 02464-1594
- Inflexxion
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Comprehensive Cancer Center
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Buddy Kemp Caring House
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Texas
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Dallas, Texas, United States, 75246
- Baylor University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jonas I. Bromberg, Inflexxion, Inc.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CDR0000068602
- INFLEXXION-000080
- ITS-000080
- NCI-V01-1659
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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