Video Support Program For Families With a Parent Newly Diagnosed With Cancer
Recruitment status was Active, not recruiting
|First Received Date ICMJE||July 11, 2001|
|Last Updated Date||July 24, 2010|
|Start Date ICMJE||August 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00020553 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Video Support Program For Families With a Parent Newly Diagnosed With Cancer|
|Official Title ICMJE||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.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Not Provided|
|Condition ICMJE||Psychosocial Effects of Cancer and Its Treatment|
|Intervention ICMJE||Procedure: psychosocial assessment and care|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00020553|
|Other Study ID Numbers ICMJE||CDR0000068602, INFLEXXION-000080, ITS-000080, NCI-V01-1659|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Inflexxion, Inc.|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||October 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP