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NCT00020553 Clinical Trial

Video Support Program For Families With a Parent Newly Diagnosed With Cancer

Psychosocial Effects of Cancer and Its Treatment Clinical Trial

Official title:
We Can Cope: Family Support When A Parent Has Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00020553
Other study ID # CDR0000068602
Secondary ID INFLEXXION-00008
Status Active, not recruiting
Phase N/A
First received July 11, 2001
Last updated September 19, 2013
Start date August 2000

Study information
Verified date October 2006
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

  • Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• psychosocial assessment and care

Locations
Country Name City State
United States Albert Einstein Comprehensive Cancer Center Bronx New York
United States Buddy Kemp Caring House Charlotte North Carolina
United States Baylor University Medical Center Dallas Texas
United States Inflexxion Newton Massachusetts
United States Maine Center for Cancer Medicine and Blood Disorders Scarborough Maine

Sponsors (2)
Lead Sponsor Collaborator
Inflexxion, Inc. National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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