Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020553
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-07-11
Brief Title:
Video Support Program For Families With a Parent Newly Diagnosed With Cancer
Sponsor:
Inflexxion Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
We Can Cope Family Support When A Parent Has Cancer
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 patientfamily 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V01-1659 | None | None | None |
| INFLEXXION-000080 | None | None | None |
| ITS-000080 | None | None | None |