Ignite Creation Date:
2024-05-05 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00734513
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2008-08-13
Brief Title:
Partner-Assisted Emotional Disclosure for GI Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Partner Assisted Emotional Disclosure for GI Cancer
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
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:
The long-range goal of this research is to develop better ways of helping GI cancer patients and their caregivers cope more effectively with the demands of the disease The study is designed to test the hypothesis that a partner-assisted emotional disclosure intervention will be more effective in enhancing patient psychological adjustment than a cancer education condition
Detailed Description:
The diagnosis and treatment of GI cancer is a traumatic and life-altering event Many patients with GI cancer experience significant emotional distress and disruptions in their social relationships as well as multiple physical symptoms and limitations in physical activities There is evidence that cancer patients who are able to confide their feelings and concerns about the cancer experience with supportive others particularly their partners fare better patients who are able to discuss cancer openly with their partners report fewer emotional and physical complaints and higher levels of self-esteem and perceived control However there are a number of barriers that often inhibit discussion of cancer-related feelings The proposed study will examine the effect of a new partner-assisted emotional disclosure ED protocol for patients with GI cancer
In this study 200 patients diagnosed with GI cancer and their partners will be recruited to participate The couples will be randomly assigned to one of two conditions 1 partner-assisted emotional disclosure or 2 cancer education Assessment measures will be collected at evaluations conducted before and after treatment and at 8 weeks post treatment All evaluations will be conducted over the phone Information will also be collected from the physician andor the patients medical record at each of the three evaluations Audiotapes of the partner-assisted emotional disclosure sessions will be transcribed and 10-minute segments will be randomly selected and analyzed to assess the extent to which patients express emotions and partners verbally reflect the partners feeling in an empathic manner
In this study 200 patients diagnosed with GI cancer and their partners will be recruited to participate The couples will be randomly assigned to one of two conditions 1 partner-assisted emotional disclosure or 2 cancer education Assessment measures will be collected at evaluations conducted before and after treatment and at 8 weeks post treatment All evaluations will be conducted over the phone Information will also be collected from the physician andor the patients medical record at each of the three evaluations Audiotapes of the partner-assisted emotional disclosure sessions will be transcribed and 10-minute segments will be randomly selected and analyzed to assess the extent to which patients express emotions and partners verbally reflect the partners feeling in an empathic manner
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 |
|---|---|---|---|
| 1R01CA10073-01A1 | None | None | None |