Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002848
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
1999-11-01
Brief Title:
Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
SUPPORTIVE-EXPRESSIVE GROUP THERAPY FOR MEN WITH PRIMARY PROSTATE CANCER
Status:
COMPLETED
Status Verified Date:
2013-03
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:
RATIONALE Developing coping strategies may help improve the quality of life of patients with prostate cancer
PURPOSE This randomized clinical trial is comparing the effect of group therapy with written educational materials on the quality of life of men with stage I or stage II prostate cancer
PURPOSE This randomized clinical trial is comparing the effect of group therapy with written educational materials on the quality of life of men with stage I or stage II prostate cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of providing group support and evaluate the effect of supportive-expressive group therapy vs written educational material on the psychological health and quality of life of men with stage III prostate cancer
OUTLINE Patients are stratified by prior hormonal therapy
Patients continue standard oncologic treatment concurrently with supportive-expressive group therapy
Supportive-expressive group therapy consists of twelve 90-minute weekly meetings with 8-12 members and 2 cotherapists and is based on the following themes building bonds expressing emotions detoxifying dying taking time to prioritize and set realistic goals fortifying families and dealing with doctors Each session commences with a brief stress reduction exercise and ends with a brief cognitive restructuring imagery exercise The main portion of the meeting emphasizes providing an environment in which patients can share their concerns feelings and thoughts openly and honestly The role of the cotherapist is to facilitate expression of patients concerns offer empathy and continue to encourage patients to express their feelings and thoughts
Quality-of-life questionnaires are filled out at 3 and 6 months and then every 6 months for a total of 2 years
PROJECTED ACCRUAL Approximately 480 patients including an estimated 53 minority patients will be entered in this multicenter study
Determine the feasibility of providing group support and evaluate the effect of supportive-expressive group therapy vs written educational material on the psychological health and quality of life of men with stage III prostate cancer
OUTLINE Patients are stratified by prior hormonal therapy
Patients continue standard oncologic treatment concurrently with supportive-expressive group therapy
Supportive-expressive group therapy consists of twelve 90-minute weekly meetings with 8-12 members and 2 cotherapists and is based on the following themes building bonds expressing emotions detoxifying dying taking time to prioritize and set realistic goals fortifying families and dealing with doctors Each session commences with a brief stress reduction exercise and ends with a brief cognitive restructuring imagery exercise The main portion of the meeting emphasizes providing an environment in which patients can share their concerns feelings and thoughts openly and honestly The role of the cotherapist is to facilitate expression of patients concerns offer empathy and continue to encourage patients to express their feelings and thoughts
Quality-of-life questionnaires are filled out at 3 and 6 months and then every 6 months for a total of 2 years
PROJECTED ACCRUAL Approximately 480 patients including an estimated 53 minority patients will be entered in this multicenter 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-P96-0072 | None | None | None |
| URCC-U9994 | None | None | None |
| NCI-CCC-94-32 | None | None | None |
| URCC-9994PA | None | None | None |