Ignite Creation Date:
2024-05-05 @ 9:20 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00869739
Status:
COMPLETED
Last Update Posted:
2013-02-25
First Post:
2009-03-25
Brief Title:
Helping African American Prostate Cancer Survivors and Their Partners Cope With Challenges After Surgery for Prostate Cancer
Sponsor:
East Carolina University
Organization:
East Carolina University
Study Overview
Official Title:
Prostate Cancer Recovery Enhancement for African American Men and Their Intimate Partners
Status:
COMPLETED
Status Verified Date:
2013-02
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 Telephone counseling after radical prostatectomy may help African American prostate cancer survivors and their intimate partners cope with the problems and challenges of surgery and may reduce distress and improve quality of life It is not yet known which counseling and education program is more effective in helping prostate cancer survivors and their partners
PURPOSE This randomized clinical trial is studying effective ways to help African American prostate cancer survivors and their partners cope with challenges after surgery for early-stage prostate cancer
PURPOSE This randomized clinical trial is studying effective ways to help African American prostate cancer survivors and their partners cope with challenges after surgery for early-stage prostate cancer
Detailed Description:
OBJECTIVES
Primary
To develop more effective ways to help both African American prostate cancer survivors and their intimate partners cope with the problems and challenges experienced after radical prostatectomy for prostate cancer
To evaluate the efficacy of a new telephone-based partner-assisted coping skills training CST protocol for reducing survivor and partner disease-related and overall distress addressing cancer-related strain and overall distress in survivors intimate partners and improving relationship quality between survivors and partners by enhancing intimacy and adjustment within the relationship
Secondary
To identify for whom the intervention may be more or less efficacious by exploring the association between initial relationship functioning ie dyadic adjustment scores reported by survivors and partners and survivor outcomes and between initial relationship functioning and partner outcomes
OUTLINE Survivors are stratified according to symptom severity low vs moderate vs high and clinical risk category low vs moderate vs high Survivorpartner dyads are randomized to 1 of 3 intervention arms
Arm I Partner-assisted coping skills training PA-CST Survivorpartner dyads undergo a telephone-based culturally sensitive PA-CST intervention in six weekly telephone sessions 60-minutes each over 8 weeks conducted by African American doctoral level clinical psychologists knowledgeable about prostate cancer and experienced in CST and cancer education During these sessions participants are trained in a variety of cognitive and behavioral skills to manage symptom-related distress and to improve their quality of life after prostate cancer treatment Among these skills are strategies for communication ie effective speaking and listening behavioral coping methods ie activity pacing applied relaxation techniques and goal setting to increase pleasant activities and skills for managing negative mood and reducing emotional stress Participants also receive guidance in working cooperatively with their partners to improve symptom management including joint practicing of coping skills and problem-solving strategies
Arm II Cancer education Survivorpartner dyads undergo a telephone-based culturally sensitive cancer education intervention in six weekly telephone sessions 60 minutes each over 8 weeks conducted by African American doctoral level clinical psychologists knowledgeable about prostate cancer and experienced in CST and cancer education During the sessions participants are educated about symptoms commonly experienced after prostatectomy ie erectile dysfunction urinary incontinence nutrition bowel problems and fatigue and medical treatment options for these symptoms Participants also receive written materials about these information
Arm III Wait-list control Survivorpartner dyads receive usual care and are placed on a wait-list After completing the study survivors and their partners have the option of participating in either the CST or cancer education interventions
All participants complete questionnaires at baseline right after intervention 2 months and 3 months after intervention 5 months Survivors complete questionnaires over approximately 28 minutes to measure symptom distressseverity depressed mood quality of life self-efficacy for symptom management relationship quality and coping strategies Partners complete questionnaires over approximately 17 minutes to measure caregiver strain depressed mood partners self-efficacy for symptom control relationship quality and coping strategies At each evaluation physicians provide ratings of illness severity documentation of medical treatments for cancer and symptom management and frequency of clinic visits for each survivor
Primary
To develop more effective ways to help both African American prostate cancer survivors and their intimate partners cope with the problems and challenges experienced after radical prostatectomy for prostate cancer
To evaluate the efficacy of a new telephone-based partner-assisted coping skills training CST protocol for reducing survivor and partner disease-related and overall distress addressing cancer-related strain and overall distress in survivors intimate partners and improving relationship quality between survivors and partners by enhancing intimacy and adjustment within the relationship
Secondary
To identify for whom the intervention may be more or less efficacious by exploring the association between initial relationship functioning ie dyadic adjustment scores reported by survivors and partners and survivor outcomes and between initial relationship functioning and partner outcomes
OUTLINE Survivors are stratified according to symptom severity low vs moderate vs high and clinical risk category low vs moderate vs high Survivorpartner dyads are randomized to 1 of 3 intervention arms
Arm I Partner-assisted coping skills training PA-CST Survivorpartner dyads undergo a telephone-based culturally sensitive PA-CST intervention in six weekly telephone sessions 60-minutes each over 8 weeks conducted by African American doctoral level clinical psychologists knowledgeable about prostate cancer and experienced in CST and cancer education During these sessions participants are trained in a variety of cognitive and behavioral skills to manage symptom-related distress and to improve their quality of life after prostate cancer treatment Among these skills are strategies for communication ie effective speaking and listening behavioral coping methods ie activity pacing applied relaxation techniques and goal setting to increase pleasant activities and skills for managing negative mood and reducing emotional stress Participants also receive guidance in working cooperatively with their partners to improve symptom management including joint practicing of coping skills and problem-solving strategies
Arm II Cancer education Survivorpartner dyads undergo a telephone-based culturally sensitive cancer education intervention in six weekly telephone sessions 60 minutes each over 8 weeks conducted by African American doctoral level clinical psychologists knowledgeable about prostate cancer and experienced in CST and cancer education During the sessions participants are educated about symptoms commonly experienced after prostatectomy ie erectile dysfunction urinary incontinence nutrition bowel problems and fatigue and medical treatment options for these symptoms Participants also receive written materials about these information
Arm III Wait-list control Survivorpartner dyads receive usual care and are placed on a wait-list After completing the study survivors and their partners have the option of participating in either the CST or cancer education interventions
All participants complete questionnaires at baseline right after intervention 2 months and 3 months after intervention 5 months Survivors complete questionnaires over approximately 28 minutes to measure symptom distressseverity depressed mood quality of life self-efficacy for symptom management relationship quality and coping strategies Partners complete questionnaires over approximately 17 minutes to measure caregiver strain depressed mood partners self-efficacy for symptom control relationship quality and coping strategies At each evaluation physicians provide ratings of illness severity documentation of medical treatments for cancer and symptom management and frequency of clinic visits for each survivor
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 |
|---|---|---|---|
| ECU-08-0485 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01CA122704 |
| R01CA122704 | NIH | None | None |