Cancer SurvivorNCT00869739
Helping African American Prostate Cancer Survivors and Their Partners Cope With Challenges After Surgery for Prostate Cancer
A study testing telephone-based intervention, educational intervention and partner-assisted coping skills training in people with Cancer Survivor and Depression, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivor, Depression, Gastrointestinal Complications
- What is being tested?
- telephone-based intervention, educational intervention and partner-assisted coping skills training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- African American prostate cancer survivor
- Diagnosis of early-stage prostate cancer
- Stage T1-T3 disease
- No regional or metastatic prostate cancer
- Underwent radical prostatectomy as the primary treatment for prostate cancer within the past 2 years
- Prior adjunctive radiotherapy secondary to surgery allowed
- No radiotherapy (i.e., external beam radiation or brachytherapy) as primary form of treatment
- Intimate partner of cancer survivor
- Spouse or any cohabiting intimate partner identified by the survivor
- Same sex partners and partners of all ethnicities allowed
PATIENT CHARACTERISTICS:
- No dementia or unstable psychiatric condition
- No significant hearing impairment
- Fluent in English
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, 27834
About this study
Official title: Prostate Cancer Recovery Enhancement for African American Men and Their Intimate Partners
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.
Read the 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 (i.e., 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). Survivor/partner dyads are randomized to 1 of 3 intervention arms.
- Arm I (Partner-assisted coping skills training [PA-CST]): Survivor/partner 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 (i.e., effective speaking and listening); behavioral coping methods (i.e., 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): Survivor/partner 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 (i.e., 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): Survivor/partner 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 distress/severity, 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.
- Conditions
- Cancer Survivor, Depression, Gastrointestinal Complications, Male Erectile Disorder, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- telephone-based intervention, educational intervention, partner-assisted coping skills training, questionnaire administration, psychosocial assessment and care
- Keywords
- cancer survivor, depression, psychosocial effects of cancer and its treatment, male erectile disorder, urinary complications, gastrointestinal complications, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Medical subject headings
- Depression, Erectile Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based interventionBehavioural
educational interventionOther
partner-assisted coping skills trainingOther
questionnaire administrationOther
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom distress in survivors as assessed by the Sexual, Urinary, and Bowel Bother subscales of the Prostate Cancer Index Composite (EPIC) (16) at baseline, 2 months, and 5 months
Depressed mood in survivors and partners as assessed by the depression subscale of the Profile of Mood States-SF (POMS-SF, 95) at baseline, 2 months, and 5 months
Quality of life of survivors as assessed by the Physical Well-being, Functional Well-being, and Prostate Cancer subscales of FACT-P (127) at baseline, 2 months, and 5 months
Caregiver strain in partners as assessed by the Caregiver Strain Index (CSI) at baseline, 2 months, and 5 months
Self-efficacy for symptom control in survivors and partners as assessed by the Self-Efficacy for Symptom Control Inventory; EPIC; and CSI at baseline, 2 months, and 5 months
Relationship functioning in survivors and partners as assessed by the Dyadic Adjustment Scale (129) and the Miller Social Intimacy Scale (130) at baseline, 2 months, and 5 months
Secondary outcomes (1)
Coping skills in survivors and partners as assessed by the Coping Strategies, Social Problem Solving Scale-Revised, and La Trobe Communication Questionnaires at baseline, 2 months, and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startAug 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lisa Campbell, East Carolina University
- Investigators
- Lisa C Campbell, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869739
- Sponsor's protocol ID
- CDR0000634536
- Other IDs
- R01CA122704, ECU-08-0485
- Status last verified
- Feb 2013
- First submitted
- 25 Mar 2009
- Last updated
- 25 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Recovery Enhancement for African American Men and Their Intimate Partners
- ClinicalTrials.gov ID
- NCT00869739
- Acronym / sponsor ID
- CDR0000634536
- Conditions
- Cancer Survivor, Depression, Gastrointestinal Complications, Male Erectile Disorder, Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- cancer survivor, depression, psychosocial effects of cancer and its treatment, male erectile disorder, urinary complications, gastrointestinal complications, stage I prostate cancer, stage IIB prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (i.e., 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). Survivor/partner dyads are randomized to 1 of 3 intervention arms.
- Arm I (Partner-assisted coping skills training [PA-CST]): Survivor/partner 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 (i.e., effective speaking and listening); behavioral coping methods (i.e., 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): Survivor/partner 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 (i.e., 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): Survivor/partner 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 distress/severity, 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone-based intervention | Behavioural | – |
| educational intervention | Other | – |
| partner-assisted coping skills training | Other | – |
| questionnaire administration | Other | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Symptom distress in survivors as assessed by the Sexual, Urinary, and Bowel Bother subscales of the Prostate Cancer Index Composite (EPIC) (16) at baseline, 2 months, and 5 months
Depressed mood in survivors and partners as assessed by the depression subscale of the Profile of Mood States-SF (POMS-SF, 95) at baseline, 2 months, and 5 months
Quality of life of survivors as assessed by the Physical Well-being, Functional Well-being, and Prostate Cancer subscales of FACT-P (127) at baseline, 2 months, and 5 months
Caregiver strain in partners as assessed by the Caregiver Strain Index (CSI) at baseline, 2 months, and 5 months
Self-efficacy for symptom control in survivors and partners as assessed by the Self-Efficacy for Symptom Control Inventory; EPIC; and CSI at baseline, 2 months, and 5 months
Relationship functioning in survivors and partners as assessed by the Dyadic Adjustment Scale (129) and the Miller Social Intimacy Scale (130) at baseline, 2 months, and 5 months
1 secondary outcome
Coping skills in survivors and partners as assessed by the Coping Strategies, Social Problem Solving Scale-Revised, and La Trobe Communication Questionnaires at baseline, 2 months, and 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa C Campbell, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone-based intervention, educational intervention and partner-assisted coping skills training in people with Cancer Survivor and Depression, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom distress in survivors as assessed by the Sexual, Urinary, and Bowel Bother subscales of the Prostate Cancer Index Composite (EPIC) (16) at baseline, 2 months, and 5 months. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.