Prostate Cancer
Conditions
Keywords
Erectile Dysfunction, focus group, Quality of Life, 10-204
Brief summary
The investigators know that treatment for prostate cancer and erectile dysfunction can impact sexual health and quality of life. They want to learn how the treatment affects one's emotional and social well-being. They have developed a new type of counseling. Cancer patients seek counseling for lots of reasons. It often helps them cope because they can express their feelings with a trained professional. They hope that this counseling will teach patients skills that they can use to comply with erectile treatment programs, improve their sexual health and quality of life. These skills may also improve physical and emotional well-being. As part of this study they will ask the patient to provide feedback on the proposed counseling.
Interventions
BEHAVIORALSexual Medicine Rehabilitation Program + nurse practitioner information phone calls
Baseline Assessment which is 90-minute patient focus group interviews. SMRP, provided to all participating patients, consists of the following steps: 1) An introductory visit with SMRP Director, Dr. Mulhall, to orient the patient to post-surgery erectile rehabilitation and assess the patients success with PDE-5 inhibitors; 2) Penile injection training provided by a NP over two visits, with follow-up calls as necessary until injection method and dose are deemed correct; 3) Follow-up visits with Dr. Mulhall every 4 months to monitor progress with rehabilitation. Study assessments will be administered at baseline, at 4-8 months post baseline (follow up 1) and 4-8- months post follow up 1 (follow up 2).
BEHAVIORALSexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction
Baseline Assessment which is 90-minute patient focus group interviews. SMRP+ACT-ED will receive four individual ACT-ED counseling sessions (60 minutes each) over a period of approximately four months, and will also be followed up with questionnaires 4 and 8 months post baseline These sessions focus on the four core elements of ACT: values, acceptance, exposure, and commitment. Study assessments will be administered at baseline, at 4-8 months post baseline (follow up 1) and 4-8- months post follow up 1 (follow up 2).
Sponsors
National Institutes of Health (NIH)
Center for Marital and Sexual Health of South Florida
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Part A * Men who are 1 to 3 years post radical prostatectomy for early stage prostate cancer * Participated in penile injection program * Are able to speak, read, write and understand English well enough to complete study assessment and communicate with an English speaking therapist Part B * Men who are up to 9 months post radical prostatectomy. * Had good erectile functioning pre-surgery (i.e., 24 or greater on the IIEF Erectile Function Domain (EFD) score), graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale) or have a score of 7 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment) * Seen at MSKCCs Sexual Medicine Rehabilitation Program (SMRP) * Advised by the clinical staff of the SMRP to start penile injections.
Exclusion criteria
Part A * Recurrence or progression of disease, * Specific injection phobia (self report) * A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review) * Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a focus group Part B * Specific injection phobia (self report) * A history of bipolar disorder or psychotic disorder (determined from self-report and/or chart review) * Current major depression (determined by self report and/or clinician observation and assessment) that would preclude from giving informed consent or being an active participant in a therapeutic session.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the feasibility | 2 years | acceptability, tolerability and adherence) of adapted ACT psychotherapy treatment integrated into an erectile rehabilitation program (i.e., ACT-ED). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the impact of ACT-ED | 2 years | on penile injection compliance, ED treatment satisfaction, sexual functioning, sexual self-esteem, ED bother, depression symptoms, acceptance and self-awareness. |
Countries
United States
Outcome results
None listed