Acceptance and Commitment Therapy or Enhanced Monitoring and Education in Helping Men Adhere to Sexual Rehabilitation after Prostate Cancer Surgery

Status: active

This randomized clinical trial studies how well Acceptance and Commitment Therapy or Enhanced Monitoring and Education works in helping men adhere to sexual rehabilitation after prostate cancer surgery. Acceptance and Commitment Therapy may help men focus on the long-term goals of rehabilitation, accept the frustration related to erectile dysfunction, identify and overcome barriers, and commit to an erectile rehabilitation program. Enhanced Monitoring and Education may provide education and simple sexual strategies for the patients, and provides content to control for time and attention.

Inclusion Criteria

As per medical record, early stage prostate cancer (pathologic stage 1-2 with Gleason score =< 8; or pathologic stage 3 with Gleason score =< 7)
As per medical record, radical prostatectomy (RP) conducted either at Memorial Sloan-Kettering (MSK) or at another institution
As per medical record, =< 9 months post-RP
As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the International Index of Erectile Function [IIEF] Erectile Function Domain [EFD] score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment, have a total score of 15 or greater on items 2-7 on the Prostate Quality of Life Survey: Sexual Domain or graded themselves 6 or greater on the 1-10 erectile grade prior to RP on the Urology Sexual Function New Patient form)
As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSK
In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English

Exclusion Criteria

Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSK surgeon note), or documented in the progress note that the nerves were fully resected
Currently on or has a history of being on androgen deprivation therapy (ADT)
Has any indication of prostate-specific antigen (PSA), if available
As per self report, specific injection phobia
In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment
As per self report or as documented in the medical record, current untreated (e.g. no medication, no therapy) major psychiatric disorder (schizophrenia, major depression); patients diagnosed with a major psychiatric disorder will be reviewed by the study principal investigator (PI) to determine eligibility prior to consent

PRIMARY OBJECTIVES:

I. To investigate the impact of Acceptance and Commitment Therapy-erectile dysfunction (ACT-ED), compared to Enhanced Monitoring and Education (EME), on erectile function at the 24 month assessment (final assessment).

II. To investigate the impact of ACT-ED, compared to EME, on sexual self-esteem, ED bother, depressive symptoms, ED treatment satisfaction, satisfaction with sex life, interest in sexual activity, orgasm, and prostate cancer anxiety and treatment regret.

III. To investigate the natural history of injection use and impact on sexual self-esteem, ED bother, depressive symptoms, ED treatment satisfaction, satisfaction with sex life, interest in sexual activity, orgasm, and prostate cancer anxiety and treatment regret.

OUTLINE: Patients are randomized to 1 of 2 groups. Once enrollment is complete for phase I, patients are assigned to group III.

GROUP I (ACT-ED): Patients participate in 3 in-person or phone sessions over 30-45 minutes at weeks 1-2 and 1 in-person session over 15-30 minutes at 6 months. Patients receive 6 telephone calls over 5-10 minutes between week 3 and month 5. Patients also receive 6 monthly phone calls over 5-10 minutes at months 6-12. Five components of ACT are utilized: values, acceptance and willingness, mindfulness, experiential exposure, and commitment. Patients also receive standard of care.

GROUP II (EME): Patients participate in 3 in-person or phone sessions and receive 12 phone calls as in Group I. EME focuses rehabilitation program, management of technical issues related to injections, and dose titration of injection medication, which includes the side effects of prostate surgery, the prevalence and impact of ED after surgery, strategies for restarting sexual activity, integrating penile injections into intimate relations, strategies to address couples' communication, review and monitoring of Sensate Focus and review strategies to address urinary incontinence. Patients also receive standard of care.

GROUP III: Patients receive standard of care.

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Acceptance and Commitment Therapy or Enhanced Monitoring and Education in Helping Men Adhere to Sexual Rehabilitation after Prostate Cancer Surgery

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Exclusion Criteria

United States

New York

New York

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Acceptance and Commitment Therapy or Enhanced Monitoring and Education in Helping Men Adhere to Sexual Rehabilitation after Prostate Cancer Surgery

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