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Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

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ClinicalTrials.gov Identifier: NCT02706561
Recruitment Status : Recruiting
First Posted : March 11, 2016
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Center for Marital and Sexual Health of South Florida
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to test two different ways to help men with sexual rehabilitation.

Condition or disease Intervention/treatment Phase
Prostate Cancer Erectile Dysfunction Behavioral: questionnaires Behavioral: three in-person sessions Behavioral: monthly phone calls Behavioral: Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED) Behavioral: Enhanced Monitoring and Education (EME) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Study Start Date : December 8, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Standard care plus the ACT intervention (ACT-ED)
SC + ACT-ED-Group A uses Acceptance and Commitment Therapy (ACT). In this group, men focus on: long-term goals of rehabilitation; acceptance of the frustration related to ED; identifying and overcoming barriers; and committing to an erectile rehabilitation program. All participants will be asked to complete a set of questionnaires (baseline). The participants can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. You will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes)
Behavioral: questionnaires
Behavioral: three in-person sessions
Behavioral: monthly phone calls
Behavioral: Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
Experimental: SC plus nurse Enhanced Monitoring and Education (EME)
SC + EME-Group B uses enhanced monitoring and education. This group focuses on answering questions about the rehabilitation program, manage technical issues related to injections, and the dose titration of injection medication. Participants in this group will also receive education on the side effects and impact of prostate cancer surgery, and strategies for restarting sexual activity. All participants will be asked to complete a set of questionnaires (baseline). You can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. The participant will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes).
Behavioral: questionnaires
Behavioral: three in-person sessions
Behavioral: monthly phone calls
Behavioral: Enhanced Monitoring and Education (EME)



Primary Outcome Measures :
  1. percentages of patients having an Erectile Function Domain (EFD) total score >= 24 [ Time Frame: 1 year ]
    The EFD score of >= 24 will be used to indicate "good" erectile function. This is both a face valid cut-off, and a cut off that is commonly used in the literature as "good" erectile function following radical prostatectomy.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 MSKCC 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 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 or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain)
  • As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC
  • 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 MSKCC surgeon note), or documented in the progress note that the nerves were fully resected.
  • Currently on or has a history of being an Androgen Deprivation Therapy (ADT)
  • 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 PI to determine eligibility prior to consent.
  • Currently a patient of Dr. Christian Nelson at Memorial Sloan Kettering Cancer Center Counseling Center.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706561


Contacts
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Contact: Christian Nelson, PhD 646-888-0030
Contact: Andrew Roth, MD 646-888-0024

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Christian Nelson, PhD    646-888-0030      
Contact: Andrew Roth, MD    646-888-0024      
Principal Investigator: Christian Nelson, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Center for Marital and Sexual Health of South Florida
Investigators
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Principal Investigator: Chris Nelson, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02706561     History of Changes
Other Study ID Numbers: 15-317
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
15-317

Additional relevant MeSH terms:
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Erectile Dysfunction
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders