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Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

Primary Purpose

Prostate Cancer, Erectile Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
questionnaires
three in-person sessions
monthly phone calls
Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
Enhanced Monitoring and Education (EME)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring 15-317

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)
  • Has any indication of Prostate-Specific Antigen (PSA)
  • 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.

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard care plus the ACT intervention (ACT-ED)

SC plus nurse Enhanced Monitoring and Education (EME)

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

percentages of patients having an Erectile Function Domain (EFD) total score >= 24
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.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2016
Last Updated
May 11, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Center for Marital and Sexual Health of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02706561
Brief Title
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Official Title
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Center for Marital and Sexual Health of South Florida

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Erectile Dysfunction
Keywords
15-317

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care plus the ACT intervention (ACT-ED)
Arm Type
Experimental
Arm Description
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)
Arm Title
SC plus nurse Enhanced Monitoring and Education (EME)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Intervention Type
Behavioral
Intervention Name(s)
three in-person sessions
Intervention Type
Behavioral
Intervention Name(s)
monthly phone calls
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Monitoring and Education (EME)
Primary Outcome Measure Information:
Title
percentages of patients having an Erectile Function Domain (EFD) total score >= 24
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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) Has any indication of Prostate-Specific Antigen (PSA) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Nelson, PhD
Phone
646-888-0030
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Roth, MD
Phone
646-888-0024
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Nelson, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Nelson, PhD
Phone
646-888-0030
First Name & Middle Initial & Last Name & Degree
Andrew Roth, MD
Phone
646-888-0024
First Name & Middle Initial & Last Name & Degree
Christian Nelson, PhD

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery

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