Prostate CancerACT-EDNCT01275404
Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
A study testing Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls and Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls and Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2010to 10 Jul 2019
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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 MSKCC"s Sexual Medicine Rehabilitation Program (SMRP)
- Advised by the clinical staff of the SMRP to start penile injections.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: ACT-ED: Acceptance and Commitment Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
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.
- Conditions
- Prostate Cancer
- Being tested
- Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls, Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction
- Keywords
- Erectile Dysfunction, focus group, Quality of Life, 10-204
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Medicine Rehabilitation Program + nurse practitioner information phone callsBehavioural
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 patient"s 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).
Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile DysfunctionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| (SMRP) + nurse practitioner information phone calls | Experimental | Part A will use focus groups to gain feedback and refine the intervention. Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus nurse practitioner information phone calls and monitoring (SMRP+I), or SMRP plus the novel psychological intervention of Acceptance and Commitment Therapy for ED (SMRP+ACT-ED). Receives: Behavioral: Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls |
| SMRP+ACT-ED | Experimental | Part A will use focus groups to gain feedback and refine the intervention. Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus nurse practitioner information phone calls and monitoring (SMRP+I), or SMRP plus the novel psychological intervention of Acceptance and Commitment Therapy for ED (SMRP+ACT-ED). Receives: Behavioral: Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the feasibility
acceptability, tolerability and adherence) of adapted ACT psychotherapy treatment integrated into an erectile rehabilitation program (i.e., ACT-ED).
Measured: 2 years
Secondary outcomes (1)
To investigate the impact of ACT-ED
on penile injection compliance, ED treatment satisfaction, sexual functioning, sexual self-esteem, ED bother, depression symptoms, acceptance and self-awareness.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study start28 Dec 2010
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Center for Marital and Sexual Health of South Florida
- Responsible party
- Sponsor
- Investigators
- Christian Nelson, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275404
- Sponsor's protocol ID
- 10-204
- Acronym
- ACT-ED
- Status last verified
- Jul 2019
- First submitted
- 11 Jan 2011
- Last updated
- 15 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT-ED: Acceptance and Commitment Therapy for Erectile Dysfunction Adaptation of ACT for Compliance With an Erectile Rehabilitation Program
- ClinicalTrials.gov ID
- NCT01275404
- Acronym / sponsor ID
- ACT-ED / 10-204
- Conditions
- Prostate Cancer
- Keywords
- Erectile Dysfunction, focus group, Quality of Life, 10-204
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Center for Marital and Sexual Health of South Florida
- Study start
- 28 Dec 2010 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 12 Jan 2011 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (SMRP) + nurse practitioner information phone calls | Experimental | Behavioral: Sexual Medicine Rehabilitation Program + nurse practitioner information phone callsPart A will use focus groups to gain feedback and refine the intervention. Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus nurse practitioner information phone calls and monitoring (SMRP+I), or SMRP plus the novel psychological intervention of Acceptance and Commitment Therapy for ED (SMRP+ACT-ED). |
| SMRP+ACT-ED | Experimental | Behavioral: Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile DysfunctionPart A will use focus groups to gain feedback and refine the intervention. Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus nurse practitioner information phone calls and monitoring (SMRP+I), or SMRP plus the novel psychological intervention of Acceptance and Commitment Therapy for ED (SMRP+ACT-ED). |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Sexual Medicine Rehabilitation Program + nurse practitioner information phone callsBaseline 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 patient"s 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). | Behavioural | (SMRP) + nurse practitioner information phone calls |
| Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile DysfunctionBaseline 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). | Behavioural | SMRP+ACT-ED |
Primary outcome
To investigate the feasibility
Time frame: 2 years
acceptability, tolerability and adherence) of adapted ACT psychotherapy treatment integrated into an erectile rehabilitation program (i.e., ACT-ED).
1 secondary outcome
To investigate the impact of ACT-ED
Time frame: 2 years
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 15 Jul 2019.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Christian Nelson, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls and Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. 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?
To investigate the feasibility (time frame: 2 years). 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 15 Jul 2019.