Prostate CancerNCT01018901
Goals of Sexual Function in Prostate Cancer Survivors and Their Partners After Cancer Treatment
A study testing Survey Administration in people with Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Gathering information about survivors of prostate cancer and their partners may help doctors learn more about the goals for sexual functioning after cancer treatment. PURPOSE: This clinical trial is studying the goals of sexual functioning in prostate cancer survivors and their partners after cancer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to 31 Dec 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prostate cancer survivors who are: willing and able to provide informed consent; able to read, write, and speak English; married or are in married-like relationship; completed radiation or surgery for their prostate cancer 6 months to 5 years ago
- Partners of prostate cancer survivors must be: willing and able to provide informed consent; able to read, write, and speak English
Who cannot join
- Prostate cancer survivors will be excluded if they have undergone androgen deprivation therapy within the past 6 months and if their partners refuse to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Goals for Sexual Functioning of Prostate Cancer Survivors and Their Partners Following Cancer Treatment
RATIONALE: Gathering information about survivors of prostate cancer and their partners may help doctors learn more about the goals for sexual functioning after cancer treatment. PURPOSE: This clinical trial is studying the goals of sexual functioning in prostate cancer survivors and their partners after cancer treatment.
Read the detailed description
Detailed DescriptionOBJECTIVES:
- To collect data on the goals of sexual functioning among prostate cancer survivors and their partners following cancer treatment in order to identify specific components of interventions for future grant submissions on the psychosexual needs of prostate cancer survivors.
OUTLINE:
Patients and their partners complete surveys. Sexual function of men is assessed by the International Index of Erectile Function; sexual function of women is assessed by the Female Sexual Function Index.
- Conditions
- Prostate Cancer
- Being tested
- Survey Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Patients complete survey
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients and their partners complete surveys. Sexual function of men is assessed by the International Index of Erectile Function; sexual function of women is assessed by the Female Sexual Function Index. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goals of sexual functioning
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 posted24 Nov 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completion31 Dec 2013
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 Abramson Cancer Center at Penn MedicineThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Coyne, PhD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018901
- Sponsor's protocol ID
- UPCC 23808
- Status last verified
- Apr 2020
- First submitted
- 23 Nov 2009
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goals for Sexual Functioning of Prostate Cancer Survivors and Their Partners Following Cancer Treatment
- ClinicalTrials.gov ID
- NCT01018901
- Acronym / sponsor ID
- UPCC 23808
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 24 Nov 2009 (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.
RATIONALE: Gathering information about survivors of prostate cancer and their partners may help doctors learn more about the goals for sexual functioning after cancer treatment. PURPOSE: This clinical trial is studying the goals of sexual functioning in prostate cancer survivors and their partners after cancer treatment.
Detailed description
Detailed DescriptionOBJECTIVES:
- To collect data on the goals of sexual functioning among prostate cancer survivors and their partners following cancer treatment in order to identify specific components of interventions for future grant submissions on the psychosexual needs of prostate cancer survivors.
OUTLINE:
Patients and their partners complete surveys. Sexual function of men is assessed by the International Index of Erectile Function; sexual function of women is assessed by the Female Sexual Function Index.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Other: Survey AdministrationPatients and their partners complete surveys. Sexual function of men is assessed by the International Index of Erectile Function; sexual function of women is assessed by the Female Sexual Function Index. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prostate cancer survivors who are: willing and able to provide informed consent; able to read, write, and speak English; married or are in married-like relationship; completed radiation or surgery for their prostate cancer 6 months to 5 years ago
- Partners of prostate cancer survivors must be: willing and able to provide informed consent; able to read, write, and speak English
Key exclusion criteria (1 listed)
- Prostate cancer survivors will be excluded if they have undergone androgen deprivation therapy within the past 6 months and if their partners refuse to participate
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 |
|---|---|---|
| Survey AdministrationPatients complete survey | Other | Arm I |
Primary outcome
Goals of sexual functioning
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 9 Apr 2020.
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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.
James Coyne, PhD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey Administration in people with Prostate Cancer, run by Abramson Cancer Center at Penn Medicine 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 2 inclusion and 1 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 9 Apr 2020. 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?
Goals of sexual functioning (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 9 Apr 2020.