Goals of Sexual Function in Prostate Cancer Survivors and... | NCT01018901

Studies
Goals of Sexual Function in Prostate Cancer Survivors and Their Partners After Cancer Treatment

NCT01018901

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Completed

Last Update Posted

Apr 9, 2020Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Survey Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009Actual

Primary Completion Date

Jan 2013Actual

Completion Date

Dec 31, 2013Actual

First Submitted Date

Nov 23, 2009

First Submission Date that Met QC Criteria

Nov 23, 2009

First Posted Date

Nov 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2020

Last Update Posted Date

Apr 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 treatment.

Detailed Description

Detailed DescriptionOBJECTIVES:

I. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Survey Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey Administration	Other	Patients complete survey	Arm I

Measure	Description	Time Frame
Goals of sexual functioning		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Coyne, PhD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided