Goals of Sexual Function in Prostate Cancer Survivors and Their Partners After Cancer Treatment
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Survey Administration
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm I
Arm Description
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.
Outcomes
Primary Outcome Measures
Goals of sexual functioning
Secondary Outcome Measures
Full Information
NCT ID
NCT01018901
First Posted
November 23, 2009
Last Updated
April 7, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01018901
Brief Title
Goals of Sexual Function in Prostate Cancer Survivors and Their Partners After Cancer Treatment
Official Title
Goals for Sexual Functioning of Prostate Cancer Survivors and Their Partners Following Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
December 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Patients complete survey
Primary Outcome Measure Information:
Title
Goals of sexual functioning
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Coyne, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Goals of Sexual Function in Prostate Cancer Survivors and Their Partners After Cancer Treatment
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