NCT01018901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

November 23, 2009

Last Update Submit

April 7, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Goals of sexual functioning

    2 years

Study Arms (1)

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

Survey AdministrationOTHER

Patients complete survey

Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • James Coyne, PhD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 24, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2013

Study Completion

December 31, 2013

Last Updated

April 9, 2020

Record last verified: 2020-04

Locations

US(1)