Assessment of Patient Experience and Needs for Patients Undergoing Invasive Inguinal Lymph Node Procedures for Penile Cancer

March 22, 2024 updated by: M.D. Anderson Cancer Center
To learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives

Primary Objective:

To understand the lived experience of patients undergoing invasive inguinal lymph node procedures.

Secondary Objective:

To determine factors that influence decisions and improve experience for patients who need invasive inguinal lymph node procedures.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

M D Anderson Cancer Center

Description

Inclusion Criteria:

--Patients diagnosed with penile cancer who have undergone invasive inguinal node procedures (ILND and/or DSNB) and are at least 6 months post-procedure

Exclusion Criteria:

  • Patient's ≤18 years of age
  • Patients who have not undergone invasive surgical procedures involving the inguinal lymph nodes
  • Non-English-speaking patients For interviews: people who are physically and/or cognitively incapable of participating in a 60minute telephone interview as determined by a clinical provider or the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Semi-structured interviews
Participants with penile cancer who have undergone invasive inguinal lymph node procedure will be recruited to participate in study via telephone recruitment.
Behavioral: Quality of Life Questionnaires
Identify what interventions may be helpful in improving quality of life.
Behavioral: Patient Educational Needs
Identify what interventions may be helpful in improving patient educational needs
Behavioral: Symptom Management
Identify what interventions may be helpful in improving symptom management Improve symptom management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision Regret Scale (DRS) questionnaires
Time Frame: through study completion; an average of 1 year

Score Scale ranges (1-5)

  1. Strongly Agree
  2. Agree
  3. Agree nor Disagree
  4. Disagree
  5. Strongly Disagree
through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Curtis Pettaway, BS, MD, MD Anderson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0112
  • NCI-2023-03504 (Registry Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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