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

Recruiting

• Conditions: Penile Cancer
• Interventions: Behavioral: Quality of Life Questionnaires; Behavioral: Patient Educational Needs; Behavioral: Symptom Management

• Registration Number: NCT05842031
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery.

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 Timeline

• Status Verified: 2023-04
• Study Start: 2023-04-14
• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Semi-structured interviews	Patient Educational Needs	Participants with penile cancer who have undergone invasive inguinal lymph node procedure will be recruited to participate in study via telephone recruitment.
Semi-structured interviews	Symptom Management	Participants with penile cancer who have undergone invasive inguinal lymph node procedure will be recruited to participate in study via telephone recruitment.
Semi-structured interviews	Quality of Life Questionnaires	Participants with penile cancer who have undergone invasive inguinal lymph node procedure will be recruited to participate in study via telephone recruitment.

Primary Outcome Measures

Name	Time	Method
Decision Regret Scale (DRS) questionnaires	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

Trial Locations

Locations (1)

MD Anderson; 🇺🇸 Houston, Texas, United States