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

Penile Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842031
• Other study ID #: 2023-0112
• Secondary ID: NCI-2023-03504
• Status: Recruiting
• Start date: April 14, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: M.D. Anderson Cancer Center
• Contact: Curtis Pettaway, BS, MD
• Phone: (713) 792-3250
• Email: cpettawa[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Penile Cancer
• Penile Neoplasms

Intervention

Behavioral:
• Quality of Life Questionnaires
Identify what interventions may be helpful in improving quality of life.
• Patient Educational Needs
Identify what interventions may be helpful in improving patient educational needs
• Symptom Management
Identify what interventions may be helpful in improving symptom management Improve symptom management

Locations

Country	Name	City	State
United States	MD Anderson	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision Regret Scale (DRS) questionnaires	Score Scale ranges (1-5); Strongly Agree; Agree; Agree nor Disagree; Disagree; Strongly Disagree	through study completion; an average of 1 year

External Links

•   MD Anderson Cancer Center