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

NCT05842031 | Suspended

• 2 other identifiers: 2023-0112NCI-2023-03504
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Penile Cancer

Outcome Measures

Primary Outcomes (1)

• Decision Regret Scale (DRS) questionnaires

  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

Study Arms (1)

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; Behavioral: Patient Educational Needs; Behavioral: Symptom Management

Interventions

Quality of Life Questionnaires BEHAVIORAL

Identify what interventions may be helpful in improving quality of life.

Semi-structured interviews

Patient Educational Needs BEHAVIORAL

Identify what interventions may be helpful in improving patient educational needs

Semi-structured interviews

Symptom Management BEHAVIORAL

Identify what interventions may be helpful in improving symptom management Improve symptom management

Semi-structured interviews

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

M D Anderson Cancer Center

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Penile Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Curtis Pettaway, BS, MD

  MD Anderson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 3, 2023
• Study Start: April 14, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)