- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05842031
Assessment of Patient Experience and Needs for Patients Undergoing Invasive Inguinal Lymph Node Procedures for Penile Cancer
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Curtis Pettaway, BS, MD
- Phone Number: (713) 792-3250
- Email: cpettawa@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson
-
Contact:
- Curtis Pettaway, BS, MD
- Phone Number: 713-792-3250
- Email: cpettawa@mdanderson.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
|
Identify what interventions may be helpful in improving quality of life.
Identify what interventions may be helpful in improving patient educational needs
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)
|
through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Curtis Pettaway, BS, MD, MD Anderson
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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