Effects of Human Papillomavirus Diagnosis on Relationships of Patients With Head and Neck Cancer

An Observational Study to Determine the Effects of Human Papillomavirus Diagnosis on Relationships of Head and Neck Cancer Patients

This trial studies the effects of human papillomavirus diagnosis on the relationships of patients with head and neck cancer. Determining the effects of human papillomavirus diagnosis on relationships may determine whether human papillomavirus-positive patients and their partners are more likely to experience decline in relationship intimacy after diagnosis than human papillomavirus-negative patients and their partners. This may help researchers provide valuable insight into the degree to which a diagnosis of human papillomavirus affects patient relationships over and above the effects of a cancer diagnosis and address the need for additional patient counseling or education following diagnosis.

Study Overview

• Status: Completed
• Conditions: Head and Neck Carcinoma

Detailed Description

PRIMARY OBJECTIVES:

I. To explore the agreement between patients' perceived intimacy level and their partners' perceived intimacy level at different time points in the course of their head and neck cancer (HNC) treatment.

II. To compare any changes in the patients' perceived intimacy scores between human papillomavirus (HPV)-positive and HPV-negative HNC patients at different time points in the course of their HNC treatment.

EXPLORATORY OBJECTIVE:

I. Identify areas of concern or misinformation among patients and partners where further patient counseling or education may be indicated.

OUTLINE:

Patients and partners complete surveys over 10 minutes prior to surgery and 3-6 months after completion of treatment.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with HNC and their partners at Thomas Jefferson University Hospital

Description

Inclusion Criteria:

• Capable of giving informed consent
• Diagnosis of head and neck cancer (previously untreated, any stage) or in a partnered relationship with an individual diagnosed with head and neck cancer
• Tumors positive for HPV
• Tumors negative for HPV
• Treatment plan is intent to cure
• In a partnered relationship
• Willing to answer brief survey prior to treatment and again after completion of treatment
• English Speaking

Exclusion Criteria:

• Prior treatment (surgery, chemotherapy, radiation therapy [XRT], or chemoradiotherapy [CRT]) for head and neck cancer
• Partners of eligible patients undergoing active cancer treatment
• Not in a partnered relationship
• Non-English speaking

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patients' and partners' perceived intimacy scores at baseline	Defined as total scores of the primary questions in patient survey and partner survey	Before treatment
Change in patients' and partners' perceived intimacy scores post treatment	Defined as total scores of the primary questions in patient survey and partner survey	within 30 weeks after treatment
Change Patients' and partners' perceived relationship intimacy levels	Categorized from the corresponding intimacy scores in the manner of loss of intimacy (0-48), stable relationships (49-71) and improvement (72-120).	within 30 weeks post treatment

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 19D.927

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No