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

Completed

• Conditions: Head and Neck Carcinoma

• Registration Number: NCT04666428
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-24
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-14
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States