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

NCT ID: NCT04666428

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-24
• Study Completion Date: 2023-01-03

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.

Conditions

Head and Neck Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 14649

Identifier Type: OTHER

Identifier Source: secondary_id

19D.927

Identifier Type: -

Identifier Source: org_study_id