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

NCT04666428 | Completed DMC

• 2 other identifiers: 19D.927JT 14649
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

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

Study Population

Patients with HNC and their partners at Thomas Jefferson University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

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

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: December 14, 2020
• Study Start: January 24, 2020
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)