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

Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666428
• Other study ID #: 19D.927
• Status: Completed
• Start date: January 24, 2020
• Est. completion date: January 3, 2023

Study information

• Verified date: November 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Head and Neck Neoplasms

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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