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

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.

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Key information

Conditions

Head and Neck Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in patients' and partners' perceived intimacy scores at baseline

Time frame: 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

Time frame: within 30 weeks after treatment

Defined as total scores of the primary questions in patient survey and partner survey
Change Patients' and partners' perceived relationship intimacy levels

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Dec 14, 2020
Registry last updated: May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed