Clinical trial NCT04666428: Effects of Human Papillomavirus Diagnosis on Relationships of Patients With Head and Neck Cancer
Official title: An Observational Study to Determine the Effects of Human Papillomavirus Diagnosis on Relationships of Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HNC and their partners at Thomas Jefferson University Hospital

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.

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

Primary outcomes:
measure: Change in patients' and partners' perceived intimacy scores at baseline
timeFrame: Before treatment
measure: Change in patients' and partners' perceived intimacy scores post treatment
timeFrame: within 30 weeks after treatment
measure: Change Patients' and partners' perceived relationship intimacy levels
timeFrame: within 30 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References: