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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04666428
Enrollment
30
Registered
2020-12-14
Start date
2020-01-24
Completion date
2023-01-03
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Carcinoma

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.

Interventions

None listed

Sponsors

Thomas Jefferson University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in patients' and partners' perceived intimacy scores at baselineBefore treatmentDefined as total scores of the primary questions in patient survey and partner survey
Change in patients' and partners' perceived intimacy scores post treatmentwithin 30 weeks after treatmentDefined as total scores of the primary questions in patient survey and partner survey
Change Patients' and partners' perceived relationship intimacy levelswithin 30 weeks post treatmentCategorized from the corresponding intimacy scores in the manner of loss of intimacy (0-48), stable relationships (49-71) and improvement (72-120).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026