Head and Neck CarcinomaNCT04666428
Effects of Human Papillomavirus Diagnosis on Relationships of Patients With Head and Neck Cancer
An observational study of Head and Neck Carcinoma, run by Thomas Jefferson University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 3 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HNC and their partners at Thomas Jefferson University Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Observational Study to Determine the Effects of Human Papillomavirus Diagnosis on Relationships of Head and Neck Cancer Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Head and Neck Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patients' and partners' perceived intimacy scores at baseline
Defined as total scores of the primary questions in patient survey and partner survey
Measured: 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
Measured: 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).
Measured: within 30 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start24 Jan 2020
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666428
- Sponsor's protocol ID
- 19D.927
- Other IDs
- JT 14649
- Status last verified
- May 2025
- First submitted
- 16 Mar 2020
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine the Effects of Human Papillomavirus Diagnosis on Relationships of Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT04666428
- Acronym / sponsor ID
- 19D.927
- Conditions
- Head and Neck Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HNC and their partners at Thomas Jefferson University Hospital
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Carcinoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patients' and partners' perceived intimacy scores at baseline (time frame: Before treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.