Malignant Head and Neck NeoplasmNCT07664241
Peer Support Program for Improving Quality of Life Among Head and Neck Patients, Connecting Through Cancer Trial
A study testing Supportive Care, Survey Administration and Interview in people with Malignant Head and Neck Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This clinical trial tests whether a peer support program is feasible for head and neck cancer patients. Social support at the time of diagnosis has been shown to improve head and neck cancer quality of life before and after treatment. However, not all patients have a strong social support system. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Head and Neck Neoplasm
- What is being tested?
- Supportive Care, Survey Administration and Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MENTEE GROUP: Ability to understand and the willingness to sign a written informed consent document
- MENTEE GROUP: Willingness to have mentor-mentee interactions with the mentor selected by Imerman Angels (documented as part of informed consent)
- MENTEE GROUP: Age 18 or older at the time of consent (upper age limit 89)
- MENTEE GROUP: Diagnosed with head \& neck cancer (all stages) and planning to receive, currently receiving or recently completed (within 12 months) active treatment OR in follow-up and reporting unmet social/support needs
- MENTEE GROUP: English-speaker
- MENTEE GROUP: Access to electronic device that can be used for communication
Show all 12Show fewer
- MENTEE GROUP: Eastern Cooperative Oncology Group (ECOG) score less than or equal to 2
- CAREGIVER GROUP: Ability to understand and the willingness to sign a written informed consent document
- CAREGIVER GROUP: Age 18 or older at the time of consent (upper age limit 89)
- CAREGIVER GROUP: Caregiver of patient diagnosed with head and neck cancer who is also enrolled in the study
- CAREGIVER GROUP: English-speaker
- CAREGIVER GROUP: Access to electronic device that can be used for communication
Who cannot join
- MENTEE GROUP: Mentee must not be regularly engaging in other support programs at the start of the study intervention
- MENTEE GROUP: Undergoing active professional treatment for cognitive or emotional difficulties or neurological deficits that preclude adherence to the study protocol
- MENTEE GROUP: Any other social, emotional, or personal situation that will preclude adherence to the study protocol, at the discretion of the investigator
- CAREGIVER GROUP: Caregivers must not be regularly engaging in other support programs at the start of the study intervention
- CAREGIVER GROUP: Undergoing active professional treatment for cognitive or emotional difficulties or neurological deficits that preclude adherence to the study protocol
- CAREGIVER GROUP: Any other social, emotional, or personal situation that will preclude adherence to the study protocol, at the discretion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Ryan J. Li, MD, 302-893-4959, lry@ohsu.edu
Ryan J. Li, MD
About this study
Official title: Connecting Through Cancer: Feasibility of a Peer Support Program for Head and Neck Patients
This clinical trial tests whether a peer support program is feasible for head and neck cancer patients. Social support at the time of diagnosis has been shown to improve head and neck cancer quality of life before and after treatment. However, not all patients have a strong social support system. Recent research has shown that peer support programs have the potential to address unmet social support needs among cancer patients. These programs involve cancer survivors (peer mentors) providing emotional and informational support to cancer patients (mentees) earlier in their disease course. Peer support programs may also reduce caregiver burden by providing an additional source of support for the patient. A one-on-one peer support program may be feasible for patients with head and neck cancer and their caregivers.
Read the detailed description
Primary objective:
- Examine the feasibility of a peer support program for head and neck cancer patients.
Secondary objective:
- Collect qualitative and quantitative data on the utilization of the mentorship program.
Exploratory objective:
- Descriptive analysis of mentee psychosocial wellbeing over time. II. Descriptive analysis of caregiver burden over time.
Outline:
Patients ("mentees") participate in the peer support program by being matched with and meeting with a peer mentor, either virtually or in-person, during the study.
- Conditions
- Malignant Head and Neck Neoplasm
- Being tested
- Supportive Care, Survey Administration, Interview
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Participate in peer support program
Survey AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (peer support program) | Experimental | Patients ("mentees") participate in the peer support program by being matched with and meeting with a peer mentor, either virtually or in-person, during the study.
Caregivers of enrolled mentees may also participate on an optional basis by completing study surveys; however, caregivers will not directly participate in the peer mentorship intervention. Receives: Other: Supportive Care; Other: Survey Administration; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mentees meeting with their mentor match at least once
Will be reported with 95% asymptotic confidence interval.
Measured: Up to 6 months
Secondary outcomes (6)
Satisfaction with peer mentor contacts
Satisfaction will be measured using a survey that was used in a prior pilot study on a one-on-one cancer peer support program by Valanjow and Weis (2024). The survey contains 14 statements and mentees will be asked to rate how much they feel the statement applies. The scale ranges from 1-5 (1= not applicable and 5=fully applies). Mean and standard deviation of the Likert score will be reported for each item at each time point.
Measured: Up to 6 months
Utilization of the mentorship program
Mean and standard deviation will be reported for number of times the mentor and mentee have made contact.
Measured: Up to 6 months
Mentorship conversation topics
Proportions of categories will be reported for topics discussed between mentor and mentee.
Measured: Up to 6 months
Rating scale for match
Mean and standard deviation will be reported for rating scale for match (in terms of similar demographics and cancer experience). This will be on a 1-10 scale, with 10 being the most similar match.
Measured: Up to 6 months
Qualitative data on the benefits and challenges of the mentorship program
A subset of mentees (estimated n=10-15) will complete structured exit interviews at 6 months. Interviews will explore perceived benefits, challenges, barriers to engagement, impact on decision-making, and recommendations for program improvement.
Measured: Up to 6 months
Demographic differences between matched mentees who meet with their mentor and those who do not
Descriptive univariate analysis to evaluate demographic differences between matched mentees who meet with their mentor and those who do not.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start16 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Head and Neck NeoplasmStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Ryan Li, MD, OHSU Knight Cancer Institute
- Investigators
- Ryan J Li, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664241
- Sponsor's protocol ID
- STUDY00029208
- Other IDs
- NCI-2026-00407, STUDY00029208
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Through Cancer: Feasibility of a Peer Support Program for Head and Neck Patients
- ClinicalTrials.gov ID
- NCT07664241
- Acronym / sponsor ID
- STUDY00029208
- Conditions
- Malignant Head and Neck Neoplasm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 16 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jun 2026 (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 clinical trial tests whether a peer support program is feasible for head and neck cancer patients. Social support at the time of diagnosis has been shown to improve head and neck cancer quality of life before and after treatment. However, not all patients have a strong social support system. Recent research has shown that peer support programs have the potential to address unmet social support needs among cancer patients. These programs involve cancer survivors (peer mentors) providing emotional and informational support to cancer patients (mentees) earlier in their disease course. Peer support programs may also reduce caregiver burden by providing an additional source of support for the patient. A one-on-one peer support program may be feasible for patients with head and neck cancer and their caregivers.
Detailed description
Primary objective:
- Examine the feasibility of a peer support program for head and neck cancer patients.
Secondary objective:
- Collect qualitative and quantitative data on the utilization of the mentorship program.
Exploratory objective:
- Descriptive analysis of mentee psychosocial wellbeing over time. II. Descriptive analysis of caregiver burden over time.
Outline:
Patients ("mentees") participate in the peer support program by being matched with and meeting with a peer mentor, either virtually or in-person, during the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (peer support program) | Experimental | Other: Supportive Care, Other: Survey Administration, Other: InterviewPatients ("mentees") participate in the peer support program by being matched with and meeting with a peer mentor, either virtually or in-person, during the study. Caregivers of enrolled mentees may also participate on an optional basis by completing study surveys; however, caregivers will not directly participate in the peer mentorship intervention. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- MENTEE GROUP: Ability to understand and the willingness to sign a written informed consent document
- MENTEE GROUP: Willingness to have mentor-mentee interactions with the mentor selected by Imerman Angels (documented as part of informed consent)
- MENTEE GROUP: Age 18 or older at the time of consent (upper age limit 89)
- MENTEE GROUP: Diagnosed with head \& neck cancer (all stages) and planning to receive, currently receiving or recently completed (within 12 months) active treatment OR in follow-up and reporting unmet social/support needs
- MENTEE GROUP: English-speaker
Key exclusion criteria (6 listed)
- MENTEE GROUP: Mentee must not be regularly engaging in other support programs at the start of the study intervention
- MENTEE GROUP: Undergoing active professional treatment for cognitive or emotional difficulties or neurological deficits that preclude adherence to the study protocol
- MENTEE GROUP: Any other social, emotional, or personal situation that will preclude adherence to the study protocol, at the discretion of the investigator
- CAREGIVER GROUP: Caregivers must not be regularly engaging in other support programs at the start of the study intervention
- CAREGIVER GROUP: Undergoing active professional treatment for cognitive or emotional difficulties or neurological deficits that preclude adherence to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveParticipate in peer support program | Other | Supportive Care (peer support program) |
| Survey AdministrationAncillary studies | Other | Supportive Care (peer support program) |
| InterviewAncillary studies | Other | Supportive Care (peer support program) |
Primary outcome
Proportion of mentees meeting with their mentor match at least once
Time frame: Up to 6 months
Will be reported with 95% asymptotic confidence interval.
6 secondary outcomes
Satisfaction with peer mentor contacts
Time frame: Up to 6 months
Utilization of the mentorship program
Time frame: Up to 6 months
Mentorship conversation topics
Time frame: Up to 6 months
Rating scale for match
Time frame: Up to 6 months
Qualitative data on the benefits and challenges of the mentorship program
Time frame: Up to 6 months
Demographic differences between matched mentees who meet with their mentor and those who do not
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ryan J Li, MD principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care, Survey Administration and Interview in people with Malignant Head and Neck Neoplasm, run by OHSU Knight Cancer Institute 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 12 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandria Lichtl, MD (5037061729, lichtl@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of mentees meeting with their mentor match at least once (time frame: Up to 6 months). 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 Jul 2026.