NCT07664241

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2027

First Submitted

Initial submission to the registry

June 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

July 16, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

June 15, 2026

Last Update Submit

July 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of mentees meeting with their mentor match at least once

    Will be reported with 95% asymptotic confidence interval.

    Up to 6 months

Secondary Outcomes (6)

  • Satisfaction with peer mentor contacts

    Up to 6 months

  • Utilization of the mentorship program

    Up to 6 months

  • Mentorship conversation topics

    Up to 6 months

  • Rating scale for match

    Up to 6 months

  • Qualitative data on the benefits and challenges of the mentorship program

    Up to 6 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • Mentee psychosocial well-being over time

    Up to 6 months

  • Caregiver burden over time (optional)

    Up to 6 months

Study Arms (1)

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.

Other: Supportive CareOther: Survey AdministrationOther: Interview

Interventions

Participate in peer support program

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Supportive Care (peer support program)

Ancillary studies

Supportive Care (peer support program)

Ancillary studies

Supportive Care (peer support program)

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Palliative CareInterviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ryan J Li, MD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandria Lichtl, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 24, 2026

Study Start

July 16, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations