Malignant Head and Neck Neoplasm
Conditions
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.
Detailed description
Primary objective: I. Examine the feasibility of a peer support program for head and neck cancer patients. Secondary objective: I. Collect qualitative and quantitative data on the utilization of the mentorship program. Exploratory objective: I. 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.
Interventions
OTHERSupportive Care
Participate in peer support program
OTHERSurvey Administration
Ancillary studies
OTHERInterview
Ancillary studies
Sponsors
OHSU Knight Cancer Institute
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of mentees meeting with their mentor match at least once | Up to 6 months | Will be reported with 95% asymptotic confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with peer mentor contacts | Up to 6 months | 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. |
| Utilization of the mentorship program | Up to 6 months | Mean and standard deviation will be reported for number of times the mentor and mentee have made contact. |
| Mentorship conversation topics | Up to 6 months | Proportions of categories will be reported for topics discussed between mentor and mentee. |
| Rating scale for match | Up to 6 months | 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. |
| Qualitative data on the benefits and challenges of the mentorship program | Up to 6 months | 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. |
| Demographic differences between matched mentees who meet with their mentor and those who do not | Up to 6 months | Descriptive univariate analysis to evaluate demographic differences between matched mentees who meet with their mentor and those who do not. |
Countries
United States
Contacts
CONTACTAlexandria Lichtl, MD
PRINCIPAL_INVESTIGATORRyan J Li, MD
OHSU Knight Cancer Institute
Outcome results
None listed