- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07664241
Peer Support Program for Improving Quality of Life Among Head and Neck Patients, Connecting Through Cancer Trial
Connecting Through Cancer: Feasibility of a Peer Support Program for Head and Neck Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandria Lichtl, MD
- Phone Number: 5037061729
- Email: lichtl@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
Contact:
- Ryan J. Li, MD
- Phone Number: 302-893-4959
- Email: lry@ohsu.edu
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Principal Investigator:
- Ryan J. Li, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive Care (peer support program)
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. |
Ancillary studies
Ancillary studies
Participate in peer support program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with peer mentor contacts
Time Frame: Up to 6 months
|
Mean and standard deviation of the Likert score will be reported for each item at each time point.
|
Up to 6 months
|
|
Utilization of the mentorship program
Time Frame: Up to 6 months
|
Mean and standard deviation will be reported for number of times the mentor and mentee have made contact.
|
Up to 6 months
|
|
Mentorship conversation topics
Time Frame: Up to 6 months
|
Proportions of categories will be reported for topics discussed between mentor and mentee.
|
Up to 6 months
|
|
Rating scale for match
Time Frame: 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.
|
Up to 6 months
|
|
Qualitative data on the benefits and challenges of the mentorship program
Time Frame: 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.
|
Up to 6 months
|
|
Mentee psychosocial well-being over time
Time Frame: Up to 6 months
|
Mentees will complete short surveys analyzing coping, anxiety and depression at three different time points to track changes over time.
|
Up to 6 months
|
|
Caregiver burden over time (optional)
Time Frame: Up to 6 months
|
Caregivers will complete surveys on caregiver burden at three different time points to track changes over time.
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan J Li, MD, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Head and Neck Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Therapeutics
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Interviews as Topic
- Palliative Care
Other Study ID Numbers
- STUDY00029208 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2026-00407 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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