- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Alexandria Lichtl, MD
- Telefonnummer: 5037061729
- E-post: lichtl@ohsu.edu
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- OHSU Knight Cancer Institute
-
Ta kontakt med:
- Ryan J. Li, MD
- Telefonnummer: 302-893-4959
- E-post: lry@ohsu.edu
-
Hovedetterforsker:
- Ryan J. Li, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hjelpestudier
Hjelpestudier
Participate in peer support program
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of mentees meeting with their mentor match at least once
Tidsramme: Up to 6 months
|
Will be reported with 95% asymptotic confidence interval.
|
Up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Utilization of the mentorship program
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
Satisfaction with peer mentor contacts
Tidsramme: 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.
|
Up to 6 months
|
|
Demographic differences between matched mentees who meet with their mentor and those who do not
Tidsramme: Up to 6 months
|
Descriptive univariate analysis to evaluate demographic differences between matched mentees who meet with their mentor and those who do not.
|
Up to 6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mentee psychosocial well-being over time
Tidsramme: 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)
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ryan J Li, MD, OHSU Knight Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer i hode og nakke
- Helsevesenets kvalitet, tilgang og evaluering
- Undersøkelsesteknikker
- Epidemiologiske metoder
- Terapeutikk
- Datainnsamling
- Helsevesenets evalueringsmekanismer
- Kvalitet på helsehjelpen
- Folkehelse
- Miljø og folkehelse
- Pasientbehandling
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Intervjuer som emne
- Palliativ omsorg
Andre studie-ID-numre
- STUDY00029208 (Annen identifikator: OHSU Knight Cancer Institute)
- NCI-2026-00407 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
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