Peer Support Program for Improving Quality of Life Among Head and Neck Patients, Connecting Through Cancer Trial
2026年7月13日 更新者：Ryan Li, MD、OHSU Knight Cancer Institute
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
56
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Alexandria Lichtl, MD
- 電話番号：5037061729
- メール：lichtl@ohsu.edu
研究場所
-
-
Oregon
-
Portland、Oregon、アメリカ、97239
- OHSU Knight Cancer Institute
-
コンタクト：
- Ryan J. Li, MD
- 電話番号：302-893-4959
- メール：lry@ohsu.edu
-
主任研究者：
- Ryan J. Li, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
補助研究
補助研究
Participate in peer support program
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of mentees meeting with their mentor match at least once
時間枠：Up to 6 months
|
Will be reported with 95% asymptotic confidence interval.
|
Up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Utilization of the mentorship program
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mentee psychosocial well-being over time
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Ryan J Li, MD、OHSU Knight Cancer Institute
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月16日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年6月15日
QC基準を満たした最初の提出物
2026年6月18日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00029208 (その他の識別子：OHSU Knight Cancer Institute)
- NCI-2026-00407 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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