肺がんと老化:肺がんを患う高齢者の健康の改善 (LuCA)
肺がんと老化(LuCA):肺がんを患う高齢者における加齢特有の懸念に対処するための介入開発
The purpose of this study is to develop a brief assessment and need-based behavioral intervention for addressing aging-specific concerns in older adults with lung cancer. The long-term goals of this research include identifying the unique concerns of these patients, providing patients with behavioral skills to address their symptom management needs, and enhancing patient engagement with healthcare specialties targeting aging-specific concerns.
In the first phase of this study, participants (12 patients with lung cancer, 6 caregivers, 12 providers) will be asked to participate in two individual interviews (each 30-45 minutes in length) via teleconference. During the first interview, participants will be asked to provide feedback on the current version of the assessment and behavioral intervention. Participants will be asked to describe strengths and weaknesses of the materials, topics to add or remove, and any other suggested changes. After the research team has made changes to the materials, participants will be invited to complete a second interview to provide feedback on the updated materials.
In the second phase of the study, 16 older adults with lung cancer will complete the revised assessment and participate in the behavioral intervention, in order to a) evaluate the feasibility and acceptability of the program and b) measure change in depression, anxiety, pain, and dyspnea.
** Phase I of the study was previously factored into the record via the overall status and start date, but the record has been revised as of 08-2026 and is now only a reflection of Phase II.
調査の概要
詳細な説明
Aim 1. The investigators will first develop a brief geriatric assessment, designed to address the specific needs of older adults with lung cancer. As a foundation, the investigators will collect existing, empirically supported geriatric assessment tools, such as the Senior Adult Oncology Program (SAOP) assessment and the Geriatric 8 (G8), and the Triage Risk Screening Tool (TRST). The investigators will combine these tools such that all relevant domains are included in the aggregated assessment. The study team will then collaboratively add further items into the assessment (as related to difficulties commonly faced by older adults with lung cancer) and remove excess or irrelevant items.
The study team will then develop the initial prototype of a need-based behavioral intervention protocol to address aging-specific concerns and multimorbidity in older adults with lung cancer. The behavioral intervention will build upon and extend a previously tested intervention, which demonstrated benefits for reducing depressive and anxiety symptoms in older adults with lung cancer. The intervention will be a 5-session protocol, to be delivered to patients in an individual therapy setting, via telehealth or in-person. The program will integrate aspects of cognitive behavioral therapy (identifying and challenging automatic thoughts, engaging in behavioral activation) and acceptance and commitment therapy (integrating one's values, distancing skills). The intervention will include skills such as problem-solving, communicating with close others and the medical team, and breathing techniques to improve shortness of breath related to lung cancer.
Aim 2. The investigators will then conduct interviews with lung cancer patients (N=12), provider stakeholders (N=12), and caregivers (N=6) in order to obtain feedback on the proposed assessment and intervention. Caregiver participants will be either a) caregivers for lung cancer patients participating in interviews for this study, or b) caregivers for other patients with lung cancer. Each interview will be 30-45 minutes in length.
All patient, caregiver, and provider interview sessions will be recorded and transcribed verbatim. During interview sessions, the participant will be provided with the current version of the geriatric assessment and behavioral intervention. A semi-structured interview script will be utilized to obtain feedback on the strengths and weaknesses of the materials, thoughts on topics to add or remove, and amendments to any wording or structural details. Data from the initial interviews will allow the investigators to refine the assessment, referral resources, and intervention content so that it best meets the needs of this patient population.
All patients, caregivers, and provider stakeholders will be invited to complete a second interview to provide feedback on the revised materials. Thus, participants will be recruited to participate in 2 interviews - one for the initial set of materials, and one for the revised set. Because all participation is voluntary, participants can choose to opt out of any portion. If the investigators are unable to obtain adequate response rates for the second interview, they will recruit new participants meeting eligibility criteria to complete interviews surrounding the revised material.
Aim 3. The investigators will then conduct a preliminary study to evaluate the feasibility and acceptability of the revised geriatric assessment and behavioral intervention protocol. N=16 older adults with lung cancer will be recruited to complete the geriatric assessment and 5-session intervention. The assessment will be completed on paper in the clinic or digitally via RedCap survey sent via email, based on participant preference. The intervention sessions will be conducted via telehealth. Sessions will occur once per week for 5 weeks, and will last approximately one hour each. Sessions will be video-recorded and transcribed verbatim.
**Aim 1 and 2 were previously factored into the record via the overall status and start date, but the record has been revised as of 08-2026 and is now only a reflection of the intervention component in aim 3.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Nicole A Arrato, PhD
- 電話番号:919-668-8660
- メール:nicole.arrato@duke.edu
研究場所
-
-
North Carolina
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Durham、North Carolina、アメリカ、27705
- Duke University Health System
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コンタクト:
- Nicole A Arrato, PhD
- 電話番号:919-668-8660
- メール:nicole.arrato@duke.edu
-
主任研究者:
- Rebecca A Shelby, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria for Patient Participants:
- Lung cancer diagnosis
- 60 years of age or older
- Receiving active treatment at Duke University Health System
- Able to speak/read English and provide informed consent
Exclusion Criteria:
- Visual or hearing impairment, cognitive impairment, or severe mental illness interfering with participation
研究計画
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:Behavioral Intervention
Participants will engage in a 5-session protocol, to be delivered in an individual therapy setting, via telehealth or in-person. The program will integrate aspects of Cognitive Behavioral Therapy and Acceptance and Commitment Therapy. |
The intervention will integrate aspects of Cognitive Behavioral Therapy (identifying and challenging automatic thoughts, engaging in behavioral activation) and Acceptance and Commitment Therapy (integrating one's values, distancing skills). The intervention will include skills such as problem-solving, communicating with close others and the medical team, and breathing techniques to improve shortness of breath related to lung cancer. |
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 |
|---|---|---|
|
Feasibility as measured by number of recruited participants who enrolled
時間枠:5 weeks
|
Study feasibility will be measured by number of recruited participants who enroll. |
5 weeks
|
|
Feasibility as measured by number of participants who completed all study activities
時間枠:5 weeks
|
Feasibility of the study will be measured by number of participants who complete all study activities. |
5 weeks
|
|
Acceptability as measured by Study Satisfaction Questionnaire
時間枠:5 weeks
|
Acceptability of the study will be measured by the Study Satisfaction Questionnaire. This is a 15-item measure using a 5-point Likert scale (from "strongly disagree" to "strongly agree") in which a higher score indicates greater satisfaction. |
5 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
時間枠:Baseline to 5 weeks
|
The Patient Health Questionnaire-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression). |
Baseline to 5 weeks
|
|
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7) scale
時間枠:Baseline to 5 weeks
|
The Generalized Anxiety Disorder-7 score ranges from 0 to 21, where a higher score indicates greater anxiety. |
Baseline to 5 weeks
|
|
Change in physical pain as measured by the Brief Pain Questionnaire (BPI)
時間枠:Baseline to 5 weeks
|
The Brief Pain Inventory (BPI) is a tool that uses a numeric rating scale (NRS) from 0 to 10, where a higher score indicates greater pain. |
Baseline to 5 weeks
|
|
Change in dyspnea as measured by the Chronic Respiratory Questionnaire (CRQ)
時間枠:Baseline to 5 weeks
|
The Chronic Respiratory Questionnaire is scored on a 7-point scale, with 1 indicating maximum impairment and 7 indicating no impairment. Higher scores indicate better health-related quality of life. |
Baseline to 5 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Rebecca A Shelby, PhD、Duke Psychiatry & Behavioral Sciences
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- Pro00116551
- 5T32AG000029-47 (米国 NIH グラント/契約)
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?
IPD プランの説明
It is the investigators' intention to make all data generated from this study freely available after it is de-identified. All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Respondent identifiers will not be shared. All other scientific data (scale composites) will be both preserved and shared. The following data will be preserved and shared: patient-reported data from study assessments, assessment and intervention utilization data, healthcare utilization data collected from the health record, and socio-demographic and medical data collected via patient report and health record. The investigators will make every effort to provide raw data in a non-proprietary format wherever possible to enhance reproducibility.
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
米国FDA規制機器製品の研究
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