- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06636721
Cancro ai polmoni e invecchiamento: migliorare il benessere degli anziani affetti da cancro ai polmoni (LuCA)
Cancro al polmone e invecchiamento (LuCA): sviluppo di interventi per affrontare i problemi specifici dell’invecchiamento negli anziani affetti da cancro al polmone
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Nicole A Arrato, PhD
- Numero di telefono: 919-668-8660
- Email: nicole.arrato@duke.edu
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27705
- Duke University Health System
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Contatto:
- Nicole A Arrato, PhD
- Numero di telefono: 919-668-8660
- Email: nicole.arrato@duke.edu
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Investigatore principale:
- Rebecca A Shelby, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility as measured by number of recruited participants who enrolled
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Rebecca A Shelby, PhD, Duke Psychiatry & Behavioral Sciences
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Disordini mentali
- Neoplasie per sede
- Neoplasie
- Sintomi comportamentali
- Malattie delle vie respiratorie
- Malattie polmonari
- Disturbi respiratori
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Segni e sintomi, respiratori
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Dolore
- Disturbi d'ansia
- Neoplasie polmonari
- Depressione
- Dispnea
Altri numeri di identificazione dello studio
- Pro00116551
- 5T32AG000029-47 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
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