A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)

Официальное название

INSPIRE: A Stepped Intervention for Coping With Dyspnea in Patients With Lung Cancer-Phase A (Open Pilot)

Обзор

Patients with lung cancer often experience shortness of breath, also known as dyspnea. It affects over 80% of patients with lung cancer at diagnosis and is linked to poorer quality of life and functioning. Unfortunately, current treatments-such as opioids, which are the most studied treatment for dyspnea-fail to provide patients with adequate care, and dyspnea can remain a chronic issue in many. Even when new treatments are developed, the benefit to public health is often limited by healthcare systems not having enough resources to use new treatments. The investigators' aim is to test a personalized treatment for dyspnea that can address patients' unique needs while efficiently using healthcare resources to make the treatment as accessible as possible for future widespread use. This project builds upon rhe investigators' prior work creating two promising psychological treatments for dyspnea. The first (a two-session behavioral treatment provided by nurses) targets dyspnea-related discomfort. The second (a five-session psychological treatment provided by psychologists) targets dyspnea-related anxiety and overall health outcomes. The investigators combined these complementary treatments with a stepped-care model into a treatment called INSPIRE. In INSPIRE, all patients will receive the brief treatment to learn basic behavioral coping skills to manage the discomfort of dyspnea before escalating to the more intensive treatment that focuses on providing patients with the confidence to cope with dyspnea and related anxiety, but only if patients' dyspnea does not improve after the first treatment. The investigators will first ask for initial feedback from patients who are receiving INSPIRE for dyspnea and the patients' study clinician to make sure the treatment and study procedures fit their needs. The investigators want to see if this approach can work in patients with lung cancer, is well-received, and shows early signs of improving dyspnea. The investigators' goal is to provide personalized relief for breathing difficulties while making the best use of healthcare resources. These findings will help the investigators learn more about how to support patients with dyspnea and provide information on how to further test INSPIRE. Additionally, this personalized supportive treatment for dyspnea may potentially help reduce the use of opioids currently used in the treatment of dyspnea.

Подробное описание

Background: Dyspnea is a debilitating symptom prevalent in more than 80% of patients with lung cancer at diagnosis and is associated with worse quality of life, functioning, and mental health. Unfortunately, current treatments for dyspnea are limited and fail to provide adequate care. Although supportive care interventions are needed, they must be personalized to the patient to address the dyspnea's diverse presentations in a resource-efficient approach, scalable for broad dissemination. The investigators developed two psychological interventions with promising efficacy for dyspnea: the first is a two-session, nurse-led behavioral intervention improving dyspnea-related discomfort, and the second is a five-session, psychologist-led cognitive-behavioral intervention improving dyspnea-related anxiety and other health outcomes. In this proposal, the investigators seek to combine these treatments using a stepped-care approach and pilot test a stepped intervention for dyspnea (INSPIRE) to offer personalized dyspnea care that optimizes healthcare resource utilization.

Specific Aims: 1) Refine INSPIRE and its stepped-care algorithm based on patient and clinician feedback.

Objective/Hypothesis: Patients with lung cancer reporting at least moderate dyspnea are the focus of the study. This first phase of the study aims to refine the study intervention and procedures.

Study Design: The investigators will use an open-pilot study of INSPIRE to gather initial feedback on the intervention (Aim 1). In INSPIRE (delivered in-person or virtually), patients receive BREEZE (Step 1) before escalating to the more intensive TAB (Step 2) if dyspnea does not improve. Qualitative exit interviews with patients will be conducted to inform potential changes. The investigators will refine the intervention and study procedures for the subsequent pilot randomized clinical trial (RCT) and for a future pilot RCT.

Вмешательства

• Поведенческое INSPIRE
  a stepped-care cognitive-behavioral based intervention for dyspnea

Первичные конечные точки

• Qualitative patient feedback [Срок оценки: 4 months]

Критерии участия

Критерии включения

• adults (age ≥ 18) diagnosed with non-small cell lung cancer or small cell lung cancer
• report of at least moderate dyspnea (scoring ≥2 on the Modified Medical Research Council Dyspnea Scale)
• ≥3 months from cancer diagnosis without plans for surgical treatment for lung cancer
• primary cancer care at Mass General Brigham
• able to read and respond to questions in English

Критерии исключения

\- no comorbidity prohibiting informed consent and study participation per oncologist judgment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Mass General Brigham — Boston

Идентификаторы

NCT: NCT07728773 · 26-149-A · CSDG-25-1375324-01-CPHP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗