A Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors

Официальное название

Randomized Trial of a Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors

Обзор

The rationale for the proposed project is to improve the experience and outcomes of individuals diagnosed with lung cancer treated for cure. Survival rates in patients with stages I-III lung cancer continue to increase given progress in early detection and more effective treatments. However, the survivorship needs of this population are considerable and too often overlooked, especially with respect to their health behaviors, such as physical activity and nutrition, as well as persistent symptoms and side effects, including breathing difficulties and sleep disturbance. To ensure that as many patients as possible can access the information, support, and skills they require to navigate the diagnosis and treatment of lung cancer, the investigators worked with a multidisciplinary team to create a digital health intervention, called "PROMOTE." The investigators designed the PROMOTE mobile app for lung cancer survivors undergoing treatment to help them improve physical function, manage breathlessness and insomnia, increase physical activity, maintain a healthy diet, and enhance their overall wellbeing. To achieve the long-term goal to have PROMOTE become widely available to all lung cancer survivors, the next step in this research program is to conduct a randomized trial to demonstrate the benefits of the digital health intervention. Specifically, the investigators hypothesize that, compared to patients receiving enhanced usual care, those assigned to PROMOTE will report improved physical function, less difficulty with breathlessness and sleep disturbance, increased physical activity, healthier eating behaviors, fewer symptoms of anxiety and depression, and better quality of life. The investigators also plan to examine whether PROMOTE leads to more effective coping and greater confidence in patients' ability to manage their health (i.e., self-efficacy). For this project, the investigators will enroll lung cancer survivors receiving care at an academic cancer center and two affiliated community sites that provide care for diverse patient populations to ensure the results apply to a wide range of individuals with lung cancer. Participants will be randomly assigned either to receive the PROMOTE app intervention for 12 weeks or to an enhanced usual care control group that includes health education materials. Participants will complete surveys at enrollment and again at 6, 12, and 24 weeks after enrollment. At the end of the study, those assigned to the control group will be permitted to receive the PROMOTE app as well.

Подробное описание

Background: The population of lung cancer survivors continues to expand given advances in early cancer detection and cancer therapeutics significantly improving survival rates for these patients. However, interventions focused on survivorship are limited for those with lung cancer due to their historically poor prognosis. To address this unmet need, the investigators developed a digital health intervention, called "PROMOTE," for patients undergoing curative therapy for lung cancer to help them improve physical function, manage breathlessness and insomnia, increase physical activity, maintain a healthy diet, and enhance their overall wellbeing.

Objectives: The goal of the proposed study is to examine the impact of the PROMOTE mobile app intervention versus enhanced usual care (consisting of health education materials) on patient-reported outcomes in adults with non-small cell lung cancer (NSCLC) receiving treatment with curative intent that includes chemotherapy.

Study Aims: The specific aims are: 1) to evaluate the efficacy of PROMOTE versus enhanced usual care for improving patient-reported physical function (primary), dyspnea, sleep disturbance, physical activity, and eating behaviors; 2) to assess the efficacy of PROMOTE versus enhanced usual care for improving patient-reported self-efficacy, mood symptoms, and quality of life; and 3) to explore mediators and moderators of the effect of PROMOTE on patient-reported outcomes.

Study Design: The investigators will conduct a randomized controlled trial of PROMOTE versus enhanced usual care in 250 adult patients with stages I-III NSCLC receiving treatment with curative intent that includes chemotherapy. The investigators will examine the effect of the intervention on patient-reported physical function and other meaningful survivorship outcomes. Patients will be recruited from the Massachusetts General Hospital Cancer Center and two affiliated community sites. Participants will be randomized in a 1:1 fashion, stratified by study site and lung cancer treatment to ensure balanced representation between the two study groups on these factors. Patients assigned to PROMOTE will receive a tablet computer with instructions on how to use the digital app. Participants will complete self-report outcome measures at enrollment and again at 6, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of PROMOTE.

Вмешательства

• Поведенческое PROMOTE Digital Health App Intervention
  Patients will receive the PROMOTE digital health app, which includes educational modules focused on helping lung cancer survivors improve their physical function, management of breathlessness, sleep, physical activity, nutrition, and overall wellbeing.
• Поведенческое Enhanced Usual Care
  Patients will receive standard oncology care plus health educational materials about treatments for lung cancer, side effect management, and survivorship from the American Cancer Society (either in electronic or hardcopy formats).

Первичные конечные точки

• Patient-reported Physical Function [Срок оценки: 12 weeks]

Вторичные конечные точки (3)

• Patient-reported Dyspnea [Срок оценки: 12 weeks]
• Patient-reported Sleep Disturbance [Срок оценки: 12 weeks]
• Patient-reported Exercise and Eating Behaviors [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Diagnosis of stage I-III non-small cell lung cancer
• Within six weeks of initiating treatment with curative intent that includes chemotherapy ± immunotherapy in the neo-adjuvant or adjuvant setting with surgery or as part of definitive chemoradiation
• Eastern Cooperative Oncology Group Performance Status = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours)
• Ability to use a digital health intervention that includes verbal and written information in English
• Ability to complete questionnaires in English or Spanish
• Primary cancer care at one of the participating institutions

Критерии исключения

• Significant uncontrolled psychiatric disorder or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the patient's ability to participate in study procedures

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07227623 · 24-529 · RSG-24-1310262-01-CPHP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗