Randomized Trial of a Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Patient-reported Physical Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PROMOTE Digital Health App Intervention
Patients will receive a study-issued tablet computer with the PROMOTE app that includes the following modules: 1) introductory education regarding the diagnosis and treatment trajectory of lung cancer; 2) behavioral interventions for improving physical function by managing fluctuations in energy and fostering engagement in valued life activities; 3) evidence-based breathing techniques for coping with dyspnea and improving lung function; 4) cognitive-behavioral strategies for enhancing sleep quality and efficiency; 5) approaches for increasing physical activity through adaptation and graded exercises; 6) tips for healthy eating and managing digestive side effects of cancer treatment, and 7) skills for managing mood symptoms through effective problem-, emotion-, and acceptance-based coping strategies. Patients will complete the intervention modules at their desired pace over approximately 10 weeks, in addition to their standard oncology care.
干预措施: PROMOTE Digital Health App Intervention (Behavioral)
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).
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Patient-reported Physical Function
时间窗: 12 weeks
To compare patient-reported physical function at 12 weeks using the PROMIS Physical Function 8b Short Form, which is an 8-item measure that evaluates self-perceived capability of one's upper extremities, lower extremities, and activities of daily living (total scale score range: 8-40), with higher scores indicating better functioning.
次要结局
- Patient-reported Dyspnea(12 weeks)
- Patient-reported Sleep Disturbance(12 weeks)
- Patient-reported Exercise and Eating Behaviors(12 weeks)
研究者
Joseph A. Greer, Ph.D.
Associate Professor of Psychology
Massachusetts General Hospital