A Digital Health Intervention to Improve Physical Function and Wellness of Lung Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PROMOTE Digital Health App Intervention
BehavioralPatients 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.
Enhanced Usual Care
BehavioralPatients 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).
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: PROMOTE Digital Health App InterventionExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient-reported Physical Function
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.
Time frame
12 weeksSecondary outcomes
1
Patient-reported Dyspnea
To compare patient-reported dyspnea using the PROMIS Dyspnea Severity 10a Short Form, which is a 10-item measure that assesses the severity of shortness of breath or difficulty breathing in response to various specific activities (total scale score range: 0-30), with higher scores indicating worse dyspnea.
Time frame
12 weeks2
Patient-reported Sleep Disturbance
To compare patient-reported sleep disturbance at 12 weeks using the PROMIS Sleep Disturbance 8a Short Form, which is an 8-item measure that evaluates difficulties with sleep onset, maintenance, and quality (total scale score: 8-40), with higher scores indicating greater sleep disturbance.
Time frame
12 weeks3
Patient-reported Exercise and Eating Behaviors
To compare patient-reported exercise and eating behaviors at 12 weeks using the Simple Lifestyle Indicator Questionnaire, which is a 12-item measure that assesses multiple health behavior and wellness domains including physical activity, diet, alcohol use, smoking, and stress level (total score range: 0-10), with higher scores indicating a healthier lifestyle.
Time frame
12 weeksOther outcomes
1
Patient-reported Self-Efficacy
To compare patient-reported self-efficacy at 12 weeks using the PROMIS Self-Efficacy for Managing Daily Activities 4a Short Form, which is a 4-item measure that evaluates a person's confidence in their ability to perform various activities of daily living (total scale score range: 4-20), with higher scores indicating greater self-efficacy.
Time frame
12 weeks2
Patient-reported Anxiety Symptoms
To compare patient-reported anxiety symptoms at 12 weeks using the Hospital Anxiety and Depression Scale-Anxiety Subscale, which is a 7-item measure of anxiety symptoms (total subscale score range: 0-21), with higher scores indicating worse anxiety.
Time frame
12 weeks3
Patient-reported Depression Symptoms
To compare patient-reported depression symptoms at 12 weeks using the Hospital Anxiety and Depression Scale-Depression Subscale, which is a 7-item measure of depression symptoms (total subscale score range: 0-21), with higher scores indicating worse depression.
Time frame
12 weeks4
Patient-reported Quality of Life
To compare patient-reported quality of life at 12 weeks using the Functional Assessment of Cancer Therapy-Lung questionnaire, which is a 36-item measure of physical, social, emotional, and functional wellbeing as well as lung-cancer specific symptoms (total scale score range: 0-144), with higher scores indicating better quality of life.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov