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

NCT07227623 | Recruiting

• 2 other identifiers: 24-529RSG-24-1310262-01-CPHP
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Function; Advanced Lung Cancer

Keywords

Lung Cancer; Behavioral Intervention; Digital Health App; Physical Function

Outcome Measures

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.

  12 weeks

Secondary Outcomes (3)

• Patient-reported Dyspnea

  12 weeks

• Patient-reported Sleep Disturbance

  12 weeks

• Patient-reported Exercise and Eating Behaviors

  12 weeks

Other Outcomes (4)

• Patient-reported Self-Efficacy

  12 weeks

• Patient-reported Anxiety Symptoms

  12 weeks

• Patient-reported Depression Symptoms

  12 weeks

Study Arms (2)

PROMOTE Digital Health App Intervention

EXPERIMENTAL

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.

Behavioral: PROMOTE Digital Health App Intervention

Enhanced Usual Care

ACTIVE COMPARATOR

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).

Behavioral: Enhanced Usual Care

Interventions

Enhanced Usual Care BEHAVIORAL

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).

Enhanced Usual Care

PROMOTE Digital Health App Intervention BEHAVIORAL

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.

PROMOTE Digital Health App Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Joseph A. Greer, PhD

CONTACT

617-643-2143; jgreer2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 13, 2025
• Study Start: February 6, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)