Non Small Cell Lung CancerNCT04629300
Supportive Care Mobile Application for Patients With NSCLC
A study testing Supportive Care Mobile Application in people with Non Small Cell Lung Cancer and Quality of Life, run by Massachusetts General Hospital at 6 sites in United States.
Trial summary
This research study is looking at the role of a supportive care mobile app in improving symptoms, coping skills, and quality of life in patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Quality of Life, Coping Skills
- What is being tested?
- Supportive Care Mobile Application
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Oct 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Diagnosed with unresectable Stage III or IV NSCLC in the past twelve weeks and receiving care with palliative intent (per clinician documentation in the electronic health record)
- Eastern Cooperative Oncology Group Performance Status = 0-3
- Plan to receive oncology care at one of the participating study sites
- Ability to read and respond to questions in English
Who cannot join
- Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Mass General/North Shore Cancer Center
Danvers, Massachusetts, 01923
Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Dana-Farber Brigham Cancer Center at South Shore
South Weymouth, Massachusetts, 02190
About this study
Official title: Randomized Trial of a Supportive Care Mobile Application to Improve Symptoms, Coping, and Quality of Life in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
This research study is looking at the role of a supportive care mobile app in improving symptoms, coping skills, and quality of life in patients with non-small cell lung cancer.
Read the detailed description
This research study is a Feasibility Study, which is the first-time investigators are examining this supportive care mobile app intervention. The goal of this research study is to refine and examine the feasibility and benefits of a supportive care mobile app to improve symptoms, coping skills, and quality of life in patients with non-small cell lung cancer. Many people diagnosed with lung cancer experience challenging symptoms and increased stress. To help address these concerns, this study is exploring how a mobile application (app) intervention, designed specifically for people with lung cancer, can expand the availability of much needed supportive care services.
The research study procedures include:
- A supportive care mobile app consisting of six intervention modules that focus on components of wellbeing, such as physical, social, functional, and emotional wellbeing
- Questionnaires asking about demographic information (e.g., gender, ethnicity, income) and participants' experience with cancer (e.g., quality of life, symptoms)
- Data collection from participants medical records
After completing a baseline study questionnaire, participants will be randomized into two (2) study groups:
- Usual Care Group: Participants will receive standard oncology care and attend their regular clinic visits. Study staff will monitor participant use of supportive care services.
- Intervention Group: Participants will be provided with a study-issued tablet computer to access the mobile app and receive tutorial and instructions for how to use the app.
Participants will be in this research study for 12-14 weeks.
It is expected that about 120 people will take part in this research study.
The sponsors of this study are the National Comprehensive Cancer Network (NCCN) and AstraZeneca Pharmaceuticals. NCCN is a non-profit alliance of leading cancer centers across the United States, and AstraZeneca Pharmaceuticals is a global bio-pharmaceutical company. These two sponsors are together providing funding and oversight for the conduct of this research study.
- Conditions
- Non Small Cell Lung Cancer, Quality of Life, Coping Skills
- Being tested
- Supportive Care Mobile Application, Usual Care
- Keywords
- Non Small Cell Lung Cancer, Portable Electronic Applications, Quality of Life, Coping Skills
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Care Mobile ApplicationBehavioural
Tablet computer with application providing modules on skills for managing symptoms and coping.
Usual CareOther
Standard oncology care with monitoring of supportive care services usage
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care Mobile Application | Experimental | Complete study questionnaires at two time points:
* upon enrollment at baseline prior to randomization
* approximately 12 weeks after the baseline assessment time point.
Participants will be provided with a study-issued tablet computer to access mobile app and receive a comprehensive tutorial and detailed instructions on how to use the app.
Participants will have approximately 10 weeks to complete the intervention modules at self initiated pace. The app will provide prompts as reminders to complete the modules.
Participants will receive standard oncology care. Study staff will monitor participant use of supportive care services, such as social work, psychology, psychiatry, and palliative care. Receives: Behavioral: Supportive Care Mobile Application; Other: Usual Care |
| Usual Care | Active comparator | Complete study questionnaires at two time points:
* upon enrollment at baseline prior to randomization
* approximately 12 weeks after the baseline assessment time point.
Participants will receive standard oncology care. Study staff will monitor participant use of supportive care services, such as social work, psychology, psychiatry, and palliative care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility based on rates of participant recruitment and completion of assigned study procedures
Study feasibility will be defined as ≥ 65% approach-to-enrollment rate of eligible participants and
≥70% completion rate of study procedures (at least four mobile app modules and assigned study questionnaires)
Measured: 12 weeks
Secondary outcomes (5)
Patient-reported acceptability and usability of the mobile application intervention on the System Usability Scale
Describe patient-reported acceptability and ease of use of the mobile application intervention based on scores from the System Usability Scale (score range: 0-100; higher scores indicate greater acceptability and ease of use)
Measured: 12 weeks
Compare patient-reported quality of life between study groups on the Functional Assessment of Cancer Therapy-Lung Scale
Compare between study groups patient-reported quality of life based on scores from the Functional Assessment Cancer Therapy-Lung Scale at 12 weeks (score range: 0-136; higher scores indicate better quality of life)
Measured: 12 weeks
Compare patient-reported symptoms between study groups on the MD Anderson Symptom Inventory
Compare between study groups patient-reported symptom severity and interference based on scores from the MD Anderson Symptom Inventory at 12 weeks (score range: 0-10 on the symptom severity and interference sub-scales; higher scores indicate worse symptoms)
Measured: 12 weeks
Compare patient-reported psychological distress between study groups on the Hospital Anxiety and Depression Scale
Compare between study groups patient-reported anxiety and depression symptoms based on scores from the Hospital Anxiety and Depression Scale at 12 weeks (score range: 0-21 on the anxiety and depression sub-scales; higher scores indicate worse psychological distress)
Measured: 12 weeks
Compare patient-reported coping between study groups on the Brief COPE Scale
Compare between study groups patient-reported coping strategies based on scores from the Brief COPE Scale at 12 weeks (score range: 2-8 on each of 14 coping sub-scales; higher scores indicate greater use of that specific coping strategy)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start15 Oct 2021
- Primary completion9 Feb 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Joseph A. Greer, Ph.D., Massachusetts General Hospital
- Investigators
- Joseph Greer, PHD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629300
- Sponsor's protocol ID
- 20-398
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2020
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Waldman LP, Centracchio JA, Jacobs JM, Petrillo LA, El-Jawahri AR, Temel JS, Greer JA. Study protocol for a randomized trial of a supportive care mobile application to improve symptoms, coping, and quality of life in patients with advanced non-small cell lung cancer. Front Psychol. 2023 Jun 22;14:1184482. doi: 10.3389/fpsyg.2023.1184482. eCollection 2023.
PubMed 37425161
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Supportive Care Mobile Application to Improve Symptoms, Coping, and Quality of Life in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04629300
- Acronym / sponsor ID
- 20-398
- Conditions
- Non Small Cell Lung Cancer, Quality of Life, Coping Skills
- Keywords
- Non Small Cell Lung Cancer, Portable Electronic Applications, Quality of Life, Coping Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is looking at the role of a supportive care mobile app in improving symptoms, coping skills, and quality of life in patients with non-small cell lung cancer.
Detailed description
This research study is a Feasibility Study, which is the first-time investigators are examining this supportive care mobile app intervention. The goal of this research study is to refine and examine the feasibility and benefits of a supportive care mobile app to improve symptoms, coping skills, and quality of life in patients with non-small cell lung cancer. Many people diagnosed with lung cancer experience challenging symptoms and increased stress. To help address these concerns, this study is exploring how a mobile application (app) intervention, designed specifically for people with lung cancer, can expand the availability of much needed supportive care services.
The research study procedures include:
- A supportive care mobile app consisting of six intervention modules that focus on components of wellbeing, such as physical, social, functional, and emotional wellbeing
- Questionnaires asking about demographic information (e.g., gender, ethnicity, income) and participants' experience with cancer (e.g., quality of life, symptoms)
- Data collection from participants medical records
After completing a baseline study questionnaire, participants will be randomized into two (2) study groups:
- Usual Care Group: Participants will receive standard oncology care and attend their regular clinic visits. Study staff will monitor participant use of supportive care services.
- Intervention Group: Participants will be provided with a study-issued tablet computer to access the mobile app and receive tutorial and instructions for how to use the app.
Participants will be in this research study for 12-14 weeks.
It is expected that about 120 people will take part in this research study.
The sponsors of this study are the National Comprehensive Cancer Network (NCCN) and AstraZeneca Pharmaceuticals. NCCN is a non-profit alliance of leading cancer centers across the United States, and AstraZeneca Pharmaceuticals is a global bio-pharmaceutical company. These two sponsors are together providing funding and oversight for the conduct of this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Care Mobile Application | Experimental | Behavioral: Supportive Care Mobile Application, Other: Usual CareComplete study questionnaires at two time points: * upon enrollment at baseline prior to randomization * approximately 12 weeks after the baseline assessment time point. Participants will be provided with a study-issued tablet computer to access mobile app and receive a comprehensive tutorial and detailed instructions on how to use the app. Participants will have approximately 10 weeks to complete the intervention modules at self initiated pace. The app will provide prompts as reminders to complete the modules. Participants will receive standard oncology care. Study staff will monitor participant use of supportive care services, such as social work, psychology, psychiatry, and palliative care. |
| Usual Care | Active comparator | Other: Usual CareComplete study questionnaires at two time points: * upon enrollment at baseline prior to randomization * approximately 12 weeks after the baseline assessment time point. Participants will receive standard oncology care. Study staff will monitor participant use of supportive care services, such as social work, psychology, psychiatry, and palliative care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Diagnosed with unresectable Stage III or IV NSCLC in the past twelve weeks and receiving care with palliative intent (per clinician documentation in the electronic health record)
- Eastern Cooperative Oncology Group Performance Status = 0-3
- Plan to receive oncology care at one of the participating study sites
- Ability to read and respond to questions in English
Key exclusion criteria (1 listed)
- Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive Care Mobile ApplicationTablet computer with application providing modules on skills for managing symptoms and coping. | Behavioural | Supportive Care Mobile Application |
| Usual CareStandard oncology care with monitoring of supportive care services usage | Other | Supportive Care Mobile Application, Usual Care |
Primary outcome
Study feasibility based on rates of participant recruitment and completion of assigned study procedures
Time frame: 12 weeks
Study feasibility will be defined as ≥ 65% approach-to-enrollment rate of eligible participants and ≥70% completion rate of study procedures (at least four mobile app modules and assigned study questionnaires)
5 secondary outcomes
Patient-reported acceptability and usability of the mobile application intervention on the System Usability Scale
Time frame: 12 weeks
Compare patient-reported quality of life between study groups on the Functional Assessment of Cancer Therapy-Lung Scale
Time frame: 12 weeks
Compare patient-reported symptoms between study groups on the MD Anderson Symptom Inventory
Time frame: 12 weeks
Compare patient-reported psychological distress between study groups on the Hospital Anxiety and Depression Scale
Time frame: 12 weeks
Compare patient-reported coping between study groups on the Brief COPE Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 37425161Waldman LP, Centracchio JA, Jacobs JM, Petrillo LA, El-Jawahri AR, Temel JS, Greer JA. Study protocol for a randomized trial of a supportive care mobile application to improve symptoms, coping, and quality of life in patients with advanced non-small cell lung cancer. Front Psychol. 2023 Jun 22;14:1184482. doi: 10.3389/fpsyg.2023.1184482. eCollection 2023.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Greer, PHD principal investigator
Massachusetts General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care Mobile Application in people with Non Small Cell Lung Cancer and Quality of Life, run by Massachusetts General Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility based on rates of participant recruitment and completion of assigned study procedures (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.