CancerePALNCT02069743
Pain Management in Cancer Patients Using a Mobile Application
A study testing ePAL Mobile Application in people with Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. This study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ePAL Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Sep 2020
- 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
- All adult patients, 18 years and above suffering from solid-organ cancer.
- Diagnosed with moderate or severe cancer pain (i.e. pain intensity score of at least 4/10 on numeric rating scale (NRS)) at the Massachusetts General Hospital (MGH) Palliative Care Center, as determined by the patient's care provider at the MGH Palliative Care Center. Subjects do not need to experience a specific nature of pain for eligibility.
- Patients must be ambulatory and not currently admitted to the hospital at time of enrollment.
- Must have a smart phone and be willing to download the study application (Phase II only)
- Must be able to read and speak English.
Who cannot join
- Life expectancy less than 2-months as determined by the palliative care provider
- Significant medical or psychiatric co-morbidities (other than depression or anxiety) or cognitive impediments that would prevent participant from being able to utilize the program
- Known history of substance abuse
- Patients currently on investigational therapies or other study protocols that may have an impact on pain intensity or quality of life which are main outcomes of this intervention.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Massachusetts General Hospital
Boston, Massachusetts, 02114
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. This study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that subjects randomized to the intervention group will have a reduction in pain and pain-related hospitalizations.
- Conditions
- Cancer
- Being tested
- ePAL Mobile Application
- Keywords
- cancer pain
- Medical subject headings
- Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePAL Mobile ApplicationOther
Also called ePAL
A mobile application designed to help cancer patients better self-manage cancer pain.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will use the study's mobile application during the 8-week study. Receives: Other: ePAL Mobile Application |
| Control | No intervention | The control group will not use the study's mobile application during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain symptoms using the Brief Pain Inventory
The primary aim is to assess the effect of a tailored, multi-dimensional mobile-based intervention on the intensity of cancer pain in cancer patients with moderate to severe pain.
Measured: up to 8 weeks
Secondary outcomes (5)
Pain related hospitalization from the Electronic Health Record
- In-patient and out-patient hospital visits
- Urgent non-scheduled clinic visits for pain crisis
Measured: up to 8 weeks
Patient-related barriers to pain management using the Barriers Questionnaire-II
compared patient-related barriers to pain management using the Barriers Questionnaire-II (BQ-II)
Measured: up to 8 weeks
Engagement as tracked by the app
Pattern of patient engagement with the study's mobile application
Measured: up to 8 weeks
Anxiety symptoms using the Generalized Anxiety Disorder (GAD-7)
compare anxiety symptoms between the two group using the Generalized Anxiety Disorder (GAD-7)
Measured: up to 8 weeks
Quality of life using the Functional Assessment of Cancer Therapy (FACT-G)
to compare quality of life between the two groups using the Functional Assessment of Cancer Therapy -General (FACT-G)
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2018
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McKesson Foundation
- Responsible party
- Principal investigator, Mihir M. Kamdar,M.D., Massachusetts General Hospital
- Investigators
- Kamal Jethwani, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069743
- Sponsor's protocol ID
- 13-080
- Acronym
- ePAL
- Status last verified
- Jun 2022
- First submitted
- 18 Feb 2014
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Kamdar M, Jethwani K, Centi AJ, Agboola S, Fischer N, Traeger L, Rinaldi S, Strand J, Ritchie C, Temel JS, Greer JA, Kvedar J, El-Jawarhi A, Jackson V. A Digital Therapeutic Application (ePAL) to Manage Pain in Patients With Advanced Cancer: A Randomized Controlled Trial. J Pain Symptom Manage. 2024 Sep;68(3):261-271. doi: 10.1016/j.jpainsymman.2024.05.033. Epub 2024 Jun 10.
PubMed 38866116Agboola S, Kamdar M, Flanagan C, Searl M, Traeger L, Kvedar J, Jethwani K. Pain management in cancer patients using a mobile app: study design of a randomized controlled trial. JMIR Res Protoc. 2014 Dec 12;3(4):e76. doi: 10.2196/resprot.3957.
PubMed 25500281
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Cancer Patients Using a Mobile Application
- ClinicalTrials.gov ID
- NCT02069743
- Acronym / sponsor ID
- ePAL / 13-080
- Conditions
- Cancer
- Keywords
- cancer pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- McKesson Foundation
- Study start
- Feb 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 24 Feb 2014 (estimated)
- 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.
The investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. This study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. The investigators' hypothesis is that subjects randomized to the intervention group will have a reduction in pain and pain-related hospitalizations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: ePAL Mobile ApplicationThe intervention group will use the study's mobile application during the 8-week study. |
| Control | No intervention | –The control group will not use the study's mobile application during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All adult patients, 18 years and above suffering from solid-organ cancer.
- Diagnosed with moderate or severe cancer pain (i.e. pain intensity score of at least 4/10 on numeric rating scale (NRS)) at the Massachusetts General Hospital (MGH) Palliative Care Center, as determined by the patient's care provider at the MGH Palliative Care Center. Subjects do not need to experience a specific nature of pain for eligibility.
- Patients must be ambulatory and not currently admitted to the hospital at time of enrollment.
- Must have a smart phone and be willing to download the study application (Phase II only)
- Must be able to read and speak English.
Key exclusion criteria (4 listed)
- Life expectancy less than 2-months as determined by the palliative care provider
- Significant medical or psychiatric co-morbidities (other than depression or anxiety) or cognitive impediments that would prevent participant from being able to utilize the program
- Known history of substance abuse
- Patients currently on investigational therapies or other study protocols that may have an impact on pain intensity or quality of life which are main outcomes of this intervention.
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 |
|---|---|---|
| ePAL Mobile ApplicationAlso: ePALA mobile application designed to help cancer patients better self-manage cancer pain. | Other | Intervention |
Primary outcome
Pain symptoms using the Brief Pain Inventory
Time frame: up to 8 weeks
The primary aim is to assess the effect of a tailored, multi-dimensional mobile-based intervention on the intensity of cancer pain in cancer patients with moderate to severe pain.
5 secondary outcomes
Pain related hospitalization from the Electronic Health Record
Time frame: up to 8 weeks
Patient-related barriers to pain management using the Barriers Questionnaire-II
Time frame: up to 8 weeks
Engagement as tracked by the app
Time frame: up to 8 weeks
Anxiety symptoms using the Generalized Anxiety Disorder (GAD-7)
Time frame: up to 8 weeks
Quality of life using the Functional Assessment of Cancer Therapy (FACT-G)
Time frame: up to 8 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 27 Jun 2022.
- Derived from this study: PubMed 38866116Kamdar M, Jethwani K, Centi AJ, Agboola S, Fischer N, Traeger L, Rinaldi S, Strand J, Ritchie C, Temel JS, Greer JA, Kvedar J, El-Jawarhi A, Jackson V. A Digital Therapeutic Application (ePAL) to Manage Pain in Patients With Advanced Cancer: A Randomized Controlled Trial. J Pain Symptom Manage. 2024 Sep;68(3):261-271. doi: 10.1016/j.jpainsymman.2024.05.033. Epub 2024 Jun 10.
- Derived from this study: PubMed 25500281Agboola S, Kamdar M, Flanagan C, Searl M, Traeger L, Kvedar J, Jethwani K. Pain management in cancer patients using a mobile app: study design of a randomized controlled trial. JMIR Res Protoc. 2014 Dec 12;3(4):e76. doi: 10.2196/resprot.3957.
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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.
Kamal Jethwani, MD, MPH principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePAL Mobile Application in people with Cancer, run by Massachusetts General Hospital at 2 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 4 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Pain symptoms using the Brief Pain Inventory (time frame: up to 8 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 NCT02069743, which also lists 2 linked publications.
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 27 Jun 2022.