Pain Management in Cancer Patients Using a Mobile Application

NCT ID: NCT02069743

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

The intervention group will use the study's mobile application during the 8-week study.

Group Type EXPERIMENTAL

ePAL Mobile Application

Intervention Type OTHER

A mobile application designed to help cancer patients better self-manage cancer pain.

Control

The control group will not use the study's mobile application during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ePAL Mobile Application

A mobile application designed to help cancer patients better self-manage cancer pain.

Intervention Type OTHER

Other Intervention Names

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ePAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McKesson Foundation

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mihir M. Kamdar,M.D.

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamal Jethwani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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The Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Agboola 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.

Reference Type DERIVED
PMID: 25500281 (View on PubMed)

Other Identifiers

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13-080

Identifier Type: -

Identifier Source: org_study_id

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