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A Prospective Study of Electronic Symptom Reporting Via Mobile Phone Among Patients With Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616522
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Description
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Brief Summary:
Symptoms are common among patients with advanced malignancy undergoing treatment, and yet often go unrecognized by treatment providers. In addition to contributing to morbidity, poorly controlled symptoms drive emergency room utilization and hospital admission in this population, representing significant cost to patients, families, and the health care system. Systematic collection of patient-reported outcomes (PROs) has been proposed as a way to arm providers with the information necessary to intervene early, intensify symptom management, and improve symptom control. Recent research suggests that a standardized, web-based program of weekly patient-reported symptom monitoring leads to improved health-related quality of life and reduced acute care utilization; it may also prolong overall survival. Despite mounting evidence supporting its use among oncology patients, systematic PRO collection is lacking at most cancer centers, and optimal models for collection of PROs are poorly understood. The objective of this study is to evaluate prospectively the feasibility of a novel mobile phone-based intervention of weekly symptom reporting, among patients undergoing treatment for advanced non-small cell lung cancer.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Other: a novel mobile phone-based intervention for automated electronic PRO collection

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Electronic Symptom Reporting Via Mobile Phone Among Patients With Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : May 21, 2018
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : February 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Intervention Details:
  • Other: a novel mobile phone-based intervention for automated electronic PRO collection
    Over the three-month study period, patients will be prompted weekly via text message to self-report up to eleven common symptoms, as well as their performance status and quality of life.

Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects who will adhere to the mobile phone-based intervention [ Time Frame: 3 months ]
    evaluate subjects to study-level adherence of a mobile phone-based intervention for automated PRO collection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Advanced non-small cell lung cancer
Criteria

Inclusion Criteria:

  • Adult patient (age ≥ 18 years) with advanced (metastatic) non-small cell lung cancer, initiating a new line of palliative-intent treatment at Abramson Cancer Center
  • Ability to read and respond to questions in English
  • Ability to provide informed consent to participate in the study
  • Access to a smart phone capable of SMS-text messaging and internet access

Exclusion Criteria:

  • Inability to read and respond to questions in English
  • Inability or unwillingness to provide informed consent to participate in the study
  • Inability to engage with SMS-text based platform
  • Current enrollment in a clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616522


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Lawrence Shulman, MD Abramson Cancer Center of the University of Pennsylvania
More Information
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03616522    
Other Study ID Numbers: UPCC 03518
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms