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

NCT03616522 | Completed

• 1 other identifier: UPCC 03518
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of subjects who will adhere to the mobile phone-based intervention

  evaluate subjects to study-level adherence of a mobile phone-based intervention for automated PRO collection

  3 months

Interventions

a novel mobile phone-based intervention for automated electronic PRO collection OTHER

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.

Eligibility Criteria

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

Study Population

Advanced non-small cell lung cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lawrence Shulman, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 6, 2018
• Study Start: May 21, 2018
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

US (1)