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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03616522
Other study ID # UPCC 03518
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 21, 2018
Est. completion date February 18, 2019

Study information

Verified date February 2020
Source Abramson Cancer Center of the University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 18, 2019
Est. primary completion date February 18, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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