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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05331625
Other study ID # UPCC 11922
Secondary ID 850807
Status Recruiting
Phase N/A
First received
Last updated
Start date November 3, 2022
Est. completion date April 2025

Study information

Verified date December 2023
Source Abramson Cancer Center at Penn Medicine
Contact Nicholas S Bishop
Phone 215-573-0779
Email nicholas.bishop@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled trial will assess the effects on quality of life of two approaches to symptom management among new patients referred to a palliative care oncology clinic.


Recruitment information / eligibility

Status Recruiting
Enrollment 208
Est. completion date April 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be a new patient at an outpatient palliative care clinic - Resident of Pennsylvania - Over 18 years of age Exclusion Criteria: - Prior use of certain symptom focused therapies - Currently pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Offering Additional Resources to Promote Symptom Management
Participants will be offered additional resources to promote symptom management.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life - McGill Quality of Life Questionnaire Quality of life will be measured through the McGill Quality of Life Questionnaire Revised (MQOL-R). The questionnaire is 15 questions assessing overall and specific areas of quality of life. Baseline - 16 weeks
Secondary Feasibility of Accessing Additional Resources for Symptom Management Feasibility will be measured by whether participants accessed the additional resources for symptom management. Baseline - 16 weeks
Secondary Acceptability of Accessing Additional Resources for Symptom Management Acceptability will be measured by whether participants accessed the additional resources for symptom management. Baseline - 16 weeks
Secondary Symptom Severity Symptom severity will be measured through the Edmonton Symptom Assessment System (ESAS). The survey is 10 questions assessing the severity of pain, nausea, depression, etc. on a 0 to 10 scale-in which a 0 representing best possible state/symptom absence and a 10 representing worst possible state. Baseline - 16 weeks
Secondary Medication Use Medication use will be measured through a medication diary created for the study. The medication diary asks participants about recent medications, amounts, and dosages. Baseline - 16 weeks
Secondary Hospital-Free Days Hospital-free days will be measured through examination of participant's electronic health record. Baseline - 16 weeks
Secondary Mortality Mortality will be measured through examination of participant's electronic health record. Baseline - 16 weeks
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