Understanding Quality of Life Among Patients With Cancer Receiving Palliative Care

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Offering Additional Resources to Promote Symptom Management

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in this group will consent to participate in a study about quality of life for patients with cancer seeking outpatient palliative care. They will be seen in a palliative care oncology clinic at which time they will be offered additional resources to promote symptom management. They will be asked to complete a series of surveys every two weeks for 16 weeks which will assess their quality of life, symptoms, and medication use.	Behavioral: Offering Additional Resources to Promote Symptom Management; Participants will be offered additional resources to promote symptom management.
No Intervention: Usual Care; Participants in this group will consent to participate in a study about quality of life for patients with cancer seeking outpatient palliative care. They will be seen in a palliative care oncology clinic where they will receive symptom management and supportive care. They will be asked to complete a series of surveys every two weeks for 16 weeks which will assess their quality of life, symptoms, and medication use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Hospital-Free Days	Hospital-free days will be measured through examination of participant's electronic health record.	Baseline - 16 weeks
Mortality	Mortality will be measured through examination of participant's electronic health record.	Baseline - 16 weeks

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UPCC 11922; 850807 (Other Identifier: University of Pennsylvania IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No