Understanding Quality of Life Among Patients With Cancer Receiving Palliative Care

Study Overview
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Brief Summary
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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.

Official Title
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Understanding Quality of Life Among Patients With Cancer Receiving Palliative Care

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Offering Additional Resources to Promote Symptom Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Participants will be offered additional resources to promote symptom management.<br>|
| No Intervention: Usual Care<br>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?
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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 |