Understanding Quality of Life Among Patients With Cancer Receiving Palliative Care

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05331625

Collaborator

(none)

208

Enrollment

Location

Arms

Anticipated Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Offering Additional Resources to Promote Symptom Management	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

208 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Understanding Quality of Life Among Patients With Cancer Receiving Palliative Care

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Quality of Life - McGill Quality of Life Questionnaire [Baseline - 16 weeks]
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.

Secondary Outcome Measures

Feasibility of Accessing Additional Resources for Symptom Management [Baseline - 16 weeks]
Feasibility will be measured by whether participants accessed the additional resources for symptom management.
Acceptability of Accessing Additional Resources for Symptom Management [Baseline - 16 weeks]
Acceptability will be measured by whether participants accessed the additional resources for symptom management.
Symptom Severity [Baseline - 16 weeks]
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.
Medication Use [Baseline - 16 weeks]
Medication use will be measured through a medication diary created for the study. The medication diary asks participants about recent medications, amounts, and dosages.
Hospital-Free Days [Baseline - 16 weeks]
Hospital-free days will be measured through examination of participant's electronic health record.
Mortality [Baseline - 16 weeks]
Mortality will be measured through examination of participant's electronic health record.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Scott Halpern, Associate Professor of Medicine, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05331625

Other Study ID Numbers:

UPCC 11922
850807

First Posted:

Apr 15, 2022

Last Update Posted:

Jun 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 27, 2022