NCT05331625

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
3mo left

Started Nov 2022

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Nov 2022Aug 2026

First Submitted

Initial submission to the registry

April 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

November 28, 2025

Status Verified

February 1, 2025

Enrollment Period

3.7 years

First QC Date

April 1, 2022

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Feasibility of Accessing Additional Resources for Symptom Management

    Baseline - 16 weeks

  • Acceptability of Accessing Additional Resources for Symptom Management

    Baseline - 16 weeks

  • Symptom Severity

    Baseline - 16 weeks

  • Medication Use

    Baseline - 16 weeks

  • Hospital-Free Days

    Baseline - 16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO 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 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.

Interventions

Participants will be offered additional resources to promote symptom management.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be a new patient at an outpatient palliative care clinic
  • Resident of Pennsylvania
  • Over 18 years of age

You may not qualify if:

  • Prior use of certain symptom focused therapies
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 1, 2022

First Posted

April 15, 2022

Study Start

November 3, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations