Clinical trial NCT01612598: Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials
Official title: Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-06
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients enrolled in phase I clinical trials could potentially benefit from palliative care concurrently, yet limited evidence is available to support such a change in care. The primary purpose of this study is to test the feasibility of a palliative care intervention (PCI) for patients participating in a phase I therapeutic clinical trial

Detailed description: PRIMARY OBJECTIVES:

I. Describe the feasibility of implementing a PCI for patients on phase I clinical trials (study accrual and retention).

II. Describe the initial impact of a PCI on key patient outcome measures (quality of life \[QOL\], psychological distress, satisfaction with communication, symptom intensity, symptom distress, and patient satisfaction) over time.

OUTLINE:

PCI PART I: Patients undergo comprehensive palliative care (PC) assessment based on baseline data and complete goals of care discussion.

PCI PART II: Following the first dose of phase I investigational treatment, patients meet with the interdisciplinary team (IDT), where PC recommendations are made. This is followed by two patient educational sessions that will cover QOL-related domains, including physical, social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT recommendations.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with solid tumors who are being assessed for participation in phase I clinical trials of investigational cancer therapies
* Able to read or understand English
* Ability to read and/or understand the study protocol requirements, and provide written informed consent

Exclusion Criteria:

* Patient diagnosed with hematologic or brain cancers

Primary outcomes:
measure: Study accrual and retention
timeFrame: 8 weeks
measure: Change in psychological distress assessed using Distress Thermometer
timeFrame: Baseline to 8 weeks
measure: Change in satisfaction with communication assessed using Satisfaction with Communication Tool
timeFrame: Baseline to 8 weeks
measure: Change in QOL using Functional Assessment of Cancer Therapy- General (FACT-G) and Functional Assessment of Chronic Illness Therapy- Spirituality (FACT-Sp-12)
timeFrame: Baseline to 8 weeks
measure: Change in symptom intensity and distress using Memorial Symptom Assessment Scale (MSAS)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: City of Hope Medical Center
name: Betty Ferrell
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrell B, Chung V, Hughes MT, Koczywas M, Azad NS, Ruel NH, Knight L, Cooper RS, Smith TJ. A Palliative Care Intervention for Patients on Phase 1 Studies. J Palliat Med. 2021 Jun;24(6):846-856. doi: 10.1089/jpm.2020.0597. Epub 2020 Oct 27.