NCT01612598

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

June 4, 2012

Last Update Submit

January 29, 2014

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (5)

  • Study accrual and retention

    8 weeks

  • Change in psychological distress assessed using Distress Thermometer

    One-way repeated measure of Analysis of Covariance (ANCOVA), controlling for baseline scores and testing for within subjects change over time (4 weeks and 8 weeks) will be conducted to examine the PCI's impact on each of the outcome measures.

    Baseline to 8 weeks

  • Change in satisfaction with communication assessed using Satisfaction with Communication Tool

    One-way repeated measure of ANCOVA, controlling for baseline scores and testing for within subjects change over time (4 weeks and 8 weeks) will be conducted to examine the PCI's impact on each of the outcome measures.

    Baseline to 8 weeks

  • Change in QOL using Functional Assessment of Cancer Therapy- General (FACT-G) and Functional Assessment of Chronic Illness Therapy- Spirituality (FACT-Sp-12)

    Multivariate ANCOVAs (MANCOVAs) will be used at 4 and 8 weeks to examine the PCI's impact on QOL and symptom intensity and distress due to the multiple subscales in these two instruments.

    Baseline to 8 weeks

  • Change in symptom intensity and distress using Memorial Symptom Assessment Scale (MSAS)

    MANCOVAs will be used at 4 and 8 weeks to examine the PCI's impact on QOL and symptom intensity and distress due to the multiple subscales in these two instruments.

    Baseline to 8 weeks

Study Arms (1)

Supportive Care (PCI)

EXPERIMENTAL

PCI PART I: Patients undergo comprehensive 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 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.

Other: counseling interventionProcedure: quality-of-life assessmentOther: questionnaire administrationOther: educational intervention

Interventions

counseling interventionOTHER

Undergo PCI

Also known as: counseling and communications studies
Supportive Care (PCI)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Supportive Care (PCI)
questionnaire administrationOTHER

Ancillary studies

Supportive Care (PCI)
educational interventionOTHER

Undergo PCI

Also known as: intervention, educational
Supportive Care (PCI)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient diagnosed with hematologic or brain cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

  • 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.

    PMID: 33103938DERIVED

MeSH Terms

Interventions

CounselingEarly Intervention, EducationalMethods

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Betty Ferrell

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 6, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2013

Study Completion

January 1, 2014

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

US(2)