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Completed

NCT Number: NCT01612598

Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials

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

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Key information

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center, Duarte, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

counseling intervention

Other

Undergo PCI

Other names: counseling and communications studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Questionnaire Administration

Other

Ancillary studies

Educational Intervention

Other

Undergo PCI

Other names: intervention, educational

Primary outcomes

  1. Study accrual and retention

    Time frame: 8 weeks

  2. Change in psychological distress assessed using Distress Thermometer

    Time frame: Baseline to 8 weeks

    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.

  3. Change in satisfaction with communication assessed using Satisfaction with Communication Tool

    Time frame: Baseline to 8 weeks

    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.

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

    Time frame: Baseline to 8 weeks

    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.

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

    Time frame: Baseline to 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 6, 2012
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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