Clinical trial NCT01828775: Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
Official title: Integration of Palliative Care for Cancer Patients on Phase I 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: 2013-04-11
Enrollment: 480
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot randomized clinical trial studies palliative care intervention in improving quality of life, psychological distress, and communication in patients with solid tumors receiving treatment on phase I trials. Cancer patients experience many symptoms related to treatment and the cancer itself that can be distressing and impact quality of life. Palliative care focuses on managing these symptoms and may help patients with solid tumors live more comfortably.

Detailed description: PRIMARY OBJECTIVES:

I. Test the effects of a palliative care intervention (PCI) on patients' quality of life (QOL), psychological distress and satisfaction with communication, comparing the experimental versus control groups.

II. Test the effects of a PCI on patients' symptom intensity and symptom interference with daily activities, comparing the experimental versus control groups.

III. Test the effects of a PCI on patients' hospital and palliative care resource utilization and clinical trial retention rates, comparing the experimental versus control groups.

IV. Test the effects of the timing of PCI initiation (early versus delayed) on patient outcomes, comparing the experimental versus control groups.

V. Describe patients' satisfaction with the PCI.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive part I of the PCI comprising quantitative surveys, comprehensive palliative care assessment by the Research Nurses, and goals of care discussions beginning prior to administration of the first dose of phase I treatment. Patients then receive part II of the PCI comprising recommendations from the interdisciplinary team, patient educational sessions, and supportive care referrals following the first dose of phase I treatment and is completed within one month of the first treatment.

ARM II: Patients receive usual care until 12 weeks post-treatment initiation. Patients then receive both part I and II of the PCI.

After completion of study, patients are followed up for 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with solid tumors who are eligible for participation in Phase I clinical trials of investigational cancer therapies
* Patients who have signed an informed consent for participation in Phase I clinical trials
* Able to read or understand English-this is included because the intervention and study materials (including outcome measures) are only in English
* Ability to read and/or understand the study protocol requirements, and provide written informed consent

Exclusion Criteria:

* Patients diagnosed with hematologic (as a population distinct from solid tumors and different trials) cancers.

Primary outcomes:
measure: Change in overall QOL scores, assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp)
timeFrame: Baseline to 12 weeks
measure: Change in psychological distress, assessed using the Psychological Distress Thermometer
timeFrame: Baseline to 12 weeks
measure: Satisfaction with communication, measured by the Family Satisfaction with Advanced Cancer Care (FAMCARE)
timeFrame: 12 weeks
measure: Patients' symptom intensity and symptom interference with daily activities
timeFrame: 12 weeks
measure: Total numbers of supportive care referrals (social work, dietitian, chaplaincy, psychologist/psychiatrist)
timeFrame: 12 weeks
measure: Total number of unscheduled outpatient encounters and inpatient admissions
timeFrame: 12 weeks
measure: Total number of hospice referrals
timeFrame: 12 weeks
measure: Retention on the Phase I trial
timeFrame: 12 weeks
measure: Patient satisfaction with the PCI
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in overall QOL scores, assessed by FACT-G and FACIT-Sp
timeFrame: Baseline to 4 weeks
measure: Change in overall QOL scores, assessed by FACT-G and FACIT-Sp
timeFrame: Baseline to 24 weeks
measure: Change in psychological distress, assessed using the Psychological Distress Thermometer
timeFrame: Baseline to 4 weeks
measure: Change in psychological distress, assessed using the Psychological Distress Thermometer
timeFrame: Baseline to 24 weeks
measure: Satisfaction with communication, measured by FAMCARE
timeFrame: 4 weeks
measure: Satisfaction with communication, measured by FAMCARE
timeFrame: Up to 24 weeks
measure: Patients' symptom intensity and symptom interference with daily activities
timeFrame: Up to 24 weeks
measure: Total numbers of supportive care referrals (social work, dietitian, chaplaincy, psychologist/psychiatrist)
timeFrame: Up to 24 weeks
measure: Total number of unscheduled outpatient encounters and inpatient admissions
timeFrame: Up to 24 weeks
measure: Total number of hospice referrals
timeFrame: Up to 24 weeks
measure: Retention on the Phase I trial
timeFrame: Up to 24 weeks
measure: Patient satisfaction with the PCI
timeFrame: Up to 24 weeks
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: