Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Integration of Palliative Care for Cancer Patients on Phase I Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828775
• Other study ID #: 13193
• Secondary ID: NCI-2013-007311R
• Status: Completed
• Phase: N/A
• Start date: September 8, 2014
• Est. completion date: May 18, 2020

Study information

• Verified date: March 2021
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• palliative care
Receive early PCI
• palliative care
Receive delayed PCI

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• survey administration
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital	Baltimore	Maryland
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 4 and 12 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05.; If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).	Baseline to 12 weeks
Primary	Change in psychological distress, assessed using the Psychological Distress Thermometer	Analyzed using a 2x2 repeated measures ANCOVA to test for differences in psychological distress (Psychological Distress Thermometer scores), at 4 and 12-week between the PCI and control groups, controlling for baseline psychological distress.	Baseline to 12 weeks
Primary	Satisfaction with communication, measured by the Family Satisfaction with Advanced Cancer Care (FAMCARE)	Analyzed using a 2x2 repeated measures ANCOVA to test for differences in satisfaction (Family Satisfaction with Advanced Cancer Care scores), at 4 and 12-week between the PCI and control groups, controlling for baseline satisfaction.	12 weeks
Primary	Patients' symptom intensity and symptom interference with daily activities	Analyzed using a 2x2 repeated measures ANCOVA to test for differences in symptom intensity and symptom interference with daily activities (using Psychological Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO - CTCAE) scores), at 4 and 12-week between the PCI and control groups, controlling for baseline symptom intensity and symptom interference.	12 weeks
Primary	Total numbers of supportive care referrals (social work, dietitian, chaplaincy, psychologist/psychiatrist)	Contingency table analysis and the chi square statistic will be used to examine the association between group and referral to various support services. In addition, total number of referrals will be counted and an independent student's t-test will be used to test for significant differences in number of total referrals between groups.	12 weeks
Primary	Total number of unscheduled outpatient encounters and inpatient admissions	Total number of encounters and admissions will be counted and an independent student's t-test for each variable will be used to test for significant differences in number of total encounters and number of unscheduled admissions between groups.	12 weeks
Primary	Total number of hospice referrals	Contingency table analysis with the chi square statistic to examine the association between group and hospice referral.	12 weeks
Primary	Retention on the Phase I trial	Contingency table analysis with the chi square statistic to examine the association between group and Phase I trial retention.	12 weeks
Primary	Patient satisfaction with the PCI	Descriptive statistics and comparisons between the two groups will be conducted for overall satisfaction with intervention content and timing of the intervention.	12 weeks
Secondary	Change in overall QOL scores, assessed by FACT-G and FACIT-Sp	To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 4 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05.; If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).	Baseline to 4 weeks
Secondary	Change in overall QOL scores, assessed by FACT-G and FACIT-Sp	To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 24 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05.; If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).	Baseline to 24 weeks
Secondary	Change in psychological distress, assessed using the Psychological Distress Thermometer	Analyzed using a 2x2 repeated measures ANCOVA to test for differences in psychological distress (Psychological Distress Thermometer scores), at 4 weeks, between the PCI and control groups, controlling for baseline psychological distress.	Baseline to 4 weeks
Secondary	Change in psychological distress, assessed using the Psychological Distress Thermometer	Analyzed using a 2x2 repeated measures ANCOVA to test for differences in psychological distress (Psychological Distress Thermometer scores), at 24 weeks, between the PCI and control groups, controlling for baseline psychological distress.	Baseline to 24 weeks
Secondary	Satisfaction with communication, measured by FAMCARE	Analyzed using a 2x2 repeated measures ANCOVA to test for differences in satisfaction (Family Satisfaction with Advanced Cancer Care scores), at 4 weeks, between the PCI and control groups, controlling for baseline satisfaction.	4 weeks
Secondary	Satisfaction with communication, measured by FAMCARE	Analyzed using a 2x2 repeated measures ANCOVA to test for differences in satisfaction (Family Satisfaction with Advanced Cancer Care scores), up to 24 weeks, between the PCI and control groups, controlling for baseline satisfaction.	Up to 24 weeks
Secondary	Patients' symptom intensity and symptom interference with daily activities	Analyzed using a 2x2 repeated measures ANCOVA to test for differences in symptom intensity and symptom interference with daily activities (Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO - CTCAE) scores), up to 24 weeks, between the PCI and control groups, controlling for baseline satisfaction.	Up to 24 weeks
Secondary	Total numbers of supportive care referrals (social work, dietitian, chaplaincy, psychologist/psychiatrist)	Contingency table analysis and the chi square statistic will be used to examine the association between group and referral to various support services for up to 24 weeks. In addition, total number of referrals will be counted and an independent student's t-test will be used to test for significant differences in number of total referrals between groups.	Up to 24 weeks
Secondary	Total number of unscheduled outpatient encounters and inpatient admissions	Total number of encounters and admissions will be counted and an independent student's t-test for each variable will be used to test for significant differences in number of total encounters and number of unscheduled admissions between groups for up to 24 weeks.	Up to 24 weeks
Secondary	Total number of hospice referrals	Contingency table analysis with the chi square statistic to examine the association between group and hospice referral for up to 24 weeks.	Up to 24 weeks
Secondary	Retention on the Phase I trial	Contingency table analysis with the chi square statistic to examine the association between group and Phase I trial retention for up to 24 weeks.	Up to 24 weeks
Secondary	Patient satisfaction with the PCI	Descriptive statistics and comparisons between the two groups will be conducted for overall satisfaction with intervention content and timing of the intervention for up to 24 weeks.	Up to 24 weeks