Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
Integration of Palliative Care for Cancer Patients on Phase I Trials
3 other identifiers
interventional
480
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2013
CompletedFirst Posted
Study publicly available on registry
April 11, 2013
CompletedStudy Start
First participant enrolled
September 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2020
CompletedMarch 10, 2021
March 1, 2021
5.7 years
April 2, 2013
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (9)
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
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
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
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
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
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
Total number of hospice referrals
Contingency table analysis with the chi square statistic to examine the association between group and hospice referral.
12 weeks
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
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 Outcomes (12)
Change in overall QOL scores, assessed by FACT-G and FACIT-Sp
Baseline to 4 weeks
Change in overall QOL scores, assessed by FACT-G and FACIT-Sp
Baseline to 24 weeks
Change in psychological distress, assessed using the Psychological Distress Thermometer
Baseline to 4 weeks
Change in psychological distress, assessed using the Psychological Distress Thermometer
Baseline to 24 weeks
Satisfaction with communication, measured by FAMCARE
4 weeks
- +7 more secondary outcomes
Study Arms (2)
Arm I (early PCI)
EXPERIMENTALPatients 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 (delayed PCI)
EXPERIMENTALPatients receive usual care until 12 weeks post-treatment initiation. Patients then receive both part I and II of the PCI.
Interventions
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients diagnosed with hematologic (as a population distinct from solid tumors and different trials) cancers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
City of Hope Medical Center
Duarte, California, 91010, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, 21231, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Betty Ferrell
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2013
First Posted
April 11, 2013
Study Start
September 8, 2014
Primary Completion
May 18, 2020
Study Completion
May 18, 2020
Last Updated
March 10, 2021
Record last verified: 2021-03