Trial record 8 of 184 for:    Open Studies | "palliative care"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01828775
First received: April 2, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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. Palliative therapy may help patients with solid tumors live more comfortably.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Other: palliative care
Procedure: quality-of-life assessment
Other: survey administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Integration of Palliative Care for Cancer Patients on Phase I Trials

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

    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).


  • Change in psychological distress, assessed using the Psychological Distress Thermometer [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Satisfaction with communication, measured by the Family Satisfaction with Advanced Cancer Care (FAMCARE) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Patients' symptom intensity and symptom interference with daily activities [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Total numbers of supportive care referrals (social work, dietitian, chaplaincy, psychologist/psychiatrist) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Total number of unscheduled outpatient encounters and inpatient admissions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Total number of hospice referrals [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Contingency table analysis with the chi square statistic to examine the association between group and hospice referral.

  • Retention on the Phase I trial [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Contingency table analysis with the chi square statistic to examine the association between group and Phase I trial retention.

  • Patient satisfaction with the PCI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Descriptive statistics and comparisons between the two groups will be conducted for overall satisfaction with intervention content and timing of the intervention.


Secondary Outcome Measures:
  • Change in overall QOL scores, assessed by FACT-G and FACIT-Sp [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]

    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).


  • Change in overall QOL scores, assessed by FACT-G and FACIT-Sp [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]

    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).


  • Change in psychological distress, assessed using the Psychological Distress Thermometer [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in psychological distress, assessed using the Psychological Distress Thermometer [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Satisfaction with communication, measured by FAMCARE [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Satisfaction with communication, measured by FAMCARE [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Patients' symptom intensity and symptom interference with daily activities [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Total numbers of supportive care referrals (social work, dietitian, chaplaincy, psychologist/psychiatrist) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Total number of unscheduled outpatient encounters and inpatient admissions [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Total number of hospice referrals [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Contingency table analysis with the chi square statistic to examine the association between group and hospice referral for up to 24 weeks.

  • Retention on the Phase I trial [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Contingency table analysis with the chi square statistic to examine the association between group and Phase I trial retention for up to 24 weeks.

  • Patient satisfaction with the PCI [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 480
Study Start Date: December 2014
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (early PCI)
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, patent educational sessions, and supportive care referrals following the first dose of phase I treatment and is completed within one month of the first treatment.
Other: palliative care
Receive early PCI
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: survey administration
Ancillary studies
Experimental: Arm II (delayed PCI)
Patients receive usual care until 12 weeks post-treatment initiation. Patients then receive both part I and II of the PCI.
Other: palliative care
Receive delayed PCI
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: survey administration
Ancillary studies

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, patent 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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) or brain cancers (due to cognitive ability)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828775

Locations
United States, California
City of Hope Medical Center Not yet recruiting
Duarte, California, United States, 91010
Contact: Betty Ferrell    800-826-4673    bferrell@coh.org   
Principal Investigator: Betty Ferrell         
Sidney Kimmel Cancer Center Not yet recruiting
San Diego, California, United States, 92121
Contact: Nilofer S. Azad    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Nilofer S. Azad         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Betty Ferrell City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01828775     History of Changes
Other Study ID Numbers: 13193, NCI-2013-00731
Study First Received: April 2, 2013
Last Updated: May 5, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 29, 2014