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Unspecified Adult Solid Tumor, Protocol SpecificNCT01828775

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

A study testing palliative care, quality-of-life assessment and survey administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
palliative care, quality-of-life assessment and survey administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
2 sitesUnited States
Study dates
17 Sep 2014to 18 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

    Baltimore, Maryland, 21231

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Integration of Palliative Care for Cancer Patients on Phase I Trials

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

  1. 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.

Being tested
palliative care, quality-of-life assessment, survey administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • palliative careOther

    Receive early PCI

  • palliative careOther

    Receive delayed PCI

  • quality-of-life assessmentProcedure or surgery

    Also called quality of life assessment

    Ancillary studies

  • survey administrationOther

    Ancillary studies

Study groups in NCT01828775
Study groupRoleWhat they receive
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.
Receives: Other: palliative care; Procedure: quality-of-life assessment; Other: survey administration
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.
Receives: Other: palliative care; Procedure: quality-of-life assessment; Other: survey administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline to 12 weeks

  2. 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.

    Measured: Baseline to 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

  6. 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.

    Measured: 12 weeks

  7. Total number of hospice referrals

    Contingency table analysis with the chi square statistic to examine the association between group and hospice referral.

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

  9. 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.

    Measured: 12 weeks

Secondary outcomes (12)
  1. 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).

    Measured: Baseline to 4 weeks

  2. 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).

    Measured: Baseline to 24 weeks

  3. 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.

    Measured: Baseline to 4 weeks

  4. 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.

    Measured: Baseline to 24 weeks

  5. 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.

    Measured: 4 weeks

  6. 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.

    Measured: Up to 24 weeks

  7. 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.

    Measured: Up to 24 weeks

  8. 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.

    Measured: Up to 24 weeks

  9. 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.

    Measured: Up to 24 weeks

  10. 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.

    Measured: Up to 24 weeks

  11. 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.

    Measured: Up to 24 weeks

  12. 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.

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2013 (estimated)
  2. Study start17 Sep 2014
  3. Primary completion18 May 2020
  4. Study completion18 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01828775
Sponsor's protocol ID
13193
Other IDs
NCI-2013-00731, 1R01CA177562-01A1
Status last verified
Oct 2026
First submitted
2 Apr 2013
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing palliative care, quality-of-life assessment and survey administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Baseline to 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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