Unspecified Adult Solid Tumor, Protocol SpecificNCT01612598
Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials
A study testing counseling intervention, quality-of-life assessment and questionnaire administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
Patients enrolled in phase I clinical trials could potentially benefit from palliative care concurrently, yet limited evidence is available to support such a change in care. The primary purpose of this study is to test the feasibility of a palliative care intervention (PCI) for patients participating in a phase I… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- counseling intervention, quality-of-life assessment and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Jan 2014
- 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 being assessed for participation in phase I clinical trials of investigational cancer therapies
- Able to read or understand English
- Ability to read and/or understand the study protocol requirements, and provide written informed consent
Who cannot join
- Patient diagnosed with hematologic or brain 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
About this study
Official title: Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials
Patients enrolled in phase I clinical trials could potentially benefit from palliative care concurrently, yet limited evidence is available to support such a change in care. The primary purpose of this study is to test the feasibility of a palliative care intervention (PCI) for patients participating in a phase I therapeutic clinical trial
Read the detailed description
PRIMARY OBJECTIVES:
- Describe the feasibility of implementing a PCI for patients on phase I clinical trials (study accrual and retention).
II. Describe the initial impact of a PCI on key patient outcome measures (quality of life [QOL], psychological distress, satisfaction with communication, symptom intensity, symptom distress, and patient satisfaction) over time.
OUTLINE:
PCI PART I: Patients undergo comprehensive palliative care (PC) assessment based on baseline data and complete goals of care discussion.
PCI PART II: Following the first dose of phase I investigational treatment, patients meet with the interdisciplinary team (IDT), where PC recommendations are made. This is followed by two patient educational sessions that will cover QOL-related domains, including physical, social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT recommendations.
- Being tested
- counseling intervention, quality-of-life assessment, questionnaire administration, educational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
Also called counseling and communications studies
Undergo PCI
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
educational interventionOther
Also called intervention, educational
Undergo PCI
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (PCI) | Experimental | PCI PART I: Patients undergo comprehensive PC assessment based on baseline data and complete goals of care discussion.
PCI PART II: Following the first dose of phase I investigational treatment, patients meet with the IDT, where PC recommendations are made. This is followed by two patient educational sessions that will cover QOL-related domains, including physical, social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT recommendations. Receives: Other: counseling intervention; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study accrual and retention
Measured: 8 weeks
Change in psychological distress assessed using Distress Thermometer
One-way repeated measure of Analysis of Covariance (ANCOVA), controlling for baseline scores and testing for within subjects change over time (4 weeks and 8 weeks) will be conducted to examine the PCI's impact on each of the outcome measures.
Measured: Baseline to 8 weeks
Change in satisfaction with communication assessed using Satisfaction with Communication Tool
One-way repeated measure of ANCOVA, controlling for baseline scores and testing for within subjects change over time (4 weeks and 8 weeks) will be conducted to examine the PCI's impact on each of the outcome measures.
Measured: Baseline to 8 weeks
Change in QOL using Functional Assessment of Cancer Therapy- General (FACT-G) and Functional Assessment of Chronic Illness Therapy- Spirituality (FACT-Sp-12)
Multivariate ANCOVAs (MANCOVAs) will be used at 4 and 8 weeks to examine the PCI's impact on QOL and symptom intensity and distress due to the multiple subscales in these two instruments.
Measured: Baseline to 8 weeks
Change in symptom intensity and distress using Memorial Symptom Assessment Scale (MSAS)
MANCOVAs will be used at 4 and 8 weeks to examine the PCI's impact on QOL and symptom intensity and distress due to the multiple subscales in these two instruments.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Betty Ferrell, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612598
- Sponsor's protocol ID
- 12123
- Other IDs
- NCI-2012-00887
- Status last verified
- Jan 2014
- First submitted
- 4 Jun 2012
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferrell B, Chung V, Hughes MT, Koczywas M, Azad NS, Ruel NH, Knight L, Cooper RS, Smith TJ. A Palliative Care Intervention for Patients on Phase 1 Studies. J Palliat Med. 2021 Jun;24(6):846-856. doi: 10.1089/jpm.2020.0597. Epub 2020 Oct 27.
PubMed 33103938
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials
- ClinicalTrials.gov ID
- NCT01612598
- Acronym / sponsor ID
- 12123
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients enrolled in phase I clinical trials could potentially benefit from palliative care concurrently, yet limited evidence is available to support such a change in care. The primary purpose of this study is to test the feasibility of a palliative care intervention (PCI) for patients participating in a phase I therapeutic clinical trial
Detailed description
PRIMARY OBJECTIVES:
- Describe the feasibility of implementing a PCI for patients on phase I clinical trials (study accrual and retention).
II. Describe the initial impact of a PCI on key patient outcome measures (quality of life [QOL], psychological distress, satisfaction with communication, symptom intensity, symptom distress, and patient satisfaction) over time.
OUTLINE:
PCI PART I: Patients undergo comprehensive palliative care (PC) assessment based on baseline data and complete goals of care discussion.
PCI PART II: Following the first dose of phase I investigational treatment, patients meet with the interdisciplinary team (IDT), where PC recommendations are made. This is followed by two patient educational sessions that will cover QOL-related domains, including physical, social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT recommendations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (PCI) | Experimental | Other: counseling intervention, Procedure: quality-of-life assessment, Other: questionnaire administration, Other: educational interventionPCI PART I: Patients undergo comprehensive PC assessment based on baseline data and complete goals of care discussion. PCI PART II: Following the first dose of phase I investigational treatment, patients meet with the IDT, where PC recommendations are made. This is followed by two patient educational sessions that will cover QOL-related domains, including physical, social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT recommendations. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with solid tumors who are being assessed for participation in phase I clinical trials of investigational cancer therapies
- Able to read or understand English
- Ability to read and/or understand the study protocol requirements, and provide written informed consent
Key exclusion criteria (1 listed)
- Patient diagnosed with hematologic or brain cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counseling interventionAlso: counseling and communications studiesUndergo PCI | Other | Supportive Care (PCI) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Supportive Care (PCI) |
| questionnaire administrationAncillary studies | Other | Supportive Care (PCI) |
| educational interventionAlso: intervention, educationalUndergo PCI | Other | Supportive Care (PCI) |
Primary outcome
Study accrual and retention
Time frame: 8 weeks
Change in psychological distress assessed using Distress Thermometer
Time frame: Baseline to 8 weeks
One-way repeated measure of Analysis of Covariance (ANCOVA), controlling for baseline scores and testing for within subjects change over time (4 weeks and 8 weeks) will be conducted to examine the PCI's impact on each of the outcome measures.
Change in satisfaction with communication assessed using Satisfaction with Communication Tool
Time frame: Baseline to 8 weeks
One-way repeated measure of ANCOVA, controlling for baseline scores and testing for within subjects change over time (4 weeks and 8 weeks) will be conducted to examine the PCI's impact on each of the outcome measures.
Change in QOL using Functional Assessment of Cancer Therapy- General (FACT-G) and Functional Assessment of Chronic Illness Therapy- Spirituality (FACT-Sp-12)
Time frame: Baseline to 8 weeks
Multivariate ANCOVAs (MANCOVAs) will be used at 4 and 8 weeks to examine the PCI's impact on QOL and symptom intensity and distress due to the multiple subscales in these two instruments.
Change in symptom intensity and distress using Memorial Symptom Assessment Scale (MSAS)
Time frame: Baseline to 8 weeks
MANCOVAs will be used at 4 and 8 weeks to examine the PCI's impact on QOL and symptom intensity and distress due to the multiple subscales in these two instruments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Derived from this study: PubMed 33103938Ferrell B, Chung V, Hughes MT, Koczywas M, Azad NS, Ruel NH, Knight L, Cooper RS, Smith TJ. A Palliative Care Intervention for Patients on Phase 1 Studies. J Palliat Med. 2021 Jun;24(6):846-856. doi: 10.1089/jpm.2020.0597. Epub 2020 Oct 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Ferrell principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, quality-of-life assessment and questionnaire 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 3 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 31 Jan 2014. 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?
Study accrual and retention (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612598, which also lists 1 linked publication.
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 31 Jan 2014.