Quality of LifeNCT02311465
A Randomized Study of Early Palliative Care
A study testing Palliative Care in people with Quality of Life, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this research study is to find out whether it is better to introduce cancer patients to the palliative care team at a later date when there is a specific issue or problem or to introduce cancer patients to the palliative care team when first diagnosed before any specific issue or problem occurs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Palliative Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Adults with newly diagnosed pancreatic, hepatocellular, esophageal, or stomach cancer
- Upcoming scheduled oncology clinic visit (2nd visit to the clinic) at Vanderbilt
- Ability to read and respond to questions in English
- Permission of oncology physician
Who cannot join
- -Receiving oncology care at non-Vanderbilt sites (to ensure appropriate follow-up)
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Oncology Care Alone in Patients With Non-colorectal Gastrointestinal Malignancies.
The purpose of this research study is to find out whether it is better to introduce cancer patients to the palliative care team at a later date when there is a specific issue or problem or to introduce cancer patients to the palliative care team when first diagnosed before any specific issue or problem occurs.
Read the detailed description
The investigators will conduct a one-year randomized, controlled study to evaluate the impact of an early, integrated palliative care services. The intervention will include comprehensive palliative care services delivered in conjunction with standard oncology care and patient friendly materials for high risk oncology patients. The investigators primary clinical endpoint will be health related quality of life, specifically focusing on measures of anxiety, depression, and well-being.
Secondary personalized palliative care outcomes are expected to include:
- Reduced deviations from care plan as captured in the medical record compared to the group who did not receive early, integrated palliative care services
- Reduced hospital utilization compared to the group who did not receive early, integrated palliative care services
- Conditions
- Quality of Life
- Being tested
- Palliative Care
- Keywords
- Palliative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareOther
Also called Support Care
Components of the palliative care service intervention are expected to include:
- Establishment of a palliative care plan
- Care coordination by palliative care team
- Informational, patient friendly materials supporting Palliative Care
- Communication by palliative care team to all providers and teams involved in patient's care
- Systematic collection of information, including identification of surrogate or health care proxy and advance care planning
- Questionnaires capturing health related quality of life at regular intervals throughout the intervention period
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care + Standard of Care | Experimental | Consenting patients will be approached by a research nurse to complete quality of life questionnaires (baseline measures) either in the oncology clinics or infusion clinics. Patients assigned to early palliative care will meet with a member of the palliative care team after enrollment and completion of the initial questionnaires to receive and review patient-oriented materials detailing palliative care services. Patients will then receive a comprehensive initial consult with a palliative care provider (a trained physician, nurse or nurse practitioner). Additional consults with the palliative care service will be scheduled approximately every 6 weeks for the duration of the study period (one year) at the discretion of the patient and palliative care provider. Receives: Other: Palliative Care |
| Standard of Care | No intervention | Patients will receive standard care from their oncologist. An assessment of health related quality of life will be conducted at regular oncology clinic visits at baseline and 3,6,9,and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire
The FACT Measurement System is a group of questions which measure health-related quality of life (QOL) in cancer patients. The FACT-G is a 26-item version that addresses multiple QOL dimensions including physical well-being, functional well-being, emotional well-being and social well-being. The response format of the FACT Measurement System consists of a 5-point Likert scale.
Measured: 1 year
Secondary outcomes (3)
PROMIS Depression Scale
Patient-Reported Outcome Measurement Information System (PROMIS) Depression scale is a highly reliable, validated, precise measures of patient-reported health status for physical, mental, and social well-being. The domains of depression are measured through four targeted questions each on a 5 point Likert scale.
Measured: 1 year
PROMIS Anxiety Scale
Patient-Reported Outcome Measurement Information System (PROMIS) Anxiety scale is a highly reliable, validated, precise measures of patient-reported health status for physical, mental, and social well-being. The domains of anxiety are measured through four targeted questions each on a 5 point Likert scale.
Measured: 1 year
Hospitalizations
Patient level data will be obtained for this study through retrospective chart review. Data to be collected from patients' charts include oncology medications and treatments, outcomes and interventions over the course of treatment (surgeries, adverse events, death), and hospitalizations. Clinical interventions, treatments, and events extracted from the charts will inform the investigators analyses regarding health care resource utilization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gordon Bernard, Vanderbilt University
- Investigators
- Gordon Bernard, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311465
- Sponsor's protocol ID
- 141854
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2014
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Oncology Care Alone in Patients With Non-colorectal Gastrointestinal Malignancies.
- ClinicalTrials.gov ID
- NCT02311465
- Acronym / sponsor ID
- 141854
- Conditions
- Quality of Life
- Keywords
- Palliative Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Dec 2014 (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.
The purpose of this research study is to find out whether it is better to introduce cancer patients to the palliative care team at a later date when there is a specific issue or problem or to introduce cancer patients to the palliative care team when first diagnosed before any specific issue or problem occurs.
Detailed description
The investigators will conduct a one-year randomized, controlled study to evaluate the impact of an early, integrated palliative care services. The intervention will include comprehensive palliative care services delivered in conjunction with standard oncology care and patient friendly materials for high risk oncology patients. The investigators primary clinical endpoint will be health related quality of life, specifically focusing on measures of anxiety, depression, and well-being.
Secondary personalized palliative care outcomes are expected to include:
- Reduced deviations from care plan as captured in the medical record compared to the group who did not receive early, integrated palliative care services
- Reduced hospital utilization compared to the group who did not receive early, integrated palliative care services
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palliative Care + Standard of Care | Experimental | Other: Palliative CareConsenting patients will be approached by a research nurse to complete quality of life questionnaires (baseline measures) either in the oncology clinics or infusion clinics. Patients assigned to early palliative care will meet with a member of the palliative care team after enrollment and completion of the initial questionnaires to receive and review patient-oriented materials detailing palliative care services. Patients will then receive a comprehensive initial consult with a palliative care provider (a trained physician, nurse or nurse practitioner). Additional consults with the palliative care service will be scheduled approximately every 6 weeks for the duration of the study period (one year) at the discretion of the patient and palliative care provider. |
| Standard of Care | No intervention | –Patients will receive standard care from their oncologist. An assessment of health related quality of life will be conducted at regular oncology clinic visits at baseline and 3,6,9,and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Adults with newly diagnosed pancreatic, hepatocellular, esophageal, or stomach cancer
- Upcoming scheduled oncology clinic visit (2nd visit to the clinic) at Vanderbilt
- Ability to read and respond to questions in English
- Permission of oncology physician
Key exclusion criteria (2 listed)
- -Receiving oncology care at non-Vanderbilt sites (to ensure appropriate follow-up)
- Participation in another clinical trial
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 |
|---|---|---|
| Palliative CareAlso: Support CareComponents of the palliative care service intervention are expected to include: * Establishment of a palliative care plan * Care coordination by palliative care team * Informational, patient friendly materials supporting Palliative Care * Communication by palliative care team to all providers and teams involved in patient's care * Systematic collection of information, including identification of surrogate or health care proxy and advance care planning * Questionnaires capturing health related quality of life at regular intervals throughout the intervention period | Other | Palliative Care + Standard of Care |
Primary outcome
Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire
Time frame: 1 year
The FACT Measurement System is a group of questions which measure health-related quality of life (QOL) in cancer patients. The FACT-G is a 26-item version that addresses multiple QOL dimensions including physical well-being, functional well-being, emotional well-being and social well-being. The response format of the FACT Measurement System consists of a 5-point Likert scale.
3 secondary outcomes
PROMIS Depression Scale
Time frame: 1 year
PROMIS Anxiety Scale
Time frame: 1 year
Hospitalizations
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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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.
Gordon Bernard, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care in people with Quality of Life, run by Vanderbilt University at 1 site 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 2 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: withdrawn, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Functional Assessment of Cancer Therapy: General (FACT-G) Health Related Quality of Life Questionnaire (time frame: 1 year). 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 11 Dec 2015.