Advanced Pancreatic CancerSCI-PNCT01885884
Supportive Care Intervention-Pancreas
A study testing Embedded Supportive Care in people with Advanced Pancreatic Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Embedded Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 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
- Patients:
- Adults (≥ 18 years old)
- Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
- Planning to receive continued care from an oncologist at the Hillman Cancer Center
- Accompanied by a caregiver (family member or friend) at the first visit
Show all 9Show fewer
- Caregivers:
- Adults (>= 18 years old)
- Family member or friend of an eligible patient
Who cannot join
- Patients:
- Unable to read and respond to questions in English
- Not planning to receive continued care from an oncologist at the Hillman Cancer Center
- Pancreatic neuroendocrine cancer
- Caregivers:
- Unable to read and respond to questions in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers. Patients will be randomized to receive either the supportive care intervention or usual care. The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Embedded Supportive Care
- Keywords
- Supportive Care, Palliative Care, Pancreatic Cancer, Embedded, coordinated model of supportive care within oncology care, Patient and Caregiver support
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embedded Supportive CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care Intervention | Experimental | Monthly (minimum) patient \& caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers). Receives: Behavioral: Embedded Supportive Care |
| Usual Care | No intervention | Participants will receive standard oncology care from their oncology providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
trial feasibility
We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.
Measured: up to 2 years
acceptability of intervention participation
We will report the percentage of patients and caregivers who found the intervention acceptable.
Measured: 3 months (+/- 3 weeks) from patient enrollment
intervention fidelity
We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
Measured: Up to 2 years
perceived effectiveness
We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.
Measured: 3 months (+/- 3 weeks) from patient enrollment
Secondary outcomes (3)
change in patient quality of life
We will summarize range and distribution of change in patient quality of life from baseline to 3 months using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep). Because this is a pilot trial, we will not conduct formal tests of efficacy.
Measured: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
patient healthcare utilization
We will summarize range and distribution of the following patient healthcare utilization outcomes: number and types of chemotherapy regimens, frequency and timing of chemotherapy regimens, number and length (days) of hospital admissions, number and length (days) of ICU admissions, number of emergency department visits, frequency and timing (days before death) of hospice use, place of death. Because this is a pilot trial, we will not conduct formal tests of efficacy.
Measured: up to 2 years
patient quality of life
We will summarize range and distribution of patient quality of life at 3 months using the FACT-Hep scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.
Measured: 3 months (+/- 3 weeks) from patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Schenker, MD, MAS, University of Pittsburgh
- Investigators
- Yael Schenker, MD, MAS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885884
- Sponsor's protocol ID
- PRO13020507
- Acronym
- SCI-P
- Status last verified
- May 2016
- First submitted
- 7 Jun 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01885884
- Acronym / sponsor ID
- SCI-P / PRO13020507
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- Supportive Care, Palliative Care, Pancreatic Cancer, Embedded, coordinated model of supportive care within oncology care, Patient and Caregiver support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jun 2013 (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.
This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer. We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers. Patients will be randomized to receive either the supportive care intervention or usual care. The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Care Intervention | Experimental | Behavioral: Embedded Supportive CareMonthly (minimum) patient \& caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers). |
| Usual Care | No intervention | –Participants will receive standard oncology care from their oncology providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients:
- Caregivers:
Key exclusion criteria (6 listed)
- Patients:
- Caregivers:
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 |
|---|---|---|
| Embedded Supportive Care | Behavioural | Supportive Care Intervention |
Primary outcome
trial feasibility
Time frame: up to 2 years
We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.
acceptability of intervention participation
Time frame: 3 months (+/- 3 weeks) from patient enrollment
We will report the percentage of patients and caregivers who found the intervention acceptable.
intervention fidelity
Time frame: Up to 2 years
We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
perceived effectiveness
Time frame: 3 months (+/- 3 weeks) from patient enrollment
We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.
3 secondary outcomes
change in patient quality of life
Time frame: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
patient healthcare utilization
Time frame: up to 2 years
patient quality of life
Time frame: 3 months (+/- 3 weeks) from patient enrollment
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 12 May 2016.
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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.
Yael Schenker, MD, MAS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embedded Supportive Care in people with Advanced Pancreatic Cancer, run by University of Pittsburgh 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 9 inclusion and 6 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 12 May 2016. 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 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?
trial feasibility (time frame: up to 2 years). The study lists 4 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 12 May 2016; AzTrials last refreshed its copy on 27 Oct 2026.