Hepatocellular CarcinomaCaSSYNCT01640522
Comprehensive Electronic Cancer Support System for the Treatment of Cancer Related Symptoms
A study testing Collaborative Care in people with Hepatocellular Carcinoma and Primary Liver Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Primary Liver Cancer, Bile Duct Cancer
- What is being tested?
- Collaborative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy, radiological, and/or biological evidence of hepatobiliary carcinoma
- age 18 years or older
- fluency in English. Exclusion criteria included:
Who cannot join
- current suicidal or homicidal ideation
- current psychosis or thought disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma
The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.
Read the detailed description
The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.
- Conditions
- Hepatocellular Carcinoma, Primary Liver Cancer, Bile Duct Cancer, Pancreatic Cancer, Gallbladder Cancer, Colorectal Carcinoma
- Being tested
- Collaborative Care, Enhanced usual Care
- Keywords
- Hepatocellular carcinoma, Cholangio carcinoma, Primary Liver Cancer, Bile Duct CancerPancreatic Cancer, Gallbladder Cancer, Colorectal Carcinoma, Other Primary Cancers with Liver Metastases
- Medical subject headings
- Carcinoma, Hepatocellular, Bile Duct Neoplasms, Pancreatic Neoplasms, Gallbladder Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareOther
Collaborative care intervention to manage cancer-related symptoms
Enhanced usual CareOther
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care Intervention | Experimental | Care coordinator facilitates the assessment and treatment of cancer-related symptoms Receives: Other: Collaborative Care |
| Enhanced Usual Care | Active comparator | Upon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated Receives: Other: Enhanced usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Center for Epidemiological Studies-Depression scale
Measured: Change from baseline at 6 and 12 months
Secondary outcomes (1)
Fatigue
Functional Assessment of Cancer Therapy-Fatigue
Measured: Change from baseline at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Model description
- Intervention versus standard of care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jennifer Steel, University of Pittsburgh
- Investigators
- Jennifer L Steel, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640522
- Sponsor's protocol ID
- PRO07050143
- Other IDs
- K07CA118576
- Acronym
- CaSSY
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2010
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Controlled Trial of a Collaborative Care Intervention to Manage Cancer Related Symptoms in Patients Diagnosed With Hepatobiliary Carcinoma
- ClinicalTrials.gov ID
- NCT01640522
- Acronym / sponsor ID
- CaSSY / PRO07050143
- Conditions
- Hepatocellular Carcinoma, Primary Liver Cancer, Bile Duct Cancer, Pancreatic Cancer, Gallbladder Cancer, Colorectal Carcinoma
- Keywords
- Hepatocellular carcinoma, Cholangio carcinoma, Primary Liver Cancer, Bile Duct CancerPancreatic Cancer, Gallbladder Cancer, Colorectal Carcinoma, Other Primary Cancers with Liver Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jul 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.
The purpose of this study is to test the efficacy of a collaborative care intervention to manage cancer-related symptoms and improve health related quality of life in patients diagnosed with hepatobiliary carcinoma.
Detailed description
The study is a collaborative care intervention designed to reduce pain, fatigue, and depressive symptoms and improve overall health related quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention versus standard of care
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care Intervention | Experimental | Other: Collaborative CareCare coordinator facilitates the assessment and treatment of cancer-related symptoms |
| Enhanced Usual Care | Active comparator | Other: Enhanced usual CareUpon evaluation of symptoms the patient will be referred for further assessment or treatment if indicated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- biopsy, radiological, and/or biological evidence of hepatobiliary carcinoma
- age 18 years or older
- fluency in English. Exclusion criteria included:
Key exclusion criteria (2 listed)
- current suicidal or homicidal ideation
- current psychosis or thought disorder
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 |
|---|---|---|
| Collaborative CareCollaborative care intervention to manage cancer-related symptoms | Other | Collaborative Care Intervention |
| Enhanced usual Care | Other | Enhanced Usual Care |
Primary outcome
Depression
Time frame: Change from baseline at 6 and 12 months
Center for Epidemiological Studies-Depression scale
1 secondary outcome
Fatigue
Time frame: Change from baseline at 6 and 12 months
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 13 Dec 2024.
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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.
Jennifer L Steel, Ph.D. 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 Collaborative Care in people with Hepatocellular Carcinoma and Primary Liver 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 3 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: finished, as of the sponsor's last update on 13 Dec 2024. 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?
Depression (time frame: Change from baseline at 6 and 12 months). 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 13 Dec 2024.