Recurrent Ovarian Epithelial CancerNCT01927393
Palliative Care in Improving Quality of Life and Symptoms in Patients With Stage III-IV Pancreatic or Ovarian Cancer
A study testing palliative care, educational intervention and quality-of-life assessment in people with Recurrent Ovarian Epithelial Cancer and Recurrent Ovarian Germ Cell Tumor, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Pancreatic Cancer
- What is being tested?
- palliative care, educational intervention and quality-of-life assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Oct 2017
- 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
- Diagnosis of pancreatic or ovarian cancer
- Confirmed stage III or IV disease
- Patients who are within one year from initial diagnosis
- Able to read or understand English-this is included because most of the patient-reported outcome measures are not validated in linguistically diverse populations; the intent is to adapt and test the intervention in a future study with linguistically diverse populations
- Ability to read and/or understand the study protocol requirements, and provide written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers
This randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably.
Read the detailed description
PRIMARY OBJECTIVES:
- Test the effects of a concurrent palliative care planning intervention (PCPI) on overall quality of life (QOL) and symptom burden.
II. Test the effects of a concurrent PCPI on anxiety and depression. III. Test the effects of a concurrent PCPI on overall survival. IV. Test the effects of a concurrent PCPI on health care resource use.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.
ARM II: Patients receive standard care plus attention comprising two telephone contacts.
After completion of study, patients are followed up at 1, 3, and 6 months.
- Conditions
- Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IIIA Ovarian Epithelial Cancer, Stage IIIA Ovarian Germ Cell Tumor
- Being tested
- palliative care, educational intervention, quality-of-life assessment, questionnaire administration, telephone-based intervention
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palliative careOther
Receive PCPI
educational interventionBehavioural
Also called intervention, educational
Receive education sessions
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
telephone-based interventionBehavioural
Receive telephone contacts
| Study group | Role | What they receive |
|---|---|---|
| Arm I (PCPI) | Experimental | Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions. Receives: Other: palliative care; Behavioral: educational intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm II (standard care plus attention control) | Active comparator | Patients receive standard care plus attention comprising two telephone contacts. Receives: Procedure: quality-of-life assessment; Other: questionnaire administration; Behavioral: telephone-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
The analysis will be a 2x2x3 repeated measures analysis of covariance (ANCOVA) statistical design.
Measured: Up to 6 months
Symptom burden using the FACT-Trial Outcome Index (TOI)
Compared between groups and by diagnoses using two-way contingency table analysis, two way analysis of variance (ANOVA) according to level of measurement.
Measured: Up to 6 months
Secondary outcomes (4)
Reduction in anxiety
Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. Tested using a 2x2 contingency table analysis and the McNemar test statistic.
Measured: Up to 6 months
Reduction in depression
Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables. Tested using a 2x2 contingency table analysis and the McNemar test statistic.
Measured: Up to 6 months
Overall survival
Compared demographically by group according to completeness of the intervention using t-tests or one-way ANOVAs according to the level of measurement of the variables.
Measured: At 6 months
Health care resource use including presence of advanced care planning, chemotherapy in the last 14 days of life, and length of time between hospice referral and death
Two way (2x2) ANOVAs will be conducted to test the differences between groups.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startDec 2014
- Primary completionOct 2017 (estimated)
Why it stopped: Study was not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian Epithelial CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- Virginia Sun, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927393
- Sponsor's protocol ID
- 13270
- Other IDs
- NCI-2013-01629, 13270, P30CA033572
- Status last verified
- Dec 2014
- First submitted
- 20 Aug 2013
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Palliative Care Planning in Pancreatic and Ovarian Cancers
- ClinicalTrials.gov ID
- NCT01927393
- Acronym / sponsor ID
- 13270
- Conditions
- Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IIIA Ovarian Epithelial Cancer, Stage IIIA Ovarian Germ Cell Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2014
- Primary completion
- Oct 2017 (estimated)
- First posted
- 22 Aug 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 randomized clinical trial studies palliative care in improving quality of life and symptoms in patients with stage III-IV pancreatic or ovarian cancer. Palliative therapy may help patients with advanced pancreatic or ovarian cancer live more comfortably.
Detailed description
PRIMARY OBJECTIVES:
- Test the effects of a concurrent palliative care planning intervention (PCPI) on overall quality of life (QOL) and symptom burden.
II. Test the effects of a concurrent PCPI on anxiety and depression. III. Test the effects of a concurrent PCPI on overall survival. IV. Test the effects of a concurrent PCPI on health care resource use.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions.
ARM II: Patients receive standard care plus attention comprising two telephone contacts.
After completion of study, patients are followed up at 1, 3, and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (PCPI) | Experimental | Other: palliative care, Behavioral: educational intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationPatients undergo a comprehensive physical, psychological, social, and spiritual palliative care assessment. Patients also receive a workbook that covers physical and psychological well-being and social and spiritual well-being, delivered over 2 educational sessions. |
| Arm II (standard care plus attention control) | Active comparator | Procedure: quality-of-life assessment, Other: questionnaire administration, Behavioral: telephone-based interventionPatients receive standard care plus attention comprising two telephone contacts. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of pancreatic or ovarian cancer
- Confirmed stage III or IV disease
- Patients who are within one year from initial diagnosis
- Able to read or understand English-this is included because most of the patient-reported outcome measures are not validated in linguistically diverse populations; the intent is to adapt and test the intervention in a future study with linguistically diverse populations
- Ability to read and/or understand the study protocol requirements, and provide written informed consent
Key exclusion criteria (0 listed)
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 careReceive PCPI | Other | Arm I (PCPI) |
| educational interventionAlso: intervention, educationalReceive education sessions | Behavioural | Arm I (PCPI) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (PCPI), Arm II (standard care plus attention control) |
| questionnaire administrationAncillary studies | Other | Arm I (PCPI), Arm II (standard care plus attention control) |
| telephone-based interventionReceive telephone contacts | Behavioural | Arm II (standard care plus attention control) |
Primary outcome
Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)
Time frame: Up to 6 months
The analysis will be a 2x2x3 repeated measures analysis of covariance (ANCOVA) statistical design.
Symptom burden using the FACT-Trial Outcome Index (TOI)
Time frame: Up to 6 months
Compared between groups and by diagnoses using two-way contingency table analysis, two way analysis of variance (ANOVA) according to level of measurement.
4 secondary outcomes
Reduction in anxiety
Time frame: Up to 6 months
Reduction in depression
Time frame: Up to 6 months
Overall survival
Time frame: At 6 months
Health care resource use including presence of advanced care planning, chemotherapy in the last 14 days of life, and length of time between hospice referral and death
Time frame: Up to 6 months
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 23 Dec 2014.
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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.
Virginia Sun principal investigator
City of Hope 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, educational intervention and quality-of-life assessment in people with Recurrent Ovarian Epithelial Cancer and Recurrent Ovarian Germ Cell Tumor, run by City of Hope Medical Center 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 5 inclusion and 0 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 23 Dec 2014. 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?
Overall QOL, assessed by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) or the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) (time frame: Up to 6 months). The study lists 2 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 23 Dec 2014.