Platinum-resistant Ovarian CancerNCT02090582
H.O.P.E: Helping Ovarian Cancer Patients Cope
A study testing Structured Palliative Care in people with Platinum-resistant Ovarian Cancer and Recurrent Ovarian Cancer, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to test the effect of the gynecologic oncologists with palliative care specialist collaboration (GO-PC) intervention on patient quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Platinum-resistant Ovarian Cancer, Recurrent Ovarian Cancer, Palliative Care
- What is being tested?
- Structured Palliative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2014to 30 Apr 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Platinum-resistant ovarian cancer or recurrent ovarian cancer
- Ability to read and respond to questions in English
Who cannot join
- Platinum-sensitive recurrent ovarian cancer without a significant clinical event
- Existence of co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence
The purpose of this study is to test the effect of the gynecologic oncologists with palliative care specialist collaboration (GO-PC) intervention on patient quality of life.
Read the detailed description
Eligible patients include women diagnosed with platinum-resistant ovarian cancer or recurrent ovarian cancer cancer. All patient participants will complete two quality of life (QOL) questionnaires and a cost-diary documenting their health care experience at time of consent and every 12 weeks thereafter. Consenting care givers will also be asked to complete two questionnaires to asses the impact of structured palliative care on them every 12 weeks.
Patients will be assigned to two arms randomly: 1) usual care or 2) structured palliative care. The primary endpoint is quality of life. A two-sided Chi-square test will be used to compare the proportion of patients who have improved quality of life after treatment between control arm and intervention arm. The average value of multiple scores after treatment will be used to compare with the baseline score before treatment for each question in the standard questionnaire.
- Being tested
- Structured Palliative Care, Usual Care
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Palliative CareOther
Structured palliative care approach, defined as the gynecologic oncology team performing comprehensive symptom assessment with the Quality Data Collection Tool Palliative Care (QDACT-PC) and providing interventions based on National Comprehensive Cancer Network (NCCN) guidelines. Symptom scores above the acceptable threshold in the QDACT-PC tool that occur after two consecutive visits will automatically trigger palliative care consultation.
Usual CareOther
Usual care described as current practice by the gynecologic oncology team with referral to PC specialist at provider discretion or at the request of the patient or their families.
| Study group | Role | What they receive |
|---|---|---|
| Structured Palliative Care | Other | Not described Receives: Other: Structured Palliative Care |
| Usual Care | Other | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (Functional Assessment of Cancer Therapy for Ovarian Cancer and Functional Assessment of Chronic Illness Therapy for Palliative Care)
A combined FACT-O and FACIT-PAL (version 4)16 will be administered at baseline and 12 week intervals on all subjects. The FACT Measurement System is a validated group of questions that measure health-related QOL in cancer patients. Both questionnaires have identical questions for physical well-being, functional well-being, emotional well-being, and social well-being. The additional subscales of the FACT-O and FACIT-PAL will be combined to provide a comprehensive quality of life assessment specific to ovarian cancer and palliative care.
Measured: Every 12 weeks for a maximum of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula S Lee, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090582
- Sponsor's protocol ID
- Pro00052239
- Status last verified
- May 2020
- First submitted
- 4 Mar 2014
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence
- ClinicalTrials.gov ID
- NCT02090582
- Acronym / sponsor ID
- Pro00052239
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 18 Mar 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 study is to test the effect of the gynecologic oncologists with palliative care specialist collaboration (GO-PC) intervention on patient quality of life.
Detailed description
Eligible patients include women diagnosed with platinum-resistant ovarian cancer or recurrent ovarian cancer cancer. All patient participants will complete two quality of life (QOL) questionnaires and a cost-diary documenting their health care experience at time of consent and every 12 weeks thereafter. Consenting care givers will also be asked to complete two questionnaires to asses the impact of structured palliative care on them every 12 weeks.
Patients will be assigned to two arms randomly: 1) usual care or 2) structured palliative care. The primary endpoint is quality of life. A two-sided Chi-square test will be used to compare the proportion of patients who have improved quality of life after treatment between control arm and intervention arm. The average value of multiple scores after treatment will be used to compare with the baseline score before treatment for each question in the standard questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Palliative Care | Other | Other: Structured Palliative Care |
| Usual Care | Other | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Platinum-resistant ovarian cancer or recurrent ovarian cancer
- Ability to read and respond to questions in English
Key exclusion criteria (2 listed)
- Platinum-sensitive recurrent ovarian cancer without a significant clinical event
- Existence of co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol
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 |
|---|---|---|
| Structured Palliative CareStructured palliative care approach, defined as the gynecologic oncology team performing comprehensive symptom assessment with the Quality Data Collection Tool Palliative Care (QDACT-PC) and providing interventions based on National Comprehensive Cancer Network (NCCN) guidelines. Symptom scores above the acceptable threshold in the QDACT-PC tool that occur after two consecutive visits will automatically trigger palliative care consultation. | Other | Structured Palliative Care |
| Usual CareUsual care described as current practice by the gynecologic oncology team with referral to PC specialist at provider discretion or at the request of the patient or their families. | Other | Usual Care |
Primary outcome
Quality of Life (Functional Assessment of Cancer Therapy for Ovarian Cancer and Functional Assessment of Chronic Illness Therapy for Palliative Care)
Time frame: Every 12 weeks for a maximum of 5 years
A combined FACT-O and FACIT-PAL (version 4)16 will be administered at baseline and 12 week intervals on all subjects. The FACT Measurement System is a validated group of questions that measure health-related QOL in cancer patients. Both questionnaires have identical questions for physical well-being, functional well-being, emotional well-being, and social well-being. The additional subscales of the FACT-O and FACIT-PAL will be combined to provide a comprehensive quality of life assessment specific to ovarian cancer and palliative care.
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 May 2020.
Related trials for Platinum-resistant Ovarian Cancer
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 2
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Ovarian Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 1
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Recurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma
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.
Paula S Lee, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Palliative Care in people with Platinum-resistant Ovarian Cancer and Recurrent Ovarian Cancer, run by Duke University 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 2 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 May 2020. 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?
Quality of Life (Functional Assessment of Cancer Therapy for Ovarian Cancer and Functional Assessment of Chronic Illness Therapy for Palliative Care) (time frame: Every 12 weeks for a maximum of 5 years). 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 May 2020.