Stage III Ovarian CancerPCOANCT02259699
Ovarian Cancer Patient-Centered Decision Aid
A study testing Decision Aid in people with Stage III Ovarian Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
The objective of this study is to develop and test a new decision aid -named Patient Centered Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on their own preferences and personal… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Stage III Ovarian Cancer
- What is being tested?
- Decision Aid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RCT participants will include stage III optimally debulked advanced ovarian cancer patients from urban and rural regions of the country, who will be randomized to either our patient-centered decision-aid or the usual care control arm
Who cannot join
- By the nature of the neoplasm under study, gender specific (ovarian cancer), only female patients will be included
- Patient enrollment will include women from all English speaking ethnic groups
- -> the age of 21
- All minority ovarian cancer survivors will be eligible
- Women under age 21 will not be included in this study because it is not common to be diagnosed with advanced epithelial ovarian cancer in females under age 21
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to develop and test a new decision aid -named Patient Centered Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on their own preferences and personal clinical characteristics, described in terms that are meaningful to them. To accomplish this, the investigators will 1)develop the PCOA, a patient- and provider-friendly decision aid and 2)test the effectiveness of PCOA through a randomized controlled trial (RCT).
The investigators hypothesize that PCOA will be significantly better than usual care, resulting in patients reporting more satisfaction with their treatment decision, less decision regret, better quality of life, and more satisfaction with their care compared with similar patients not having access to PCOA. If these hypotheses are substantiated, patients and providers will have an improved model for communication and decision making, leading to better patient outcomes.
Read the detailed description
Ovarian cancer is typically diagnosed at an advanced stage and carries the highest fatality-to-case ratio of all gynecologic malignancies diagnosed in the United States. Arguably the most effective treatment regimen to date is provided through intraperitoneal (IP) chemotherapy delivery, together with intravenous (IV) chemotherapy, which in the most recent phase III randomized trial conferred the longest median survival (65.6 months) ever reported in advanced ovarian cancer, compared to 49.7 months in the IV-only treatment arm. However, during active treatment, patients randomized to the IP therapy group reported significantly worse quality of life (QOL), and more treatment-related toxicities. In short, women are less likely to die if they receive an IP component to their chemotherapy, a finding that was underscored by an NCI Clinical Alert. However, there may be greater toxicity with IP treatment. The tradeoff between short-term reduced QOL and longer survival is difficult for patients to understand and then incorporate meaningfully into their decision-making process. In fact, for reasons that are not entirely clear, many patients are not offered IP therapy. Patient-centered care requires that they be given the opportunity to participate in treatment decision-making.
- Conditions
- Stage III Ovarian Cancer
- Being tested
- Decision Aid
- Keywords
- Ovarian Cancer, Intraperitoneal chemotherapy, Intravenous chemotherapy, decision making
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
Also called Patient Centered Outcome Aid (PCOA)
PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid (PCOA) | Experimental | PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options. Receives: Other: Decision Aid |
| UC (Standard care) | No intervention | Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With Decision
Satisfaction with Decision scale (SWD) is a 6-item scale measuring satisfaction with health care decisions, developed and validated in the context of women making decisions about hormone replacement therapy, and subsequently validated in adults with depression making decisions about treatment. The scale has good internal consistency reliability (alpha = 0.85), evidence of construct validity, relevance to designing and assessing patient-centered decision support interventions, and is sensitive to changes in information in trials of decision aids. The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.
Measured: at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)
Decisional Regret
The Decision Regret Scale is a 5-item scale which is a reliable and valid indicator of health care decision regret at a given point in time, with excellent psychometric properties. In this study, the question stem will ask "about the decision you made about selecting IP/IV treatment." Total scores were linearly transformed to a 0-100 scale. The lowest possible score, 0, means no regret. The highest possible score, 100, means high regret. This outcome will be measured from T2 - T4, but is not appropriate to ask at the time of the T1 assessment, which is just after the treatment decision has been made, but prior to treatment delivery. Use of this measure will allow us to evaluate whether the PCOA, compared to usual care, helps to reduce regret during and after cancer treatment.
Measured: At treatment completion (T3) and 9 months post enrollment (T4)
Secondary outcomes (3)
Shared Decision Making
The 9-item Shared Decision Making Questionnaire (SDM-Q-9) was developed and psychometrically tested for use in clinical encounters. It has strong reliability and validity, and use is advocated in studies investigating the effectiveness of interventions aimed at implementing shared decision-making. The question stem indicated the medical decision (IP/IV) with 6 levels of agreement from 'completely disagree to completely agree' (e.g., "My doctor and I selected a treatment option together"). Total scores were linearly transformed to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. SDM was assessed at T1 only, since this was the most proximal in time to when the decision was made.
Measured: at treatment initiation (T1)
Satisfaction With Care (EORTC) Overall Quality Rating
Satisfaction with Care was measured using the EORTC IN-PATSAT32, which assessed cancer patients' appraisal of doctors and nurses, as well as aspects of care organization and services. The measure also discriminated between cancer patients with different care expectations. Scores from these 32 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction. This measure has excellent internal consistency and convergent validity, although some scales are highly correlated. Test-retest reliability is acceptable.
Measured: at treatment completion (T3) and 9 months post enrollment (T4)
Cancer Therapy Satisfaction
While the EORTC IN-PATSAT32, assessed cancer patients' appraisal of doctors, nurses, and services, the Satisfaction with Cancer Treatment Questionnaire assessed patients' satisfaction specifically with their most recent therapy (i.e. IV or pills). The scale contained 21 items assessing seven domains. Total scores were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with their most recent therapy.
This has been validated on adults with many cancer types and treatments.
Measured: at treatment completion (T3) and 9 months post enrollment (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startDec 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage III Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Lari Wenzel, University of California, Irvine
- Investigators
- Lari Wenzel, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259699
- Sponsor's protocol ID
- PCORI CE-12-11-4755
- Acronym
- PCOA
- Status last verified
- Mar 2019
- First submitted
- 15 May 2014
- Last updated
- 10 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Cancer Patient-Centered Decision Aid
- ClinicalTrials.gov ID
- NCT02259699
- Acronym / sponsor ID
- PCOA / PCORI CE-12-11-4755
- Conditions
- Stage III Ovarian Cancer
- Keywords
- Ovarian Cancer, Intraperitoneal chemotherapy, Intravenous chemotherapy, decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Dec 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to develop and test a new decision aid -named Patient Centered Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on their own preferences and personal clinical characteristics, described in terms that are meaningful to them. To accomplish this, the investigators will 1)develop the PCOA, a patient- and provider-friendly decision aid and 2)test the effectiveness of PCOA through a randomized controlled trial (RCT).
The investigators hypothesize that PCOA will be significantly better than usual care, resulting in patients reporting more satisfaction with their treatment decision, less decision regret, better quality of life, and more satisfaction with their care compared with similar patients not having access to PCOA. If these hypotheses are substantiated, patients and providers will have an improved model for communication and decision making, leading to better patient outcomes.
Detailed description
Ovarian cancer is typically diagnosed at an advanced stage and carries the highest fatality-to-case ratio of all gynecologic malignancies diagnosed in the United States. Arguably the most effective treatment regimen to date is provided through intraperitoneal (IP) chemotherapy delivery, together with intravenous (IV) chemotherapy, which in the most recent phase III randomized trial conferred the longest median survival (65.6 months) ever reported in advanced ovarian cancer, compared to 49.7 months in the IV-only treatment arm. However, during active treatment, patients randomized to the IP therapy group reported significantly worse quality of life (QOL), and more treatment-related toxicities. In short, women are less likely to die if they receive an IP component to their chemotherapy, a finding that was underscored by an NCI Clinical Alert. However, there may be greater toxicity with IP treatment. The tradeoff between short-term reduced QOL and longer survival is difficult for patients to understand and then incorporate meaningfully into their decision-making process. In fact, for reasons that are not entirely clear, many patients are not offered IP therapy. Patient-centered care requires that they be given the opportunity to participate in treatment decision-making.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid (PCOA) | Experimental | Other: Decision AidPCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options. |
| UC (Standard care) | No intervention | –Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- RCT participants will include stage III optimally debulked advanced ovarian cancer patients from urban and rural regions of the country, who will be randomized to either our patient-centered decision-aid or the usual care control arm
Key exclusion criteria (5 listed)
- By the nature of the neoplasm under study, gender specific (ovarian cancer), only female patients will be included
- Patient enrollment will include women from all English speaking ethnic groups
- -> the age of 21
- All minority ovarian cancer survivors will be eligible
- Women under age 21 will not be included in this study because it is not common to be diagnosed with advanced epithelial ovarian cancer in females under age 21
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 |
|---|---|---|
| Decision AidAlso: Patient Centered Outcome Aid (PCOA)PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options. | Other | Decision Aid (PCOA) |
Primary outcome
Satisfaction With Decision
Time frame: at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)
Satisfaction with Decision scale (SWD) is a 6-item scale measuring satisfaction with health care decisions, developed and validated in the context of women making decisions about hormone replacement therapy, and subsequently validated in adults with depression making decisions about treatment. The scale has good internal consistency reliability (alpha = 0.85), evidence of construct validity, relevance to designing and assessing patient-centered decision support interventions, and is sensitive to changes in information in trials of decision aids. The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.
Decisional Regret
Time frame: At treatment completion (T3) and 9 months post enrollment (T4)
The Decision Regret Scale is a 5-item scale which is a reliable and valid indicator of health care decision regret at a given point in time, with excellent psychometric properties. In this study, the question stem will ask "about the decision you made about selecting IP/IV treatment." Total scores were linearly transformed to a 0-100 scale. The lowest possible score, 0, means no regret. The highest possible score, 100, means high regret. This outcome will be measured from T2 - T4, but is not appropriate to ask at the time of the T1 assessment, which is just after the treatment decision has been made, but prior to treatment delivery. Use of this measure will allow us to evaluate whether the PCOA, compared to usual care, helps to reduce regret during and after cancer treatment.
3 secondary outcomes
Shared Decision Making
Time frame: at treatment initiation (T1)
Satisfaction With Care (EORTC) Overall Quality Rating
Time frame: at treatment completion (T3) and 9 months post enrollment (T4)
Cancer Therapy Satisfaction
Time frame: at treatment completion (T3) and 9 months post enrollment (T4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Lari Wenzel, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Stage III Ovarian Cancer, run by University of California, Irvine 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 1 inclusion and 5 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 10 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Satisfaction With Decision (time frame: at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)). 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 10 Jun 2019.