Ovarian Cancer Patient-Centered Decision Aid

Stage III Ovarian Cancer Clinical Trial

— PCOA  

Official title:

Ovarian Cancer Patient-Centered Decision Aid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259699
• Other study ID #: PCORI CE-12-11-4755
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: March 2019
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Stage III Ovarian Cancer

Intervention

Other:
• Decision Aid
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.

Locations

Country	Name	City	State
United States	University of California	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process Outcome - Satisfaction With PCOA Aid	Usability and acceptability of PCOA data will be gathered only from the intervention arm. The usability and acceptability of the PCOA program will be determined both through objective data gathered as patients use the application, and through subjective data gathered through a short, self-report survey that will appear on the PCOA application at the end of the session.	at treatment initiation
Primary	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.	at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)
Primary	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.	At treatment completion (T3) and 9 months post enrollment (T4)
Secondary	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.	at treatment initiation (T1)
Secondary	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.	at treatment completion (T3) and 9 months post enrollment (T4)
Secondary	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.	at treatment completion (T3) and 9 months post enrollment (T4)