Stage III Ovarian Cancer
Conditions
Keywords
Ovarian Cancer, Intraperitoneal chemotherapy, Intravenous chemotherapy, decision making
Brief 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.
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.
Interventions
OTHERDecision 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.
Sponsors
Patient-Centered Outcomes Research Institute
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Decision | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making | at treatment initiation (T1) | 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. |
| Satisfaction With Care (EORTC) Overall Quality Rating | at treatment completion (T3) and 9 months post enrollment (T4) | 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. |
| Cancer Therapy Satisfaction | at treatment completion (T3) and 9 months post enrollment (T4) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Process Outcome - Satisfaction With PCOA Aid | at treatment initiation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid (PCOA) 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. | 64 |
| UC (Standard Care) Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies. | 60 |
| Total | 124 |
Baseline characteristics
| Characteristic | UC (Standard Care) | Decision Aid (PCOA) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 20 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 44 Participants | 89 Participants |
| Age, Continuous | 58.2 years STANDARD_DEVIATION 8.8 | 58.1 years STANDARD_DEVIATION 11 | 58.1 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 60 Participants | 64 Participants | 124 Participants |
| Sex: Female, Male Female | 60 Participants | 64 Participants | 124 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: At treatment completion (T3) and 9 months post enrollment (T4)
Population: Includes 48 PCOA and 52 UC with complete data at T3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid (PCOA) | Decisional Regret | T3 | 16.6 transformed scale score | Standard Error 2 |
| Decision Aid (PCOA) | Decisional Regret | T4 | 15.4 transformed scale score | Standard Error 2.6 |
| UC (Standard Care) | Decisional Regret | T3 | 11.7 transformed scale score | Standard Error 1.9 |
| UC (Standard Care) | Decisional Regret | T4 | 15.0 transformed scale score | Standard Error 2.5 |
Comparison: Difference between arms at T3p-value: 0.087t-test, 2 sided
Comparison: Difference between arms at T4p-value: 0.91t-test, 2 sided
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.
Time frame: at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)
Population: Includes 63 PCOA and 56 UC with complete data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid (PCOA) | Satisfaction With Decision | T1 | 85.3 transformed scale score | Standard Error 2 |
| Decision Aid (PCOA) | Satisfaction With Decision | T3 | 85.8 transformed scale score | Standard Error 2.1 |
| Decision Aid (PCOA) | Satisfaction With Decision | T4 | 87.1 transformed scale score | Standard Error 2.4 |
| UC (Standard Care) | Satisfaction With Decision | T1 | 86.9 transformed scale score | Standard Error 2.1 |
| UC (Standard Care) | Satisfaction With Decision | T3 | 91.5 transformed scale score | Standard Error 2 |
| UC (Standard Care) | Satisfaction With Decision | T4 | 90.6 transformed scale score | Standard Error 2.3 |
Comparison: Difference between arms at T1p-value: 0.582t-test, 2 sided
Comparison: Difference between arms at T3p-value: 0.053t-test, 2 sided
Comparison: Difference between arms at T4p-value: 0.288t-test, 2 sided
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.
Time frame: at treatment completion (T3) and 9 months post enrollment (T4)
Population: Includes 48 PCOA and 52 UC with complete data at T3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid (PCOA) | Cancer Therapy Satisfaction | T3 | 81.9 tansformed scale score | Standard Error 1.9 |
| Decision Aid (PCOA) | Cancer Therapy Satisfaction | T4 | 83.0 tansformed scale score | Standard Error 2.4 |
| UC (Standard Care) | Cancer Therapy Satisfaction | T3 | 85.8 tansformed scale score | Standard Error 2.1 |
| UC (Standard Care) | Cancer Therapy Satisfaction | T4 | 81.9 tansformed scale score | Standard Error 3 |
Comparison: Difference between arms at T3p-value: 0.177t-test, 2 sided
Comparison: Difference between arms at T4p-value: 0.745t-test, 2 sided
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.
Time frame: at treatment completion (T3) and 9 months post enrollment (T4)
Population: Includes 48 PCOA and 52 UC with complete data at T3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Decision Aid (PCOA) | Satisfaction With Care (EORTC) Overall Quality Rating | T3 | 84.4 tansformed scale score | Standard Error 3 |
| Decision Aid (PCOA) | Satisfaction With Care (EORTC) Overall Quality Rating | T4 | 82.4 tansformed scale score | Standard Error 3.5 |
| UC (Standard Care) | Satisfaction With Care (EORTC) Overall Quality Rating | T3 | 90.9 tansformed scale score | Standard Error 1.9 |
| UC (Standard Care) | Satisfaction With Care (EORTC) Overall Quality Rating | T4 | 86.9 tansformed scale score | Standard Error 3 |
Comparison: Difference between arms at T3p-value: 0.071t-test, 2 sided
Comparison: Difference between arms at T4p-value: 0.332t-test, 2 sided
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.
Time frame: at treatment initiation (T1)
Population: Includes 63 PCOA and 56 UC with complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid (PCOA) | Shared Decision Making | 79.5 tansformed scale score | Standard Error 2.2 |
| UC (Standard Care) | Shared Decision Making | 78.7 tansformed scale score | Standard Error 2.6 |
p-value: 0.807t-test, 2 sided
Other Pre-specified
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.
Time frame: at treatment initiation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid (PCOA) | Process Outcome - Satisfaction With PCOA Aid | Very satisfied | 17 Participants |
| Decision Aid (PCOA) | Process Outcome - Satisfaction With PCOA Aid | Quite a bit satisfied | 19 Participants |
| Decision Aid (PCOA) | Process Outcome - Satisfaction With PCOA Aid | Somewhat satisfied | 15 Participants |
| Decision Aid (PCOA) | Process Outcome - Satisfaction With PCOA Aid | A little bit satisfied | 1 Participants |
| Decision Aid (PCOA) | Process Outcome - Satisfaction With PCOA Aid | Not at all satisfied | 0 Participants |