Trial Outcomes & Findings for Ovarian Cancer Patient-Centered Decision Aid (NCT NCT02259699)
NCT ID: NCT02259699
Last Updated: 2019-06-10
Results Overview
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.
COMPLETED
NA
124 participants
at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)
2019-06-10
Participant Flow
Participant milestones
| Measure |
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.
|
UC (Standard Care)
Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
60
|
|
Overall Study
COMPLETED
|
37
|
40
|
|
Overall Study
NOT COMPLETED
|
27
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ovarian Cancer Patient-Centered Decision Aid
Baseline characteristics by cohort
| Measure |
Decision Aid (PCOA)
n=64 Participants
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.
|
UC (Standard Care)
n=60 Participants
Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)Population: Includes 63 PCOA and 56 UC with complete data
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.
Outcome measures
| Measure |
Decision Aid (PCOA)
n=63 Participants
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.
|
UC (Standard Care)
n=56 Participants
Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
|
|---|---|---|
|
Satisfaction With Decision
T1
|
85.3 transformed scale score
Standard Error 2.0
|
86.9 transformed scale score
Standard Error 2.1
|
|
Satisfaction With Decision
T3
|
85.8 transformed scale score
Standard Error 2.1
|
91.5 transformed scale score
Standard Error 2.0
|
|
Satisfaction With Decision
T4
|
87.1 transformed scale score
Standard Error 2.4
|
90.6 transformed scale score
Standard Error 2.3
|
PRIMARY outcome
Timeframe: At treatment completion (T3) and 9 months post enrollment (T4)Population: Includes 48 PCOA and 52 UC with complete data at T3
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.
Outcome measures
| Measure |
Decision Aid (PCOA)
n=48 Participants
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.
|
UC (Standard Care)
n=52 Participants
Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
|
|---|---|---|
|
Decisional Regret
T3
|
16.6 transformed scale score
Standard Error 2.0
|
11.7 transformed scale score
Standard Error 1.9
|
|
Decisional Regret
T4
|
15.4 transformed scale score
Standard Error 2.6
|
15.0 transformed scale score
Standard Error 2.5
|
SECONDARY outcome
Timeframe: at treatment initiation (T1)Population: Includes 63 PCOA and 56 UC with complete data
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.
Outcome measures
| Measure |
Decision Aid (PCOA)
n=63 Participants
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.
|
UC (Standard Care)
n=56 Participants
Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
|
|---|---|---|
|
Shared Decision Making
|
79.5 tansformed scale score
Standard Error 2.2
|
78.7 tansformed scale score
Standard Error 2.6
|
SECONDARY outcome
Timeframe: at treatment completion (T3) and 9 months post enrollment (T4)Population: Includes 48 PCOA and 52 UC with complete data at T3
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.
Outcome measures
| Measure |
Decision Aid (PCOA)
n=48 Participants
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.
|
UC (Standard Care)
n=52 Participants
Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
|
|---|---|---|
|
Satisfaction With Care (EORTC) Overall Quality Rating
T3
|
84.4 tansformed scale score
Standard Error 3.0
|
90.9 tansformed scale score
Standard Error 1.9
|
|
Satisfaction With Care (EORTC) Overall Quality Rating
T4
|
82.4 tansformed scale score
Standard Error 3.5
|
86.9 tansformed scale score
Standard Error 3.0
|
SECONDARY outcome
Timeframe: at treatment completion (T3) and 9 months post enrollment (T4)Population: Includes 48 PCOA and 52 UC with complete data at T3
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.
Outcome measures
| Measure |
Decision Aid (PCOA)
n=48 Participants
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.
|
UC (Standard Care)
n=52 Participants
Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
|
|---|---|---|
|
Cancer Therapy Satisfaction
T3
|
81.9 tansformed scale score
Standard Error 1.9
|
85.8 tansformed scale score
Standard Error 2.1
|
|
Cancer Therapy Satisfaction
T4
|
83.0 tansformed scale score
Standard Error 2.4
|
81.9 tansformed scale score
Standard Error 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at treatment initiationUsability 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.
Outcome measures
| Measure |
Decision Aid (PCOA)
n=52 Participants
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.
|
UC (Standard Care)
Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
|
|---|---|---|
|
Process Outcome - Satisfaction With PCOA Aid
Very satisfied
|
17 Participants
|
—
|
|
Process Outcome - Satisfaction With PCOA Aid
Quite a bit satisfied
|
19 Participants
|
—
|
|
Process Outcome - Satisfaction With PCOA Aid
Somewhat satisfied
|
15 Participants
|
—
|
|
Process Outcome - Satisfaction With PCOA Aid
A little bit satisfied
|
1 Participants
|
—
|
|
Process Outcome - Satisfaction With PCOA Aid
Not at all satisfied
|
0 Participants
|
—
|
Adverse Events
Decision Aid (PCOA)
UC (Standard Care)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place