Trial Outcomes & Findings for A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool (NCT NCT01840163)

NCT ID: NCT01840163

Last Updated: 2018-11-08

Results Overview

Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 537 participants
• Primary outcome timeframe: 4-5 weeks from date of enrollment
• Results posted on: 2018-11-08

Participant Flow

Participant milestones

Measure	CanSORT Online Tool (Intervention) Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
First Follow up -Primary Outcome STARTED	267	270
First Follow up -Primary Outcome COMPLETED	248	254
First Follow up -Primary Outcome NOT COMPLETED	19	16
Systemic Follow Up-secondary Outcome STARTED	265	266
Systemic Follow Up-secondary Outcome COMPLETED	174	191
Systemic Follow Up-secondary Outcome NOT COMPLETED	91	75

Reasons for withdrawal

Measure	CanSORT Online Tool (Intervention) Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
First Follow up -Primary Outcome Lost to Follow-up	19	16
Systemic Follow Up-secondary Outcome Lost to Follow-up	48	40
Systemic Follow Up-secondary Outcome excluded -DCIS not eligible	43	35

Baseline Characteristics

A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

Baseline characteristics by cohort

Measure	CanSORT Online Tool (Intervention) n=267 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=270 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool	Total n=537 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	208 Participants n=5 Participants	208 Participants n=7 Participants	416 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants	62 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Female	267 Participants n=5 Participants	270 Participants n=7 Participants	537 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	264 Participants n=5 Participants	265 Participants n=7 Participants	529 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants	44 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) White	211 Participants n=5 Participants	214 Participants n=7 Participants	425 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	267 participants n=5 Participants	270 participants n=7 Participants	537 participants n=5 Participants
Number of participants leaning towards a treatment option and felt sure about choice	178 Participants n=5 Participants	175 Participants n=7 Participants	353 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-5 weeks from date of enrollment

Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.

Outcome measures

Measure	CanSORT Online Tool (Intervention) n=251 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=245 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.	148 Participants	105 Participants

PRIMARY outcome

Timeframe: 4-5 weeks from date of enrollment

Self reported values were evaluated using a 5 item question set adapted from Decision Quality Instrument. The questions determined patient desire for outcomes such as keeping their natural breast and avoiding radiation on a scale from 0 to 10. Patients were classified as values-concordant if their actual treatment aligned with their values score predicted treatment and otherwise were classified as non-concordant. The binary values-concordance variable was modeled as a function of intervention effect using both unadjusted and adjusted logistic mixed model regression.

Outcome measures

Measure	CanSORT Online Tool (Intervention) n=251 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=245 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant	180 Participants	197 Participants

SECONDARY outcome

Timeframe: 4-5 weeks from date of enrollment

A 12 item decision preparedness scale asked whether the web intervention helped patients prepare for their treatment decision. Each item asked about a diefferent aspect of decision preparation, with responses of 'not at all'/'a little'/'somewhat'/'quite a bit'/'a great deal'. Each response was assigned a value of 1('not at all') to 5('a great deal'), with a high value representing a greater amount of preparedness. The values of all 12 items were combined using the arithmetic mean, to create a standardized scale ranging from 1(not at all) to 5 (a great deal). The decision making scale was modeled by linear mixed model to determine the effect intervention on patient preparation for decision making.

Outcome measures

Measure	CanSORT Online Tool (Intervention) n=251 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=245 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Patient Preparedness Decision Making for Locoregional Treatment.	3.9 units on a scale Standard Deviation 0.9	3.7 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 4-5 weeks from date of enrollment

Population: participants

A 4 item Breast Cancer Treatment Deliberation Scale asked how deliberative patients were in making their treatment decision. The items asked how often they performed deliberative activities with answers of 'not at all'/'a little'/'somewhat'/'quite a bit'/'a lot'. Each response was assigned a value of 1('not at all') to 5('a lot), with a high value representing a greater amount of deliberation. The values of all 4 items were combined using the arithmetic mean, to create a standardized scale ranging from 1 (not at all) to 5 (a lot). The deliberation scale was then modeled using linear mixed models to determine the effect of the intervention on patient deliberation.

Outcome measures

Measure	CanSORT Online Tool (Intervention) n=251 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=245 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Patient Deliberation for Locoregional Breast Cancer Treatment.	3.9 units on a scale Standard Deviation 0.8	3.7 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 4-5 weeks from date of enrollment

A 5 item subjective decision quality scale measured how satisfied patients were with their treatment decision. Patients were asked how well they agreed with 5 statements, with responses of 'not at all'/'a little bit'/'somewhat'/'quite a bit'/'very much'. All responses were assigned values from 1 to 5, with higher values reflecting greater decision satisfaction. Two of the statements reflected satisfaction with the decision and were coded as 1 for 'not at all' through 5 for 'very much'. The other three statements reflected dissatisfaction with the decision and were coded as 5 for 'not at all' through 1 for 'very much' The values of all 5 items were combined using the arithmetic mean, to create a standardized scale ranging from 1 (not at all) to 5 (very much). The subjective decision quality scale was modeled by linear mixed model to determine the effect of intervention on patient response.

Outcome measures

Measure	CanSORT Online Tool (Intervention) n=251 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=245 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment	4.5 units on a scale Standard Deviation 0.5	4.4 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 9 months after enrollment

Population: The numbers analyzed for these secondary outcomes were taken from the study's systemic portion of the study which took place 9 months after enrollment at which point response rate dropped and therefore numbers are less than those for primary outcomes which were done 4-5 weeks after enrollment.

Self-reported knowledge about systemic treatment using a 5 item Breast Cancer Knowledge Measure (adapted) consisting of 5 questions to test patients' knowledge about systemic treatment options for breast cancer. We compared the number of patients who gave correct answers to at least 80% of the questions between two groups. We used both unadjusted and adjusted generalized linear mixed models with logit as the link function.

Outcome measures

Measure	CanSORT Online Tool (Intervention) n=174 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=191 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer	55 Participants	43 Participants

SECONDARY outcome

Timeframe: 9 months after enrollment

A 10-item decision preparedness scale asked whether the web intervention helped patients prepare for their treatment decision. Each item asked about a different aspect of decision preparation, with responses of 'not at all'/'a little'/'somewhat'/'quite a bit'/'a great deal'. Each response was assigned a value of 1('not at all') to 5('a great deal'), with a high value representing a greater amount of preparedness. The values of all 10 items were combined using the arithmetic mean, to create a standardized scale ranging from 1(not at all) to 5 (a great deal). The decision making scale was modeled by linear mixed model to determine the effect intervention on patient preparation for decision making.

Outcome measures

Measure	CanSORT Online Tool (Intervention) n=174 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=191 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Patient Preparedness Decision Making for Systemic Treatment	3.76 units on a scale Standard Deviation 0.96	3.61 units on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: 9 months after enrollment

A 4 item subjective decision quality scale measured how satisfied patients were with their chemotherapy treatment decision. Patients were asked to rate the amounts of information, involvement, time, and overall satisfaction associated with their chemotherapy decisions. Possible responses ranged from 'not enough' to 'just right' to 'too much'. All responses were assigned values from 1 to 5, with a response of 'just right' coded as 5 points, and both 'not enough' and 'too much' coded as 1 point. The values of all 4 items were combined using the arithmetic mean, to create a standardized scale ranging from 1 (low decision quality) to 5 (high decision quality). The subjective decision quality scale was used as an outcome in linear mixed models to determine the effect of intervention on patient decision quality.

Outcome measures

Measure	CanSORT Online Tool (Intervention) n=174 Participants Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static Version of CanSORT Tool (Control) n=191 Participants Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Patient Subjective Decision Quality for Systemic Breast Cancer Treatment	3.61 units on a scale Standard Deviation 1.07	3.76 units on a scale Standard Deviation 0.96

Adverse Events

CanSORT Online Tool (Intervention)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Static Version of CanSORT Tool (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Hawley

University of Michigan

Phone: 734-936-8816

Email: sarahawl@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place