A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01840163
• Collaborator: Emory University (Other)
• Enrollment: 537
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief Summary

This study examines the impact of an online decision tool for patients with early stage invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas. Participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). Our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Static version of CanSORT tool; Other: CanSORT Online Tool	N/A

Detailed Description

Patients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. Currently many of these decisions do not meet the definition of a high quality decision, defined as one that is both informed (i.e., based on an accurate understanding of the treatment risks and benefits) and preference-concordant (i.e., consistent with the patients' underlying preferences). Moreover, the introduction of evaluative tests has made these decisions more complicated for many patients. There is a need to improve the quality of locoregional and systemic treatment decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. Ensuring patients can deliberate effectively about these decisions, assert their views and communicate with their clinicians is likely to improve their overall decision preparedness and satisfaction. This study will focus on the third pillar of individualized care by evaluating the impact of an innovative decision tool on locoregional and systemic therapy decision making for newly diagnosed breast cancer patients. The innovative online decision tool has been developed and tested over the past two years by the CanSORT team (R21 CA129859). Pilot data suggests that this tool has a positive impact on patient knowledge and decision outcomes. The goal of this study is to evaluate the impact of this tool, after it is enhanced in collaboration with our Communication and Dissemination Core, on the quality of decision making for locoregional and systemic breast cancer treatment decision making.

Study Design

• Study Type: Interventional
• Actual Enrollment: 537 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: CanSORT Online Tool Comprehensive decision tool	Other: CanSORT Online Tool
Other: Static version of CanSORT tool Static version (non-interactive) version of CanSORT decision tool	Other: Static version of CanSORT tool

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer. [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.

2. Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant [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.

Secondary Outcome Measures

1. Patient Preparedness Decision Making for Locoregional Treatment. [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.

2. Patient Deliberation for Locoregional Breast Cancer Treatment. [4-5 weeks from date of enrollment]

   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.

3. Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment [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.

4. Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer [9 months 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.

5. Patient Preparedness Decision Making for Systemic Treatment [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.

6. Patient Subjective Decision Quality for Systemic Breast Cancer Treatment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 84 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stage 1-2 invasive breast cancer diagnosis,

• DCIS

• Ability to read English

Exclusion Criteria:

• Male

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Medical School	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• Emory University

Investigators

• Principal Investigator: Sarah T. Hawley, PhD, MPH, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hawley ST, Li Y, Jeanpierre LA, Goodell S, Jagsi R, Ward KC, Sabel MS, Katz SJ. Study protocol: A Randomized Controlled Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool (iCanDecide). Contemp Clin Trials Commun. 2017 Mar;5:123-132. doi: 10.1016/j.conctc.2017.02.001. Epub 2017 Feb 3.

• Responsible Party: Sarah T. Hawley, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT01840163
• Other Study ID Numbers: P01CA163233
• First Posted: Apr 25, 2013
• Last Update Posted: Nov 8, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Period Title: First Follow up -Primary Outcome
STARTED	267	270
COMPLETED	248	254
NOT COMPLETED	19	16
Period Title: First Follow up -Primary Outcome
STARTED	265	266
COMPLETED	174	191
NOT COMPLETED	91	75

Baseline Characteristics

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)	Total
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool	Total of all reporting groups
Overall Participants	267	270	537
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	208 77.9%	208 77%	416 77.5%
>=65 years	59 22.1%	62 23%	121 22.5%
Sex: Female, Male (Count of Participants)
Female	267 100%	270 100%	537 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 1.1%	5 1.9%	8 1.5%
Not Hispanic or Latino	264 98.9%	265 98.1%	529 98.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.7%	0 0%	2 0.4%
Asian	8 3%	7 2.6%	15 2.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	42 15.7%	44 16.3%	86 16%
White	211 79%	214 79.3%	425 79.1%
More than one race	0 0%	1 0.4%	1 0.2%
Unknown or Not Reported	4 1.5%	4 1.5%	8 1.5%
Region of Enrollment (participants) [Number]
United States	267 100%	270 100%	537 100%
Number of participants leaning towards a treatment option and felt sure about choice (Count of Participants)
Count of Participants [Participants]	178 66.7%	175 64.8%	353 65.7%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.
Description	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.
Time Frame	4-5 weeks from date of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Measure Participants	251	245
Count of Participants [Participants]	148 55.4%	105 38.9%

2. Primary Outcome

Title	Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant
Description	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.
Time Frame	4-5 weeks from date of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Measure Participants	251	245
Count of Participants [Participants]	180 67.4%	197 73%

3. Secondary Outcome

Title	Patient Preparedness Decision Making for Locoregional Treatment.
Description	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.
Time Frame	4-5 weeks from date of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Measure Participants	251	245
Mean (Standard Deviation) [units on a scale]	3.9 (0.9)	3.7 (0.9)

4. Secondary Outcome

Title	Patient Deliberation for Locoregional Breast Cancer Treatment.
Description	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.
Time Frame	4-5 weeks from date of enrollment

Outcome Measure Data

Analysis Population Description

participants

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Measure Participants	251	245
Mean (Standard Deviation) [units on a scale]	3.9 (0.8)	3.7 (0.9)

5. Secondary Outcome

Title	Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment
Description	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.
Time Frame	4-5 weeks from date of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Measure Participants	251	245
Mean (Standard Deviation) [units on a scale]	4.5 (0.5)	4.4 (0.6)

6. Secondary Outcome

Title	Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer
Description	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.
Time Frame	9 months after enrollment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Measure Participants	174	191
Count of Participants [Participants]	55 20.6%	43 15.9%

7. Secondary Outcome

Title	Patient Preparedness Decision Making for Systemic Treatment
Description	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.
Time Frame	9 months after enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Measure Participants	174	191
Mean (Standard Deviation) [units on a scale]	3.76 (0.96)	3.61 (1.07)

8. Secondary Outcome

Title	Patient Subjective Decision Quality for Systemic Breast Cancer Treatment
Description	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.
Time Frame	9 months after enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CanSORT Online Tool (Intervention)	Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool	Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
Measure Participants	174	191
Mean (Standard Deviation) [units on a scale]	3.61 (1.07)	3.76 (0.96)

Adverse Events

Time Frame	from start of study until completion of last follow up survey (up to approximately 9 months)
Adverse Event Reporting Description	Since only survey data was collected for this research, Adverse Events were not systematically collected
Arm/Group Title	CanSORT Online Tool (Intervention)		Static Version of CanSORT Tool (Control)
Arm/Group Description	Comprehensive (interactive) version of decision tool CanSORT Online Tool		Static version (non-interactive) version of CanSORT decision tool Static version of CanSORT tool
All Cause Mortality
	CanSORT Online Tool (Intervention)		Static Version of CanSORT Tool (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/267 (0%)		0/270 (0%)
Serious Adverse Events
	CanSORT Online Tool (Intervention)		Static Version of CanSORT Tool (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/267 (0%)		0/270 (0%)
Other (Not Including Serious) Adverse Events
	CanSORT Online Tool (Intervention)		Static Version of CanSORT Tool (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/267 (0%)		0/270 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.