A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool
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ClinicalTrials.gov Identifier: NCT01840163 |
Recruitment Status :
Completed
First Posted : April 25, 2013
Results First Posted : July 5, 2018
Last Update Posted : November 8, 2018
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Other: Static version of CanSORT tool Other: CanSORT Online Tool | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | February 2014 |
Actual Primary Completion Date : | August 1, 2016 |
Actual Study Completion Date : | September 1, 2017 |

Arm | Intervention/treatment |
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CanSORT Online Tool
Comprehensive decision tool
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Other: CanSORT Online Tool |
Static version of CanSORT tool
Static version (non-interactive) version of CanSORT decision tool
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Other: Static version of CanSORT tool |
- Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer. [ Time Frame: 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.
- Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant [ Time Frame: 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.
- Patient Preparedness Decision Making for Locoregional Treatment. [ Time Frame: 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.
- Patient Deliberation for Locoregional Breast Cancer Treatment. [ Time Frame: 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.
- Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment [ Time Frame: 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.
- Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer [ Time Frame: 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.
- Patient Preparedness Decision Making for Systemic Treatment [ Time Frame: 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.
- Patient Subjective Decision Quality for Systemic Breast Cancer Treatment [ Time Frame: 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.

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Ages Eligible for Study: | 21 Years to 84 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840163
United States, Michigan | |
University of Michigan Medical School | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Sarah T. Hawley, PhD, MPH | University of Michigan |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sarah T. Hawley, Associate Professor, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01840163 |
Other Study ID Numbers: |
P01CA163233 ( U.S. NIH Grant/Contract ) |
First Posted: | April 25, 2013 Key Record Dates |
Results First Posted: | July 5, 2018 |
Last Update Posted: | November 8, 2018 |
Last Verified: | October 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |