Breast CancerNCT01840163
A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool
A study testing Static version of CanSORT tool and CanSORT Online Tool in people with Breast Cancer, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 84 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Static version of CanSORT tool and CanSORT Online Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 537 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 84 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1-2 invasive breast cancer diagnosis,
- DCIS
- Ability to read English
Who cannot join
- Male
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical School
Ann Arbor, Michigan, 48109
About this study
Official title: Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Static version of CanSORT tool, CanSORT Online Tool
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static version of CanSORT toolOther
CanSORT Online ToolOther
| Study group | Role | What they receive |
|---|---|---|
| CanSORT Online Tool | Other | Comprehensive decision tool Receives: Other: CanSORT Online Tool |
| Static version of CanSORT tool | Other | Static version (non-interactive) version of CanSORT decision tool Receives: Other: Static version of CanSORT tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.
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.
Measured: 4-5 weeks from date of enrollment
Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant
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.
Measured: 4-5 weeks from date of enrollment
Secondary outcomes (6)
Patient Preparedness Decision Making for Locoregional Treatment.
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.
Measured: 4-5 weeks from date of enrollment
Patient Deliberation for Locoregional Breast Cancer Treatment.
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.
Measured: 4-5 weeks from date of enrollment
Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment
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.
Measured: 4-5 weeks from date of enrollment
Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer
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.
Measured: 9 months after enrollment
Patient Preparedness Decision Making for Systemic Treatment
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.
Measured: 9 months after enrollment
Patient Subjective Decision Quality for Systemic Breast Cancer Treatment
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.
Measured: 9 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startFeb 2014
- Primary completion1 Aug 2016
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Sarah T. Hawley, University of Michigan
- Investigators
- Sarah T. Hawley, PhD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840163
- Sponsor's protocol ID
- P01CA163233
- Status last verified
- Oct 2018
- First submitted
- 16 Apr 2013
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29152598Hawley ST, Li Y, An LC, Resnicow K, Janz NK, Sabel MS, Ward KC, Fagerlin A, Morrow M, Jagsi R, Hofer TP, Katz SJ. Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial. J Clin Oncol. 2018 Mar 1;36(7):659-666. doi: 10.1200/JCO.2017.74.8442. Epub 2018 Jan 24.
PubMed 29364772
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Decision Quality for Patients With Breast Cancer: A RCT of a Comprehensive Breast Cancer Treatment Patient Decision Tool
- ClinicalTrials.gov ID
- NCT01840163
- Acronym / sponsor ID
- P01CA163233
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- Feb 2014
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Posted 5 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CanSORT Online Tool | Other | Other: CanSORT Online ToolComprehensive decision tool |
| Static version of CanSORT tool | Other | Other: Static version of CanSORT toolStatic version (non-interactive) version of CanSORT decision tool |
Who may qualify
- Ages
- 21 to 84 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage 1-2 invasive breast cancer diagnosis,
- DCIS
- Ability to read English
Key exclusion criteria (1 listed)
- Male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static version of CanSORT tool | Other | Static version of CanSORT tool |
| CanSORT Online Tool | Other | CanSORT Online Tool |
Primary outcome
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.
6 secondary outcomes
Patient Preparedness Decision Making for Locoregional Treatment.
Time frame: 4-5 weeks from date of enrollment
Patient Deliberation for Locoregional Breast Cancer Treatment.
Time frame: 4-5 weeks from date of enrollment
Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment
Time frame: 4-5 weeks from date of enrollment
Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer
Time frame: 9 months after enrollment
Patient Preparedness Decision Making for Systemic Treatment
Time frame: 9 months after enrollment
Patient Subjective Decision Quality for Systemic Breast Cancer Treatment
Time frame: 9 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29152598Hawley 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.
- Derived from this study: PubMed 29364772Hawley ST, Li Y, An LC, Resnicow K, Janz NK, Sabel MS, Ward KC, Fagerlin A, Morrow M, Jagsi R, Hofer TP, Katz SJ. Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial. J Clin Oncol. 2018 Mar 1;36(7):659-666. doi: 10.1200/JCO.2017.74.8442. Epub 2018 Jan 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah T. Hawley, PhD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static version of CanSORT tool and CanSORT Online Tool in people with Breast Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840163, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.