A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

NCT01840163 | Completed Results DMC

• 1 other identifier: P01CA163233
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4-5 weeks from date of enrollment

Secondary Outcomes (6)

• Patient Preparedness Decision Making for Locoregional Treatment.

  4-5 weeks from date of enrollment

• Patient Deliberation for Locoregional Breast Cancer Treatment.

  4-5 weeks from date of enrollment

• Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment

  4-5 weeks from date of enrollment

• Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer

  9 months after enrollment

• Patient Preparedness Decision Making for Systemic Treatment

  9 months after enrollment

Study Arms (2)

CanSORT Online Tool

OTHER

Comprehensive decision tool

Other: CanSORT Online Tool

Static version of CanSORT tool

OTHER

Static version (non-interactive) version of CanSORT decision tool

Other: Static version of CanSORT tool

Interventions

Static version of CanSORT tool OTHER

Static version of CanSORT tool

CanSORT Online Tool OTHER

CanSORT Online Tool

Eligibility Criteria

• Age: 21 Years - 84 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 1-2 invasive breast cancer diagnosis,
• DCIS
• Ability to read English

You may not qualify if:

• Male

Sponsors & Collaborators

• University of Michigan: lead
• Emory University: collaborator

Study Sites (1)

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• 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.

  PMID: 29152598 BACKGROUND

• Hawley 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.

  PMID: 29364772 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Sarah Hawley
• Organization: University of Michigan

sarahawl@med.umich.edu

734-936-8816

Study Officials

• Sarah T. Hawley, PhD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 25, 2013
• Study Start: February 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2017
• Last Updated: November 8, 2018
• Results First Posted: July 5, 2018

Record last verified: 2018-10

Locations

US (1)