Impact of Decision Aids on Breast Cancer Surgery Choice: A Randomized Controlled Trial
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Decision aids
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Taiwanese women newly diagnosed with stage 0 to 3 breast cancer (including patients with ductal carcinoma in situ), who were suitable for breast surgery
- Patients who were able to give consent and complete the interview
Exclusion Criteria:
- Patients were diagnosed with nonmalignant breast disease
- Patients were offered neoadjuvant chemotherapy
- Patients had cognitive impairment
- Patients were physically unfit to be interviewed
- Patients were non-Mandarin or -Taiwanese
Sites / Locations
- Shuang Ho Hospital, Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DAs group
Control group
Arm Description
Shared decision making using decision aids
Standard oral explanation guided with booklets
Outcomes
Primary Outcome Measures
Decisional conflict
Total score of decisional conflict scale
Knowledge
Total score on knowledge scale
Secondary Outcome Measures
Decision regret
Total score of decision regret
Postsurgical depression
Total score of Hospital anxiety and depression scale (HADS)
Full Information
NCT ID
NCT03105076
First Posted
March 29, 2017
Last Updated
March 16, 2020
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03105076
Brief Title
Impact of Decision Aids on Breast Cancer Surgery Choice: A Randomized Controlled Trial
Official Title
Impact of Decision Aids on Breast Cancer Surgery Choice: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Both simple mastectomy and breast conservation therapy (BCT) with radiotherapy yield similar survival rates in breast cancer. These two treatment strategies have diverted cosmetic outcome and convenience. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. We have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on cancer patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and postsurgical depression. We expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after thier treatment sessions.
Detailed Description
Background:
For women with early-stage breast cancer, both simple mastectomy and breast conservation therapy (BCT) with radiotherapy yield similar survival rates, making psychological adjustment and quality-of-life issues pivotal in treatment choice. Using decision aids (DAs) is one way to provide information to patients and to involve them in making decisions about their treatment. We have developed a DAs to be administered after consultation for Taiwanese women deciding on breast surgery, and plan to conduct a randomized controlled trial (RCT) to evaluate the benefit of DAs on breast surgery decision making.
Patients and Methods:
Decision aids are interventions designed to help patients with early breast cancer to make deliberate choices among treatment options by providing information on those options and any potential outcome relevant to different breast cancer surgeries. Women considering breast cancer surgery are randomly assigned to receive a DAs or the standard oral conversation (control condition) after initial consultation, wherein surgeons disclosed the diagnosis and discussed treatment options with patients. Participants complete interview-based questionnaires 1 day before and 4 weeks after surgery. Primary outcome measures 1 day before surgery are decisional conflict and decision-making difficulties after consultation. Secondary outcomes are decision regret and postsurgical depression 1 month after surgery.
Hypothesis:
The DAs group are predicted to lower decisional conflict scores before surgery, and lower decision regret scores and depression scores 1 month after surgery compared with women in the control arm. Our study hopes to support the efficacy of DAs in helping breast cancer women to arrive at their breast surgery decision.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAs group
Arm Type
Experimental
Arm Description
Shared decision making using decision aids
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard oral explanation guided with booklets
Intervention Type
Other
Intervention Name(s)
Decision aids
Intervention Description
Shared decision making with decision aids
Primary Outcome Measure Information:
Title
Decisional conflict
Description
Total score of decisional conflict scale
Time Frame
1 day before surgery
Title
Knowledge
Description
Total score on knowledge scale
Time Frame
1 day before surgery
Secondary Outcome Measure Information:
Title
Decision regret
Description
Total score of decision regret
Time Frame
4 weeks after surgery
Title
Postsurgical depression
Description
Total score of Hospital anxiety and depression scale (HADS)
Time Frame
4 weeks after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Taiwanese women newly diagnosed with stage 0 to 3 breast cancer (including patients with ductal carcinoma in situ), who were suitable for breast surgery
Patients who were able to give consent and complete the interview
Exclusion Criteria:
Patients were diagnosed with nonmalignant breast disease
Patients were offered neoadjuvant chemotherapy
Patients had cognitive impairment
Patients were physically unfit to be interviewed
Patients were non-Mandarin or -Taiwanese
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shared Decision Making Resource Center
Organizational Affiliation
Shuang Ho Hospital, Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shuang Ho Hospital, Taipei Medical University
City
New Taipei City
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35589905
Citation
Lin SQ, Su CM, Wu HC, Chou YY, Yen YC, Tam KW. Effect of patient decision aids on decisional conflict and regret associated with breast cancer surgery: a randomized controlled trial. Breast Cancer. 2022 Sep;29(5):880-888. doi: 10.1007/s12282-022-01370-0. Epub 2022 May 19.
Results Reference
derived
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Impact of Decision Aids on Breast Cancer Surgery Choice: A Randomized Controlled Trial
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