Impact of Decision Aids on Breast Cancer Surgery Choice: A Randomized Controlled Trial
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Decision aids
Intervention type(s): Other
Intervention description(s): Shared decision making with decision aids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research