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A Patient-centered Continuous and Interdisciplinary Shared Decision Making Approach for Breast Cancer Rehabilitation

T

Taipei Medical University

Status

Unknown

Conditions

Shared Decision Making
Self-Efficacy for Decision Making

Treatments

Other: Shared decision making support tool

Study type

Interventional

Funder types

Other

Identifiers

NCT04378816
N201912134

Details and patient eligibility

About

Background: Breast cancer rehabilitation has gradually expanded from post-surgery rehabilitation to continuous rehabilitation including prehabilitation between cancer diagnosis and surgical treatment, post-surgery rehabilitation, and return-to-work/return-home interventions. Continuous rehabilitation provides patients with tailored training at each treatment period, in order to maintain patients' functions or accelerate the recovery of functions, reduce the burden of symptoms, and improve patients' independence and quality of life. As the functional rehabilitation needs and lifestyle adjustment needs of each patient's life role are different, only with an interprofessional rehabilitation team, patients can obtain patient-centered and comprehensive rehabilitation interventions. Interprofessional shared decision making (IP-SDM) is an decision-making process that interprofessional team and patients discussion the treatment options, based on the best evidence and patient values and preferences, to make a patient-centered treatment decision. However, the major barriers of the implementation of IP-SDM are the lack of IP-SDM skills of clinicians and the lack of medical knowledge of patients.

Purposes: The project aims (1) to develop a patient-centered continuous and interdisciplinary shared decision making approach for breast cancer rehabilitation, including IP-SDM training for interprofessional rehabilitation team, as well as decision coaching, patient decision aid and question prompt list for patients; and (2) to examine the effects of IP-SDM approach on the IP-SDM self-efficacy of interprofessional rehabilitation team and patients, quality of IP-SDM process, patients' satisfaction with decision, concordance between preferences and the chosen options, patients' upper limb function and health-related quality of life.

Full description

Methods: This 3-year prospective project will be divided into four phases: (1) Exploration of the IP-SDM needs of continuous breast cancer rehabilitation: We will interview breast cancer patients and consult breast cancer care professionals with different disciplines to understand the IP-SDM needs of breast cancer rehabilitation in each treatment period. (2) Development of communication and decision aids: An expert panel will develop a mobile application prototype of communication and decision aids. The prototype will be testes for the understandability and applicability by breast cancer patients. (3) Development of decision coaching and IP-SDM training programs: We will consult experts to develop a decision coaching training program for breast cancer patients and an IP-SDM training program for interprofessional rehabilitation team. (4) Evaluation of the effectiveness of the patient-centered continuous and interdisciplinary shared decision making approach for breast cancer rehabilitation: We will conduct a parallel-group, single-blinded randomized controlled trial and recruit 116 breast cancer patients at Taipei Medical University Hospital to evaluate the effectiveness of the IP-SDM approach.

Expected results and impacts: We expect that the patient-centered continuous and interdisciplinary shared decision making approach for breast cancer rehabilitation will effectively improve patients' IP-SDM self-efficacy, quality of IP-SDM process, patients' satisfaction with decision, concordance between preferences and the chosen options, patients' upper limb function and health-related quality of life. In the future, this IP-SDM approach will be promising to be applied to other medical institutions and other cancer populations, so as to enhance patient-centered, interprofessional and continuous practice in cancer care.

Enrollment

264 estimated patients

Sex

Female

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • diagnosis of Breast cancer ICD-10 codes C50、C79.2、C79.81、D05.00-D05.92、D48.60-D48.62、Z51.0、Z51.11; ICD-9 codes 174.0~174.9、198.2、198.81、233.0、238.3、V58.0、V58.1)
  • Age>20 years
  • Ability to follow instructions and complete the interviews
  • Agree to record the doctor-patient communication process

Exclusion criteria

  • Diagnoses mental problems
  • Patient with Cancer terminal stage and weakness
  • Cancer has brain metastases or other major diseases (such as dementia) that may affect cognitive function.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

264 participants in 2 patient groups

QPL intervention group
Experimental group
Description:
Using shared decision making support tool(Question Prompt List) for intervention
Treatment:
Other: Shared decision making support tool
Usual care group
No Intervention group
Description:
No intervention, just continue using usual care

Trial contacts and locations

1

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Central trial contact

YI-HSUAN LAN

Data sourced from clinicaltrials.gov

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