Clinical trial NCT04378816: A Patient-centered Continuous and Interdisciplinary Shared Decision Making Approach for Breast Cancer Rehabilitation
Official title: A Patient-centered Continuous and Interdisciplinary Shared Decision Making Approach for Breast Cancer Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shared Decision Making
Self-Efficacy for Decision Making
Keywords: breast cancer
shared decision making
patient decision aid
question prompt list
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 264
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Control Preference Scale
timeFrame: After intervention immediately
measure: Patient-Physician Interactions Questionnaire
timeFrame: After intervention immediately
measure: Decision Self Efficacy Scale
timeFrame: After intervention immediately
measure: Patients' Perceived Involvement in Care Scale
timeFrame: After intervention immediately
Secondary outcomes:
measure: modified brief version of the Health Care Climate Questionnaire
timeFrame: After intervention immediately
measure: SURE test
timeFrame: After intervention immediately
measure: State-Trait Anxiety Inventory
timeFrame: After intervention immediately
measure: collaboRATE
timeFrame: After intervention immediately
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University
name: WEN-HSUAN HOU
role: STUDY_DIRECTOR
References: