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

Shared Decision Making Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04378816
• Other study ID #: N201912134
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2020
• Est. completion date: May 5, 2021

Study information

• Verified date: May 2020
• Source: Taipei Medical University
• Contact: YI-HSUAN LAN
• Phone: +886973007396
• Email: m437108006[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: May 5, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Self-Efficacy for Decision Making
• Shared Decision Making

Intervention

Other:
• Shared decision making support tool
Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions.A question prompt list (QPL) is a structured list of questions that serves as a prompt for patients to consider questions to ask their physician.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control Preference Scale	Control Preference Scale (CPS) is to measure the patients' preferred role whether change in making decisions with the medical provider before intervention and after intervention. It consists of five cards, each of which presents a different character in medical decision-making in a cartoon pattern, and performs a series of comparisons to rank the preference.	After intervention immediately
Primary	Patient-Physician Interactions Questionnaire	Patient-Physician Interactions Questionnaire (PEPPI) is to measure patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. It has 10 items and higher scores means self-efficacy performance.	After intervention immediately
Primary	Decision Self Efficacy Scale	Decision Self Efficacy Scale (DSES) is to measure patients' self-confidence and belief in measuring the ability of patients to participate in decision-making. It has 11 items with 5 level Likert scale. The scale range is 0-100 and higher scores indicate better decision self-efficacy.	After intervention immediately
Primary	Patients' Perceived Involvement in Care Scale	Patients' Perceived Involvement in Care Scale (PICS) is to measure three relatively distinct factors: (1) doctor facilitation of patient involvement, (2) level of information exchange, and (3) patient participation in decision making. It has 13 items.	After intervention immediately
Secondary	modified brief version of the Health Care Climate Questionnaire	modified brief version of the Health Care Climate Questionnaire (mHCCQ) is to measure patient perceptions of their clinician's autonomy supportive communication. It has 6 items and higher scores means autonomy support performance.	After intervention immediately
Secondary	SURE test	SURE test is to measure: (1) certainty about the decision, (2) knowledge of benefits and risks of each option, (3) personal values for benefits and risks, and (4) support and advice to make a choice.11 . It has 6 items and higher score on the SURE test indicates low decisional conflict	After intervention immediately
Secondary	State-Trait Anxiety Inventory	State-Trait Anxiety Inventory (STAI) is to measure the level of trait and state anxiety . It has 20 items.	After intervention immediately
Secondary	collaboRATE	collaboRATE is to measure the level of shared decision making in the clinical encounter from the patient's perspective is an important part of assessing health care quality and provider performance.It has 3 items.	After intervention immediately