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

Primary Purpose

Shared Decision Making, Self-Efficacy for Decision Making

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Shared decision making support tool
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Shared Decision Making focused on measuring breast cancer, shared decision making, patient decision aid, question prompt list

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Taipei Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

QPL intervention group

Usual care group

Arm Description

Using shared decision making support tool(Question Prompt List) for intervention

No intervention, just continue using usual care

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI) is to measure the level of trait and state anxiety . It has 20 items.
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.

Full Information

First Posted
May 5, 2020
Last Updated
August 17, 2020
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04378816
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
May 5, 2021 (Anticipated)
Study Completion Date
May 5, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shared Decision Making, Self-Efficacy for Decision Making
Keywords
breast cancer, shared decision making, patient decision aid, question prompt list

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QPL intervention group
Arm Type
Experimental
Arm Description
Using shared decision making support tool(Question Prompt List) for intervention
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
No intervention, just continue using usual care
Intervention Type
Other
Intervention Name(s)
Shared decision making support tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Control Preference Scale
Description
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.
Time Frame
After intervention immediately
Title
Patient-Physician Interactions Questionnaire
Description
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.
Time Frame
After intervention immediately
Title
Decision Self Efficacy Scale
Description
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.
Time Frame
After intervention immediately
Title
Patients' Perceived Involvement in Care Scale
Description
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.
Time Frame
After intervention immediately
Secondary Outcome Measure Information:
Title
modified brief version of the Health Care Climate Questionnaire
Description
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.
Time Frame
After intervention immediately
Title
SURE test
Description
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
Time Frame
After intervention immediately
Title
State-Trait Anxiety Inventory
Description
State-Trait Anxiety Inventory (STAI) is to measure the level of trait and state anxiety . It has 20 items.
Time Frame
After intervention immediately
Title
collaboRATE
Description
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.
Time Frame
After intervention immediately

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YI-HSUAN LAN
Phone
+886973007396
Email
m437108006@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WEN-HSUAN HOU
Organizational Affiliation
Taipei Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YI-HSUAN LAN
Phone
+886973007396
Email
m437108006@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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