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

NCT04378816 | Unknown DMC

• 1 other identifier: N201912134
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Shared Decision Making; Self-Efficacy for Decision Making

Keywords

breast cancer; shared decision making; patient decision aid; question prompt list

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• modified brief version of the Health Care Climate Questionnaire

  After intervention immediately

• SURE test

  After intervention immediately

• State-Trait Anxiety Inventory

  After intervention immediately

• collaboRATE

  After intervention immediately

Study Arms (2)

QPL intervention group

EXPERIMENTAL

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

Other: Shared decision making support tool

Usual care group

NO INTERVENTION

No intervention, just continue using usual care

Interventions

Shared decision making support tool OTHER

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.

QPL intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• WEN-HSUAN HOU

  Taipei Medical University

  STUDY DIRECTOR

Central Study Contacts

YI-HSUAN LAN

CONTACT

+886973007396; m437108006@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: May 5, 2020
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: August 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)