Shared Decision MakingNCT04378816
A Patient-centered Continuous and Interdisciplinary Shared Decision Making Approach for Breast Cancer Rehabilitation
A study testing Shared decision making support tool in people with Shared Decision Making and Self-Efficacy for Decision Making, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shared Decision Making, Self-Efficacy for Decision Making
- What is being tested?
- Shared decision making support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 May 2020to 5 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei
YI-HSUAN LAN, +886973007396, m437108006@tmu.edu.tw
About this study
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.
Read the 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.
- Being tested
- Shared decision making support tool
- Keywords
- breast cancer, shared decision making, patient decision aid, question prompt list
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision making support toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| QPL intervention group | Experimental | Using shared decision making support tool(Question Prompt List) for intervention Receives: Other: Shared decision making support tool |
| Usual care group | No intervention | No intervention, just continue using usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After intervention immediately
Secondary outcomes (4)
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.
Measured: After intervention immediately
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
Measured: After intervention immediately
State-Trait Anxiety Inventory
State-Trait Anxiety Inventory (STAI) is to measure the level of trait and state anxiety . It has 20 items.
Measured: After intervention immediately
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.
Measured: After intervention immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start5 May 2020
- Primary completion5 May 2021 (estimated)
- Study completion5 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shared Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WEN-HSUAN HOU, Study director, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378816
- Sponsor's protocol ID
- N201912134
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-centered Continuous and Interdisciplinary Shared Decision Making Approach for Breast Cancer Rehabilitation
- ClinicalTrials.gov ID
- NCT04378816
- Acronym / sponsor ID
- N201912134
- Keywords
- breast cancer, shared decision making, patient decision aid, question prompt list
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 5 May 2021 (estimated)
- Study completion
- 5 May 2021 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QPL intervention group | Experimental | Other: Shared decision making support toolUsing shared decision making support tool(Question Prompt List) for intervention |
| Usual care group | No intervention | –No intervention, just continue using usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision making support toolHealth 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. | Other | QPL intervention group |
Primary outcome
Control Preference Scale
Time frame: After intervention immediately
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
Time frame: After intervention immediately
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
Time frame: After intervention immediately
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
Time frame: After intervention immediately
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.
4 secondary outcomes
modified brief version of the Health Care Climate Questionnaire
Time frame: After intervention immediately
SURE test
Time frame: After intervention immediately
State-Trait Anxiety Inventory
Time frame: After intervention immediately
collaboRATE
Time frame: After intervention immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WEN-HSUAN HOU study director
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making support tool in people with Shared Decision Making and Self-Efficacy for Decision Making, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YI-HSUAN LAN (+886973007396, m437108006@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control Preference Scale (time frame: After intervention immediately). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.