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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education.
Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. The breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. However ¼ of women report being dissatisfied with some component of their cancer or reconstructive care. Failure of the physician to provide adequate information about treatment options is the most frequent source of cancer patient dissatisfaction and breast reconstruction patients have expressed a need for further information regarding the complex decision to pursue breast reconstruction. In such scenarios of complex medical decision-making, decision support techniques may be an effective solution to information provision and shared decision-making. As a result, the investigators developed a pre-consultation educational group intervention delivered in a group setting for women considering breast reconstruction, with the aims to fill an existing information-gap, promote high-quality decision-making and enhance decision self-efficacy and other decision measures. This pilot study will be the first step in the evaluation of the educational group intervention and the results will be used to determine the feasibility and inform the optimal design for a definitive randomized controlled trial. This study will first examine the feasibility and acceptability of the intervention through implementation in a pilot, mixed-methods, 1:1 allocation parallel-arm randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Support Workshop | Experimental | The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology. |
|
| Standard Care | No Intervention | Routine pre-consultation education |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Support Workshop | Other | Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
|
| Measure | Description | Time Frame |
|---|---|---|
| Decision Self-efficacy Scale | Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population. The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy). The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation. | Change from baseline decision self-efficacy at 1 week after surgical consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Decision Conflict Scale | Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25). | Change from baseline decision conflict at 1 week after surgical consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate-feasibility Outcome | As this is a pilot study, the feasibility of conducting the study is highly important. The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months. | Duration of recruiting, expected on average two months |
| Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toni Zhong, MD, MHS | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25351455 | Result | Causarano N, Platt J, Baxter NN, Bagher S, Jones JM, Metcalfe KA, Hofer SO, O'Neill AC, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. Support Care Cancer. 2015 May;23(5):1365-75. doi: 10.1007/s00520-014-2479-6. Epub 2014 Oct 29. | |
| 23829442 |
| Label | URL |
|---|---|
| E-publication link | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Support Workshop | The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology. Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
|
| FG001 | Standard Care | Routine pre-consultation education |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients reported baseline clinical characteristics. One patient in each arm did not have evaluable decisional self-efficacy and conflict scores post-treatment, so their baseline scores were not included in the analysis of these variables. Therefore, for these measures at baseline, n=19 in the standard care arm and n=20 in the workshop arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Support Workshop | The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology. Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decision Self-efficacy Scale | Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population. The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy). The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline decision self-efficacy at 1 week after surgical consultation |
|
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Adverse events were not assessed. Patients were not at risk for adverse events from this intervention ( 2 hour group workshop), as it was not medically invasive.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision Support Workshop | The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology. Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Toni Zhong | University Health Network | 416-340-3858 | toni.zhong@uhn.ca |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Decision Preference and Decision Choice | Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention. | baseline |
| Patient Involvement in Care Scale (PICS) | PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon. | T1 (1 week after surgical consultation) |
| Satisfaction With Information (Sub-scale of BREAST-Q) | The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The "Satisfaction with Information" Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction. | T1 (1 week after surgical consultation) |
| Qualitative Interview Assessment | A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop. | Within three months after initial consultation |
| Uptake Rate of Breast Reconstruction-Service Outcome | The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction) | Six months after initial consultation |
| Length of Consultation-service Outcome | The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins. | Duration of initial consultation |
| Number of Consultations-service Outcomes | The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation. | Six months after initial consultation |
| Breast Reconstruction Knowledge Test | This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction. | Change in baseline breast reconstruction knowledge at 1 week after initial consultation |
| Medical Outcomes Study Social Support Survey | Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support. | baseline |
The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded. This will be recorded directly after each day the treatment is delivered. |
| Duration of treatment-8 hours on day of treatment |
| Completion of Primary Outcome Measure-feasibility Outcome | Patients are to complete the primary outcome one week after initial consultation. However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls. | 1 week after initial consultation |
| Derived |
| Platt J, Baxter N, Jones J, Metcalfe K, Causarano N, Hofer SO, O'Neill A, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 6;14:199. doi: 10.1186/1745-6215-14-199. |
| BG001 | Standard Care | Routine pre-consultation education |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Decisional conflict Scale | Decisional conflict at baseline. Standard Care n=19, Decision Support Workshop n=20. The decisional conflict scale measures personal perceptions of uncertainty in choosing options. It is a 16-item 5-response instrument that reports a total score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25). | Mean | Standard Deviation | units on a scale |
|
| OG000 | Decision Support Workshop | The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology. Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
|
| OG001 | Standard Care | Routine pre-consultation education |
|
|
| Secondary | Decision Conflict Scale | Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25). | Not Posted | Change from baseline decision conflict at 1 week after surgical consultation |
| Secondary | Decision Preference and Decision Choice | Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention. | Not Posted | baseline |
| Secondary | Patient Involvement in Care Scale (PICS) | PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon. | Not Posted | T1 (1 week after surgical consultation) |
| Secondary | Satisfaction With Information (Sub-scale of BREAST-Q) | The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The "Satisfaction with Information" Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction. | Not Posted | T1 (1 week after surgical consultation) |
| Secondary | Qualitative Interview Assessment | A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop. | Not Posted | Within three months after initial consultation |
| Secondary | Uptake Rate of Breast Reconstruction-Service Outcome | The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction) | Not Posted | Six months after initial consultation |
| Secondary | Length of Consultation-service Outcome | The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins. | Not Posted | Duration of initial consultation |
| Secondary | Number of Consultations-service Outcomes | The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation. | Not Posted | Six months after initial consultation |
| Secondary | Breast Reconstruction Knowledge Test | This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction. | Not Posted | Change in baseline breast reconstruction knowledge at 1 week after initial consultation |
| Secondary | Medical Outcomes Study Social Support Survey | Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support. | Not Posted | baseline |
| Other Pre-specified | Recruitment Rate-feasibility Outcome | As this is a pilot study, the feasibility of conducting the study is highly important. The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months. | Not Posted | Duration of recruiting, expected on average two months |
| Other Pre-specified | Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome | The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded. This will be recorded directly after each day the treatment is delivered. | Not Posted | Duration of treatment-8 hours on day of treatment |
| Other Pre-specified | Completion of Primary Outcome Measure-feasibility Outcome | Patients are to complete the primary outcome one week after initial consultation. However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls. | Not Posted | 1 week after initial consultation |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Care | Routine pre-consultation education | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |