Breast Cancer
Conditions
Keywords
breast cancer, breast reconstruction, shared decision making, decision support intervention
Brief summary
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.
Detailed description
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.
Interventions
OTHERDecision Support Workshop
Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients. * Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities * Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system * Social worker (30 mins): values clarification exercise * Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience
Sponsors
The Physicians' Services Incorporated Foundation
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patient age: 18 - 79 years at the time of consultation * In situ or invasive biopsy confirmed breast adenocarcinoma * Considered for immediate or delayed breast reconstruction * First consultation for breast reconstruction
Exclusion criteria
* Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast * Completion any phase of reconstruction, or for revision reconstruction * Patient cannot read or write in English. * Cognitive impairment or uncontrolled psychiatric diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision Self-efficacy Scale | Change from baseline decision self-efficacy at 1 week after surgical consultation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Interview Assessment | Within three months after initial consultation | 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. |
| Number of Consultations-service Outcomes | Six months after initial consultation | 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. |
| Breast Reconstruction Knowledge Test | Change in baseline breast reconstruction knowledge at 1 week after initial consultation | 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. |
| Medical Outcomes Study Social Support Survey | baseline | 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. |
| Decision Conflict Scale | Change from baseline decision conflict at 1 week after surgical consultation | 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). |
| Decision Preference and Decision Choice | baseline | 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. |
| Patient Involvement in Care Scale (PICS) | T1 (1 week after surgical consultation) | 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. |
| Satisfaction With Information (Sub-scale of BREAST-Q) | T1 (1 week after surgical consultation) | 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. |
| Uptake Rate of Breast Reconstruction-Service Outcome | Six months after initial consultation | The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction) |
| Length of Consultation-service Outcome | Duration of initial consultation | The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Completion of Primary Outcome Measure-feasibility Outcome | 1 week after initial consultation | 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. |
| Recruitment Rate-feasibility Outcome | Duration of recruiting, expected on average two months | 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. |
| Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome | Duration of treatment-8 hours on day of treatment | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
* Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
* Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
* Social worker (30 mins): values clarification exercise
* Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience | 21 |
| Standard Care Routine pre-consultation education | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Decision Support Workshop | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 50.9 years STANDARD_DEVIATION 5.5 | 51.5 years STANDARD_DEVIATION 9.1 | 51.2 years STANDARD_DEVIATION 7.4 |
| Decisional conflict Scale | 56.8 units on a scale STANDARD_DEVIATION 18 | 41.3 units on a scale STANDARD_DEVIATION 17.1 | 49.3 units on a scale STANDARD_DEVIATION 19 |
| Region of Enrollment Canada | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Change from baseline decision self-efficacy at 1 week after surgical consultation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Support Workshop | Decision Self-efficacy Scale | 5.7 units on a scale | Standard Deviation 12.8 |
| Standard Care | Decision Self-efficacy Scale | 5.1 units on a scale | Standard Deviation 9.8 |
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.
Time frame: Change in baseline breast reconstruction knowledge at 1 week after initial consultation
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).
Time frame: 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.
Time frame: baseline
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.
Time frame: Duration of 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.
Time frame: baseline
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.
Time frame: Six months after initial consultation
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.
Time frame: 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.
Time frame: Within three months after initial 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.
Time frame: T1 (1 week after surgical consultation)
Secondary
Uptake Rate of Breast Reconstruction-Service Outcome
The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)
Time frame: Six months after initial consultation
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.
Time frame: 1 week after initial consultation
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.
Time frame: 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.
Time frame: Duration of treatment-8 hours on day of treatment