Trial Outcomes & Findings for Decision Support Workshop for Breast Reconstruction (NCT NCT01857882)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

Change from baseline decision self-efficacy at 1 week after surgical consultation

Results posted on

2015-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	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	Standard Care Routine pre-consultation education
Overall Study STARTED	21	20
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decision Support Workshop for Breast Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Support Workshop n=21 Participants 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	Standard Care n=20 Participants Routine pre-consultation education	Total n=41 Participants Total of all reporting groups
Age, Continuous	50.9 years STANDARD_DEVIATION 5.5 • n=5 Participants	51.5 years STANDARD_DEVIATION 9.1 • n=7 Participants	51.2 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants
Decisional conflict Scale	56.8 units on a scale STANDARD_DEVIATION 18.0 • n=5 Participants	41.3 units on a scale STANDARD_DEVIATION 17.1 • n=7 Participants	49.3 units on a scale STANDARD_DEVIATION 19.0 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Decision Support Workshop n=20 Participants 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	Standard Care n=19 Participants Routine pre-consultation education
Decision Self-efficacy Scale	5.7 units on a scale Standard Deviation 12.8	5.1 units on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Six months after initial consultation

The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Decision Support Workshop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Toni Zhong

University Health Network

Phone: 416-340-3858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place