Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Feasibility of the research study as measured by retention rate |
The primary feasibility outcome will be retention rate at the 6 month-follow up. Retention rate is the percentage of enrolled participants who remain in the study until all study requirements are complete. A retention rate of >90% will indicate that a larger scale study is feasible. |
This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up. |
|
| Secondary |
Patient Satisfaction |
This will be measured using the BREAST-Q questionnaire. The BREAST-Q is a patient reported outcome measure of patient satisfaction with breast reconstruction.The reconstructive module of the BREAST-Q will be administered. The questionnaire is composed of 10-13 sections depending on whether the participants underwent autologous or alloplastic reconstruction and whether the participant underwent radiation. All questions are answered on 3, 4, or 5 point Likert scales. The answers of each sections are totaled and compared to the equivalent Rasch transformed score. Zero represents the worst possible score and 100 represents the best. |
This questionnaire will be administered at the 1-2 week pre-operative visit and at the 2-4 weeks, 3 months and 6 months post-operation. (Also administered 1-2 weeks before, 2-4 weeks and 3 months after the 2nd surgery for implant based reconstruction).) |
|
| Secondary |
Anxiety |
This will be measured using the Spielberger State-Trait Anxiety Inventory (STAI) for adults questionnaire. The STAI is a patient reported outcome that measures situational and trait anxiety. Of the two subscales, the State Anxiety Scale (S-Anxiety) evaluates the current state of anxiety. The Trait Anxiety Scale (T-Anxiety) evaluates relatively stable aspects of "anxiety proneness", including general states of calmness, confidence and security. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point Likert Scale. Scores range from 20 to 80, where higher scores indicate higher anxiety. |
This questionnaire will be administered at the 1-2 week pre-operative visit and at the 2-4 weeks, 3 months and 6 months post-operation. (Also administered 1-2 weeks before, 2-4 weeks and 3 months after the 2nd surgery for implant based reconstruction).) |
|
| Secondary |
Health-related quality of life |
This will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS-29) questionnaire. The PROMIS-29 is a generic health-related quality of life survey that assesses 7 domains (physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, satisfaction with participation in social roles) and is designed to measure self-reported physical, mental and social health and wellbeing. The questions are answered on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. In symptom-oriented domains (pain interference, fatigue, sleep disturbance, anxiety and depression) higher scores represent worse symptomatology. In function-oriented domains (physical functioning and social role) higher scores represent better functioning. |
This questionnaire will be administered at the 1-2 week pre-operative visit and at the 2-4 weeks, 3 months and 6 months post-operation. (Also administered 1-2 weeks before, 2-4 weeks and 3 months after the 2nd surgery for implant based reconstruction).) |
|
| Secondary |
Feasibility measure: Recruitment rate |
This secondary, feasibility outcome is recruitment rate, the number of participants who were enrolled in the study out of the number who were assessed for eligibility, as described as a percentage. A recruitment rate of >70% will indicate that a larger scale study is feasible. |
This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up. |
|
| Secondary |
Feasibility measure: Compliance rate |
This secondary, feasibility outcome is compliance rate, the percentage of participants who were randomized to the experimental group who completed the intervention. |
This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up. |
|
| Secondary |
Feasibility measure: Percent of patients who meet eligibility criteria |
This secondary, feasibility outcome is eligibility, the percentage of patients who were assessed for eligibility who meet all the eligibility criteria. An eligibility percentage of >80% will indicate that a larger scale study is feasible. |
This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up. |
|
| Secondary |
Feasibility measure: Time assessment |
This secondary, feasibility outcome is a time assessment, the number of months it take to complete the research study. |
This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up. |
|
| Secondary |
Feasibility measure: Budget assessment |
This secondary, feasibility outcome is a budget assessment, the amount of money and the allocation of money that is required to complete the study. This will be compared to the budget designed prior to study commencement. |
This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up. |
|
| Secondary |
Feasibility measure: Personnel time |
This secondary, feasibility outcome is personnel time, the number of hours and the allocation of hours each member of the research time has dedicated to completing this study. |
This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up. |
|
| Secondary |
Feasibility measure: Treatment effect size and variance of the primary, secondary outcome. |
This secondary, feasibility outcome is treatment effect size. This will be calculated using the mean difference between the control and experimental groups of the Satisfaction with Information subscale in the BREAST-Q at the 3 month follow up time. The mean difference will be divided by the pooled standard deviation (variance) to determine the effect size. |
This will be calculated through study completion, an average of 1 year, at the time when every enrolled participant is set to complete the final follow up. |
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