Background
Methods/Design
Design
Study setting
Eligibility criteria
Procedure
Intervention
Module | Description of module |
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1. Diagnosis | Based on patient’s treatment options as provided to them by their clinician during the clinical encounter, patients tailor the pDA to their situation (i.e. whether or not the patient is eligible for nipple-sparing surgery, whether or not radiotherapy is or might be necessary following surgery, and whether or not the patient is eligible for BCS). |
2. Immediate reconstruction or not (yet)? | Breast reconstruction options and their pros and cons are described. Options include undergoing immediate breast reconstruction, undergoing delayed breast reconstruction, and undergoing no breast reconstruction. Information is structured as answers to the following questions: ‘What choices do I have?’, ‘What are my options?’, ‘What are the pros and cons?’, ‘How much time do I have to think?’, ‘A period without a breast?’, ‘Sparing my skin and nipple?‘a, ‘When can I resume my normal activities?’, ‘When is breast reconstruction finished?’, ‘What is breast-conserving surgery?‘b |
3. Expectations | Information about what patients can expect from undergoing breast reconstruction is provided. Also, the different types of breast reconstruction and their pros and cons are described. Options include implant-based breast reconstruction and autologous breast reconstruction. Information is structured as answers to the following questions: ‘What can I expect of a new breast?’, ‘What are the pros and cons of implant-based and autologous breast reconstruction?’, ‘What if I received breast radiation in the past?’, ‘What is implant-based breast reconstruction?’, ‘What is autologous breast reconstruction?’, ‘How will my breast look like?’, ‘How will my breast feel like?’, ‘Will this impact my body image?’, ‘What are potential complications?’, ‘What if I need breast radiation following surgery?‘c |
4. Considerations | With value clarification exercises, women are actively encouraged to weigh the options of undergoing immediate breast reconstruction or not undergoing breast reconstruction (and potentially undergoing delayed breast reconstruction). Furthermore, women are invited to indicate their breast reconstruction preference and note questions they have for their plastic surgeon. |
5. Patient stories | Short stories of six women who underwent breast surgery with or without breast reconstruction. The stories illustrate the experiences of these women with decision making about breast reconstruction and the impact of their decision on their daily life. |
6. Summary | A summary sheet (A4 format), including patient’s personal considerations, preferences and questions for the plastic surgeon. The sheet can be saved as PDF and printed. Patients are encouraged to discuss the summary sheet with their plastic surgeon. |
Development of the intervention
Control group
Study measures
Sociodemographic and clinical data
Outcome measures
Outcome measure | Instrument | Details | T0 | T1 | T2 | T3 |
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Decision-making process and decision quality | ||||||
Decisional conflict | 16 items, 5-point Likert-type scale, score range: 0–100, higher scores indicate more decisional conflict. Scores ≤25 are associated with follow-through decisions, and scores > 37.5 are associated with decision delay. | x | x | x | x | |
Satisfaction with information | Three study-specific questions | How satisfied are you with the information about breast reconstruction? (5-point Likert-type scale: not at all – very satisfied), Did you miss information? (y/n), Would you have preferred less information? (y/n) | x | x | ||
Subscale Satisfaction with Information of the BREAST-Q [49] (slightly adapted), for women with breast reconstruction only | Satisfaction with information (Reconstruction module): 15 items, 4-point Likert-type scale, very unsatisfied – very satisfied, score range: 0–100, higher scores indicating higher satisfaction. Cronbach’s alpha = 0.94 [49] | |||||
Satisfaction with plastic surgeon | Subscale Satisfaction with the Plastic Surgeon of the BREAST-Q [49] | Satisfaction with the Plastic Surgeon (Reconstruction module): 12 items, 4-point Likert-type scale, score range: 0–100, higher scores indicating higher satisfaction. Cronbach’s alpha = 0.97 [49] | x | |||
Preparedness for decision making | 10 items, 5-point Likert-type scale, score range: 0–100, higher scores indicate higher perceived level of preparation for decision making. Cronbach’s alpha = 0.92–0.96 [51] | x | ||||
Shared Decision Making | 9 items, 6-point Likert-type scale, score range: 0–100, higher scores indicate higher levels of perceived shared decision making. Cronbach’s alpha = 0.88 [53] | x | ||||
Patient involvement in decision making | Control Preferences Scale [54] | 1 item, 5-point Likert-type scale | x | x | ||
Knowledge of breast reconstruction | Study-specific questionnaire, translated and adapted from a questionnaire used in prior research [55] | 10 items that can be answered with true/false/I don’t know. Items are about contraindications, risk factors, duration of the recovery period, impact of breast reconstruction on sensation, number of surgical procedures, complexity of types of breast reconstruction, complications, impact of breast reconstruction on breast cancer treatment and survival rates and the opportunity to spare the nipple. Total score is the number of correctly answered items, ranging from 0 to 10. | x | x | x | x |
Decision regret | 5 items, 5-point Likert-type scale, score range: 0–100, higher scores indicating greater regret. Cronbach’s alpha = 0.81–0.92 [56] | x | x | |||
Health outcomes | ||||||
Choice regarding breast reconstruction | Patient-reported questions and data from EMR | x | x | |||
Satisfaction with breasts | Subscale Satisfaction with Breasts of the BREAST-Q Subscale Satisfaction with Breast Outcome of the BREAST-Q [49] (women with breast reconstruction only) | Satisfaction with Breasts (Reconstruction or Mastectomy Module, as appropriate): 16 items (women with breast reconstruction)/4 items (women without breast reconstruction)). Cronbach’s alpha = 0.96 (Reconstruction) [49]. Satisfaction with Breast Outcome (Reconstruction Module): 7 items, recall period: past 2 weeks. Higher scores indicate higher satisfaction. Cronbach’s alpha = 0.88 [49] | x | x | ||
Body image | Subscale Body Image of the EORTC QLQ-BR23 [58] | 4 items, 4-point Likert-type scale. Cronbach’s alpha = 0.69–0.91 [58] | x | x | ||
Sexual functioning | Subscale Sexual Functioning of the EORTC QLQ-BR23 [58] | 2 items + 1 item sexual enjoyment (if applicable), 4-point Likert-type scale. Cronbach’s alpha =0.87–0.94 [58] | x | X | ||
Breast symptoms | Subscale Breast Symptoms of the EORTC QLQ-BR23 [58] | 4 items, 4-point Likert-type scale. Cronbach’s alpha =0.46–0.85 [58] | x | X | ||
Anxiety | STAI-6 (State scale of the State-Trait Anxiety Inventory) [59] | 6 items, 4-point Likert-type scale,score range: 20–80, higher scores indicate higher levels of anxiety. Cronbach’s alpha = 0.82 [59] | x | x | x | x |
Cost-effectiveness | ||||||
Use of health care services | A selection of questions of the Medical Consumption Questionnaire (see https://www.imta.nl/), and data from EMR | Selection of questions on the number of consultations related to breast surgery with a (plastic) surgeon, nurse practitioner/ nurse specialist, social worker, psychologist, general practitioner and a physiotherapist, and the amount of received home care during the last 3 months (T2) or 9 months (T3). | x | x | ||
Health-Related Quality of life | EuroQoL-5D-5 L [60] | EuroQoL-5D-5 L descriptive system: 5 items, 5-point Likert-type scale, and the EQ Visual Analogue Scale: patients’ self-rated health. | x | x | x |