The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction

Study Overview
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Brief Summary
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This study evaluates the impact of an online patient decision aid on the process of decision making regarding breast reconstruction and the decision quality in women with breast cancer undergoing mastectomy and considering immediate breast reconstruction. Half of participants will receive care as usual and access to the online decision aid, while the other half will receive care as usual including a standard information leaflet.

Detailed Description
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Rationale: In the Netherlands, of the approximately 15,000 women who are diagnosed with breast cancer each year, about 40% undergo mastectomy. A wide variety of breast reconstructive methods are offered to these women. In most cases, there is no clear medical recommendation on which procedure is the best. Decisions for breast surgery and reconstruction are frequently made during an emotionally burdensome and restricted timeframe. Women may find it hard to make a decision for the type of surgery and reconstruction, some feel that the decision is hurried and uninformed, and many have some degree of regret about their decision at a later date. To support women in making a well-informed decision about breast reconstruction, an online patient decision aid (pDA) has been developed. Objective: The primary objective of the study is to evaluate the impact of the use of the online pDA on the process of decision making regarding breast reconstruction and the decision quality. The secondary objective of the study is to evaluate the impact of the use of the online pDA on patient reported health outcomes, to identify possible moderators of the effect, and to investigate the cost-effectiveness. Hypotheses: It is hypothesized that the online pDA, as compared to usual care, will improve the decision making process about breast reconstruction (i.e. leads to less decisional conflict, higher satisfaction with information, higher levels of preparedness for decision making and higher perceived levels of shared decision making) and that it will improve the decision quality (i.e. leads to higher levels of knowledge about breast reconstruction and lower levels of regret). Study design: A multicenter randomized controlled trial (RCT) will be performed in eight hospitals. All consenting participants will be randomized into one of the two study arms (intervention group or control group). Women in both groups will be invited to complete questionnaires at baseline (i.e. before randomization), 1 week after consultation with a plastic surgeon and 3 and 12 months after breast surgery. Study population: 250 women will participate.

Official Title
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The Impact of a Web-based Decision Aid for Women Considering Breast Reconstruction: a Randomized Controlled Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: online patient decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female (≥18 years); diagnosed with breast cancer or carcinoma in situ; will be treated with mastectomy and is eligible for immediate breast reconstruction; is referred to a plastic surgeon (consultation takes place ≥3 working days after study invitation); has internet access and sufficient computer skills; is able to read and speak the Dutch language. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Care as usual and an online patient decision aid | Other: online patient decision aid<br>* An online, interactive tool that can be used to prepare for consultation with a plastic surgeon which contains evidence-based information about breast reconstruction options, the pros and cons of the options, value clarification exercises and patient narratives. It results in a summary sheet with patients' personal values and questions that can be discussed during consultation with a plastic surgeon.<br>* Other names: Breast Reconstruction Decision Aid;|
| No Intervention: control group<br>Care as usual with a standard information leaflet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decisional conflict | decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict. | 1 week after consultation with a plastic surgeon (T1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decisional conflict | decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict. | 3 months after surgery (T2); 12 months after surgery (T3) | 
| decision regret | decision regret scale (DRS); the DRS consists of 5 items, rated on a 5 point Likert-type scale (strongly agree - strongly disagree). Scores range from 0 - 100, with higher scores indicating higher levels of regret. | 3 months after surgery (T2); 12 months after surgery (T3) | 
| knowledge about breast reconstruction | study-specific questionnaire consisting of 10 items (true/false/I don't know) | 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3) | 
| preparedness for decision making | preparation for decision making scale; 10 items, rated on a 5-point Likert-type scale (Not at all - a great deal). Scores range from 0 - 100, with higher scores indicating higher perceived level of preparation for decision making. | 1 week after consultation with a plastic surgeon (T1) | 
| satisfaction with information | three study-specific questions (a. How satisfied are you with the information about breast reconstruction? (5 point Likert-scale: not at all - very satisfied), b. Did you miss information? (yes/no), and c. Would you have preferred less information? (yes/no)). The subsample of women who opted for breast reconstruction will also complete the Satisfaction with Information-subscale of the Breast-Q (14 items, 4 point Likert-type scale, very dissatisfied - very satisfied, scores range from 0 -100, with higher scores indicating higher levels of satisfaction with information). | 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3) | 
| patient's perception of shared decision making | shared decision making questionnaire (SDM-Q-9); the SDM-Q-9 consists of 9 items, rated on a 6 point Likert-type scale (completely disagree - completely agree). The sum of all items (score between 0 - 45) will be multiplied by 20/9 to transform scores to range from 0 -100, where 0 indicates the lowest possible level of shared decision making and 100 indicates the highest extent of shared decision making. | 1 week after consultation with a plastic surgeon (T1) | 
| satisfaction with plastic surgeon | The subscale Satisfaction with Surgeon of the Breast-Q consists of 12 items, rated on a 4 point Likert-type scale (completely disagree - completely agree). Scores range from 0 - 100. | 1 week after consultation with plastic surgeon (T1) | 
| actual choice | actual choice about breast reconstruction (self-reported and verified against patients' medical records) | 3 months after surgery (T2); 12 months after surgery (T3) | 
| satisfaction with outcome | The Breast-Q subscale Satisfaction with Breast measures body image in terms of a woman's satisfaction with her breasts. It consists of 4 to 16 items (depending on the type of surgery), rated on a 4 point Likert-type scale (very dissatisfied - very satisfied). The subsample of women who opted for breast reconstruction also completes the Breast-Q subscale Satisfaction with Breast Outcome (7 items, 3 point Likert-type scale (disagree - completely agree)), measuring a woman's overall appraisal of the outcome of her breast surgery. For both subscales, scores range from 0 -100, with higher scores indicating higher satisfaction. | 3 months after surgery (T2); 12 months after surgery (T3) | 
| body image | Subscale Body Image of the EORTC QLQ-BR23 (4 items, 4 point likert-type scale (not at all - very much), scores range from: 0-100 , a higher score is better. | 3 months after surgery (T2); 12 months after surgery (T3) | 
| sexual functioning | Subscales of Sexual Functioning (2 items) and Sexual Enjoyment (1 item) of the EORTC-QLQ BR23. Both subscale are rated on a 4 point Likert-type scale (not at all - very much). Scores range from 0-100, a higher score is better. | 3 months after surgery (T2); 12 months after surgery (T3) | 
| breast symptoms | Subscale Breast Symptoms (4 items, 4 point Likert-type scale, not at all - very much) of the EORTC QLQ-BR23. Scores range from 0-100, a higher score is worse. | 3 months after surgery (T2); 12 months after surgery (T3) | 
| anxiety | The short-form of the state scale of the spielberger state-trait anxiety inventory (STAI), consisting of 6 items, rated on a 4 point Likert-type scale (not at all - very much). Scores range from 20 - 80, with higher scores indicating higher levels of anxiety. | 1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast reconstruction, patient decision aid, decisional conflict, randomized controlled trial