Decision Support Workshop for Breast Reconstruction (DSW)
2015년 6월 16일 업데이트: University Health Network, Toronto
Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
41
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 2C4
- Toronto General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
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간섭 없음: Standard Care
Routine pre-consultation education
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Decision Self-efficacy Scale
기간: Change from baseline decision self-efficacy at 1 week after surgical consultation
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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. |
Change from baseline decision self-efficacy at 1 week after surgical consultation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Decision Conflict Scale
기간: Change from baseline decision conflict at 1 week after surgical consultation
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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).
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Change from baseline decision conflict at 1 week after surgical consultation
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Decision Preference and Decision Choice
기간: baseline
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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.
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baseline
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Patient Involvement in Care Scale (PICS)
기간: T1 (1 week after surgical consultation)
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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.
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T1 (1 week after surgical consultation)
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Satisfaction With Information (Sub-scale of BREAST-Q)
기간: T1 (1 week after surgical consultation)
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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.
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T1 (1 week after surgical consultation)
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Qualitative Interview Assessment
기간: Within three months after initial consultation
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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.
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Within three months after initial consultation
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Uptake Rate of Breast Reconstruction-Service Outcome
기간: Six months after initial consultation
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The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)
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Six months after initial consultation
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Length of Consultation-service Outcome
기간: Duration of initial consultation
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The length of the initial consultation with the plastic surgeon, measured in minutes.
Consultations are expected to be between 20-60 mins.
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Duration of initial consultation
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Number of Consultations-service Outcomes
기간: Six months after initial consultation
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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.
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Six months after initial consultation
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Breast Reconstruction Knowledge Test
기간: Change in baseline breast reconstruction knowledge at 1 week after initial consultation
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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.
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Change in baseline breast reconstruction knowledge at 1 week after initial consultation
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Medical Outcomes Study Social Support Survey
기간: baseline
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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.
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baseline
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Recruitment Rate-feasibility Outcome
기간: Duration of recruiting, expected on average two months
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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.
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Duration of recruiting, expected on average two months
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Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome
기간: Duration of treatment-8 hours on day of treatment
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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.
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Duration of treatment-8 hours on day of treatment
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Completion of Primary Outcome Measure-feasibility Outcome
기간: 1 week after initial consultation
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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.
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1 week after initial consultation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Toni Zhong, MD, MHS, University Health Network, Toronto
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Causarano N, Platt J, Baxter NN, Bagher S, Jones JM, Metcalfe KA, Hofer SO, O'Neill AC, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. Support Care Cancer. 2015 May;23(5):1365-75. doi: 10.1007/s00520-014-2479-6. Epub 2014 Oct 29.
- Platt J, Baxter N, Jones J, Metcalfe K, Causarano N, Hofer SO, O'Neill A, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 6;14:199. doi: 10.1186/1745-6215-14-199.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 9월 1일
기본 완료 (실제)
2013년 7월 1일
연구 완료 (실제)
2013년 7월 1일
연구 등록 날짜
최초 제출
2013년 5월 6일
QC 기준을 충족하는 최초 제출
2013년 5월 15일
처음 게시됨 (추정)
2013년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 6월 16일
마지막으로 확인됨
2015년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .