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Decision Support Workshop for Breast Reconstruction (DSW)

16 czerwca 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

41

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2C4
        • Toronto General Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 79 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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
Brak interwencji: Standard Care
Routine pre-consultation education

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Decision Self-efficacy Scale
Ramy czasowe: 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.
Change from baseline decision self-efficacy at 1 week after surgical consultation

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Decision Conflict Scale
Ramy czasowe: 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).
Change from baseline decision conflict at 1 week after surgical consultation
Decision Preference and Decision Choice
Ramy czasowe: 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.
baseline
Patient Involvement in Care Scale (PICS)
Ramy czasowe: 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.
T1 (1 week after surgical consultation)
Satisfaction With Information (Sub-scale of BREAST-Q)
Ramy czasowe: 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.
T1 (1 week after surgical consultation)
Qualitative Interview Assessment
Ramy czasowe: 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.
Within three months after initial consultation
Uptake Rate of Breast Reconstruction-Service Outcome
Ramy czasowe: Six months after initial consultation
The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)
Six months after initial consultation
Length of Consultation-service Outcome
Ramy czasowe: 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.
Duration of initial consultation
Number of Consultations-service Outcomes
Ramy czasowe: 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.
Six months after initial consultation
Breast Reconstruction Knowledge Test
Ramy czasowe: 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.
Change in baseline breast reconstruction knowledge at 1 week after initial consultation
Medical Outcomes Study Social Support Survey
Ramy czasowe: 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.
baseline

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Recruitment Rate-feasibility Outcome
Ramy czasowe: 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.
Duration of recruiting, expected on average two months
Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome
Ramy czasowe: 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.
Duration of treatment-8 hours on day of treatment
Completion of Primary Outcome Measure-feasibility Outcome
Ramy czasowe: 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.
1 week after initial consultation

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Health Network, Toronto

Współpracownicy

The Physicians' Services Incorporated Foundation

Śledczy

  • Główny śledczy: Toni Zhong, MD, MHS, University Health Network, Toronto

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2012

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2013

Ukończenie studiów (Rzeczywisty)

1 lipca 2013

Daty rejestracji na studia

Pierwszy przesłany

6 maja 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 maja 2013

Pierwszy wysłany (Oszacować)

20 maja 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

17 czerwca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 czerwca 2015

Ostatnia weryfikacja

1 czerwca 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 11-1027-CE

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