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Decision Support Workshop for Breast Reconstruction (DSW)

16. června 2015 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Aktuální)

41

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 79 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: 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
Žádný zásah: Standard Care
Routine pre-consultation education

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Decision Self-efficacy Scale
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Decision Conflict Scale
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Recruitment Rate-feasibility Outcome
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Health Network, Toronto

Spolupracovníci

The Physicians' Services Incorporated Foundation

Vyšetřovatelé

  • Vrchní vyšetřovatel: Toni Zhong, MD, MHS, University Health Network, Toronto

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2012

Primární dokončení (Aktuální)

1. července 2013

Dokončení studie (Aktuální)

1. července 2013

Termíny zápisu do studia

První předloženo

6. května 2013

První předloženo, které splnilo kritéria kontroly kvality

15. května 2013

První zveřejněno (Odhad)

20. května 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

17. června 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. června 2015

Naposledy ověřeno

1. června 2015

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 11-1027-CE

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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