- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03350854
Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients
An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In addition, role concordance will be associated with improved short-term and longer-term improvements in outcomes of the following parameters: a) satisfaction with decision process b) breast specific QOL, and c) decision regret.
The investigators propose a mixed methods, interventional study with concurrent controls performed in a breast cancer surgery clinic at a comprehensive cancer center. The Patient Preference Scale will be used to identify the preferred involvement in decision making of newly diagnosed breast cancer patients prior to their first clinic visit. The Patient Perception Scale will be used after the encounter in order to evaluate role concordance. The Provider Perception Scale will also be used to assess the perception of the achieved role by the provider. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process. Clinical encounters will be audiotaped, transcribed, and scored for patient involvement. The investigators propose the following aims and hypotheses:
Investigate the impact of a brief provider-led intervention about the patients' preferred role in treatment decision making on role concordance. The investigators hypothesize that:
1. Role concordance will be improved when the preferred role is discussed with the patient at the beginning of the encounter.
2. The provider's perception of the role achieved will be more concordant with the patient's perception when the preferred role is discussed. 3. Investigate the impact of role concordance in the treatment decision making process on short term and long term quality of life and decision outcomes. The investigators hypothesize that: Patients who achieve role concordance will be more satisfied with the decision process.
- Patients who achieve role concordance will have better QOL and less decision regret at early (2 to 6 weeks) and later (6 months) time points after the clinic visit.
- Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments.
- Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
Exclusion Criteria:
- Men with breast cancer.
- Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: The non-intervention control group
In the non-intervention control group, providers are blind to the patient's preferred decision making role.
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Experimental: The intervention group
The provider will be informed of the patient preference in treatment decision making (preferred role) and have a discussion about this with the patient in the intervention group.
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The roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire.
Once the questionnaire is administered, the patient will then proceed to original surgical appointment.
The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Decision role concordance before and after a surgical consultation
Periodo de tiempo: The estimated period is 3 hours (before and immediately after a surgical consultation)
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The primary outcome measures the changes from patient's preferred role in baseline (before a surgical consultation) to the perception of whether the patient achieved the preferred role (immediately after a surgical consultation) in the surgical consultation.
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The estimated period is 3 hours (before and immediately after a surgical consultation)
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Decision role concordance of provider and patient
Periodo de tiempo: This is an one-time measurement (Immediately after a surgical consultation)
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It measures the difference in the patient's perception of the achieved role and provider's perception of the patient's preferred role.
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This is an one-time measurement (Immediately after a surgical consultation)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient's satisfaction with the decision making process
Periodo de tiempo: immediately after a surgical consultation
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Satisfaction with the decision making process will be measured directly after the clinic encounter using a modified version of the Holmes-Rovner Satisfaction with Decision scale.
The scale uses a Likert-type ranking of 6 items related to decision making, with 1 being strongly disagree and 5 being strongly agree.
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immediately after a surgical consultation
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Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups
Periodo de tiempo: This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.
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Quality of life will be assessed using the (FACT-B) questionnaire.
FACT-B measures 27 items in five different areas: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific to this patient population.
FACT-B is measured on the scale from 0 to 4, with a total minimum score of 0 and maximum score of 144.
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This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.
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The Decision Regret outcome
Periodo de tiempo: The scale will be administered at 2 weeks and 6 months after initial clinic visit.
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The decision regret outcome will be measured using the Decision Regret Scale.
The Decision Regret Scale is is a 5 item scale with items ranked on a 5-point Likert-type scale and added together with higher score indicating more regret.
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The scale will be administered at 2 weeks and 6 months after initial clinic visit.
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Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement
Periodo de tiempo: 4 months after initial clinic visit
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The outcome of patient involvement at the clinic encounter will be measured using the OPTION scale.
This scale measures 12 item from 0 to 4, with 0 being "this behavior is not observed" to 4 "This behavior is exhibited to a very high standard"
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4 months after initial clinic visit
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completion or intention to complete therapies
Periodo de tiempo: 6 months after initial clinic visit
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Group differences in completion or intention to complete recommended therapies will be assessed at 6 months after the clinic visit through chart review of all participants' charts.
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6 months after initial clinic visit
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cindy Matsen, MD, University of Utah
Publicaciones y enlaces útiles
Publicaciones Generales
- Degner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau B, Watson P, Mueller B. Information needs and decisional preferences in women with breast cancer. JAMA. 1997 May 14;277(18):1485-92.
- Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
- Hack TF, Degner LF, Watson P, Sinha L. Do patients benefit from participating in medical decision making? Longitudinal follow-up of women with breast cancer. Psychooncology. 2006 Jan;15(1):9-19. doi: 10.1002/pon.907.
- Janz NK, Wren PA, Copeland LA, Lowery JC, Goldfarb SL, Wilkins EG. Patient-physician concordance: preferences, perceptions, and factors influencing the breast cancer surgical decision. J Clin Oncol. 2004 Aug 1;22(15):3091-8. doi: 10.1200/JCO.2004.09.069.
- Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns. 2012 Jan;86(1):9-18. doi: 10.1016/j.pec.2011.02.004. Epub 2011 Apr 6.
- Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9. doi: 10.1016/j.pec.2015.06.022. Epub 2015 Jul 15.
- Tariman JD, Berry DL, Cochrane B, Doorenbos A, Schepp K. Preferred and actual participation roles during health care decision making in persons with cancer: a systematic review. Ann Oncol. 2010 Jun;21(6):1145-1151. doi: 10.1093/annonc/mdp534. Epub 2009 Nov 25.
- Dwamena F, Holmes-Rovner M, Gaulden CM, Jorgenson S, Sadigh G, Sikorskii A, Lewin S, Smith RC, Coffey J, Olomu A. Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev. 2012 Dec 12;12:CD003267. doi: 10.1002/14651858.CD003267.pub2.
- Sepucha K, Ozanne EM. How to define and measure concordance between patients' preferences and medical treatments: A systematic review of approaches and recommendations for standardization. Patient Educ Couns. 2010 Jan;78(1):12-23. doi: 10.1016/j.pec.2009.05.011. Epub 2009 Jun 30.
- Sepucha KR, Barry MJ. Making patient-centered cancer care a reality. Cancer. 2009 Dec 15;115(24):5610-1. doi: 10.1002/cncr.24824. No abstract available.
- Livaudais JC, Franco R, Fei K, Bickell NA. Breast cancer treatment decision-making: are we asking too much of patients? J Gen Intern Med. 2013 May;28(5):630-6. doi: 10.1007/s11606-012-2274-3. Epub 2012 Nov 15.
- Katz SJ, Lantz PM, Janz NK, Fagerlin A, Schwartz K, Liu L, Deapen D, Salem B, Lakhani I, Morrow M. Patient involvement in surgery treatment decisions for breast cancer. J Clin Oncol. 2005 Aug 20;23(24):5526-33. doi: 10.1200/JCO.2005.06.217.
- Singh JA, Sloan JA, Atherton PJ, Smith T, Hack TF, Huschka MM, Rummans TA, Clark MM, Diekmann B, Degner LF. Preferred roles in treatment decision making among patients with cancer: a pooled analysis of studies using the Control Preferences Scale. Am J Manag Care. 2010 Sep;16(9):688-96.
- Frongillo M, Feibelmann S, Belkora J, Lee C, Sepucha K. Is there shared decision making when the provider makes a recommendation? Patient Educ Couns. 2013 Jan;90(1):69-73. doi: 10.1016/j.pec.2012.08.016. Epub 2012 Sep 20.
- Johnson JD, Roberts CS, Cox CE, Reintgen DS, Levine JS, Parsons M. Breast cancer patients' personality style, age, and treatment decision making. J Surg Oncol. 1996 Nov;63(3):183-6. doi: 10.1002/(SICI)1096-9098(199611)63:33.0.CO;2-9.
- Almyroudi A, Degner LF, Paika V, Pavlidis N, Hyphantis T. Decision-making preferences and information needs among Greek breast cancer patients. Psychooncology. 2011 Aug;20(8):871-9. doi: 10.1002/pon.1798. Epub 2010 Jul 11.
- Budden LM, Pierce PF, Hayes BA, Buettner PG. Australian women's prediagnostic decision-making styles, relating to treatment choices for early breast cancer treatment. Res Theory Nurs Pract. 2003 Summer;17(2):117-36. doi: 10.1891/rtnp.17.2.117.53178.
- Vogel BA, Bengel J, Helmes AW. Information and decision making: patients' needs and experiences in the course of breast cancer treatment. Patient Educ Couns. 2008 Apr;71(1):79-85. doi: 10.1016/j.pec.2007.11.023. Epub 2008 Jan 8.
- Vogel BA, Helmes AW, Hasenburg A. Concordance between patients' desired and actual decision-making roles in breast cancer care. Psychooncology. 2008 Feb;17(2):182-9. doi: 10.1002/pon.1215.
- Wallberg B, Michelson H, Nystedt M, Bolund C, Degner LF, Wilking N. Information needs and preferences for participation in treatment decisions among Swedish breast cancer patients. Acta Oncol. 2000;39(4):467-76. doi: 10.1080/028418600750013375.
- Lantz PM, Janz NK, Fagerlin A, Schwartz K, Liu L, Lakhani I, Salem B, Katz SJ. Satisfaction with surgery outcomes and the decision process in a population-based sample of women with breast cancer. Health Serv Res. 2005 Jun;40(3):745-67. doi: 10.1111/j.1475-6773.2005.00383.x.
- Hack TF, Pickles T, Ruether JD, Weir L, Bultz BD, Mackey J, Degner LF. Predictors of distress and quality of life in patients undergoing cancer therapy: impact of treatment type and decisional role. Psychooncology. 2010 Jun;19(6):606-16. doi: 10.1002/pon.1590.
- Hyphantis T, Almyroudi A, Paika V, Degner LF, Carvalho AF, Pavlidis N. Anxiety, depression and defense mechanisms associated with treatment decisional preferences and quality of life in non-metastatic breast cancer: a 1-year prospective study. Psychooncology. 2013 Nov;22(11):2470-7. doi: 10.1002/pon.3308. Epub 2013 May 27.
- Hawley ST, Lillie SE, Morris A, Graff JJ, Hamilton A, Katz SJ. Surgeon-level variation in patients' appraisals of their breast cancer treatment experiences. Ann Surg Oncol. 2013 Jan;20(1):7-14. doi: 10.1245/s10434-012-2582-1. Epub 2012 Oct 6.
- Gattellari M, Butow PN, Tattersall MH. Sharing decisions in cancer care. Soc Sci Med. 2001 Jun;52(12):1865-78. doi: 10.1016/s0277-9536(00)00303-8.
- Keating NL, Guadagnoli E, Landrum MB, Borbas C, Weeks JC. Treatment decision making in early-stage breast cancer: should surgeons match patients' desired level of involvement? J Clin Oncol. 2002 Mar 15;20(6):1473-9. doi: 10.1200/JCO.2002.20.6.1473.
- Hillyer GC, Hershman DL, Kushi LH, Lamerato L, Ambrosone CB, Bovbjerg DH, Mandelblatt JS, Rana S, Neugut AI. A survey of breast cancer physicians regarding patient involvement in breast cancer treatment decisions. Breast. 2013 Aug;22(4):548-54. doi: 10.1016/j.breast.2012.10.001. Epub 2012 Oct 27.
- Nguyen F, Moumjid N, Charles C, Gafni A, Whelan T, Carrere MO. Treatment decision-making in the medical encounter: comparing the attitudes of French surgeons and their patients in breast cancer care. Patient Educ Couns. 2014 Feb;94(2):230-7. doi: 10.1016/j.pec.2013.07.011. Epub 2013 Dec 8.
- de Haes H. Dilemmas in patient centeredness and shared decision making: a case for vulnerability. Patient Educ Couns. 2006 Sep;62(3):291-8. doi: 10.1016/j.pec.2006.06.012. Epub 2006 Jul 21. No abstract available.
- Sivell S, Elwyn G, Edwards A, Manstead AS; BresDex group. Factors influencing the surgery intentions and choices of women with early breast cancer: the predictive utility of an extended theory of planned behaviour. BMC Med Inform Decis Mak. 2013 Aug 20;13:92. doi: 10.1186/1472-6947-13-92.
- Fagerlin A, Lakhani I, Lantz PM, Janz NK, Morrow M, Schwartz K, Deapen D, Salem B, Liu L, Katz SJ. An informed decision? Breast cancer patients and their knowledge about treatment. Patient Educ Couns. 2006 Dec;64(1-3):303-12. doi: 10.1016/j.pec.2006.03.010. Epub 2006 Jul 24.
- O'Leary KA, Estabrooks CA, Olson K, Cumming C. Information acquisition for women facing surgical treatment for breast cancer: influencing factors and selected outcomes. Patient Educ Couns. 2007 Dec;69(1-3):5-19. doi: 10.1016/j.pec.2007.08.002. Epub 2007 Sep 24.
- Singer E, Couper MP, Fagerlin A, Fowler FJ, Levin CA, Ubel PA, Van Hoewyk J, Zikmund-Fisher BJ. The role of perceived benefits and costs in patients' medical decisions. Health Expect. 2014 Feb;17(1):4-14. doi: 10.1111/j.1369-7625.2011.00739.x. Epub 2011 Nov 10.
- Sepucha K, Mulley AG Jr. A perspective on the patient's role in treatment decisions. Med Care Res Rev. 2009 Feb;66(1 Suppl):53S-74S. doi: 10.1177/1077558708325511. Epub 2008 Nov 10.
- Street RL Jr, Elwyn G, Epstein RM. Patient preferences and healthcare outcomes: an ecological perspective. Expert Rev Pharmacoecon Outcomes Res. 2012 Apr;12(2):167-80. doi: 10.1586/erp.12.3.
- Gutnik L, Allen CM, Presson AP, Matsen CB. Breast Cancer Surgery Decision Role Perceptions and Choice of Surgery. Ann Surg Oncol. 2020 Oct;27(10):3623-3632. doi: 10.1245/s10434-020-08485-8. Epub 2020 Jun 3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB_00081898
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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