Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350854
• Other study ID #: IRB_00081898
• Status: Completed
• Phase: N/A
• First received: October 13, 2017
• Last updated: November 20, 2017
• Start date: March 7, 2016
• Est. completion date: August 9, 2017

Study information

• Verified date: November 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 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.

Description:

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.

1. 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.

2. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments.

3. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 9, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Patient Preference in Treatment Decision Making
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

References & Publications (35)

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. — View Citation

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. — View Citation

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de Haes H. Dilemmas in patient centeredness and shared decision making: a case for vulnerability. Patient Educ Couns. 2006 Sep;62(3):291-8. Epub 2006 Jul 21. Review. — View Citation

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. — View Citation

Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43. — View Citation

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. Review. — View Citation

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. Epub 2006 Jul 24. — View Citation

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. — View Citation

Gattellari M, Butow PN, Tattersall MH. Sharing decisions in cancer care. Soc Sci Med. 2001 Jun;52(12):1865-78. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nguyen F, Moumjid N, Charles C, Gafni A, Whelan T, Carrère 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. — View Citation

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. Epub 2007 Sep 24. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Sepucha KR, Barry MJ. Making patient-centered cancer care a reality. Cancer. 2009 Dec 15;115(24):5610-1. doi: 10.1002/cncr.24824. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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):1145-51. doi: 10.1093/annonc/mdp534. Epub 2009 Nov 25. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision role concordance before and after a surgical consultation	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.	The estimated period is 3 hours (before and immediately after a surgical consultation)
Primary	Decision role concordance of provider and patient	It measures the difference in the patient's perception of the achieved role and provider's perception of the patient's preferred role.	This is an one-time measurement (Immediately after a surgical consultation)
Secondary	Patient's satisfaction with the decision making process	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.	immediately after a surgical consultation
Secondary	Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups	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.	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.
Secondary	The Decision Regret outcome	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.	The scale will be administered at 2 weeks and 6 months after initial clinic visit.
Secondary	Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement	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"	4 months after initial clinic visit
Secondary	completion or intention to complete therapies	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.	6 months after initial clinic visit

External Links

•   AHRQ. National Healthcare Quality Report. 2005 [cited 2015 August 13]
•   Committee on Quality Health Care in America, I.o.M., Crossing the quality chasm: a new health system for the 21st century. 2001: Washington, DC.
•   Epstein RM, S.R., Jr., Patient-Centered Communication in Cancer Care: Promoting Healing and Reducing Suffering. 2007, National Cancer Institute: Bethesda, MD.