Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial

Jennica Platt, Nancy Baxter, Jennifer Jones, Kelly Metcalfe, Natalie Causarano, Stefan O P Hofer, Anne O'Neill, Terry Cheng, Elizabeth Starenkyj, Toni Zhong, Jennica Platt, Nancy Baxter, Jennifer Jones, Kelly Metcalfe, Natalie Causarano, Stefan O P Hofer, Anne O'Neill, Terry Cheng, Elizabeth Starenkyj, Toni Zhong

Abstract

Background: The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.

Methods/design: This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.

Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada.

Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.

Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.

Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired.

Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.

Discussion: Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.

Trial registration: NCT01857882.

Figures

Figure 1
Figure 1
Delayed breast reconstruction. (A) Preoperative photograph demonstrating right mastectomy defect after post-mastectomy radiation. (B) Postoperative photograph after delayed breast reconstruction using autologous tissue reconstruction.
Figure 2
Figure 2
Study design flowchart and participant timeline.
Figure 3
Figure 3
Values clarification exercise. The last component of the Pre-Consultation Educational Group Intervention is the values clarification exercise. Using an interactive example, the purpose of the values clarification exercise is explained, and patients are invited to consider their personal values and complete the exercise. This is brought to the surgical consultation to incorporate patient values into the shared decision-making process.

References

    1. Rowland JH, Aziz N, Tesauro G, Feuer EJ. The changing face of cancer survivorship. Semin Oncol Nurs. 2001;17(4):236–240. doi: 10.1053/sonu.2001.27912.
    1. Canadian Cancer Society’s Steering Committee on Cancer Statistics. Canadian Cancer Statistics. Canadian Cancer Society. 2011. Available at: - Policy - Canadian Cancer Statistics - English/Canadian Cancer Statistics 2011 - English.ashx. Accessed Oct. 29, 2011.
    1. Habermann EB, Abbott A, Parsons HM, Virnig BA, Al-Refaie WB, Tuttle TM. Are mastectomy rates really increasing in the United States? J Clin Oncol. 2010;28(21):3437–3441. doi: 10.1200/JCO.2009.27.6774.
    1. Cordeiro PG. Breast reconstruction after surgery for breast cancer. N Engl J Med. 2008;359(15):1590–1601. doi: 10.1056/NEJMct0802899.
    1. Zhong TC M, Min S, Satisfaction and health-related quality of life following autologous tissue breast reconstruction: a prospective analysis of early postoperative outcomes. Cancer.
    1. Potter S, Winters ZE. Does breast reconstruction improve quality of life for women facing mastectomy? A systematic review. Eur J Surg Oncol. 2008;34:1181. Abstract P1163.
    1. Elder EE, Brandberg Y, Bjorklund T. et al.Quality of life and patient satisfaction in breast cancer patients after immediate breast reconstruction: a prospective study. Breast. 2005;14(3):201–208. doi: 10.1016/j.breast.2004.10.008.
    1. Wilkins EG, Cederna PS, Lowery JC. et al.Prospective analysis of psychosocial outcomes in breast reconstruction: one-year postoperative results from the Michigan Breast Reconstruction Outcome Study. Plast Reconstr Surg. 2000;106(5):1014–1025. doi: 10.1097/00006534-200010000-00010. discussion 1026–1017.
    1. Yueh JH, Slavin SA, Adesiyun T. et al.Patient satisfaction in postmastectomy breast reconstruction: a comparative evaluation of DIEP, TRAM, latissimus flap, and implant techniques. Plast Reconstr Surg. 2010;125(6):1585–1595. doi: 10.1097/PRS.0b013e3181cb6351.
    1. Cordeiro PG, McCarthy CM. A single surgeon’s 12-year experience with tissue expander/implant breast reconstruction: part II. An analysis of long-term complications, aesthetic outcomes, and patient satisfaction. Plast Reconstr Surg. 2006;118(4):832–839. doi: 10.1097/01.prs.0000232397.14818.0e.
    1. Hu ES, Pusic AL, Waljee JF. et al.Patient-reported aesthetic satisfaction with breast reconstruction during the long-term survivorship period. Plast Reconstr Surg. 2009;124(1):1–8. doi: 10.1097/PRS.0b013e3181ab10b2.
    1. Lantz PM, Janz NK, Fagerlin A. et al.Satisfaction with surgery outcomes and the decision process in a population-based sample of women with breast cancer. Health Serv Res. 2005;40(3):745–767. doi: 10.1111/j.1475-6773.2005.00383.x.
    1. Coulter A. Patient information and shared decision-making in cancer care. Br J Cancer. 2003;89(Suppl 1):S15–S16.
    1. Lee CN, Hultman CS, Sepucha K. Do patients and providers agree about the most important facts and goals for breast reconstruction decisions? Ann Plast Surg. 2010;64(5):563–566.
    1. Spector D, Mayer DK, Knafl K, Pusic A. Not what I expected: informational needs of women undergoing breast surgery. Plast Sur Nurs. 2010;30(2):70–74. quiz 75–76.
    1. Nissen MJ, Swenson KK, Kind EA. Quality of life after postmastectomy breast reconstruction. Oncol Nurs Forum. 2002;29(3):547–553. doi: 10.1188/02.ONF.547-553.
    1. Fernandes-Taylor S, Bloom JR. Post-treatment regret among young breast cancer survivors. Psychooncology. 2011;20(5):506–516. doi: 10.1002/pon.1749.
    1. 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;15(1):9–19. doi: 10.1002/pon.907.
    1. Sheehan J, Sherman KA, Lam T, Boyages J. Association of information satisfaction, psychological distress and monitoring coping style with post-decision regret following breast reconstruction. Psychooncology. 2007;16(4):342–351. doi: 10.1002/pon.1067.
    1. Wennberg JE, Fisher ES, Skinner JS. Geography and the debate over medicare reform. Health Aff. 2002.
    1. O’Connor Annette M. User manual - decision self-efficacy scale [document on the internet]. 1995 [modified 2002] Ottawa Hospital Research Institute; Available at: . Accessed Jan 21, 2012.
    1. Hacking B, Wallace L, Scott S, Kosmala-Anderson J, Belkora J, McNeill A. Testing the feasibility, acceptability and effectiveness of a ‘decision navigation’ intervention for early stage prostate cancer patients in Scotland – a randomised controlled trial. Psychooncology. 2012. May 9.
    1. Platt J, Baxter N, Zhong T. Breast reconstruction after mastectomy for breast cancer. CMAJ Canadian Med Assoc J. 2011;183(18):2109–2116. doi: 10.1503/cmaj.110513.
    1. Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med. 1999;49(5):651–661. doi: 10.1016/S0277-9536(99)00145-8.
    1. O’Connor Annette M. Ottawa Decision Support Framework to address decisional conflict. 2006. . Accessed Oct. 29, 2011.
    1. Stacey D, Bennett Carol L, Barry Michael J, Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011. .
    1. O’Connor Annette M, Llewellyn-Thomas H, Stacey DH. International Patient Decision Aid Standards Collaboration: Background Document. 2005. .
    1. Fitch M. Supportive care for cancer patients. Hosp Q. 2000;3(4):39–46.
    1. Adamsen L, Rasmussen JM. Sociological perspectives on self-help groups: reflections on conceptualization and social processes. J Adv Nurs. 2001;35(6):909–917. doi: 10.1046/j.1365-2648.2001.01928.x.
    1. Jones JM, Cheng T, Jackman M, Getting back on track: evaluation of a brief group psychoeducation intervention for women completing primary treatment for breast cancer. Psychooncology. 2011. Sep 9.
    1. Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82. doi: 10.1177/1525822X05279903.
    1. O’Connor Annette M. User Manual - Decision Conflict Scale (16 item statement format) [document on the Internet] Ottawa Hospital Research Institute; 1993. Available at: . Accessed; cited 2011.11.10.
    1. O’Connor Annette M. User Manual - Measures of Decision/Choice Predisposition [document on the Internet] Ottawa Hospital Research Insitute; 1996. Available at: . Accessed 03 OCTOBER, 2012.
    1. McCaffery K, Irwig L, Bossuyt P. Patient decision aids to support clinical decision making: evaluating the decision or the outcomes of the decision. Med Decis Making. 2007;27(5):619–625. doi: 10.1177/0272989X07306787.
    1. Lerman CE, Brody DS, Caputo GC, Smith DG, Lazaro CG, Wolfson HG. Patients’ perceived involvement in care scale: relationship to attitudes about illness and medical care. J Gen Intern Med. 1990;5:29–33. doi: 10.1007/BF02602306.
    1. Klassen AF, Pusic AL, Scott A, Klok J, Cano SJ. Satisfaction and quality of life in women who undergo breast surgery: a qualitative study. BMC Womens Health. 2009;9:11. doi: 10.1186/1472-6874-9-11.
    1. Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009;124(2):345–353. doi: 10.1097/PRS.0b013e3181aee807.
    1. Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality of life instruments: attributes and review criteria. Qual Life Res. 2002;11:193–205. doi: 10.1023/A:1015291021312.
    1. U.S. Food and Drug Administration. Patient reported outcome measures: Use in medical product development to support labelling claims. 2006.
    1. Sepucha K, Belkora J, Mutchnick S, Esserman L. Consultation planning to help breast cancer patients prepare for medical consultations: effect on communication and satisfaction for patients and physicians. J Clin Oncol. 2002;20(11):2695–2700. doi: 10.1200/JCO.2002.10.068.
    1. Lee CN, Belkora J, Chang Y, Moy B, Partridge A, Sepucha K. Are patients making high-quality decisions about breast reconstruction after mastectomy? [outcomes article] Plast Reconstr Surg. 2011;127(1):18–26. doi: 10.1097/PRS.0b013e3181f958de.
    1. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.
    1. Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705–714. doi: 10.1016/0277-9536(91)90150-B.
    1. Degner LF, Kristjanson LJ, Bowman D. et al.Information needs and decisional preferences in women with breast cancer. JAMA. 1997;277(18):1485–1492. doi: 10.1001/jama.1997.03540420081039.
    1. Creswell JW. Qualitative Inquiry and Research Design. Thousand Oaks, CA: Sage Publications; 1998.
    1. Straus A, Corbin J. Basics of Qualitative Research. 2. Thousand Oaks, CA: Sage Publications; 1998.
    1. Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008;31(2):180–191. doi: 10.1002/nur.20247.
    1. Waljee JF, Rogers MA, Alderman AK. Decision aids and breast cancer: do they influence choice for surgery and knowledge of treatment options? J Clin Oncol. 2007;25(9):1067–1073. doi: 10.1200/JCO.2006.08.5472.
    1. Sepucha KR, Fowler FJ, Jr, Mulley AG. , JrPolicy support for patient-centered care: the need for measurable improvements in decision quality. Health Aff (Millwood) 2004. Suppl Variation: VAR54-62.
    1. Preminger BA, Lemaine V, Sulimanoff I, Pusic AL, McCarthy CM. Preoperative patient education for breast reconstruction: a systematic review of the literature. J Cancer Educ. 2011;26(2):270–276. doi: 10.1007/s13187-010-0182-y.
    1. Heller L, Parker PA, Youssef A, Miller MJ. Interactive digital education aid in breast reconstruction. Plast Reconstr Surg. 2008;122(3):717–724. doi: 10.1097/PRS.0b013e318180ed06.
    1. Lee BT, Chen C, Yueh JH, Nguyen M-D, Lin SJ, Tobias AM. Computer-based learning module increases shared decision making in breast reconstruction. Ann Surg Oncol. 2009;17(3):738–743.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj