In Chinese women who require breast cancer surgery, use of a decision aid booklet reduces decisional conflict, treatment decision-making difficulty, and post-surgery decision regret. Decision aids should be available as part of the routine clinical service, specifically to support post-consultation decision making.published_or_final_versio

Butow, P

Chan, M

Cowling, BJ

Fielding, R

Kwong, A

Lam, WWT

Or, A

Suen, DTK

Hong Kong Medical Journal

HKU Scholars Hub

Title Decision aids for breast cancer surgery: a randomisedcontrolled trialAuthor(s) Lam, WWT; Fielding, R; Butow, P; Cowling, BJ; Chan, M; Or, A;Kwong, A; Suen, DTKCitation Hong Kong Medical Journal, 2014, v. 20 n. 6, Suppl. 7, p. 24-27Issued Date 2014URL http://hdl.handle.net/10722/208765Rights Hong Kong Medical Journal. Copyright © Hong Kong Academyof Medicine Press.24 Hong Kong Med J  ⎥  Volume 20 Number 6 (Supplement 7)  ⎥  December 2014  ⎥  www.hkmj.org Hong Kong Med J  ⎥  Volume 20 Number 6 (Supplement 7)  ⎥  December 2014  ⎥  www.hkmj.orgK e y  M e s s a g e In Chinese women who require breast cancer surgery, use of a decision aid booklet reduces decisional conflict, treatment decision-making difficulty, and post-surgery decision regret. Decision aids should be available as part of the routine clinical service, specifically to support post-consultation decision making.Decision aids for breast cancer surgery:  a randomised controlled trialIntroductionBreast cancer management involves medical, surgical, and radiotherapeutic treatments. Our previous study showed that approximately one in seven of the ~2500 Chinese women diagnosed with breast cancer each year suffer from increased psychological morbidity attributable to treatment decision-making (TDM) difficulty.1,2 Two-thirds of the women preferred shared rather than sole responsibility for TDM, with guidance received from doctors.3 However, most women were left to decide on treatment alone, and many opted to have more extensive surgery than necessary, owing to a fear of prolonged treatment and associated social stigmatisation.3 The social and relationship consequences of this choice are often poorly comprehended before treatment and thus compound subsequent psychosocial morbidity. Information and decision-support strategies are needed to optimise women’s breast cancer TDM.  Decision aids facilitate decision making by emphasising alternatives, probability of risks and benefits, and personal values.4 In a systematic review of the effect of decision aids in women with breast cancer, those who used a decision aid were more likely to choose breast-conserving therapy, were more knowledgeable about breast cancer, and had less decisional conflict and were more satisfied with the decision-making process.5 Nonetheless, there is no evidence that decision aids directly benefit health outcomes such as psychological morbidity. Their benefit may be mediated by patient satisfaction with the decision process.  This study assessed the effect of decision aids on the decision-making process, satisfaction with TDM, and psychological morbidity in women undergoing breast cancer surgery.Hong Kong Med J 2014;20(Suppl 7):S24-7HHSRF project number: 07080651WWT Lam *, R Fielding, P Butow, BJ Cowling, M Chan, A Or, A Kwong, D Suen1 WWT Lam *, 1 R Fielding, 2 P Butow, 1 BJ Cowling, 3 M Chan, 3 A Or, 4 A Kwong, 4 D Suen1  Department of Community Medicine, School of Public Health, The University of Hong Kong2 School of Psychology, University of Sydney3 The Breast Centre, Department of Surgery, Kwong Wah Hospital4 Breast Surgery Division, Department of Surgery, The University of Hong Kong* Principal applicant and corresponding author: wwtlam@hku.hkMethodsThis randomised controlled trial was conducted from December 2009 to November 2011 at Kwong Wah Hospital Breast Centre and Tung Wah Hospital Breast Centre. Ethical approval was obtained. Cantonese/Mandarin-speaking Chinese women with early-stage breast cancer who had no other cancer history, were fit for surgery, and consented to be interviewed were invited to participate. Patients were excluded if they were to receive chemotherapy as a neo-adjuvant therapy, came for a second opinion, had metastasis or recurrence of breast cancer, or were cognitively impaired or physically unfit to complete the interview.  Women were block randomised by week to either an intervention (decision aid booklet) or control (standard-information booklet) arm. Procedures and wordings were identical. The corresponding booklet was provided prior to making a decision by telephone about treatment. The decision aid booklet comprised information about (1) the main differences between the available treatment options and their associated probable outcome, (2) benefits and costs of the available treatments, (3) methods for clarifying patients’ values, and (4) structured guidance in reaching a decision. The standard-information booklet contained information on diagnosis, treatment, and management of breast cancer in general terms and was not designed to help make a specific, personal treatment decision.  Women were asked to complete questionnaires immediately (baseline: time 1) and within 7 days (time 2) of consultation, and at 4 weeks (time 3), 4 months (time 4), and 10 months (time 5) post-surgery. Face-to-face interviews were conducted at HEALTH AND HEALTH SERVICES RESEARCH FUNDHong Kong Med J  ⎥  Volume 20 Number 6 (Supplement 7)  ⎥  December 2014  ⎥  www.hkmj.org#  Decision aids for breast cancer surgery  # 25Hong Kong Med J  ⎥  Volume 20 Number 6 (Supplement 7)  ⎥  December 2014  ⎥  www.hkmj.orgbaseline and follow-up assessments.  Outcome measures included satisfaction with the decision process (scores of TDM difficulty and decisional conflict), psychological morbidity (scores of Chinese Health Questionnaire and Hospital Anxiety and Depression Scale [HADS]), satisfaction with the treatment decision (scores of decision regret), and knowledge of breast cancer.  The two groups were compared using linear mixed effects (LME) models to control the random effects of hospital sites and surgeons. Covariates correlated with outcome measures were also included in the models to adjust for confounders. Intention-to-treat analysis was also used. For repeated measures (decision regret, psychological distress, and realistic outcome expectation), mean differences within and between groups were analysed using LME models, with random subject effects estimated for the intercept, slope for time, time-squared, and time-cubed. The quadratic and cubic effects of time were included to account for non-linear change over time. The LEM model was adjusted for relevant demographic and clinical variables, and decision-making factors. To assess whether the booklet significantly influenced psychological morbidity, the mediating effect of patient satisfaction with TDM and use of the booklet on psychological morbidity was tested.ResultsA total of 276 women were randomised to the intervention (n=138) or control (n=138) group (Fig 1); 225 (81.5%) women (113 in intervention and 112 in control groups) were offered more than one treatment option (Table 1). Compared with controls, decision aids were associated with lower scores for TDM difficulty (β=1.8, P=0.016), decisional conflict (β=5.8, P=0.004), and decision regret (β=4.55, P<0.05) [Table 2]. Nonetheless, the two groups did not differ significantly in terms of decision regret at 4 weeks, FIG.  The CONSORT diagramAssessed for eligibility (n=540)Block randomisation (by week of attendance) (n=276)Pre-intervention assessment completed (n=276)Allocated to intervention (n=138)1st post-intervention assessment completed (n=138)2nd post-intervention assessment completed (n=118), lost to follow-up (n=15), and refused (n=5)3rd post-intervention assessment completed (n=110), lost to follow-up (n=13), and refused (n=15)4th post-intervention assessment completed (n=107), lost to follow-up (n=8), refused (n=21), and deceased (n=2)Excluded from analysis (n=25)Analysed at baseline and 1st, 2nd, 3rd, and 4th post-intervention assessment (n=113, 113, 101, 91, 88, respectively) 1st post-intervention assessment completed (n=138)2nd post-intervention assessment completed (n=119), lost to follow-up (n=15), and refused (n=4)3rd post-intervention assessment completed (n=106), lost to follow-up (n=17), and refused (n=15)4th post-intervention assessment completed (n=107), lost to follow-up (n=9), refused (n=21), and deceased (n=1)Excluded from analysis (n=26) Analysed at baseline and 1st, 2nd, 3rd, and 4th post-intervention assessment (n=112, 112, 97, 88, 90, respectively)Allocated to Control (n=138)Excluded (n=264)•  Not meeting inclusion criteria (n=217)•  Declined to participate (n=30)•  Failed to trace the patients (n=17)  #  Lam et al #26 Hong Kong Med J  ⎥  Volume 20 Number 6 (Supplement 7)  ⎥  December 2014  ⎥  www.hkmj.org Hong Kong Med J  ⎥  Volume 20 Number 6 (Supplement 7)  ⎥  December 2014  ⎥  www.hkmj.orgrealistic outcome expectation, knowledge of breast cancer, or scores of Chinese Health Questionnaire, HADS-Anxiety and HADS-Depression. DiscussionDecision aids decreased TDM difficulty, decisional conflict, and decision regret, without increasing anxiety. Decision aids could be an adjunct to post-consultation support in TDM. The effect of decision aids on psychological morbidity was not mediated by patient satisfaction with the decision process. Psychological distress was associated with TDM difficulty, decision regret, and lack of treatment recommendation from the surgeon. Decision aids minimised TDM difficulty. This highlights the importance of reducing the level of TDM difficulty for women considering breast cancer surgery. Future study is needed to identify the optimal strategy TABLE 1.  Patient demographics*Variable Decision aids (n=138) Controls (n=138) P valueAge (years) 56.8±10.8 54.6±10.1 >0.05Marital status >0.05Married 85 (61.6) 87 (63)Single 21 (15.2) 19 (13.8)Divorced 12 (8.7) 12 (8.7)Widowed 20 (14.5) 20 (14.5)Education level >0.05No formal education 8 (5.8) 11 (8.0)Primary 44 (31.9) 40 (29.0)Secondary 71 (51.4) 73 (52.9)Tertiary 15 (10.9) 14 (10.1)Occupation >0.05Employed 51 (36.9) 63 (45.6)Retired 37 (26.8) 27 (19.6)Housewife 40 (29) 30 (21.7)Unemployed 10 (7.25) 18 (13.0)Monthly household income (HK$) >0.05≤10 000 55 (42) 56 (43.8)10 001-20 000 43 (32.8) 36 (28.1)20 001-30 000 18 (13.7) 20 (15.6)30 001-40 000 8 (6.1) 9 (7.0)>40 000 7 (5.3) 7 (5.5)Family history of breast cancer 14 (10.1) 13 (9.4) >0.05More than one treatment choice 113 (83.7) 112 (83.0) >0.05Stage of breast cancer >0.050 31 (37.8) 21 (28.8)I/II 42 (51.3) 47 64.4)III 9 (11) 5 (6.8)Active chemotherapyAt 1 month 21 (18.1) 19 (22) >0.05At 4 months 29 (28.2) 26 (25) >0.05At 10 months 0 (0) 0 (0) >0.05Active radiotherapyAt 1 month 9 (8.6) 5 (4.8) >0.05At 4 months 9 (8.6) 4 (4.8) >0.05At 10 months 2 (2) 1 (1) >0.05Active hormonal therapyAt 4 months 31 (30.1) 33 (31.7) >0.05At 10 months 65 (63.7) 64 (62.7) >0.05* Data are presented as mean±SD or No. (%) of patientsHong Kong Med J  ⎥  Volume 20 Number 6 (Supplement 7)  ⎥  December 2014  ⎥  www.hkmj.org#  Decision aids for breast cancer surgery  # 27Hong Kong Med J  ⎥  Volume 20 Number 6 (Supplement 7)  ⎥  December 2014  ⎥  www.hkmj.orgTABLE 2.  Comparison of outcomesVariable Decision aid (n=113) Mean±SDControls (n=112) Mean±SDAdjusted β±SE (95% CI) [decision aid as reference]P value (95% CI)Treatment decision-making difficulty 17.5±6.3 19.1±6.4 1.8±0.7 (0.34-3.24) 0.016 (0.34-3.24)Decisional conflict 15.8±15.5 19.9±16.3 5.8±1.9 (1.85-9.71) 0.004 (1.85-9.71)Knowledge of breast cancer 6.1±2.1 5.9±2.1 -0.17±0.2 (-0.65-0.31) >0.05 (-0.65-0.31)Chinese Health Questionnaire 4 weeks 7.8±4.8 8.3±5.8 0.5±0.6 (-0.71-1.70) >0.05 (-0.71-1.70)4 months 7.6±5.3 7.3±5.6 0.21±0.69 (-1.17-1.57) >0.0510 months 6.7±4.9 7.5±5.6 1.4±0.7 (-0.07-2.86) >0.05Hospital Anxiety and Depression Scale (HADS)-Anxiety4 weeks 2.5±3.2 2,6±3.3 -0.1±0.4 (-0.94-0.67) >0.05 (-0.94-0.67)4 months 2.2±3.2 2.1±3.1 -0.08±0.38 (-0.85-0.68) >0.0510 months 2.7±3.5 2.8±3.6 0.28±0.47 (-0.65-1.22) >0.05HADS-Depression4 weeks 2.3±2.7 2.3±2.7 0.1±0.3 (-0.58-0.61) >0.05 (-0.58-0.61)4 months 2.1±3.3 1.9±2.4 0.07±0.32 (-0.56-0.71) >0.0510 months 1.4±1.9 2.5±3.4 1.38±0.41 (0.58-2.19) 0.001 Decision regret4 weeks 21.4±17.2 23.1±18.3 1.6±2.4 (-3.19-6.47) >0.05 (-3.19-6.47)4 months 18.8±15.8 24.4±18.9 5.9±2.5 (0.95-10.84) 0.02 10 months 20.1±14.5 24.6±18.8 6.1±2.4 (1.28-10.94) 0.014 Realistic outcome expectation4 weeks -0.01±0.64 -0.11±0.56 -0.04±0.08 (-0.20-0.11) >0.05 (-0.20-0.11)4 months -0.19±0.64 -0.20±0.56 0.05±0.09 (-0.13-0.24) >0.05 (-0.13-0.24)10 months -0.28±0.56 -0.22±0.57 0.15±0.09 (-0.21-0.33) >0.05Surgical decisionNo. (%) of patients having breast-conserving therapy (BCT) as an optionOut of 73 Out of 86 >0.05BCT 29 (43) 41 (51)Modified radical mastectomy (MRM) 31 (46) 32 (39)MRM plus reconstruction 7 (10) 7 (10)No. (%) of patients not having BCT as an option Out of 40 Out of 26 >0.05BCT 3 (7.9) 1 (4.3)MRM 30 (78.9) 14 (60.9)MRM plus reconstruction 5 (13.2) 8  (34.8)to integrate decision aids into routine clinical practice. AcknowledgementsThis study was supported by the Health and Health Services Research Fund, Food and Health Bureau, Hong Kong SAR Government (#07080651). Results of this study have been published in: Lam WW, Chan M, Or A, Kwong A, Suen D, Fielding R. Reducing treatment decision conflict difficulties for breast cancer surgery: a randomized controlled trial. J Clin Oncol 2013;31:2879-85.References1. Lam WW, Chan M, Ka HW, Fielding R. Treatment decision difficulties and post-operative distress predict persistence of psychological morbidity in Chinese women following breast cancer surgery. Psychooncology 2007;16:904-12.2. Lam WW, Bonanno GA, Mancini AD, et al. Trajectories of psychological distress among Chinese women diagnosed with breast cancer. Psychooncology 2010;19:1044-51.3. Lam W, Fielding R, Chan M, Chow L, Ho E. Participation and satisfaction with surgical treatment decision-making in breast cancer among Chinese women. Breast Cancer Res Treat 2003;80:171-80.4. O’Connor AM, Bennett CL, Stacey D, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Sys Rev 2009;3:CD001431.5. 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;25:1067-73.

Decision aids for breast cancer surgery: a randomised controlled trial

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Decision aids for breast cancer surgery: a randomised controlled trial

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