PURPOSE:Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction. METHODS: We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT. RESULTS: Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06. CONCLUSIONS: A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.
RCT Entities:
PURPOSE:Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction. METHODS: We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT. RESULTS: Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06. CONCLUSIONS: A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.
Authors: Elizabeth B Habermann; Andrea Abbott; Helen M Parsons; Beth A Virnig; Waddah B Al-Refaie; Todd M Tuttle Journal: J Clin Oncol Date: 2010-06-14 Impact factor: 44.544
Authors: Andrea L Pusic; Anne F Klassen; Amie M Scott; Jennifer A Klok; Peter G Cordeiro; Stefan J Cano Journal: Plast Reconstr Surg Date: 2009-08 Impact factor: 4.730
Authors: Lehana Thabane; Jinhui Ma; Rong Chu; Ji Cheng; Afisi Ismaila; Lorena P Rios; Reid Robson; Marroon Thabane; Lora Giangregorio; Charles H Goldsmith Journal: BMC Med Res Methodol Date: 2010-01-06 Impact factor: 4.615
Authors: Janet Jull; Sascha Köpke; Maureen Smith; Meg Carley; Jeanette Finderup; Anne C Rahn; Laura Boland; Sandra Dunn; Andrew A Dwyer; Jürgen Kasper; Simone Maria Kienlin; France Légaré; Krystina B Lewis; Anne Lyddiatt; Claudia Rutherford; Junqiang Zhao; Tamara Rader; Ian D Graham; Dawn Stacey Journal: Cochrane Database Syst Rev Date: 2021-11-08
Authors: Clara Nan-Hi Lee; Allison M Deal; Ruth Huh; Peter Anthony Ubel; Yuen-Jong Liu; Lillian Blizard; Caprice Hunt; Michael Patrick Pignone Journal: JAMA Surg Date: 2017-08-01 Impact factor: 14.766
Authors: Toni Zhong; Whitney L Quong; Terry Cheng; Isabel Kerrebijn; Kate Butler; Stefan O P Hofer; Anne C O'Neill; Tulin D Cil; Kelly A Metcalfe Journal: Ann Plast Surg Date: 2021-06-01 Impact factor: 1.539
Authors: France Légaré; Rhéda Adekpedjou; Dawn Stacey; Stéphane Turcotte; Jennifer Kryworuchko; Ian D Graham; Anne Lyddiatt; Mary C Politi; Richard Thomson; Glyn Elwyn; Norbert Donner-Banzhoff Journal: Cochrane Database Syst Rev Date: 2018-07-19
Authors: Ayako Matsuda; Kenichi Inoue; Manami Momiyama; Kobayashi Kunihiko; Kaoru Kubota; Soerindra S R S Ramai; Maarten J Fischer; Judith R Kroep; Adrian A Kaptein; Kazue Yamaoka Journal: Asian Pac J Cancer Prev Date: 2022-01-01
Authors: Rossella Sgarzani; Luca Negosanti; Paolo Giovanni Morselli; Veronica Vietti Michelina; Luigi Maria Lapalorcia; Riccardo Cipriani Journal: Surg Res Pract Date: 2015-11-16