Long-Term Effectiveness of a Decision Support App (Pink Journey) for Women Considering Breast Reconstruction Surgery: Pilot Randomized Controlled Trial

Background Various kinds of breast reconstruction (BR) options, including implants and autologous, and surgery techniques, including traditional and endoscope assisted, can be used to perform surgery. All options have their own advantages and disadvantages. Women decide on an option depending on the values and preferences they emphasize. Lacking knowledge about BR or having decision difficulties during the treatment decision process makes women experience more decision regret, psychological distress, and poor body image. Delivering decision support with a values clarification exercise using eHealth approaches would be beneficial for patient outcomes. Objective This study aims to examine the effects of a decision support app on decision-making quality and psychological morbidity for women considering BR surgery. Methods This randomized controlled trial included women who were over 20 years of age and were newly diagnosed with breast cancer and candidates for mastectomy. Women having an option for breast conservation were excluded. After being referred from the outpatient physician, the women provided consent and completed the baseline assessment. Women allocated to the control group (CG) received usual care and were provided with a pamphlet with information about types of surgery and the advantages and disadvantages of different surgery types. Women allocated to the intervention group (IG) were given the same pamphlet and guided to use the Pink Journey app to support their decision. Then they were also prompted to discuss the opinions with their significant others. Finally, the decision-making process of using the app was printed out for women that they could take home. Decision conflict, anxiety, and depression were measured at baseline. At 1 week after the intervention (T1) and at 1 month (T2), 8 months (T3), and 12 months (T4) after surgery, the women completed decision conflict, decision regret, anxiety, depression, and body image scales. An intention-to-treat analysis was performed. Results From February 2018 to July 2019, 96 women were randomly assigned to the CG (n=48) or the IG (n=48). Results revealed that body image distress declined significantly for the IG but increased for the CG. The interaction of time and group also reached significance, indicating a significant decrease in body image distress from baseline in the IG compared with the CG after the 12th month (T4) follow-up (β=–2.25, standard error=1.01, P=.027). However, there was no significant difference in decision conflict (P=.21-.87), decision regret (P=.44-.55), anxiety (P=.26-.33), and depression (P=.20-.75), indicating that the decrease in these outcomes in the IG was not greater than those in the CG. Conclusions Although we found no effect on decision conflict, decision regret, anxiety, and depression, a decision aid that combines surgery information and values clarification can help women reduce their body image distress. Trial Registration ClinicalTrials.gov NCT04190992; https://clinicaltrials.gov/ct2/show/NCT04190992

Relationship Between Decision Conflict and Decision Regret Among Postoperative Breast Cancer Patients in China: the Regulating Role of Decision-making Preparation

Objective: Different surgical methods have different risks and benefits.Chinese breast cancer(BC) patients’ decision-making of surgical treatment becomes a critical research question. Patients are often offered several options before surgery, and decision preparation plays an important role in the decision process. However some patients regret the original decision afterward. To understand the current situation, this study explore mainly explores the status of decision regret among postoperative breast cancer patients,and tests the relationship between decision conflicts, decision-making preparation, and decision regret. Methods: A cross-sectional survey was carried out. Totally 320 postoperative BC patients were studied using a self-made general data scale, Decision Regret Scale, Decision Conflict Scale, and Preparation for Decision Making Scale. Basic descriptive analyses, Pearson’s correlation analyses and regression analyses were performed. Results: The average score of decision regret among BC patients after surgery was 34.28. Decision regret was positively associated with decision conflict (r=0.853, p<0.01), and negatively associated decision preparation (r=-0.404, p<0.01). Decision-making preparation plays a regulatory role for the emergence of decision conflicts and regrets. The correlation between decision conflicts and decision regret increases with the increase in decision-making preparation. Conclusion: The adverse effects of decision conflicts on decision regret gradually increase with the increase in decision-making preparation. Results indicate that reducing decision preparation can be expected to improve the level of decision regret among Chinese postoperative BC patients.Thus, Clinical staffs should encourage patients to take an active part in decision-making, provide specialized information support, and improve the level of decision regret among Chinese BC patients after surgery.

Long-Term Effectiveness of a Decision Support App (Pink Journey) for Women Considering Breast Reconstruction Surgery: Pilot Randomized Controlled Trial (Preprint)

BACKGROUND Various kinds of breast reconstruction (BR) options, including implants and autologous, and surgery techniques, including traditional and endoscope assisted, can be used to perform surgery. All options have their own advantages and disadvantages. Women decide on an option depending on the values and preferences they emphasize. Lacking knowledge about BR or having decision difficulties during the treatment decision process makes women experience more decision regret, psychological distress, and poor body image. Delivering decision support with a values clarification exercise using eHealth approaches would be beneficial for patient outcomes. OBJECTIVE This study aims to examine the effects of a decision support app on decision-making quality and psychological morbidity for women considering BR surgery. METHODS This randomized controlled trial included women who were over 20 years of age and were newly diagnosed with breast cancer and candidates for mastectomy. Women having an option for breast conservation were excluded. After being referred from the outpatient physician, the women provided consent and completed the baseline assessment. Women allocated to the control group (CG) received usual care and were provided with a pamphlet with information about types of surgery and the advantages and disadvantages of different surgery types. Women allocated to the intervention group (IG) were given the same pamphlet and guided to use the Pink Journey app to support their decision. Then they were also prompted to discuss the opinions with their significant others. Finally, the decision-making process of using the app was printed out for women that they could take home. Decision conflict, anxiety, and depression were measured at baseline. At 1 week after the intervention (T1) and at 1 month (T2), 8 months (T3), and 12 months (T4) after surgery, the women completed decision conflict, decision regret, anxiety, depression, and body image scales. An intention-to-treat analysis was performed. RESULTS From February 2018 to July 2019, 96 women were randomly assigned to the CG (n=48) or the IG (n=48). Results revealed that body image distress declined significantly for the IG but increased for the CG. The interaction of time and group also reached significance, indicating a significant decrease in body image distress from baseline in the IG compared with the CG after the 12th month (T4) follow-up (β=–2.25, standard error=1.01, <i>P</i>=.027). However, there was no significant difference in decision conflict (<i>P</i>=.21-.87), decision regret (<i>P</i>=.44-.55), anxiety (<i>P</i>=.26-.33), and depression (<i>P</i>=.20-.75), indicating that the decrease in these outcomes in the IG was not greater than those in the CG. CONCLUSIONS Although we found no effect on decision conflict, decision regret, anxiety, and depression, a decision aid that combines surgery information and values clarification can help women reduce their body image distress. CLINICALTRIAL ClinicalTrials.gov NCT04190992; https://clinicaltrials.gov/ct2/show/NCT04190992

Relationship Between Decision Conflict and Decision Regret Among Postoperative Breast Cancer Patients in China: The Regulating Role of Decision-Making Preparation

Objective: Different surgical methods have different risks and benefits. The Chinese breast cancer(BC) patients’ decision-making of surgical treatment become a critical research question. Patients are often offered several options before surgery, and decision preparation play an important role in decision process. However some patients regret the original decision afterward. To understand the current situation, this study explore mainly explores the status of decision regret among newly diagnosed BC patients,and tests the relationship between decision conflicts, decision-making preparation, and decision regrets. Methods: A cross-sectional survey was conducted. Totally 320 postoperative BC patients were studied using a self-made general data scale, Decision Regret Scale, Decision Conflict Scale, and Preparation for Decision Making Scale. Basic descriptive analyses, Pearson’s correlation analyses and regression analyses were performed. Results: The average score of decision regret among BC patients after surgery was 34.28. Decision regret was positively associated with decision conflict (r=0.853, p<0.01), and negatively associated decision preparation (r=-0.404, p<0.01). Decision-making preparation plays a regulatory role for the emergence of decision conflicts and regrets. The correlation between decision conflicts and decision regrets increases with the increase of decision-making preparation. Conclusion: The adverse effects of decision conflicts on decision regrets gradually increase with the increase of decision-making preparation. Results indicate that reducing decision preparation can be expected to improve the level of decision regret among Chinese BC patients.Thus, Clinical staffs should encourage patients to actively participate in decision-making, provide specialized information support, and improve the level of decision regret among Chinese BCpatients after surgery.

The Impact of Implementing Steps of Empowerment Model on Decisional Conflict for Re-Pregnancy for Women with Failed Pregnancies: A Randomized Controlled Trial

Background: Failed pregnancy is known as a common and destructive experience. It has physical and psychological effects on both women and their families. Due to this experience, they may become reluctant to be pregnant again. In this regard, providing the coping strategies can help in being adapted to failed pregnancies, and making informed decisions on future pregnancies. So, this study was designed and then performed to determine the effect of implementing steps of empowerment model on decision conflict for re-pregnancy for women with failed pregnancies Method: This interventional research was a randomized controlled trial with a control group conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during the past 3-6 weeks due to failed pregnancies. Afterward, the eligible women were divided into the two groups of intervention (n=40) and control (n=40) with random allocation of sealed envelope site and a separate code was then determined for each person. The intervention was performed in four sessions lasted for 90-minute based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed in both groups once before and once six weeks after intervention. The obtained data were analyzed using SPSS edition 16 with the independent T-test, Fisher, and chi-squared tests. Results The scores of decisional conflict and its subscales had no differences between the two groups before the intervention (P = 0.65). However, by passing six weeks from the intervention, the decisional conflict and all its subscales have reduced in the intervention group. (P < 0.001). Conclusion: Empowerment education in women with failed pregnancies improved their decision conflict in immune re-pregnancy, so empowerment education along with health care services is recommended for women with failed pregnancies. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019. https://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=5336 Keywords: Empowerment, Conflict, Decision Making, Failed Pregnancy.

One Foot Out the Door: Stay/Leave Ambivalence Predicts Day-to-Day Fluctuations in Commitment and Intentions to End the Relationship

Why do some people maintain stable feelings of commitment toward their partners, whereas others’ feelings wax and wane from day to day? The current paper draws insight from decision conflict research suggesting that individuals torn between decision options are particularly susceptible to attitude change. In three samples, we validated a stay/leave ambivalence scale to capture internal conflict about whether to remain in versus exit a relationship. In two dyadic daily experience studies, individuals who felt more ambivalent about their relationships experienced greater daily fluctuation in commitment and breakup contemplation compared to less ambivalent individuals. Ambivalent individuals’ relationship intentions were also more strongly tied to their daily experiences, such that they felt more motivated to stay on days with greater relationship positivity, and more motivated to leave on days with greater relationship negativity. We discuss implications of these results for ambivalent individuals, their partners, and our understanding of stay/leave decision processes.

Preliminary Evaluation of a Breast Cancer Screening Shared Decision-Making Aid Utilized Within the Primary Care Clinical Encounter

Introduction: The US Preventative Services Task Force recommends shared decision-making (SDM) between women aged 40 and 49 years and their physician regarding timing of mammography screening. This preliminary study evaluates women’s and physician’s satisfaction using Breast Cancer Risk Estimator & Decision Aid (BCARE-DA), a shared decision aid utilized during the clinical encounter, and examines SDM quality for these encounters. Methods: Fifty-three women and their physician utilized BCARE-DA and completed surveys measuring satisfaction with Likert-type and open-ended items and women completed the Decision Conflict Scale. Clinic visit transcripts were evaluated for SDM quality using Observer OPTION-5 and Breast Cancer Screening Decision Core Components Checklist. Results: Women and physicians positively evaluated BCARE-DA. Women had low decision conflict. Physicians demonstrated moderate effort toward SDM, greatest in offering options, and lowest for team talk. Physicians demonstrated 2/3 of core SDM elements in 80% to 100% of encounters. Conclusion: Preliminary findings suggest specific promise for such Decision Aids to facilitate SDM through understanding of personal risks for breast cancer formulated within each screening option, while some SDM elements likely require additional facilitating.