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

10.2196/31092 ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. e31092
Author(s):  
Su-Ying Fang ◽  
Pin-Jun Lin ◽  
Yao-Lung Kuo
Keyword(s):  
Decision Making ◽  
Body Image ◽  
Randomized Controlled Trial ◽  
Decision Support ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Decision Conflict ◽  
Decision Regret ◽  
Advantages And Disadvantages ◽  
Randomized Controlled

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

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

2021 ◽  
Author(s):  
Su-Ying Fang ◽  
Pin-Jun Lin ◽  
Yao-Lung Kuo
Keyword(s):  
Decision Making ◽  
Body Image ◽  
Randomized Controlled Trial ◽  
Decision Support ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Decision Conflict ◽  
Decision Regret ◽  
Advantages And Disadvantages ◽  
Randomized Controlled

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

scholarly journals Employing a mobile health decision aid to improve decision-making for patients with advanced prostate cancer and their decision partners/proxies: the CHAMPION randomized controlled trial study design

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lourdes R. Carhuapoma ◽  
Winter M. Thayer ◽  
Catherine E. Elmore ◽  
Jane Gildersleeve ◽  
Tanmay Singh ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Randomized Controlled Trial ◽  
Decision Support ◽  
Cancer Patients ◽  
Mobile Health ◽  
Advanced Prostate Cancer ◽  
Controlled Trial ◽  
Minority Populations ◽  
Randomized Controlled

Abstract Background Metastatic prostate cancer remains a lethal malignancy that warrants novel supportive interventions for patients and their decision partners and proxies. Decision aids have been applied primarily to patients with localized disease, with minimal inclusion of patients with advanced prostate cancer and their decision partners. The use of a community patient navigator (CPN) has been shown to have a positive supportive role in health care, particularly with individuals from minority populations. Research is needed to evaluate decision support interventions tailored to the needs of advanced prostate cancer patients and their decision partners in diverse populations. Methods Guided by Janis and Mann’s Conflict Model of Decision Making, the Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION) is a randomized controlled trial to assess the feasibility and acceptability of a mobile health (mHealth), CPN-administered decision support intervention designed to facilitate communication between patients, their decision partners, and the healthcare team. Adult prostate cancer patients and their decision partners at three mid-Atlantic hospitals in the USA were randomized to receive enhanced usual care or the decision intervention. The CHAMPION intervention includes a theory-based decision-making process tutorial, immediate and health-related quality of life graphical summaries over time (using mHealth), values clarification via a balance sheet procedure with the CPN support during difficult decisions, and facilitated discussions with providers to enhance informed, shared decision-making. Discussion The CHAMPION intervention is designed to leverage dynamic resources, such as CPN teams, mHealth technology, and theory-based information, to support decision-making for advanced prostate cancer patients and their decision partners. This intervention is intended to engage decision partners in addition to patients and represents a novel, sustainable, and scalable way to build on individual and community strengths. Patients from minority populations, in particular, may face unique challenges during clinical communication. CHAMPION emphasizes the inclusion of decision partners and CPNs as facilitators to help address these barriers to care. Thus, the CHAMPION intervention has the potential to positively impact patient and decision partner well-being by reducing decisional conflict and decision regret related to complex, treatment-based decisions, and to reduce cancer health disparities. Trial registration ClinicalTrials.govNCT03327103. Registered on 31 October 2017—retrospectively registered. World Health Organization Trial Registration Data Set included in Supplementary Materials.

scholarly journals Randomized Controlled Trial of a Video Decision Support Tool for Cardiopulmonary Resuscitation Decision Making in Advanced Cancer

2013 ◽  
Vol 31 (3) ◽  
pp. 380-386 ◽  
Author(s):  
Angelo E. Volandes ◽  
Michael K. Paasche-Orlow ◽  
Susan L. Mitchell ◽  
Areej El-Jawahri ◽  
Aretha Delight Davis ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Decision Support ◽  
Cardiopulmonary Resuscitation ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Decision Support Tool ◽  
Successful Resuscitation ◽  
Support Tool ◽  
Randomized Controlled

Purpose Decision making regarding cardiopulmonary resuscitation (CPR) is challenging. This study examined the effect of a video decision support tool on CPR preferences among patients with advanced cancer. Patients and Methods We performed a randomized controlled trial of 150 patients with advanced cancer from four oncology centers. Participants in the control arm (n = 80) listened to a verbal narrative describing CPR and the likelihood of successful resuscitation. Participants in the intervention arm (n = 70) listened to the identical narrative and viewed a 3-minute video depicting a patient on a ventilator and CPR being performed on a simulated patient. The primary outcome was participants' preference for or against CPR measured immediately after exposure to either modality. Secondary outcomes were participants' knowledge of CPR (score range of 0 to 4, with higher score indicating more knowledge) and comfort with video. Results The mean age of participants was 62 years (standard deviation, 11 years); 49% were women, 44% were African American or Latino, and 47% had lung or colon cancer. After the verbal narrative, in the control arm, 38 participants (48%) wanted CPR, 41 (51%) wanted no CPR, and one (1%) was uncertain. In contrast, in the intervention arm, 14 participants (20%) wanted CPR, 55 (79%) wanted no CPR, and 1 (1%) was uncertain (unadjusted odds ratio, 3.5; 95% CI, 1.7 to 7.2; P < .001). Mean knowledge scores were higher in the intervention arm than in the control arm (3.3 ± 1.0 v 2.6 ± 1.3, respectively; P < .001), and 65 participants (93%) in the intervention arm were comfortable watching the video. Conclusion Participants with advanced cancer who viewed a video of CPR were less likely to opt for CPR than those who listened to a verbal narrative.

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