Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jul 6, 2021
Date Accepted: Oct 27, 2021
Long-term Effectiveness of the Decision Support App for Women Considering Breast Reconstruction Surgery: A Pilot Randomized Controlled Trial
ABSTRACT
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 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 make 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 application (app) on decision-making quality and psychological morbidity for women considering BR surgery.
Methods:
This randomized controlled trial includes 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 of their significant others. Finally, the decision-making process of using the app was printed out for women to bring home. Decision conflict, anxiety and depression were measured at baseline. At one week after intervention (T1) and at one month (T2), eight 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 CG (n = 48) or IG (n = 48). Body image distress declined significantly over time for both groups. The interaction of time and group also reached significance, indicating a significant decrease in body image distress from the baseline in IG compared to CG after the 12th month (T4) follow-up (ß = -2.25, SE = 1.01, P = .027). However, there was no significant difference on decision conflict, decision regret, anxiety, and depression indicating that the decrease in these outcomes in IG was not greater than those in CG.
Conclusions:
Although we found no effect on decision conflict, decision regret, anxiety, and depression, decision aid that combines surgery information and values clarification can help women reduce their body image distress. Clinical Trial: ClinicalTrials.gov NCT04190992; https://clinicaltrials.gov/ct2/show/NCT04190992
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.