Clinical trial NCT04858282: Application-Enabled Shared Decision-Making
Official title: Department of Nursing, Chang Gung Memorial Hospital-Kaohsiung Medical Center,RN, MSN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Mastectomy
Breast-Conserving Surgery
Keywords: early breast cancer
surgery
shared decision-making
m-health
application
patient decision aid
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To develop application-enabled shared decision-making among patients with early breast cancer and evaluate the preliminary effects of the interventions.

Detailed description: Female breast is an amazing organ that it symbolizes not only the female gender, but also the continuity of human race. In the past treating breast cancer may signal a termination of the breast's predestined role in a woman or a mother. Nowadays, surgical treatment of early breast cancer has two options, one is breast-conserving surgery and the other one is total mastectomy. The former treatment option preserves most of the breast tissue but may spare dormant cancer cells in the preserved tissue. The latter treatment option spares no breast tissue and as a result no dormant cancer cells would remain. This treatment dilemma may bother most of the patients especially when they are still under the shade of the bad news. Many women are reluctant to discuss their diseased breasts with their folks or even their doctors because of privacy; instead they would seek information through internet. Unfortunately, most of their final decision is doctor's preferred choice despite they may have doubts or concerns on doctor's choice of treatment.

Share decision making (SDM) is a recently developed strategy that allows patients taking part in their treatment plan. Patients are invited to join the meeting where doctors explain the latest treatment options and patients express their concerns and finally a decision, both doctors' and patients' concerns well integrated, is reached. One of the drawbacks of SDM is too time consuming; doctors have to prepare a lot of pertinent information, while patients have to try their best to understand the provided information, though many patients may not fully understand their treatment options. It has been reported that a well designed patient decision aids (PDAs) could serve as a virtue connection between patients and doctors. Instead of merely taking information from the PDAs, it allows patients to know all the possible options of treatment and the side effects in an interactive way. It is supposed that patients could be well prepared to discuss with their doctors after interaction with the customized PDAs. In Taiwan, decision conflict and decision regret are commonly encountered among most cancer patients. The impetus for developing a PDAs for female breast cancer patients and evaluating its role on lowering decision conflict and decision regret among these patients comes from the high rates of decision conflict and decision regret among cancer patients in Taiwan.

Eligibility criteria: Inclusion Criteria:

* women, aged \>20 years
* newly diagnosed early breast cancer (stages 0-II)
* no surgery yet
* no metastases
* tumor size \<3 cm

Exclusion Criteria:

•tumor located \<2 cm from the nipple

Primary outcomes:
measure: knowledge tests
timeFrame: immediately after the intervention
measure: decision conflict-sure
timeFrame: immediately after the intervention
measure: Decision Regret Scale DRS
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: