Application-Enabled Shared Decision-Making

NCT04858282 | Completed

• 1 other identifier: mavis20023
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Mastectomy; Breast-Conserving Surgery

Keywords

early breast cancer; surgery; shared decision-making; m-health; application; patient decision aid

Outcome Measures

Primary Outcomes (3)

• knowledge tests

  The knowledge tests included five items,1. Are the survival rates of breast cancer the same with conserving surgery and total mastectomy? 2. Breast-conserving surgery has a higher local-regional recurrence rate? 3. Is radiation therapy required for Breast-conserving surgery? 4. Does total mastectomy require longer recovery time? 5. Do both total mastectomy and breast-conserving surgery have the same bleeding and infection rate? The knowledge tests included five items, such as "Are the survival rates of breast cancer the same with conserving surgery and total mastectomy?" The correct answer was coded as one point. The scores of the knowledge tests ranged from zero to five points. Higher scores indicated more correct knowledge.

  immediately after the intervention

• decision conflict-sure

  The Decision Conflict Scale (DCS\_SURE) included four items: uncertainty, information, values clarity, and support and effective decision. On the scale, "Yes" answers scored one point, while "No" responses were zero points. The higher score, the lesser conflict.

  immediately after the intervention

• Decision Regret Scale DRS

  The Decision Regret Scale was composed of five items: "It was the right decision," "I regret the choice that was made," "I would go for the same choices if I had to do it over again," "The choices did me a lot of harm," and "The decision was a wise one." Items were scored using a five-point Likert scale, ranging from very agreed (1 point) to very disagreed (5 points), but two items were reversely scored. The higher score, the more regret.

  immediately after the intervention

Study Arms (2)

shared decision-making group (SDMG)

EXPERIMENTAL

Receiving mobile application( BC-SDM)

Other: mobile application (BC-SDM)

usual care group (UCG)

NO INTERVENTION

Receiving material health education

Interventions

mobile application (BC-SDM) OTHER

The mobile application (BC-SDM)includes four functions to support SDM activity: "Understanding breast cancer," "Surgical approach," "Choose the right breast cancer knowledge," and "Let's make a decision for myself". Patients first read the information in "Understanding breast cancer" and "Surgical approach" to receive a tailored education in breast cancer

shared decision-making group (SDMG)

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• tumor located \<2 cm from the nipple

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nursing, RN, MSN

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: August 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)