Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education

Breast Cancer Clinical Trial

Official title:

Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education for Nurses and Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600869
• Other study ID #: HSM/VGH-2017-01-011AC
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: October 2020
• Source: Mackay Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

his study examined the effects of an oncofertility education program on decisional conflict in nurses caring for breast cancer patients and patients with breast cancer. Other predictors of decisional conflict were also examined.

Description:

Background: Nurses play an essential role in transferring knowledge to patients. However, several factors cause nurses to adopt a negative attitude toward providing oncofertility care. Objective: This study examined the effects of an oncofertility education program on decisional conflict in nurses caring for breast cancer patients and patients with breast cancer. Other predictors of decisional conflict were also examined. Design: Randomized, controlled experimental research. Settings and Participants: Patients (61) with breast cancer and nurses (79) were recruited from a hospital in Taipei, Taiwan. Methods: The nursing participants were randomly assigned to receive oncofertility education (experimental group) or usual education (control group). Data from female patients in the control and experimental groups were collected before and after the nurses' educational training, respectively. The oncofertility education consisted of one face-to-face educational session and reading one educational booklet based on the Naturalistic Decision-Making (NDM) Model. The decisional conflict was measured using the Chinese version of the decisional conflict scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• All nurses involved in breast care were recruited into the study.
• Female patients with breast cancer who were younger than 50 years and who were about to start cancer treatment were recruited from one teaching hospital in Taipei, Taiwan.

Exclusion Criteria:

• Women with a major illness or mental disorder before their cancer diagnosis were excluded.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Education
• Fertility Issues
• Infertility

Intervention

Other:
• Naturalistic Decision-Making Model-based Oncofertility Care Education
We designed the education program according to Klein's NDM model, which explored the reasoning mechanism behind decision-making (Klein, 1993). It depends on the on-the-job training date in each unit. The education program consisted of the following: (1) Information accumulation: explanations of common cancer therapies related to subsequent infertility, psychological and mental change in cancer survivors with infertility, the necessity and method of early determination of fertility intention, and type of fertility preservation. (2) Sense-making: situational case sharing, emphasis on the guidance interaction between experienced and novice nurses to understand the patient's situation. (3) Decision-making: how to provide support, how to correspond, and attitudes toward people with strong fertility intention.

Locations

Country	Name	City	State
Taiwan	Department of Nursing	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Medical College

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	The decisional con?ict was measured using the Chinese version of the decisional con?ict scale. Each item was rated on a five-point Likert scale, ranging from zero to 4. The score was calculated by averaging the sum of individual item scores, then multiplying the product by 25. Hence, the scores range from 0 to 100. A higher score indicates higher decisional con?ict. Both nursing and patient participants were asked to fill out the questionnaire.	Nurses: 1 month; Patients: 6 months
Primary	Oncofertility Barrier Scale	An Oncofertility Barrier Scale was developed to assess nurses' perceptions of comprehensive barriers regarding oncofertility care. The responses to each item were provided using a five-point Likert scale. A higher scale score meant the nurses perceived that it was more difficult to provide oncofertility care.	Nurses: 1 month
Primary	Infertility Knowledge Questionnaire	We used the Infertility Knowledge Questionnaire to measure both of nurses' and patients' knowledge of infertility in patients with breast cancer. Total scores for the 11 items ranged from zero to 11. Centimeters were used to show the ratio of correct answers visually. A higher score meant a greater level of knowledge about infertility. Both nursing and patient participants were asked to fill out the questionnaire.	Nurses: 1 month; Patients: 6 months
Secondary	Fertility Intention Scale	The Fertility Intention Scale with 15 items was used to measure patients' fertility intentions. The standardized scale ranged from 1 to 5 points on a five-point Likert scale. Higher scores indicated a greater degree of fertility intention.	Patients: 6 months