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

Not Applicable

Completed

• Conditions: Fertility Issues; Education; Breast Cancer
• Interventions: Other: Naturalistic Decision-Making Model-based Oncofertility Care Education

• Registration Number: NCT04600869
• Lead Sponsor: Mackay Medical College

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2020-07-30
• Study Completion: 2020-08-30
• Status Verified: 2020-10
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-23
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nursing Group	Naturalistic Decision-Making Model-based Oncofertility Care Education	Nurses in the control group accepted the other non-fertility (standard) nursing training for the intervention, whereas those in the experimental group accepted the oncofertility training. Based on research ethics and design, a standard education course was held for the control group after completing data collection in the nursing experimental group. We began to recruit patients into the patient experimental group after all nurses completed their educational courses.

Primary Outcome Measures

Name	Time	Method
Oncofertility Barrier Scale	Nurses: 1 month	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.
Infertility Knowledge Questionnaire	Nurses: 1 month; Patients: 6 months	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.
Decisional conflict	Nurses: 1 month; Patients: 6 months	The decisional conflict was measured using the Chinese version of the decisional conflict 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 conflict. Both nursing and patient participants were asked to fill out the questionnaire.

Secondary Outcome Measures

Name	Time	Method
Fertility Intention Scale	Patients: 6 months	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.

Trial Locations

Locations (1)

Department of Nursing; 🇨🇳 New Taipei City, Taiwan