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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04600869
Other study ID # HSM/VGH-2017-01-011AC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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