Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education
October 21, 2020 updated by: Chin-Tsung Shen, Mackay Medical College
Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education for Nurses and Patients With Breast Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Taipei City, Taiwan
- Department of Nursing
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Nursing Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Decisional conflict
Time Frame: Nurses: 1 month; Patients: 6 months
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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.
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Nurses: 1 month; Patients: 6 months
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Oncofertility Barrier Scale
Time Frame: Nurses: 1 month
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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.
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Nurses: 1 month
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Infertility Knowledge Questionnaire
Time Frame: Nurses: 1 month; Patients: 6 months
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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.
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Nurses: 1 month; Patients: 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fertility Intention Scale
Time Frame: Patients: 6 months
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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.
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Patients: 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sheng-Miauh Huang, PhD, Department of Nursing, Mackay Medical College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
July 30, 2020
Study Completion (Actual)
August 30, 2020
Study Registration Dates
First Submitted
October 16, 2020
First Submitted That Met QC Criteria
October 21, 2020
First Posted (Actual)
October 23, 2020
Study Record Updates
Last Update Posted (Actual)
October 23, 2020
Last Update Submitted That Met QC Criteria
October 21, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSM/VGH-2017-01-011AC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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