Effects of Naturalistic Decision-Making Model-based Oncofertility Care Education
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedFirst Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedOctober 23, 2020
October 1, 2020
2.2 years
October 16, 2020
October 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Decisional conflict
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.
Nurses: 1 month; Patients: 6 months
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
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 Outcomes (1)
Fertility Intention Scale
Patients: 6 months
Study Arms (1)
Nursing Group
EXPERIMENTALNurses 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women with a major illness or mental disorder before their cancer diagnosis were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nursing
New Taipei City, Taiwan
Related Publications (1)
Huang SM, Tseng LM, Lien PJ. Effects of naturalistic decision-making model-based oncofertility care education for nurses and patients with breast cancer: a cluster randomized controlled trial. Support Care Cancer. 2022 Oct;30(10):8313-8322. doi: 10.1007/s00520-022-07279-w. Epub 2022 Jul 15.
PMID: 35835904DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheng-Miauh Huang, PhD
Department of Nursing, Mackay Medical College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- the Office of Research and Development
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 23, 2020
Study Start
May 1, 2018
Primary Completion
July 30, 2020
Study Completion
August 30, 2020
Last Updated
October 23, 2020
Record last verified: 2020-10