Effectiveness of Tailored Rehabilitation Education on Health Literacy and Health Status of Postoperative Patients With Breast Cancer: a Randomized Controlled Trial
1 other identifier
interventional
99
1 country
1
Brief Summary
For the past few years, the survival rate of breast cancer improved due to the advancement of surgery techniques and popularization of cancer screening. However, prolonged survival rate is definitely not equal to achieving a sound quality of life among breast cancer survivors. The health status of cancer survivors might deteriorate according to the severe side effect of multiple therapies. Health literacy is the ability to access, understand, evaluate and communication information as a way to promote and maintain health. Therefore, good health literacy raise the quality of life of breast cancer survivors by a good competence in searching and using medical resources. Moreover, how to improve health literacy after cancer surgery becomes an important part recently. Even if the most fundamental concept has promoted for decades, the clinical workers still use the identical education of medical care after surgery for breast cancer survivors. However, the identical education is not appropriate for each of patients. In fact, each of breast cancer survivors has the different cancer stage leading to accept different therapy and producing different side effect. Besides, the background and the role of life are very different from each other. Because of the above reasons, the aim of the study is going to develop a tailored rehabilitated education, which fit for each breast cancer patients after surgery in clinic. At the same time, the health literacy ability might be improved by tailored rehabilitated education. When health literacy level is raised, the breast cancer survivors have a good quality of life and beautiful health status.
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 Mar 2016
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
First Submitted
Initial submission to the registry
December 27, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedNovember 22, 2017
January 1, 2016
6 months
December 27, 2015
November 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health literacy Assessments in breast cancer
The Health Literacy scale is five point likert scale of choices, which is evaluated by patient. There are 47 items and the higher scores means the higher literacy performance.
one month
Secondary Outcomes (5)
Disability of Arm Shoulder and Hand(DASH)
one month
Barthel Index
one month
Frenchay activities index (FAI)
one month
EuroQol-5 dimension (EQ5D)
one month
Brief Symptom Rating Scale
one month
Study Arms (2)
tailored education
EXPERIMENTALTailored rehabilitated education is which fit for each breast cancer patients after surgery in clinic. We design three of tailored books for experimental group. Each patients will be tailored by three principles. First, the educated times and hours are depended on patients physical function and learning ability. Second, the material is depended on each patient's life experience. Finally, the educated content is depended on patient's operation method.
standard education
NO INTERVENTIONOnly provide one paper of post operation and give education of rehabilitated exercise
Interventions
Tailored rehabilitated education is which fit for each breast cancer patients after surgery in clinic. We design three of tailored books for experimental group. Each patients will be tailored by three principles. First, the educated times and hours are depended on patients physical function and learning ability. Second, the material is depended on each patient's life experience. Finally, the educated content is depended on patient's operation method.
Eligibility Criteria
You may qualify if:
- Adult patient has been diagnosed breast cancer (age \> 20)
- Have a good motivation and cooperation when accept breast cancer education
- Read words or speak in Chinese fluently
You may not qualify if:
- Diagnoses mental problems
- Patient with Cancer terminal stage and weakness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huang Szu-Chi
Taipei, 10561, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bi-Chu Lin
Taipei Medical University
- STUDY DIRECTOR
Wen-Hsuan Hou
Taipei Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2015
First Posted
January 27, 2016
Study Start
March 1, 2016
Primary Completion
September 1, 2016
Study Completion
September 1, 2017
Last Updated
November 22, 2017
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL