Effectiveness of Tailored Rehabilitation Education on Health Literacy and Health Status of Postoperative Patients With Breast Cancer: a Randomized Controlled Trial

NCT ID: NCT02664662

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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This evaluator-blinded, randomized, prospective, controlled trial enrolled consecutive patients who fulfilled the inclusion criteria. Patients were stratified into four strata according to the side of the lesion and the surgical approach. A set of numbered envelopes containing cards indicating the allocated group was prepared for each stratum. When a new eligible participant was registered, an envelope was randomly drawn, and the therapist was informed of group allocation.

To ensure consistent intervention, two certified occupational therapists were trained by two primary investigators to administer the intervention and control group protocols independently. The two trained occupational therapists recorded outcome measurements at the baseline and immediately after the intervention. The evaluators were blinded to group allocation, and participants were blinded to the study hypotheses.

Conditions

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Health Behavior

Keywords

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Breast cancer Health literacy Tailored education Rehabilitation International Classification of Functioning, Disability and Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tailored education

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.

Group Type EXPERIMENTAL

tailored education

Intervention Type OTHER

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.

standard education

Only provide one paper of post operation and give education of rehabilitated exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tailored education

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adult patient has been diagnosed breast cancer (age \> 20)
2. Have a good motivation and cooperation when accept breast cancer education
3. Read words or speak in Chinese fluently

Exclusion Criteria

1. Diagnoses mental problems
2. Patient with Cancer terminal stage and weakness
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bi-Chu Lin

Role: STUDY_DIRECTOR

Taipei Medical University

Wen-Hsuan Hou

Role: STUDY_DIRECTOR

Taipei Medical University

Locations

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Huang Szu-Chi

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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Medical University Hospital

Identifier Type: -

Identifier Source: org_study_id