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

Not Applicable

Completed

• Conditions: Health Behavior
• Interventions: Other: tailored education

• Registration Number: NCT02664662
• Lead Sponsor: Taipei Medical University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-12-27
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Study Start: 2016-03
• Primary Completion: 2016-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tailored education	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.

Primary Outcome Measures

Name	Time	Method
Health literacy Assessments in breast cancer	one month	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.

Secondary Outcome Measures

Name	Time	Method
Disability of Arm Shoulder and Hand(DASH)	one month	DASH evaluate the patient's hand function. There are 15 items and get higher get higher hand function performance
Barthel Index	one month	Barthel Index is an assessment tool which evaluate activity participated performance. There are 10 items and higher scores means higher activity participated performance.
Frenchay activities index (FAI)	one month	FAI is an assessment tool which evaluate instrumental activity participated performance. There are 15 items and higher scores means higher performance.
EuroQol-5 dimension (EQ5D)	one month	EQ5D is an assessment tool which evaluate quality of life. There are 5 items and 1 visual analogue scale. The higher scores means good quality of life performance.
Brief Symptom Rating Scale	one month	Brief Symptom Rating Scale is an assessment tool which evaluate the psychosis performance. There are 6 items and higher scores means good psychosis performance.

Trial Locations

Locations (1)

Huang Szu-Chi; 🇨🇳 Taipei, Taiwan