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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664662
• Other study ID #: Medical University Hospital
• Status: Completed
• Phase: N/A
• First received: December 27, 2015
• Last updated: November 21, 2017
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2016
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Health Behavior

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	Huang Szu-Chi	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disability of Arm Shoulder and Hand(DASH)	DASH evaluate the patient's hand function. There are 15 items and get higher get higher hand function performance	one month
Secondary	Barthel Index	Barthel Index is an assessment tool which evaluate activity participated performance. There are 10 items and higher scores means higher activity participated performance.	one month
Secondary	Frenchay activities index (FAI)	FAI is an assessment tool which evaluate instrumental activity participated performance. There are 15 items and higher scores means higher performance.	one month
Secondary	EuroQol-5 dimension (EQ5D)	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.	one month
Secondary	Brief Symptom Rating Scale	Brief Symptom Rating Scale is an assessment tool which evaluate the psychosis performance. There are 6 items and higher scores means good psychosis performance.	one month