search
Back to results

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

Primary Purpose

Health Behavior

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
tailored education
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Health Behavior focused on measuring Breast cancer, Health literacy, Tailored education, Rehabilitation, International Classification of Functioning, Disability and Health

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Huang Szu-Chi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

tailored education

standard education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.

Full Information

First Posted
December 27, 2015
Last Updated
November 21, 2017
Sponsor
Taipei Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT02664662
Brief Title
Effectiveness of Tailored Rehabilitation Education on Health Literacy and Health Status of Postoperative Patients With Breast Cancer: a Randomized Controlled Trial
Official Title
Effectiveness of Tailored Rehabilitation Education on Health Literacy and Health Status of Postoperative Patients With Breast Cancer: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior
Keywords
Breast cancer, Health literacy, Tailored education, Rehabilitation, International Classification of Functioning, Disability and Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tailored education
Arm Type
Experimental
Arm Description
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.
Arm Title
standard education
Arm Type
No Intervention
Arm Description
Only provide one paper of post operation and give education of rehabilitated exercise
Intervention Type
Other
Intervention Name(s)
tailored education
Intervention Description
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 Measure Information:
Title
Health literacy Assessments in breast cancer
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Disability of Arm Shoulder and Hand(DASH)
Description
DASH evaluate the patient's hand function. There are 15 items and get higher get higher hand function performance
Time Frame
one month
Title
Barthel Index
Description
Barthel Index is an assessment tool which evaluate activity participated performance. There are 10 items and higher scores means higher activity participated performance.
Time Frame
one month
Title
Frenchay activities index (FAI)
Description
FAI is an assessment tool which evaluate instrumental activity participated performance. There are 15 items and higher scores means higher performance.
Time Frame
one month
Title
EuroQol-5 dimension (EQ5D)
Description
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.
Time Frame
one month
Title
Brief Symptom Rating Scale
Description
Brief Symptom Rating Scale is an assessment tool which evaluate the psychosis performance. There are 6 items and higher scores means good psychosis performance.
Time Frame
one month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Diagnoses mental problems Patient with Cancer terminal stage and weakness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bi-Chu Lin
Organizational Affiliation
Taipei Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wen-Hsuan Hou
Organizational Affiliation
Taipei Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Huang Szu-Chi
City
Taipei
ZIP/Postal Code
10561
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs