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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02664662
Enrollment
99
Registered
2016-01-27
Start date
2016-03-31
Completion date
2017-09-30
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

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

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.

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.

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Health literacy Assessments in breast cancerone monthThe 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

MeasureTime frameDescription
Disability of Arm Shoulder and Hand(DASH)one monthDASH evaluate the patient's hand function. There are 15 items and get higher get higher hand function performance
Barthel Indexone monthBarthel 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 monthFAI 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 monthEQ5D 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 Scaleone monthBrief Symptom Rating Scale is an assessment tool which evaluate the psychosis performance. There are 6 items and higher scores means good psychosis performance.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026