Clinical trial NCT02664662: 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
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Breast cancer
Health literacy
Tailored education
Rehabilitation
International Classification of Functioning, Disability and Health
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 99
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health literacy Assessments in breast cancer
timeFrame: one month
Secondary outcomes:
measure: Disability of Arm Shoulder and Hand(DASH)
timeFrame: one month
measure: Barthel Index
timeFrame: one month
measure: Frenchay activities index (FAI)
timeFrame: one month
measure: EuroQol-5 dimension (EQ5D)
timeFrame: one month
measure: Brief Symptom Rating Scale
timeFrame: one month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Huang Szu-Chi
Study officials:
affiliation: Taipei Medical University
name: Bi-Chu Lin
role: STUDY_DIRECTOR
affiliation: Taipei Medical University
name: Wen-Hsuan Hou
role: STUDY_DIRECTOR
References: