NCT02664662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 22, 2017

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

December 27, 2015

Last Update Submit

November 21, 2017

Conditions

Keywords

Breast cancerHealth literacyTailored educationRehabilitationInternational Classification of Functioning, Disability and Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Disability of Arm Shoulder and Hand(DASH)

    one month

  • Barthel Index

    one month

  • Frenchay activities index (FAI)

    one month

  • EuroQol-5 dimension (EQ5D)

    one month

  • Brief Symptom Rating Scale

    one month

Study Arms (2)

tailored education

EXPERIMENTAL

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.

Other: tailored education

standard education

NO INTERVENTION

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

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.

tailored education

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnoses mental problems
  • Patient with Cancer terminal stage and weakness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huang Szu-Chi

Taipei, 10561, Taiwan

Location

MeSH Terms

Conditions

Health BehaviorBreast Neoplasms

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bi-Chu Lin

    Taipei Medical University

    STUDY DIRECTOR
  • Wen-Hsuan Hou

    Taipei Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2015

First Posted

January 27, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

November 22, 2017

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations