Health BehaviorNCT02664662
Effectiveness of Tailored Rehabilitation Education on Health Literacy and Health Status of Postoperative Patients With Breast Cancer: a Randomized Controlled Trial
A study testing tailored education in people with Health Behavior, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- tailored education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnoses mental problems
- Patient with Cancer terminal stage and weakness
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- tailored education
- Keywords
- Breast cancer, Health literacy, Tailored education, Rehabilitation, International Classification of Functioning, Disability and Health
- Medical subject headings
- Health Behavior, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: tailored education |
| standard education | No intervention | Only provide one paper of post operation and give education of rehabilitated exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (5)
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
Measured: one month
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.
Measured: one month
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.
Measured: one month
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.
Measured: one month
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bi-Chu Lin, Study director, Taipei Medical UniversityWen-Hsuan Hou, Study director, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664662
- Sponsor's protocol ID
- Medical University Hospital
- Status last verified
- Jan 2016
- First submitted
- 27 Dec 2015
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tailored Rehabilitation Education on Health Literacy and Health Status of Postoperative Patients With Breast Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02664662
- Acronym / sponsor ID
- Medical University Hospital
- Conditions
- Health Behavior
- Keywords
- Breast cancer, Health literacy, Tailored education, Rehabilitation, International Classification of Functioning, Disability and Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tailored education | Experimental | Other: tailored educationTailored 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. |
| standard education | No intervention | –Only provide one paper of post operation and give education of rehabilitated exercise |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnoses mental problems
- Patient with Cancer terminal stage and weakness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tailored educationTailored 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 |
Primary outcome
Health literacy Assessments in breast cancer
Time frame: one month
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.
5 secondary outcomes
Disability of Arm Shoulder and Hand(DASH)
Time frame: one month
Barthel Index
Time frame: one month
Frenchay activities index (FAI)
Time frame: one month
EuroQol-5 dimension (EQ5D)
Time frame: one month
Brief Symptom Rating Scale
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bi-Chu Lin study director
Taipei Medical University
Wen-Hsuan Hou study director
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tailored education in people with Health Behavior, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy Assessments in breast cancer (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.