AzTrials
AzTrials

Breast CancerNCT01963572

A Continuing Cancer Service Model Emphasizing on Functional Restoration: Model for Breast Cancer

A study testing SG will be screened every time when they visit the clinics. in people with Breast Cancer and Quality of Life, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Background and Purposes: Cancer is the leading cause of our mortality. It threatens people's life and quality of life (QOL). Although the incidence of cancer is still rising, with the promotion of cancer screening and progression of medical technology, its survival rate is improving. 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
Breast Cancer, Quality of Life
What is being tested?
SG will be screened every time when they visit the clinics.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteTaiwan
Study dates
Aug 2013to Jul 2015
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

  • Women being newly diagnosed with breast cancer and first OPD visit after operation at National Taiwan University Hospital will be invited to join the surveillance and care system

Who cannot join

  • Younger than 20 years old, stage IV, recurrent or both sides involved, with other cancer diagnosis, functional impairments from previous injury or operation on the affected upper extremity and other physical or mental problem to influence the test or filling the questionnaire.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Graduate Scahool of Physical Therapy, College of Medicine, National Taiwan University

    Taipei

    Jau-Yih Tsauo, PhD, +886-2-33668130, jytsauo@ntu.edu.tw

    Heuifen Lin, MS

    Recruiting

Other trials in Taiwan

About this study

Background and Purposes: Cancer is the leading cause of our mortality. It threatens people's life and quality of life (QOL). Although the incidence of cancer is still rising, with the promotion of cancer screening and progression of medical technology, its survival rate is improving. However, the sequels from cancer or its treatment and the side effects impact the patients along with their lives. Breast cancer is the most incident cancer in women with high survival rate, continuing care after the diagnosis and treatment is much more needed. This study is using breast cancer as an example to establish a continuing service model. This study aims (1) to establish a tailored, continuing care model which emphasizes on breast cancer patients' function. (2) To investigate the effectiveness of the new care model comparing with the control. (3) To find a cutting point of bioelectrical impedance to identify late development of lymphedema.

Methods: This is a randomized-controlled trial expanding for 3 years. Women being newly diagnosed with breast cancer and first OPD visit after operation at National Taiwan University Hospital will be invited to join the surveillance and care system. Exclusion criteria are: younger than 20 years old, stage IV, recurrent or both sides involved, with other cancer diagnosis, functional impairments from previous injury or operation on the affected upper extremity and other physical or mental problem to influence the test or filling the questionnaire. It is estimated there will be 100 subjects participate this study every year. After the initial evaluation, they will be randomly allocated to surveillance group (SG) or general care group (CG). Totally, in this three-year study, there will be 200 subjects (100/group), follow-up for 0.5 to 2 years. SG will have health education brochure and free class from the first visit post-operatively but CG will only have the brochure. Moreover, SG will be screened every time when they visit the clinics. If there is any early sign of impairment, professional advice and counseling will be given additionally. In these visits, if CG raises any health-related question, they can be answered. Detailed physical examination to identify their impairments and QOL are at 3, 6, 12, 18, 24 months after operation for both groups. Patients' characteristics, functional status, QOL will be presented by descriptive statistics. T-test/Mann-Whitney U test will be used to compare the differences between patients in two groups. Survival analysis and log-rank test will be used to show the prevalence of various functional impairments and test their difference. ROC curve will be used to find the cutting point for prediction of lymphedema.

Expected Results: It is expected (1) to set up the education program and brochure for breast cancer patients. (2) to establish a continuing surveillance and care model for breast cancer patients and extending to all cancers. (3) Women in the new care model will have less impairment and higher QOL comparing with women at the same post-operative stage. (4) To find out the prevalence of functional impairments from the data of control group. (5) A cutting point of bioelectrical impedance to identify late development of lymphedema will be found. (6) To train the team members of cancer care and research.

Being tested
SG will be screened every time when they visit the clinics.
Keywords
Breast cancer, Care model, Physical Therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SG will be screened every time when they visit the clinics.Other

Study groups in NCT01963572
Study groupRoleWhat they receive
surveillance group (SG)ExperimentalSG will have health education brochure and free class from the first visit post-operatively but CG will only have the brochure. Moreover, SG will be screened every time when they visit the clinics. If there is any early sign of impairment, professional advice and counseling will be given additionally.
Receives: Other: SG will be screened every time when they visit the clinics.
general care group (CG)No interventionCG raises any health-related question, they can be answered.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prevalence of body impairments

    Standard physical examination including body composition, arm circumferences, shoulder range of motion and strength, grip strength, muscle length, posture, pain assessment will be performed at baseline and 5 time points of follow-up for both groups for detecting any kind of body impairment.

    Measured: 2 years

  2. changes of functional status

    several self-administrated questionnaires including ECOG, DASH, EORTC QLQ-C30, CFS, HADS will be used for assessing changes of functional status from baseline and 5 time points of follow-up.

    Measured: baseline, 3,6,12,18 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionJul 2015 (estimated)
  4. Study completionJul 2015 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01963572
Sponsor's protocol ID
201212092RINC
Other IDs
NSC 102-2314-B-002-030-MY3
Status last verified
Oct 2013
First submitted
6 Oct 2013
Last updated
16 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing SG will be screened every time when they visit the clinics. in people with Breast Cancer and Quality of Life, run by National Taiwan University Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Oct 2013. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jau-Yih Tsauo, PhD (+886-2-33668130, jytsauo@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prevalence of body impairments (time frame: 2 years). The study lists 2 primary outcomes in all. 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 16 Oct 2013.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT01963572 | AzTrials