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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Breast Cancer
• Intervention / Treatment: Other: SG will be screened every time when they visit the clinics.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Graduate Scahool of Physical Therapy, College of Medicine, National Taiwan University
    • Contact: Jau-Yih Tsauo, PhD; Phone Number: +886-2-33668130; Email: jytsauo@ntu.edu.tw
    • Contact: Heuifen Lin, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surveillance group (SG); 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.	Other: SG will be screened every time when they visit the clinics.
No Intervention: general care group (CG); CG raises any health-related question, they can be answered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	baseline, 3,6,12,18 and 24 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: Jau-Yih Tsauo, PhD, Gratuate School of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: October 6, 2013
• First Submitted That Met QC Criteria: October 13, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 13, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Breast cancer; Physical Therapy; Care model
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 201212092RINC; NSC 102-2314-B-002-030-MY3