Prevention of Lymphedema Among Breast Cancer Patients Through Implementation of an Integrative Therapy Program (ITP)
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|ClinicalTrials.gov Identifier: NCT02528539|
Recruitment Status : Unknown
Verified September 2016 by Suzie Kline, Huntington Memorial Hospital.
Recruitment status was: Recruiting
First Posted : August 19, 2015
Last Update Posted : September 21, 2016
Introduction: Breast cancer women who are treated with axillary node dissection are at increased risk for lymphedema - the lifetime risk in these women is estimated at 15-50% and the risk can significantly increase with chemotherapy and radiation therapy
- To evaluate the feasibility and effectiveness of implementing the integrative therapy program (ITP) intervention. ITP consists of self-management education in conjunction with acupuncture.
- To determine if ITP affects quality of life, self-efficacy, lymphedema knowledge, pain, and early detection and management of lymphedema.
Design: the exploratory study aims to evaluate the feasibility and benefits of the integrative therapy program (ITP) intervention post-operatively for 18 months.
Subjects: Women with breast cancer treated with axillary node dissection with normal baseline pre-operative bioimpedance (L-dex U400) score.
Sample size: 30 subjects
|Condition or disease||Intervention/treatment||Phase|
|Lymphedema||Other: ITP||Not Applicable|
Recruitment and Intervention:
The study participants are recruited by their breast surgeon after they undergo axillary node dissection surgery. 4-6 weeks following surgery, the participants will receive a combination of acupuncture and self management education .
Contents of self-management education include:
- Lymphedema knowledge: functions of the lymphatic system, anatomy of the lymph nodes and direction of the lymphatic drainage, risk factors that could precipitate lymphedema, the signs and symptoms of lymphedema and infection, and lymphedema resources.
- Selfcare techniques:healthy diet (eating whole food encouraged), neck, shoulder and chest wall stretching exercises, walk daily, self-manual lymphatic drainage with deep breathing techniques, and self-acupressure over eighteen months following their surgery.
Outcome measurements include: L-Dex U400 measurement, arm circumference, pain scale, self-efficacy, and lymphedema knowledge, and Functional Assessment of Cancer Therapy-Breast FACT-B.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Secondary Lymphedema by Utilizing Self-management Education in Conjunction With Acupuncture Among Breast Cancer Patients Who Are at High Risk of Developing Lymphedema|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: ITP (Integrative Thearpy Program)
This ITP intervention consists of two distinct phases, Phase I, the active treatment phase and Phase II, the follow-up phase.
Phase I (Intervention phase) begins post-operatively in 4-6 weeks with a baseline visit that includes 30-minute acupuncture treatment, followed by the 30-minute self-management educational session, and the participants will return weekly for 10 weeks.
Phase II (Follow up phase) begins at month 6 and ends at month 18 from the surgery. The phase II consists of 1-hour quarterly ITP therapy at months 6, 9, 12, 15, and 18 and monthly telephone visits between ITP therapies at months 7, 8, 10, 11, 13, 14, 16, and 17. Self-management reinforcement and support will be implemented during telephone follow up visits
The study participants will receive weekly acupuncture treatment plus education on self-management for 10 weeks after axillary node dissection, then a total of five follow up acupuncture treatments once every 3 months at 6, 9, 12, 15, and 18 months. The education and self management will be reinforced monthly by telephone visit.
Acupuncture points include: LI 4, LV3, HT3, SP9, GB 20, KD 3, Yintang, and Ashi points
Other Name: Integrative Therapy Program
- Bioimpedance (L-dex U400) [ Time Frame: 18 months ]
- Arm circumference measurements of the upper limbs using at 4 cm interval [ Time Frame: 18 months ]
- Self-Efficacy Scale [ Time Frame: 18 months ]
- Lymphedema Knowledge Scale [ Time Frame: 18 months ]
- Quality of Life (Functional Assessment of Cancer Therapy-Breast) [ Time Frame: 18 months ]
- Wong-Baker FACES Pain Scale [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02528539
|Contact: Suzie S Kline, PhDemail@example.com|
|Contact: Jeannie Shen, M.D.||626-356-3167|
|United States, California|
|Huntington Memorial Hospital||Recruiting|
|Pasadena, California, United States, 91105|
|Contact: Suzie S kline, PhD 626-807-9168 firstname.lastname@example.org|
|Sub-Investigator: Jeannie Shen, M.D.|
|Sub-Investigator: Ruth Williamson, M.D.|
|Sub-Investigator: Robin Gemmill, MSN, RN|
|Principal Investigator:||Suzie S Kline, PhD||Huntington Hospital|