Enhancing Management of Chronic Pain and Symptoms Among Women Treated for Breast Cancer (Lymph-Flow)



Status:Completed
Conditions:Breast Cancer, Cancer, Chronic Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:21 - 89
Updated:4/21/2017
Start Date:May 1, 2015
End Date:December 1, 2016

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The-Optimal-Lymph-Flow ™: An e-Health Approach to Enhancing Management of Chronic Pain and Symptoms Related to Lymphedema Among Women Treated for Breast Cancer

The purpose of this research study is to conduct a randomized clinical trial to evaluate the
efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and
symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary
outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index,
quality of life related to pain.

Recruitment includes 120 patients who will be randomized according to pain/aching/soreness,
and tenderness. Participants in the intervention group will be provided the web-based
The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program
during the 1-4 weeks of the study. Participants in the control group will receive the
web-based arm precaution program. All the participants will have monthly online assessment
of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research
visits, that is, prior to intervention and 12 weeks post-intervention.

Despite current advances in cancer treatment, many breast cancer survivors still face
long-term post-operative challenges as a result of suffering from daily pain and other
distressing symptoms related to lymphedema, i.e. abnormal accumulation of lymph fluid in the
ipsilateral upper limb or body.

The purpose of this research study is to conduct a randomized clinical trial to evaluate the
efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and
symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary
outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index,
quality of life related to pain.

Recruitment includes 120 patients who will be randomized according to pain/aching/soreness,
and tenderness. Participants in the intervention group will be provided the web-based
The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program
during the 1-4 weeks of the study. Participants in the control group will receive the
web-based arm precaution program. All the participants will have monthly online assessment
of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research
visits, that is, prior to intervention and 12 weeks post-intervention. The study length for
patients is 12 weeks.

Inclusion Criteria:

1. Patients who have been surgically treated for breast cancer more than 3 months;
healing usually occurs within 3 months of surgical treatment for cancer

2. Patients who report persistent or intermittent pain, including aching, tenderness,
soreness;

3. Patients may or may not report any of symptoms related to lymphedema (i.e. swelling,
heaviness, tightness, firmness, numbness, tingling, stiffness, limb fatigue, limb
weakness, and impaired limb mobility of shoulder, arm, elbow, wrist, and fingers);

4. Patients may or may not have a history of lymphedema or have been treated for
lymphedema.

5. Patients have Internet access to the web-based program at home or willing to access
the web-based program using the computer provided by the researchers at the Cancer
Center.

6. Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

1. Patients who do not report any pain, including aching, tenderness, and soreness;

2. Patients who have known metastatic disease or other bulk disease in the thoracic or
cervical regions;

3. Patients who have lymphedema due to cancer recurrence.

4. Patients with documented advanced cardiac or renal disease.
We found this trial at
1
site
New York, New York 10016
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from
New York, NY
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