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

Completed · Not applicable

Conditions studied: Breast Cancer, Pain, Lymphedema

In brief

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.

Key facts

Study ID

NCT02462226

Run by

NYU Langone Health

People needed

120

Starts

2015-05-01

Expected to finish

2016-12-01

Last updated by the study team

2017-04-20

Who can join

Age: 21 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have been surgically treated for breast cancer more than 3 months; healing usually occurs within 3 months of surgical treatment for cancer
• Patients who report persistent or intermittent pain, including aching, tenderness, soreness;
• 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);
• Patients may or may not have a history of lymphedema or have been treated for lymphedema.
• 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.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Patients who do not report any pain, including aching, tenderness, and soreness;
• Patients who have known metastatic disease or other bulk disease in the thoracic or cervical regions;
• Patients who have lymphedema due to cancer recurrence.
• Patients with documented advanced cardiac or renal disease.

Where it is running

• NYU Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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