Enhancing Management of Chronic Pain and Symptoms Among Women Treated for Breast Cancer (Lymph-Flow)
NCT02462226
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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.
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.
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Descriptive Information | |||||
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Brief Title ICMJE | Enhancing Management of Chronic Pain and Symptoms Among Women Treated for Breast Cancer (Lymph-Flow) | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. | ||||
Detailed Description | 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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Supportive Care | ||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Fu MR, Axelrod D, Guth A, Scagliola J, Rampertaap K, El-Shammaa N, Fletcher J, Zhang Y, Qiu JM, Schnabel F, Hiotis K, Wang Y, D'Eramo Melkus G. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Randomized Clinical Trial Rationale and Protocol. JMIR Res Protoc. 2016 Jan 21;5(1):e7. doi: 10.2196/resprot.5104. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 120 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | December 1, 2016 | ||||
Actual Primary Completion Date | December 1, 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 89 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02462226 | ||||
Other Study ID Numbers ICMJE | 15-00221 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | NYU Langone Health | ||||
Study Sponsor ICMJE | NYU Langone Health | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | NYU Langone Health | ||||
Verification Date | April 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |