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

NCT02462226

Last updated date
Study Location
NYU Cancer Center
New York, New York, 10016, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Pain, Lymphedema
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-89 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Breast Cancer, Pain, LymphedemaEnhancing Management of Chronic Pain and Symptoms Among Women Treated for Breast Cancer (Lymph-Flow)
NCT02462226
  1. New York, New York
Female
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Breast Cancer
  • Pain
  • Lymphedema
Intervention  ICMJE
  • Behavioral: The-Optimal-Lymph-Flow
    The-Optimal-Lymph-Flow ? is a web-based educational and behavioral program focusing on self-care strategies to manage pain and symptoms related to lymphedema. The Optimal Lymph-Flow? is the only evidence-based self-care program designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Grounded in research-driven behavioral strategies, the program is premised on empowering, rather than inhibiting, how breast cancer survivors live their lives. It emphasizes "what to do," rather than "what to avoid." It features a safe, feasible and easily-integrated-into-daily-routine of exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal BMI.
  • Behavioral: Arm Precaution
    The webpage also has a section entitled "Arm Precautions," representing current patient education that emphasizes precautionary lifestyle behaviors, such as avoidance of repetitive limb movement, lifting weighted objects, needle punctures, blood draw, and the use of compression garments for air travel in the affected limb.
Study Arms  ICMJE
  • Active Comparator: Arm Precaution

    Patients assigned to Education #1 will receive arm precaution self-care strategies. The webpage also has a section entitled "Arm Precautions," representing current patient education that emphasizes precautionary lifestyle behaviors, such as avoidance of repetitive limb movement, lifting weighted objects, needle punctures, blood draw, and the use of compression garments for air travel in the affected limb. Exercises to promote limb mobility will also provided. Only the patients in the control group will be given access to Arm Precautions section.

    Patients will be given access to the website to learn about the arm precaution program.

    Intervention: Behavioral: Arm Precaution
  • Experimental: The-Optimal-Lymph-Flow

    The Optimal Lymph-Flow? is the only evidence-based self-care program designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Grounded in research-driven behavioral strategies, the program is premised on empowering, rather than inhibiting, how breast cancer survivors live their lives. It emphasizes "what to do," rather than "what to avoid." It features a safe, feasible and easily-integrated-into-daily-routine of exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal BMI.

    Patients will be given the access to the website to learn about the The-optimal-Lymph-Flow program

    Intervention: Behavioral: The-Optimal-Lymph-Flow
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
 (submitted: June 3, 2015)
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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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