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

NCT02462226 | Completed DMC

• 1 other identifier: 15-00221
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Pain; Lymphedema

Outcome Measures

Primary Outcomes (1)

• The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI

  The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI) is a valid and reliable self-report tool to assess pain, including aching, soreness, tenderness, as well as symptoms related to lymphedema (i.e. , arm swelling, breast swelling, chest wall swelling, heaviness, firmness, tightness, stiffness, burning, stabbing numbness, tenderness, stiffness, redness, blistering, and tingling (pins and needles. Each symptom can be treated as categorical variable by choosing a "Yes" or "No" to indicate the presence or absence of a given symptom. Each item can also be rated on a Likert-type scale from 0 (no presence of a given symptom) to 4 (greatest severity of a given symptom). Higher scores indicate more severe symptom presence. A response frame of last three months will be used for all participants to ensure the chronicity of symptom presence.

  12 weeks

Secondary Outcomes (4)

• Limb Volume Difference by Infra-red Perometer.

  12 weeks

• The Pain Impact Questionnaire™ (PIQ-6™)

  12 Weeks

• Body Weight and Body Mass Index [BMI]

  12 Weeks

• Risk Reduction Behavior Checklist

  12 Weeks

Study Arms (2)

Arm Precaution

ACTIVE COMPARATOR

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.

Behavioral: Arm Precaution

The-Optimal-Lymph-Flow

EXPERIMENTAL

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

Behavioral: The-Optimal-Lymph-Flow

Interventions

The-Optimal-Lymph-Flow BEHAVIORAL

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.

The-Optimal-Lymph-Flow

Arm Precaution BEHAVIORAL

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.

Arm Precaution

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Pfizer: collaborator

Study Sites (1)

NYU Cancer Center

New York, New York, 10016, United States

Location

Related Publications (2)

• Fu MR, Axelrod D, Guth AA, Scagliola J, Rampertaap K, El-Shammaa N, Qiu JM, McTernan ML, Frye L, Park CS, Yu G, Tilley C, Wang Y. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial. JMIR Cancer. 2022 Jan 17;8(1):e29485. doi: 10.2196/29485.

  PMID: 35037883 DERIVED

• 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.

  PMID: 26795447 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pain; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: June 4, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (1)