Enhancing Management of Chronic Pain and Symptoms Among Women Treated for Breast Cancer (Lymph-Flow)
Condition: Breast Cancer; Pain; Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema; Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): The-Optimal-Lymph-Flow; Arm Precaution
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care