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Integrative Medicine for Pain in patients with Advanced Cancer Trial (IMPACT)
Investigator (PI): Mao, Jun
Performing Organization (PO): (Current): Memorial Sloan-Kettering Cancer Center / (212) 639-2000
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2023
Record Source/Award ID: PCORI/ SMPAI-2018C2-12883
Funding: Total Award Amount: $2,780,640
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Comparing Non-Medicine Pain Management Therapies for Adults with Advanced Cancer -- The IMPACT Trial PCORI has identified relief of symptoms that patients with advanced illness often experience as an important research topic. Patients, clinicians, and others want to learn how different treatment strategies affect pain, fatigue, insomnia, nausea, depression, and other common symptoms. To address this issue, PCORI launched an initiative in 2017 on Symptom Management for Patients with Advanced Illness . The initiative funded this research project. This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. What is the research about? Pain is one of the most common and upsetting symptoms for patients living with advanced cancer. Pain can disrupt sleep and lead to fatigue and decreased quality of life. Doctors often prescribe opioids to manage pain. But these medicines can have side effects such as constipation, dizziness, and increased risk for falls. Non-medicine pain management treatments, such as acupuncture and massage, can be used along with standard medical treatment, including opioids, to treat pain in cancer patients. But patients and doctors may find it hard to decide which treatment approach will best manage their pain and related symptoms. This study is comparing two ways to manage pain in adults with advanced cancer: Acupuncture, which involves inserting thin needles into different parts of the body Massage, which involves using hands to work muscles and other soft tissues Who can this research help? Patients with advanced cancer and their doctors can use these findings when considering ways to manage pain and related symptoms. What is the research team doing? The research team is enrolling 300 adults with advanced cancer in New York and New Jersey. These patients have had pain that affects the muscles, ligaments, tendons, or bones for at least one month and moderate to severe pain for at least one week. The team is assigning patients by chance to receive acupuncture or massage in addition to their current pain management treatment. In the first 10 weeks of the study, patients assigned to acupuncture or massage receive up to 10 treatments; for the next 16 weeks, they get treatment once every 4 weeks. All patients are completing surveys on their pain and related symptoms at 10 and 26 weeks. Patients with advanced cancer and patient advocates are helping to plan and carry out the study. Research methods at a glance Design Element Description Design Randomized controlled trial Population Adults with advanced cancer and musculoskeletal pain Interventions/ Comparators Acupuncture Massage Outcomes Primary: pain Secondary: fatigue, sleep disturbance, quality of life Timeframe 26-week follow-up for primary outcome.
Abstract Archived: Background: Pain is one of the most common and distressing symptoms for patients living with advanced cancer. Pain can disrupt sleep and lead to fatigue and decreased quality of life. With the widespread opioid crisis in the United States, current clinical guidelines recommend using non-medication therapies, including acupuncture and massage, for pain management in adult cancer patients in addition to pain medications. However, it remains difficult for patients to decide which treatment approach will best address their pain and other associated symptoms. Objectives: We propose a patient-centered clinical trial to evaluate and compare the short- and long-term effectiveness of acupuncture and massage for pain and related symptoms in 300 patients living with advanced cancer who have moderate to severe pain. We also want to identify how patient characteristics (for example: sex, age, and race), and clinical and psychological factors affect treatment results. Methods: To be eligible for the study, patients will be 18 years or older, have an advanced cancer diagnosis, have musculoskeletal pain for at least one month, and have moderate to severe pain in the past week. We will randomly assign patients to either the acupuncture, massage, or waitlist control (WLC) group. Patients randomized to the acupuncture or massage groups will receive up to ten treatments during the first ten weeks and then receive monthly booster treatments for up to 26 weeks. Patients in the WLC group will continue to receive their standard medical care and pain management as prescribed by their physicians. Ten weeks after randomization, patients in the WLC group will receive up to ten treatments of either acupuncture or massage. Patient outcomes: Patient-reported pain severity is the primary outcome. We will also collect patient reports of sleep quality, fatigue, and quality of life (mental and physical health) as well as track medication use. Patient and stakeholder engagement: We have formed a patient and stakeholder partner advisory board, which consists of patient and community advocates diverse in age, race/ethnicity, educational level, occupational status, and cancer community/advocacy group affiliations (e.g., American Cancer Society, SHARE, and Memorial Sloan Kettering's Patient and Family Advisory Council for Quality). Our partner advisory board has helped to develop our research questions, modify our study eligibility criteria, refine the research protocol, and choose the most appropriate tools to measure our study outcomes. Two of our patient partners will also participate as co-investigators in the study. Each advisory board member has specific roles in the research and will continue to advise us on the study conduct and help plan how best to share our results. Anticipated impact: The results of the proposed study will have an immediate impact by helping patients with advanced cancer and their health care providers make informed, personalized, and evidence-based decisions about how best to manage pain and related symptoms.

MeSH Terms:
  • Acupuncture
  • Ethnic Groups
  • Evidence-Based Medicine
  • Female
  • Humans
  • Integrative Medicine /*organization & administration
  • Male
  • Massage
  • Medical Oncology /*organization & administration
  • Neoplasms /*therapy
  • Outcome Assessment (Health Care)
  • Pain Management
  • Pain Measurement
  • Patient Reported Outcome Measures
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Sleep
  • United States
Country: United States
State: New York
Zip Code: 10065
UI: 20201488
CTgovId: NCT04095234
Project Status: Ongoing
Record History: ('2021: Abstract archived and replaced. ',)