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), and 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 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.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.