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Abstract
Introduction Pain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited.
Methods and analysis We describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks.
Ethics and dissemination The Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer.
Trial registration number NCT04095234.
- pain management
- complementary medicine
- cancer pain
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Footnotes
Contributors SADR, REB, KP, JMac, DW, MB-B, JMao, AE: conceptualisation. REB, KP, JMao: data curation. REB, KP, JF: formal analysis. JMao: funding acquisition. SADR, NE, JMao: investigation. SADR, NE, JMao: project administration. JMao: resources. SADR, NE, KL, GD, HX, JMao: supervision. SADR, NE, JMao: writing-original draft. All authors: writing-review and editing.
Funding Research reported in this article was funded through a Patient-Centered Outcomes Research Institute (PCORI) award (SMPAI-2018C2-12883). The statements presented in this work are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee. It was also supported in part through the National Institutes of Health/National Cancer Institute Cancer Center Support Grant (P30 CA008748) and the Translational and Integrative Medicine Research Fund (award/grant number not applicable) at Memorial Sloan Kettering Cancer Center.
Disclaimer The funders do not have any role in study design; collection, management, analysis, and interpretation of data; writing of the report; and decision to submit for publication.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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