Results Summary

What was the research about?

Pain is one of the most common symptoms for patients living with advanced cancer. Pain can disrupt sleep, lead to fatigue, and decrease quality of life. Medicine can help ease pain, but it may have side effects. Treatments without medicine can be used to reduce pain and improve quality of life in patients with cancer. 

In this study, the research team compared two approaches to treat pain without medicine in adults with advanced cancer:

  • Acupuncture, which involves inserting thin needles into different parts of the body
  • Massage, which involves using the hands to work muscles and other soft tissues

Patients received up to ten 30-minute treatments for 10 weeks. After that, they received treatments once a month for up to 26 weeks. The research team looked at how well each treatment worked to reduce severe pain.

What were the results?

After 10 weeks, patients using either approach had less pain and fatigue and had improved sleep and quality of life. These changes were maintained through the end of the study with the monthly sessions. Patients also used less pain medicine over time.

At the end of study, patients who received acupuncture and patients who received massage did not differ in:

  • Decreases in severe pain
  • Problems sleeping
  • Symptoms of depression and anxiety
  • Fatigue
  • Quality of life

Who was in the study?

The study included 298 adults with advanced cancer, including breast, blood, lung, and stomach cancers. All patients reported moderate to severe pain from their cancer or cancer treatment. Patients were receiving care at cancer centers in New York, New Jersey, or Florida.

Of these patients, 74 percent were White, 11 percent were Black, 6 percent were Asian, and 8 percent were multiple races; 15 percent were Hispanic. The average age was 59, and 67 percent were women.

What did the research team do?

The research team assigned patients by chance to receive acupuncture or massage. Patients completed surveys online or by phone on their pain and other health outcomes. They filled out surveys at the start of the study and again after 4, 10, 14, 18, 22, and 26 weeks.

Patients with advanced cancer, doctors, and patient advocates helped to plan and conduct the study.

What were the limits of the study?

The therapists provided acupuncture and massage treatment in a clinical setting. The research team trained and monitored therapists regularly to make sure they applied the therapy in a standard way each time. Results may differ in community settings where care delivery may vary.

Future research could look at these treatments in community settings.

How can people use the results?

Patients with advanced cancer and their doctors can use these results when considering ways to treat pain.

PCORI identified relief of symptoms that patients with advanced illness often experience as an important research topic. Patients, clinicians, and others wanted 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.

Final Research Report

This project's final research report is expected to be available by December 2024.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The report indicated that the therapists were study personnel, the participant inclusion criteria were somewhat narrow, and the research data were collected separately from regular clinic visits. As such, the reviewers questioned whether this study was really pragmatic. The researchers explained that the therapists conducting the study interventions saw patients regularly outside of the research project and that the inclusion criteria were actually broader than a typical efficacy study. They felt the diversity of sources for pain among participants justified calling this study pragmatic.
  • The reviewers asked the researchers to revise their primary conclusions, which stated that both acupuncture and massage reduced pain in participants. The reviewers noted that because the change in level of pain was assessed without a usual care comparator, it was not possible to know whether the interventions improved pain or whether the changes would happen over time without intervention. The researchers removed causal language indicating that massage and acupuncture were responsible for the improvement in pain symptoms throughout the report.
  • The reviewers noted that the primary aim of this study was to test whether one of the interventions was better than the other at reducing pain. The fact that there was no measurable difference between the two interventions should be the first result reported in the abstract and in the main text rather than the change in pain level. The researchers made this change.
  • The reviewers asked the researchers to expand their presentation of results of the heterogeneity of treatment effects (HTE) analyses, noting that this was the second aim of the study and should be mentioned in the abstract and discussion. The researchers initially disagreed because the study was not powered for the HTE analyses so these analyses should not be given any prominence. However, they did eventually add information about these analyses to the abstract and discussion of the report to follow PCORI guidelines for final report content.

Conflict of Interest Disclosures

Project Information

Jun J. Mao, MD, MSCE
Memorial Sloan Kettering
$2,814,485
Integrative Medicine for Pain in Patients with Advanced Cancer Trial (IMPACT)

Key Dates

April 2019
December 2023
2019
2024

Study Registration Information

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 29, 2024