Results Summary
What was the research about?
Patients with cancer often have pain while in the hospital. Medicine can help ease pain but may have side effects. Adding treatments like acupuncture and pain counseling may reduce pain and improve quality of life. More hospitals might offer these treatments if more research shows they help patients.
In this study, the research team compared four ways to reduce pain among patients with cancer in the hospital:
- Usual care alone. Patients received pain medicine based on their level of pain and how well their medicines have worked in the past.
- Usual care plus acupuncture. Acupuncture involves inserting small needles into different parts of the body to treat health problems. Patients had at least one session in the hospital.
- Usual care plus pain counseling. During counseling, patients discussed their attitude toward pain, pain treatments and side effects, coping skills, and ways to talk with healthcare providers, like doctors and nurses. Patients had at least one session in the hospital.
- Usual care plus acupuncture and pain counseling. Patients had at least one session of acupuncture and one session of pain counseling.
What were the results?
About 41 percent of patients didn’t receive their assigned treatment, mostly due to patients’ choosing not to have it. As a result, the research team decided to analyze the data in two ways. The first way looked at all patients in the study. The second way looked just at patients who received their treatment.
Looking at all patients assigned to treatments, the four treatments didn’t differ in the decrease in pain.
Looking at patients who received treatments, patients who received acupuncture had larger decreases in pain than patients who received usual care alone. The decrease in pain didn’t differ for the other two treatments.
The four treatments didn’t differ in patients’ quality of life, emotional distress, or pain relief while in the hospital in any of the research team’s analyses.
Who was in the study?
The study included 447 adults with cancer who received care at one of two hospitals in California. Among patients, 53 percent were White, 25 percent were Latino, 10 percent were Asian, 7 percent were Black, and 6 percent identified as another race or ethnicity. The average age was 59, 50 percent were men, and 78 percent had early-stage cancer.
What did the research team do?
The research team assigned patients by chance to one of the four treatment approaches. At the start of the study and every day for up to four days during the hospital stay, the team surveyed patients on how they would rate their pain level, quality of life, emotional distress, and pain relief.
Patients, doctors, and administrators helped design the study.
What were the limits of the study?
Results may have differed if more patients had received their treatment.
Future research could continue to look at ways to help reduce pain for patients with cancer in the hospital.
How can people use the results?
Hospitals can use the results when considering ways to manage pain for patients with cancer.
Professional Abstract
Objective
To compare the effectiveness of supplementing usual care with acupuncture, pain counseling, or both versus usual care alone on improving pain management among patients hospitalized with a malignant solid tumor
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 447 patients ages 21 and older with a malignant solid tumor |
| Interventions/ Comparators |
|
| Outcomes | Primary: patient-reported worst pain intensity on 0 to 10 scale Secondary: health-related quality of life, emotional distress, pain relief |
| Timeframe | 4-day follow-up for primary outcome |
This two-by-two factorial randomized controlled trial compared the effect of usual care plus acupuncture, pain counseling, or both versus usual care alone on pain intensity among patients with cancer.
Researchers randomized patients to one of four treatment groups:
- Usual care alone. Patients received varying medication types and doses to treat their pain based on their level of pain and experience with medication. Doctors followed the three-step ladder of pain medication administration developed by the World Health Organization.
- Usual care plus acupuncture. Licensed acupuncturists provided daily, protocolized acupuncture treatments based on techniques shown to be effective in studies of acupuncture and cancer pain. The average number of sessions received per patient in the hospital was 1.7.
- Usual care plus pain counseling. In counseling, patients discussed their attitude toward pain and learned about pain treatments and side effects, coping skills, and ways to communicate with healthcare providers. The average number of sessions received per patient was 1.5.
- Usual care plus pain counseling and acupuncture. Patients received pain counseling and acupuncture. The average number of sessions received per patient was 2.4.
The study included 447 adults with a malignant solid tumor who were admitted to a public safety-net hospital or a university teaching hospital in California. Of these patients, 53% were White, 25% were Latino, 10% were Asian, 7% were Black, and 6% identified as another race or ethnicity. The average age was 59, 50% were male, and 78% of patients had nonmetastatic cancer.
At baseline and every day up to four days while at the hospital, researchers surveyed patients about their worst pain intensity, quality of life, emotional distress, and pain relief.
Because 41% of patients did not receive their assigned treatment, mostly when they chose to decline it, researchers conducted both an intention-to-treat analysis and per-protocol analysis.
Patients, clinicians, and health administrators helped design the study.
Results
Using intention-to-treat analysis, the three treatment groups did not differ significantly in worst pain intensity compared with usual care alone.
Using per-protocol analysis, compared with usual care alone, patients who received usual care plus acupuncture had a statistically significant decrease in worst pain intensity while in the hospital (95% confidence interval [CI]: -1.09, -0.53; p=0.03). The other two treatment groups did not differ significantly in worst pain intensity compared with usual care alone.
Regardless of analysis type, quality of life, emotional distress, and pain relief during patients’ hospital stay did not differ significantly among treatment groups.
Limitations
The low rates of consent to assigned treatment may have biased study findings. Further, patients may not have received an optimal number of intervention sessions to affect their pain.
Conclusions and Relevance
Supplementing pain medication with acupuncture may improve hospital-based pain management for patients with cancer.
Future Research Needs
Future research could continue to investigate nonpharmacologic ways to manage pain for patients with cancer.
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
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 reviewers noted that the researchers used a factorial study design, but their analyses were not a good match for this design. They also said that analyzing the treatment effects based on change scores rather than adjusted between-groups analysis was a study limitation but acknowledged that changing the analyses was unlikely to affect study conclusions. The researchers revised the report to put more emphasis on between-group analyses and made sure that their descriptions of analyses matched what they had stated as their planned analyses.
- The reviewers cautioned the researchers against focusing on statistical significance rather than clinically important differences, and about calling out “borderline” effects on outcomes that were not significant. The researchers added information about the magnitude and clinical significance of between-group differences and removed references to borderline significance.
- The reviewers questioned the researchers’ focus on per-protocol analyses rather than intention-to-treat (ITT) analyses when the study design and missing data would indicate that ITT analyses could offset any biases in the results. The researchers revised the report to make the ITT analyses more prominent. In the discussion the researchers suggested that the ITT analyses may not accurately measure treatment effect when there were so many people who dropped out right after treatment assignment, but also acknowledged the problems in interpreting per-protocol analyses precisely because so many people did drop out.
- The reviewers asked the researchers to add more information about the potential for bias in their study results because the per-protocol analysis only included participants who started treatment, but a large percentage of participants in each arm never started treatment, possibly because they preferred to be in a different intervention arm. The reviewers noted that excluding so many people could bias the results in either a positive or negative direction. The researchers responded to these requests by moving the ITT analyses to the beginning of the results section and added paragraphs to the discussion related to the potential biases in per-protocol analyses because the participants who stayed in the study were more likely to believe in the effects of the treatment, and pain intensity can be subjective.