Guinigundo, A.S., Maxwell, C.L., Vanni, L., Morrow, P.K., Reiner, M., Shih, A., . . . Blanchard, E. (2018). A randomized, single-blind study evaluating the effect of a bone pain education video on reported bone pain in patients with breast cancer receiving chemotherapy and pegfilgrastim. Pain Management Nursing, 19, 693–706.

DOI Link

Study Purpose

To investigate the effect of bone pain education on pegfilgrastim-related bone pain in patients with breast cancer receiving chemotherapy and pegfilgrastim. Patients were either shown a general video or specific bone pain video and then bone pain was assessed using patient surveys that asked about bone pain severity and location, medications usage, and information from adverse reporting.

Intervention Characteristics/Basic Study Process

Patients were randomized 1:1 to view either a generalized education video on chemotherapy side effects or a video on bone pain following chemotherapy and pegfilgrastim.

Sample Characteristics

  • N = 300   
  • AGE: Older than 18 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: Stage I-III newly diagnosed patients with breast cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: Planning on getting four cycles of neoadjuvant or adjuvant chemotherapy with pegfilgrastim support starting in cycle 1. Pegfilgrastim was given within 72 hours of chemotherapy. All received a 6 mg dose of pegfilgrastim and all were English speaking.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: 48 community oncology clinics in the United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Elder care

Study Design

Randomized single-blind study

Measurement Instruments/Methods

  • Severity of pain by a 0-10 scale
  • Location of pain noted on a body map
  • Both videos were developed by oncology nurses and oncologists but professionally produced by Amgen
  • Adverse effects were graded using the CTCAE standards
  • Medication logs
  • Every patient watched the video at least twice and could take the video home. The videos did not replace existing patient education.  
  • Area under the curve was used to capture both the magnitude and duration of pain in a single continuous measure.

Results

Patient-reported maximum bone pain was similar in both groups. General versus specific C1 3.2 versus 3.5 (p = 0.3479); across all cycles, 4.1 versus 4.6 (p = 0.2196). Other measures of bone pain were also similar between groups. 

Bone pain was highest in C1 and then decreased and remained stable in subsequent cycles. Bone pain medication usage was also similar between the two groups with the highest usage in C1. 

The only area that showed significance was in the 65-75 age group. Maximum bone pain for general video was 2.9 versus 4.6 (p = 0.0599); mean bone pain was 1.3 versus 2.6 (p = 0.0220) and AUC was 5.3 versus 10.9 (p = 0.018).

Conclusions

The bone pain-specific education did not improve patient’s perception of bone pain reported in this patient population. However, this study did provide information on the prevalence, timing, severity, and location of pegfilgrastim-related bone pain. This may help focus future research on treatments for bone pain.

Limitations

  • Unintended interventions or applicable interventions not described that would influence results
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Other limitations/explanation: Pain is highly subjective and could be influenced by other factors. It is difficult to predict and assess. Supplemental teaching was not standardized between sites. Age also could influence patient’s perception of pain.  
  • The videos were only two minutes in length, which may not have been significant to generate a meaningful difference in reported pain. The videos may have been too similar.
  • No control for patients watching video at home for other distractions. No pain management counseling given.

Nursing Implications

The major nursing implication is that pain is highest in C1. It is important to educate patients so they do not stop pegfilgrastim treatments due to pain. They need to know the amount of pain decreased is subsequent cycles. Education must always be individualized to be effective. Videos do not replace one-on-one teaching, but new educational methods need to be developed. More research is needed in different patient populations and on specific treatment experiences.