Komatsu, H., Hayashi, N., Suzuki, K., Yagasaki, K., Iioka, Y., Neumann, J., . . . & Ueno, N.T. (2012). Guided self-help for prevention of depression and anxiety in women with breast cancer. ISRN Nursing, 716367.

Evaluate the effects of a self-help program on depression and anxiety in women with breast cancer receiving chemotherapy

Patients were assigned to intervention or treatment groups by authors (not random assignment). The intervention was a self-learning package aimed at rehearsing the chemotherapy procedure, improving beliefs in managing side effects, and helping build problem-solving skills. This group also was given a professional-led support group that met two to three times during the study. The control group received usual care including a chemotherapy education leaflet. Nurses monitored patient progress from review of patient diaries in the intervention group that documented side effects and self management performed at the beginning of each cycle of chemotherapy. Nurses involved with the intervention were educated and demonstrated increased knowledge regarding improving coping processes in daily living. Data were collected at baseline, one week, three months, and six months.

• N = 65      
• MEAN AGE: Intervention = 47.7 years (SD = 8 years), control = 49.5 years (SD = 10.9 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer at stages 1–3. All had previous surgery.
• OTHER KEY SAMPLE CHARACTERISTICS: Most had breast-conserving surgery. The majority had less than a bachelor’s degree education level.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Non-random, two-group comparison, quasi-experimental—historical control approach

• Center for Epidemiological Studies Depression Scale (CESD)
• State-Trait Anxiety Inventory (STAI)
• SF-36
• National Cancer Institute-Common Toxicity Criteria version 2.0

No significant differences were found in outcomes between study groups. Study measures improved over time in all patients.

This study did not find that the intervention tested here had an effect on depression or anxiety.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Questionable protocol fidelity
• No information is provided about patient compliance with diaries and symptoms experienced. No method was used for determining intervention fidelity. No information is provided as to patients' actual attendance at support group sessions. If patients in both groups were being treated in the same location, whether group contamination could have occurred is unclear. The control comparison used was actually a historic control. How the program was designed is unclear, and no apparent theoretical foundation of the program design exists. Although not statistically significant, baseline anxiety and depression scores were lower in the control group, which may have affected the ability to detect differences. Analysis was the comparison of average scores at each study time point, but changes in these scores were not analyzed. Changes in anxiety and depression scores appeared to be greater in the intervention group—analysis of differences in the size of the improvement may have shown different significance. Data reporting is questionable—confidence intervals reported with F values do not appear to be actually related to those values.

This particular study did not demonstrate effectiveness of the intervention tested here. The study had several limitations. Anxiety and depression improved in all patients, suggesting that usual nursing education provided was just as effective as the expanded approach used here. Several study results have suggested that interventions aimed at improving anxiety and depression are most effective for patients who have clinically relevant anxiety and depression.