Malignancy of the breast is the most common cancer in women after melanoma and it is responsible for about one-third of all cancers in women. Mortality because of the cancer is on the decline in the United States due to better detection and treatment. Breast cancer is a disease of epithelial cells that line the ducts of the breast. It is a clonal disease, meaning that a single transformed cell that eventually expresses full malignant potential causes it. Therefore, it may exist for a long period before it becomes invasive and metastatic. (Harrisons, 2008, p.563)
Park, et al, are affiliated with Massachusetts General Hospital in Boston, Massachusetts. Early screening has been credited with a reduction in breast cancer mortality, but this early screening is not without a risk of psychological harm of stress and anxiety. Park, et al., performed a single armed clinical trial to assess the feasibility, acceptability, and efficacy of relaxation response training in order to limit the distress faced by women about to undergo breast biopsy for breast cancer.
The trial subjects were forty women enrolled over a fourteen month period. 75% of the enrollees completed the full course of relaxation response training and 75% completed the assessment that followed. The participants were over 18 years old, spoke English and were to have a breast biopsy performed between June 2010 and August 2011. The mean age of participants was 52.5 years old, primarily white, 35% had a history of a prior breast biopsy, 10% had a history of diagnosed breast cancer. Women who had biopsies scheduled within 24 hours of referral, breast cyst aspirations, or otherwise unable to participate were excluded from the study.
The single arm trial consisted of participants undergoing three half-hour sessions with a psychologist. The first session was done over the telephone the day before the biopsy where the participant was guided through breathing exercises and was introduced to relaxation exercise. The second session was done one hour before biopsy in a private waiting area where the participants were again going guided through a relaxation exercise. The final session was performed by telephone one week after the biopsy, prior to the receipt of results. At the follow-up assessment, the participants were asked closed and open-ended questions about their experiences.
Feasibility was measured by establishing the proportions of biopsy patients screened, recruited, and enrolled for the study as well as the proportions of patients who completed the study. Acceptability was measured via feedback from the participants about their satisfaction with the program. Changes in levels of distress were explored via repeated measurements.
75% of the women completed the post study assessment. A comparison of the study completers to patients who did not complete the study found that the completers were slightly more likely to have health insurance and had a history of cancer. All participants diagnosed with breast cancer completed the study, whereas 26.3% with benign findings and 50% with discordant findings did not complete the study. 35 women completed the first two sessions of relaxation response training, and 31 completed all three sessions of the training. 3 did not attend any sessions. In the follow-up survey it was determined that 60% practiced the techniques they learned a few times a week and 20% practiced the techniques daily. The assessments suggested that the intervention had a positive impact on the woman’s perception of the care. It also may have helped to improve the experience of the procedure itself, and the waiting periods associated with the procedure. Participants were satisfied with the sessions and expressed interest in more sessions. Patients diagnosed with malignancy tended to want to continue with the program throughout their cancer care.
Acute distress was lowered in all three sessions. There was no statistical difference in perceived stress or global distress. However, both measures showed slight decreases in stress for the patients with benign findings. Percieved stress was measured as lower 2 weeks after biopsy for the malignant patients, but their levels of global distress were higher. In patients with unresolved findings, their stresses were higher 2 weeks after biopsy. Perceived stress reductions were marginally greater in women with spouses or domestic partners than for women without a spouse/domestic partner.
The next phase of research should involve control groups rather than just a cohort being followed. It would also be valuable to look at various relaxation exercises and compare them to each other and a control group. Furthermore, the studies should be larger and more diverse in order to really gain some sort of understanding about stress reduction during this clearly trying time for a woman. Future studies should also look at the different types of distress elicited from different types of breast biopsy procedures.
The study was a respectable study except for the small number of participants and the fact that it was a single-armed study with no control group. The authors concluded that relaxation response therapy was acceptable and feasible to implement and there is no reason to disagree with these findings. The reduction in acute distress levels seen in all groups preparing to get the biopsy is promising, even if in the after period, distress levels did not show statistical difference.
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