Implications of a postoperative rehabilitation program on quality of life in women with primary breast cancer treated with sentinel lymph node biopsy or complete axillary lymph node dissection.
ABSTRACT The aim of this clinical study was to evaluate quality of life (QoL) in early-stage breast cancer patients and to investigate the effects of a comprehensive rehabilitation program comparing women undergoing sentinel node biopsy (SNB) versus complete axillary lymph node dissection (ALND). QoL was assessed with the Functional Assessment of Cancer Therapy--General and Functional Assessment of Cancer Therapy--Breast (FACT-B) questionnaire.
Eighty-nine women with histologically confirmed primary breast cancer stages I-II were enrolled. Recruitment began on May 2006 and ended on December 2007. According to current standards of care, 58 women were found clinically fit to undergo SNB, and the other 31 were elected for ALND. Thirty women who underwent SNB were randomly allocated to participate in a comprehensive postoperative rehabilitation program, and the 28 remaining were dismissed and scheduled to return for clinical follow-up.
Women undergoing ALND had a better QoL within 30 days of surgery on the FACT-B, FACT-G, Trial Outcome Index (TOI), emotional well-being (EWB), and breast concern subscale (BCS) (P < .005) and at 6 months after surgery on the EWB subscale only. Women undergoing SNB had a significant improvement in QoL only on the EWB subscale 6 months after surgery in the group with rehabilitation and 30 days after surgery in the group without rehabilitation.
Women undergoing ALND benefited from a rehabilitation program and had a better QoL. Women undergoing BLS, regardless of rehabilitation, showed improvement in QoL for the emotional well-being subscale only.
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ABSTRACT: This study is the first large prospective RCT of sentinel node biopsy (SNB) compared with standard axillary treatment (level I-III axillary lymph node dissection or four node sampling), which includes comprehensive and repeated quality of life (QOL) assessments over 18 months. Patients (n = 829) completed the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the Spielberger State/Trait Anxiety Inventory (STAI) at baseline (pre-surgery) and at 1, 3, 6, 12, and 18 months post-surgery. There were significant differences between treatment groups favouring the SNB group throughout the 18 months assessment. Patients in the standard treatment group showed a greater decline in Trial Outcome Index (TOI) scores (physical well-being, functional well-being and breast cancer concerns subscales in FACT-B+4) and recovered more slowly than patients in the SNB group (p < 0.01). The change in total FACT-B+4 scores (measuring global QOL) closely resembled the TOI results. 18 months post-surgery approximately twice as many patients in the standard group compared with the SNB group reported substantial arm swelling (14% versus 7%) (p = 0.002) or numbness (19% versus 8.7%) (p < 0.001). Despite the uncertainty about undergoing a relatively new procedure and the possible need for further surgery, there was no evidence of increased anxiety amongst patients randomised to SNB (p > 0.05). For 6 months post-surgery younger patients reported less favourable QOL scores (p < 0.001) and greater levels of anxiety (p < 0.01). In view of the benefits regarding arm functioning and quality of life, the data from this randomised study support the use of SNB in patients with clinically node negative breast cancer.Breast Cancer Research and Treatment 03/2006; 95(3):279-93. · 4.47 Impact Factor
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ABSTRACT: Arm edema occurs in 20 to 30 per cent of patients who undergo axillary lymph node dissection (ALND) for carcinoma of the breast. Sentinel lymph node biopsy (SLNB) in lieu of ALND for staging of breast cancer significantly lowers this morbidity. We hypothesized that SLNB would have a lower lymphedema rate than conventional axillary dissection. Patients who underwent SLNB were compared with those who underwent level I and II axillary node dissection. A total of 125 patients were evaluated with 77 patients who underwent SLNB and 48 patients who underwent ALND. The arm circumference 10 cm above and 10 cm below the olecranon process was measured on both arms. In this series a difference in arm circumference greater than 3 cm between the operated and nonoperated side was defined as significant for lymphedema. Lymphedema was seen in two of 77 (2.6%) patients in the SLNB group as compared with 13 of 48 (27%) ALND patients. Given the above data patients who underwent sentinel lymph node biopsy show a significantly lower rate of lymphedema than those who had axillary lymph node dissection. This has an important impact on long-term postoperative management of patients with breast cancer.The American surgeon 04/2003; 69(3):209-11; discussion 212. · 0.92 Impact Factor
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ABSTRACT: This is the first published report on the validation of the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer. The FACT-B consists of the FACT-General (FACT-G) plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to QL in breast cancer. The FACT-B was developed with an emphasis on patients' values and brevity and is available in nine languages. Two validation samples were used for this report. The first (n = 47) was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample (n = 295). The alpha coefficient (internal consistency) for the FACT-B total score was high (alpha = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. The FACT-B is appropriate for use in oncology clinical trials, as well as in clinical practice. It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change.Journal of Clinical Oncology 04/1997; 15(3):974-86. · 18.04 Impact Factor