Early Intervention with a Compression Sleeve in Mild Breast Cancer-Related Arm Lymphedema: A 12-Month Prospective Observational Study.

BACKGROUND: In our previous randomized controlled trial (RCT), the progression/no progression of mild breast cancer-related arm lymphedema (BCRL) was examined among women randomized to a compression group (CG) with a compression sleeve (compression class (ccl) 1) or not (NCG) for 6 months. In the present prospective study, BCRL in the CG and NCG was followed for 12 months. METHODS: At the end of the RCT, 33 women with mild BCRL were eligible in the CG and 37 in the NCG. The proportional differences in no progression/progression of BCRL were defined as a >2% increase from start of RCT or exceeding 10% in the lymphedema relative volume as measured by the water displacement method. In addition, changes in the lymphedema relative volume and tissue dielectric constant ratio, which measures local tissue water, were examined. At the end of the RCT (i.e., after 6 months), a one-month break of the compression treatment was made in the CG. If the lymphedema relative volume progressed by definition, the compression treatment was resumed and continued, with follow-up of all women at 9 and 12 months. RESULTS: A larger proportion of women in the NCG showed progression (57%, 61%, 67%) compared to the CG (16%, 22%, 31%) at 6, 9, and 12 months (p < 0.001, 0.005, 0.012), respectively. Twelve (33%) women in the NCG did not progress at all. No changes of the lymphedema relative volume and local tissue water were found over time at any follow-ups, but were stable on a low level. CONCLUSIONS: To avoid the progression of mild BCRL into a chronic issue in the long-term, compression sleeve ccl 1 may be applied immediately after early diagnosis of mild BCRL.

Impact on Health-Related quality of life after wearing compression garment or not for six months in women with mild breast cancer-related arm lymphedema. A cross-sectional study.

BACKGROUND: Women with mild breast cancer-related arm lymphedema (BCRAL) mostly receive treatment with compression garments and instructions in self-care to prevent the progression of lymphedema. However, wearing a compression garment may be experienced as negative and may affect health-related quality of life (HRQOL) more than the lymphedema itself. The aim of this study was to investigate if there is a difference in lymphedema-specific HRQOL, between women with mild BCRAL wearing compression garments or not for 6 months. MATERIAL AND METHODS: Participants with mild BCRAL (Lymphedema relative volume <10%) rated their HRQOL by the Lymphedema Quality of Life Inventory (LyQLI), 6 months after diagnosis and being randomized to compression group (CG) or non-compression group (NCG). Both groups received self-care instructions, and the CG was treated with a standard compression garment, compression class 1. Data from 51 women (30 in the CG and 21 in the NCG), were analyzed. RESULTS: Both the CG and the NCG experienced a low negative impact on HRQOL in physical, psychosocial, and practical domains (score <1). However, the CG experienced a higher negative impact on median HRQOL in the practical domain compared to the NCG, 0.23/0.08 respectively, (p = 0.026). In the specific items, more participants in the CG reported a negative impact on HRQOL compared to the NCG in employment activities 23%/0%, (p = 0.032), embarrassment by lymphedema/compression garments 33%/5%, (p = 0.017), feeling discomfort/embarrassment while doing sports and hobbies 30%/5%, (p = 0.034) and having to answer questions about the lymphedema 27%/0% (p = 0.015). CONCLUSION: Overall, the lymphedema-specific HRQOL was high after 6 months in women with mild lymphedema, with only a minor difference between the groups. Some women may however perceive practical and emotional issues with the compression garment. These aspects should be considered in patient education and when planning/evaluating treatment. Trial registration: ISRCTN51918431.

Early intervention with compression garments prevents progression in mild breast cancer-related arm lymphedema: a randomized controlled trial.

BACKGROUND: Early diagnosis and compression treatment are important to prevent progression in breast cancer-related arm lymphedema (BCRAL). However, some mild BCRAL can be reversible, and therefore, compression treatment may not be needed. The aim of this study was to investigate the proportion of women with mild BCRAL showing progression/no progression of lymphedema after treatment with or without compression garments, differences in changes of lymphedema relative volume (LRV), local tissue water and subjective symptoms during 6 months. Also, adherence to self-care was examined. MATERIAL AND METHODS: Seventy-five women diagnosed with mild BCRAL were randomized to a compression group (CG) or noncompression group (NCG). Both groups received self-care instructions, and the CG were treated with a standard compression garment (ccl 1). Women in the NCG who progressed in LRV ≥2%, or exceeded 10% dropped out, and received appropriate treatment. The proportion showing progression/no progression of LRV, and changes in LRV was measured by Water Displacement Method. Changes in local tissue water were measured by Tissue Dielectric Constant (TDC), subjective symptoms by Visual Analogue Scale, and self-care by a questionnaire. RESULTS: A smaller proportion of LRV progression was found in the CG compared to the NCG at 1, 2 and 6 months follow-up (p ≤ 0.013). At 6 months, 16% had progression of LRV in the CG, compared to 57% in the NCG, (p = 0.001). Thus, 43% in the NCG showed no progression and could manage without compression. Also, CG had a larger reduction in LRV, at all time-points (p ≤ 0.005), and in the highest TDC ratio, when same site followed, at 6 months (p = 0.025). Subjective symptoms did not differ between the groups, except at 1 month, where the CG experienced more reduced tension (p = 0.008). There were no differences in adherence to self-care. CONCLUSION: Early treatment with compression garment can prevent progression in mild BCRAL. Trial registration: ISRCT nr ISRCTN51918431.

An Explorative Study of Qualities in Interactive Processes with Children and Their Parents in Music Therapy during and after Pediatric Hematopoietic Stem Cell Transplantation.

Background: Hematopoietic stem cell transplantation (HSCT) is an established treatment for severe disorders of the pediatric hematopoietic system. However, there is a need for supportive interventions due to physiological and psychological strain. Music therapy is used in health care to help patients through difficult experiences and enable well-being. Our previous randomized studies showed significantly reduced heart rates four to eight hours after intervention as well as increased health-related quality of life. Methods: The aim of this qualitative study was to explore the participants' and parents' own experiences of the interactive processes during the music therapy intervention. Six families were included. The data collection used collaborative research interviews. An independent psychologist facilitated the interviews with the children, the parents, and the music therapist and also performed the analysis. Results: Three main themes emerged: experiences of competency and recognition of self, interactive affect regulation as change potential, and importance of the therapeutic relationship. Conclusions: For the participants, music therapy developed into a significant and helpful experience, an important ingredient in coping with and managing the treatment period at the hospital.

Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: randomized study in healthy girls.

BACKGROUND: To evaluate co-administration of GlaxoSmithKline Biologicals' human papillomavirus-16/18 AS04-adjuvanted vaccine (HPV) and hepatitis B vaccine (HepB). METHODS: This was a randomized, controlled, open, multicenter study. Healthy girls, aged 9-15 years, were randomized to receive HPV (n=247), HepB (n=247) or HPV co-administered with HepB (HPV+HepB; n=247) at Months 0, 1 and 6. Antibodies against hepatitis B surface antigen (HBs), HPV-16 and HPV-18 were measured, and reactogenicity and safety monitored. Co-primary objectives were to demonstrate non-inferiority of hepatitis B and HPV-16/18 immune responses at Month 7 for co-administered vaccines, compared with vaccines administered alone, in the according-to-protocol cohort. RESULTS: The pre-defined criteria for non-inferiority were met for all co-primary immunogenicity endpoints at Month 7. Anti-HBs seroprotection rates ≥10mIU/mL were achieved by 97.9% and 100% of girls, respectively, following co-administration or HepB alone. Anti-HBs geometric mean titers (GMTs) (95% confidence interval) were 1280.9 (973.3-1685.7) and 3107.7 (2473.1-3905.1) milli-international units/mL, respectively. Anti-HPV-16 and -18 seroconversion rates were achieved by ≥99% of girls following co-administration or HPV alone. Anti-HPV-16 GMTs were 19819.8 (16856.9-23303.6) and 21712.6 (19460.2-24225.6) ELISA units (ELU)/mL, respectively. Anti-HPV-18 GMTs were 8835.1 (7636.3-10222.1) and 8838.6 (7948.5-9828.4) ELU/mL, respectively. Co-administration was generally well tolerated. CONCLUSIONS: The study results support the co-administration of HPV-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine in adolescent girls aged 9-15 years. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov registration number NCT00652938.