BackgroundDespite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women’s Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers.MethodsA single-blinded, multi-centre randomized controlled trial recruited a total of 330 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura’s social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All participants were assessed with these measures at baseline (at the start of the intervention), 12 weeks (at completion of the intervention), and 24 months (to determine the level of sustained behaviour change). Further, a simultaneous cost-effectiveness evaluation will consider if the WWACP provides value for money and will be reported separately.DiscussionWomen treated for blood, breast and gynaecological cancers demonstrate increasingly good survival rates. However, they experience residual health problems that are potentially modifiable through behavioural lifestyle interventions such as the WWACP.Trial registrationThe protocol for this study was registered with the Australian and New Zealand Clinical Trials Registry, Trial ID: ACTRN12614000800628, July 28, 2014.
We conclude that aromatase inhibitor induced musculoskeletal syndrome is a significant issue for Australian women and is an important reason for treatment discontinuation. Women use a variety of interventions to manage this syndrome; however, their efficacy appears limited.
Neither the physicians, nurses, nor the patients could detect a difference between sedation produced by the drugs. We conclude that both drugs were equally effective for sedation for both upper and lower endoscopic procedures. Based on the results of this trial, we suggest that increased use of emulsified diazepam would markedly reduce the cost without altering the quality of sedation. The cost savings would be at least $50,000/yr at our institution.
Background: AIMSS is experienced by approximately half of women taking an aromatase inhibitor (AI), impairing quality of life and in some leading to AI discontinuation. There is a lack of evidence for effective AIMSS treatments. Aim: To investigate the importance of AIMSS in Australian women with early breast cancer. Method: A survey invitation was distributed to 2390 members of the BCNA Review and Survey Group in April 2014. The online questionnaire consisted of 45 questions covering demographics, AI use, clinical manifestations and risk factors for AIMSS, reasons for AI discontinuation and efficacy of interventions used for AIMSS. AIMSS was defined as joint pain or stiffness that developed or worsened after commencing an AI. Results: Of 594 respondents, 370 (62%) were eligible. Reasons for exclusion were: preinvasive disease, locally advanced/metastatic breast cancer, or other reason. Eligible respondents had a median age range of 50-59 years. Duration of AI use varied (26%1year, 64% 1-5years, 10% 5years). 57% had received adjuvant chemotherapy. 43% of these commenced AI within 3 months of chemotherapy and 30% within 3-6 months of chemotherapy. A vitamin D test was performed in 64% of women and 68% were currently using vitamin D supplements. Joint pain during menopause was reported by 22% of respondents. AIMSS occurred in 302/370 women (81%). Of those who developed AIMSS, sites affected were feet (68%), hands or wrists (65%), knees (62%), hips (56%), shoulders or elbows (49%), back (46%), or neck (3%). 34% of women had considered stopping an AI because of AIMSS. 99 (27%) of respondents had discontinued AI for any reason and of these 68% discontinued because of AIMSS. Non-AIMSS symptoms identified as reasons for discontinuation included fatigue, vaginal/urinary symptoms and hot flushes. In respondents who discontinued AI, 20% ceased use in the first 3 months, 30% during months 3-12 and 38%12 months. 42% of respondents who discontinued an AI restarted the same or a different AI after a treatment break. To manage AIMSS 23% of respondents used doctor prescribed medications (eg anti-inflammatories, codeine, morphine,), 55% over the counter (OTC) or complementary medicines (eg low dose anti-inflammatories, paracetamol, chondroitin, fish or krill oil, glucosamine, and vitamin D) and 29% alternative therapies (eg acupuncture, massage, Tai Chi and yoga). Respondents identified the following in each of the above categories as most successful in relieving AIMSS symptoms: doctor prescribed anti-inflammatories, paracetamol and yoga. Doctor prescribed medications and OTC/complementary medicine either completely or significantly relieved AIMSS in 12% and 25% of cases respectively. 27% of respondents found that one or more of the interventions that they had used to manage AIMSS helped prevent AI discontinuation. Conclusion: AIMSS is a significant issue for Australian women and is an important reason for AI discontinuation. Women use a number of interventions to manage AIMSS, however their efficacy appears limited. Effective AIMSS interventions are needed, to improve quality of life and reduce AI discontinuation. Citation Format: Janine M Lombard, Nicholas Zdenkowski, Kathy Wells, Nicca Grant, Linda Reaby, John F Forbes, Jacquie Chirgwin. Aromatase inhibitor induced musculoskeletal syndrome (AIMSS) in Australian women with early breast cancer: An Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) survey of members of the Breast Cancer Network Australia (BCNA) [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-12-05.
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