Protocol: mHealth innovation for early detection of patient-reported symptom distress

Cancer patients are predominantly treated as out-patients and as they often experience difficult symptoms and side effects it is important to facilitate and improve patient-clinician communication to support symptom management and self-care | BMC Cancer

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Background: Although the number of projects within supportive cancer care evaluating mobile health is increasing, few evidence-based interventions are described in the literature and thus there is a need for good quality clinical studies with a randomised design and sufficient power to guide future implementations. An interactive information and communications technology platform, including a smartphone/computer tablet app for reporting symptoms during cancer treatment was created in collaboration with a company specialising in health care management. The aim of this paper is to evaluate the effects of using the platform for patients with breast cancer during neo adjuvant chemotherapy treatment and patients with locally advanced prostate cancer during curative radiotherapy treatment. The main hypothesis is that the use of the platform will improve clinical management, reduce costs, and promote safe and participatory care.

Method: The study is a prospective, randomised, controlled trial for each patient group and it is based on repeated measurements. Patients are consecutively included and randomised. The intervention groups report symptoms via the app daily, during treatment and up to three weeks after end of treatment, as a complement to standard care. Patients in the control groups receive standard care alone. Outcomes targeted are symptom burden, quality of life, health literacy (capacity to understand and communicate health needs and promote healthy behaviours), disease progress and health care costs. Data will be collected before and after treatment by questionnaires, registers, medical records and biomarkers. Lastly, participants will be interviewed about participatory and meaningful care.

Discussion: Results will generate knowledge to enhance understanding about how to develop person-centred care using mobile technology. Supporting patients’ involvement in their care to identify problems early, promotes more timely initiation of necessary treatment. This can benefit patients treated outside the hospital setting in regard to maintaining their safety.

Full reference: Langius-Eklöf, A. et al. (2017) Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer. BMC Cancer. 17:466

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NICE set to approve trastuzumab emtansine for breast cancer

The NHS in England will soon be able to routinely fund the use of trastuzumab emtansine for people with certain categories of breast cancer, the National Institute for Health and Care Excellence (NICE) has announced in new draft guidance | OnMedica

NICE’s decision means that, by late summer, more than a thousand women and men could benefit from the drug.

HER2-positive breast cancer accounts for about a fifth of the roughly 41,500 women and 300 men who are diagnosed with breast cancer each year in England, but HER2-positive tumours are typically more aggressive than other types of breast cancer. The targeted treatment trastuzumab (Herceptin) is only effective for this type of breast cancer. Trastuzumab emtansine (Kadcyla) is licensed for the treatment of locally advanced or metastatic HER2-positive breast cancer, after trastuzumab and a taxane, taken either in combination or separately.

Currently, trastuzumab emtansine – which at full list price costs about £90,000 per patient – is only available on the NHS through the Cancer Drugs Fund (CDF). But NICE revealed yesterday afternoon that the drug’s manufacturer Roche had agreed a new commercial access arrangement with NHS England. When NICE factored this confidential agreement into a new clinical and cost-effectiveness analysis, also applying end-of-life criteria, it concluded that it can now recommend the drug as cost effective for routine use on the NHS.

New chemotherapy approach offers breast cancer patients a better quality of life

The chemotherapy drug capecitabine gives patients a better quality of life and is as effective at preventing breast cancer from returning as the alternative regimen called CMF, when given following epirubicin. | ScienceDaily | Cancer Research UK

Around 4,400 patients on the TACT2 clinical trial were treated with the chemotherapy drug epirubicin followed by either capecitabine or CMF, after surgery.

Researchers at The Institute of Cancer Research, London, and the Cancer Research UK Edinburgh Centre found that capecitabine resulted in patients experiencing fewer side effects and having a better quality of life, and it was as effective at preventing cancer’s return as CMF.

Most patients experienced some side effects regardless of the treatment they were given. But those taking CMF were more likely to experience severe side effects including early menopause, nausea, infection, thrombosis, and anemia.

During the trial, patients were followed up after 12, 18 and 24 months, and then yearly for at least 10 years, to see if their cancer had returned and to monitor side effects. More than 85 per cent of patients did not experience their cancer returning for at least five years.

More detail at

Link to the research:

Cameron, D., et al.  Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial. The Lancet Oncology.

Diet, nutrition, physical activity and breast cancer

The report analysed 119 studies and including data on 12 million women and 260,000 cases of breast cancer | World Cancer Research Fund

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Image source: WCRF

Many epidemiologic studies have classified breast cancer cases by menopausal status at time of diagnosis, and therefore in this report we chose to highlight associations between diet, weight, and physical activity separately in premenopausal and postmenopausal breast cancer, where possible.

Key findings: premenopausal breast cancer

There is strong evidence that:

  • consuming alcoholic drinks increases risk
  • undertaking vigorous physical activity decreases risk
  • being overweight or obese between the ages of about 18 and 30 years decreases risk
  • being overweight or obese in adulthood before the menopause decreases risk
  • developmental factors leading to greater linear growth (marked by adult attained height) increase risk
  • factors that lead to greater birthweight, or its consequences, increase risk
  • breastfeeding decreases risk (breast cancer type unspecified) in the mother
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Image Source: WCRF

Key findings: postmenopausal breast cancer

There is strong evidence that:

  • consuming alcoholic drinks increases risk
  • being physically active (including vigorous physical activity) decreases risk
  • being overweight or obese between the ages of about 18 and 30 years decreases risk
  • being overweight or obese throughout adulthood increases risk
  • greater weight gain in adulthood increases risk
  • developmental factors leading to greater linear growth (marked by adult attained height) increase risk
  • breastfeeding decreases risk (breast cancer type unspecified) in the mother
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Image source: WCRF

Benefits and harms of breast cancer screening in women aged 40-49 years

Early detection of breast cancer through screening can lower breast cancer mortality rates and reduce the burden of this disease in the population | International Journal of Cancer

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In most western countries, mammography screening starting from age 50 is recommended. However, there is debate about whether breast cancer screening should be extended to younger women. This systematic review provides an overview of the evidence from RCT’s on the benefits and harms of breast cancer screening with mammography in women aged 40 to 49 years. The quality of the evidence for each outcome was appraised using the GRADE approach.

Four articles reporting on two different trials, the Age trial and the Canadian National Breast Screening Study-I (CNBSS-I), were included. The results showed no significant effect on breast cancer mortality (Age trial: RR 0.93, 95% CI 0.80-1.09; CNBSS-I: HR 1.10 (95% CI 0.86-1.40) nor on all-cause mortality (RR 0.98, 95% CI 0.93-1.03) in women aged 40 to 49 years offered screening. Among regularly attending women the cumulative risk of experiencing a false-positive recall was 20.5%. Overdiagnosis of invasive breast cancer at five years post cessation of screening for women aged 40to 49 years was estimated to be 32%; 20 years post cessation of screening 48%. Including ductal carcinoma in situ, these numbers were 41% and 55%.

Based on the current evidence from randomised trials, extending mammography screening to younger age groups cannot be recommended. However there were limitations including relatively low sensitivity of screening and screening attendance, insufficient power, and contamination, which may explain the non-significant results.

Full reference: van den Ende, C. et al. (2017) Benefits and harms of breast cancer screening with mammography in women aged 40-49 years: A systematic review. International Journal of Cancer. DOI: 10.1002/ijc.30794

Mindfulness-based stress reduction for breast cancer patients

A mixed method study on what patients experience as a suitable stage to participate | Supportive Care in Cancer

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Purpose: Breast cancer is associated with high levels of psychological distress. Mindfulness-based stress reduction (MBSR) has proven to be effective in reducing distress in cancer patients. In several studies, patients who are currently undergoing somatic anticancer treatment are excluded from participating in MBSR. Little is known about what would be the most suitable stage of disease to offer MBSR. We examined whether stage of disease facilitated and/or hindered participation in MBSR for breast cancer patients.

Conclusions: In contrast to the common practice to tailoring the timing of MBSR to physical impairments or demands of the anticancer treatment, our findings revealed that emotional readiness is equally important to take into account. These findings might support professionals in their choices whether and when to inform and refer patients to MBSR.

Full reference: Bisseling, E.M., Schellekens, M.P., Jansen, E.T. et al. (2017) Mindfulness-based stress reduction for breast cancer patients: a mixed method study on what patients experience as a suitable stage to participate. Support Care Cancer.  doi:10.1007/s00520-017-3714-8

Clinics should choose women’s breast screening appointment times to improve attendance

For women who miss a breast screening appointment, giving a fixed date and time for a new appointment could improve poor attendance and be a cost-effective way to shift national participation trends | ScienceDaily

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In England, participation in breast cancer screening has been falling in the last ten years, getting close to the national minimum standard of 70 per cent, with screening particularly low in areas of socioeconomic deprivation.

The NHS Breast Screening Programme (NHSBSP) invites women aged 50-70 to mammographic screening every three years. The usual practice for those who don’t attend their first offered appointment is to issue them with a second invitation letter. Some centres supply ‘open’ invitations, asking women to telephone to make an appointment, while others send an invitation with a fixed date and time, requiring no effort from the invitee to book an appointment.

Read the full overview via ScienceDaily here

Read the original research article here