Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial

Background: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mortality). Moreover, cancer rehabilitation programs supervised by health professionals are needed due to the inherent characteristics of these breast cancer patients. Our main objective is to compare the clinical efficacy of a m-health lifestyle intervention system alone versus an integral strategy to improve Quality of Life in breast cancer survivors. Methods: This therapeutic superiority study will use a two-arm, assessor blinded parallel RCT design. Women will be eligible if: they are diagnosed of stage I, II or III-A breast cancer; are between 25 and 75 years old; have a Body Mass Index > 25 kg/m2; they have basic ability to use mobile apps; they had completed adjuvant therapy except for hormone therapy; and they have some functional shoulder limitations. Participants will be randomized to one of the following groups: integral group will use a mobile application (BENECA APP) and will receive a face-to-face rehabilitation (8-weeks); m-health group will use the BENECA app for 2-months and will received usual care information. Study endpoints will be assessed after 8 weeks and 6 months. The primary outcome will be Quality of Life measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core and breast module. The secondary outcomes: body composition; upper-body functionality (handgrip, Disability of the Arm, Shoulder and Hand questionnaire, goniometry); cognitive function (Wechsler Adult Intelligence Scale, Trail Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); physical fitness (Short version of the Minnesota Leisure Time Physical Activity Questionnaire, Self-Efficacy Scale for Physical Activity); accelerometry and lymphedema. Discussion: This study has been designed to seek to address the new needs for support and treatment of breast cancer survivors, reflecting the emerging need to merge new low cost treatment options with much-needed involvement of health professionals in this type of patients. Trial registration: ClinicalTrials.gov Identifier: NCT02817724 (date of registration: 22/06/2016).The study was funded by the Spanish Ministry of Economy and Competitiveness (Plan Estatal de I + D + I 2013-2016), Fondo de Investigación Sanitaria del Instituto de Salud Carlos III (PI14/01627), Fondos Estructurales de la Unión Europea (FEDER) and by the Spanish Ministry of Education (FPU14/01069). This is part of a Ph.D. Thesis conducted in the Clinical Medicine and Public Health Doctoral Studies of the University of Granada, Spain

DISABILITY, PSYCHOLOGICAL DISTRESS AND QUALITY OF LIFE IN BREAST CANCER SURVIVORS WITH ARM LYMPHEDEMA

The aim of this study was to assess disability, psychological distress and quality of life inPolish breast cancer survivors with arm lymphedema. One thousand sets of questionnairesconsisting of WHO-DAS II, GHQ-30, EORTC QLQ-C30 and QLQ-BR23 were sent to members ofthe Polish Federation of Breast Cancer Survivors Clubs “Amazonki.” The response rate was28.3% of whom 31.70% reported arm lymphedema. The WHO-DAS II survey showed thatpatients with arm lymphedema had a higher overall disability score (45.04 versus 38.80 in groupwithout arm lymphedema; p=0.01) and higher mean values in the scales of understanding andcommunicating, getting around, life activities at home, getting along with people, participatingin society. The EORTC QLQ-C30 survey showed that patients with lymphedema had lower meanvalues in physical (0.55 versus 0.65; p=0.001), emotional (0.47 versus 0.57; p=0.01), social(0.59 versus 0.73; p=0.002), cognitive and role functioning, increased fatigue, pain, insomnia,dyspnea, nausea/vomiting and financial problems. The EORTC QLQ-BR23 data demonstratedworse future perspectives and an increase in breast and arm symptoms, and the GHQ-30 surveyproduced higher psychological distress (scores 15.18 versus 11.24; p=0.004).In conclusion, breast cancer survivors with arm lymphedema were more disabled,experienced a poorer quality of life and had increased psychological distress in comparison tosurvivors without this condition

PRESENCE OF FUNCTIONAL AXILLARY LYMPH NODES AND LYMPH DRAINAGE WITHIN ARMS IN WOMEN WITH AND WITHOUT BREAST CANCER-RELATED LYMPHEDEMA

This pilot study was designed to investigatelymphatic transport in the arms of womenafter breast cancer treatment withoutlymphedema and with mild and severe armlymphedema. Nineteen breast cancer survivors[6 without (Group 1), 6 with mild (Group 2)and 7 with severe (Group 3) lymphedema]were examined. Lymphatic transport in thearm and to axillary lymph nodes wereevaluated using quantitative radionuclidelymphscintigraphy. The radioactivity ratiobetween the operated and unoperated axillae(axillary ratio), and both lymphatic transportand tracer disappearance rates (TDR) fromthe injection sites were calculated. We foundthat axillary ratio and lymphatic transportwere significantly higher in Groups 1 and 2compared to 3 and that TDR was not affectedin any Group. Additionally, lymphscintigraphyrevealed presence of functional axillary lymphnodes within the operated axilla in womenwithout or with mild lymphedema, while inwomen with severe lymphedema, no axillarylymph nodes were visualized. We concludefrom our subjects that breast cancer survivorswho did not develop or had mild arm lymphedemahave functional lymphatic transportand lymph nodes in the axillary area on theoperated side. This suggests that efficientcollateral circulation and/or peripherallymphovenous communications has developedin these subjects which may be preventativefor the development of severe lymphedema