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

Abstract

BackgroundTechnological 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov Identifier: NCT02817724 (date of registration: 22/06/2016).

eHealth and mHealth interventions in the treatment of fatigued cancer survivors: A systematic review and meta-analysis

“…Furthermore, there are some study protocols in the literature for planned trials that encompass mHealth interventions for cancer survivors, suggesting that mHealth intervention studies will increase considerable over the next few years.…”

MOBILE HEALTH APPLICATION - PREVENTING PATIENTS OF BREAST CANCER POST-TREATMENT FROM UPPER LIMB DYSFUNCTION (ULD) (Chemotherapy, Radiotherapy, and Surgery) : LITERATURE REVIEW

“…In the research conducted by Noelia (2016), there was a significant decrease in the level of pain in the group using the e-CUIDATE system. This also happened to the research conducted by House et al, (2016) which, found out that the reduction in pain, measured using NRS (18).…”

“…There are several types of mobile health applications used in these nine journals, namely bWell (demonstration videos and documentation), Smart After Care, Smart goal (games application), BrightArm duo rehabilitation system (games application), e-CUIDATE system, telephone, Short Message Service, web-based internet, and m-Health BENECA application. The main focus of 9 journals used in examining the contents of Mobile Health application is physical exercise (ROM, arm and shoulder movements, resistance and muscle strength) for breast cancer survivor, although there are other variables also measured by these journals, such as quality of life, level of pain, cognitive function, and level of patient depression (8,(12)(13)(14)(15)(16)(17)(18)(19). The duration of application from journals used averaged 8-12 weeks which then evaluated until six months, except in 1 journal which uses the cross-sectional method…”

Patient Experiences of Rehabilitation and the Potential for an mHealth System with Biofeedback After Breast Cancer Surgery: Qualitative Study

“…However, these technologies are still in the very early stages of development and adoption in breast cancer rehabilitation. To date, innovations have mainly focused on physical activity interventions [ 40 - 42 ], lymphedema management [ 28 ], psychological well-being [ 43 ], and general survivorship care [ 29 , 44 ]. Very few interventions concentrate on physiotherapy rehabilitation exercises.…”