Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial

Abstract

BackgroundBreast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increase the prevalence of handicaps associated to unhealthy lifestyle (for example, decreased aerobic capacity and strength, weight gain, and fatigue). Recent work has shown that exercise adapted to individual characteristics of patients is related to improved overall and disease-free survival. Nowadays, technological support using telerehabilitation systems is a promising strategy with great advantage of a quick and efficient contact with the health professional. It is not known the role of telerehabilitation through therapeutic exercise as a support tool to implement an active lifestyle which has been shown as an effective resource to improve fitness and reduce musculoskeletal disorders of these women.Methods / DesignThis study will use a two-arm, assessor blinded, parallel randomized controlled trial design. People will be eligible if: their diagnosis is of stages I, II, or IIIA breast cancer; they are without chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program; they had access to the Internet and basic knowledge of computer use or living with a relative who has this knowledge; they had completed adjuvant therapy except for hormone therapy and not have a history of cancer recurrence; and they have an interest in improving lifestyle. Participants will be randomized into e-CUIDATE or usual care groups. E-CUIDATE give participants access to a range of contents: planning exercise arranged in series with breathing exercises, mobility, strength, and stretching. All of these exercises will be assigned to women in the telerehabilitation group according to perceived needs. The control group will be asked to maintain their usual routine. Study endpoints will be assessed after 8 weeks (immediate effects) and after 6 months. The primary outcome will be QoL measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 and breast module called The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire. The secondary outcomes: pain (algometry, Visual Analogue Scale, Brief Pain Inventory short form); body composition; physical measurement (abdominal test, handgrip strength, back muscle strength, and multiple sit-to-stand test); cardiorespiratory fitness (International Fitness Scale, 6-minute walk test, International Physical Activity Questionnaire-Short Form); fatigue (Piper Fatigue Scale and Borg Fatigue Scale); anxiety and depression (Hospital Anxiety and Depression Scale); cognitive function (Trail Making Test and Auditory Consonant Trigram); accelerometry; lymphedema; and anthropometric perimeters.DiscussionThis study investigates the feasibility and effectiveness of a telerehabilitation system during adjuvant treatment of patients with breast cancer. If this treatment option is effective, telehealth syst...

Telerehabilitation and recovery of motor function: a systematic review and meta-analysis

“…Among these 64 papers were excluded for the following reasons: 35 because the ICTs used were not aimed to rehabilitation purposes ; eight papers were protocols of ongoing studies and results were not available [52][53][54][55][56][57][58][59] ; seven studies did not have a control group [60][61][62][63][64][65][66] ; five because the intervention setting was the same in the two groups 8,[67][68][69][70] ; five were pilot studies [71][72][73][74][75] ; two were secondary analysis of RCTs already included 76,77 ; two studies were excluded because the poor reporting precluded any possible assessment of its eligibility 78,79 . Finally, 12 RCTs for a total of 1047 participants were included in the review ( Figure 1).…”

Effects of vibration therapy in the musculoskeletal system in post-surgical breast cancer women: longitudinal controlled clinical study

“…Another common complication relative to breast cancer is the reduced range of motion of the shoulder (Galiano-Castillo et al, 2013). Smoot et al (2010) stated that the deficit in the range of motion for post-treatment of breast cancer results from the formation of a scar tissue, radiation-induced fibrosis, antalgic posture of shoulder, disuse, and pain.…”

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

“…Following the protocol described by Ruiz-Ruiz et al [47], the optimal grip span will be determined by a simple algorithm to adapt the dynamometer. Throughout the whole test, BCS will be in a bipedal position; they have to put their arm in complete extension without touching any part of their body [18], repeating the test three times with each hand, alternately. There will be a delay of one minute between each test.…”

“…Nonwear periods (intervals of 60 consecutive minutes with zero counts) and the first day of wearing the device will be excluded from analyses. Accelerometer data will be downloaded to the same computer used to initialize them [18]. …”

“…Currently, technological support is a promising strategy that could improve issues, such as barriers of distance, time, cost and motivational aspects [16]. Telehealth systems, which are based on computers and mobile applications (m-health), offer a promising approach for both dietary and physical activity assessments [17] and the patients’ motivation can be significantly increased through the immediate feedback provided by these systems [18]. A recent study has developed a mobile application to simultaneously collect data on diet and physical activity in adults [17], but, to our knowledge, no programs exist that simultaneously collect data on diet and physical activity in cancer patients and provide immediate feedback with individualized recommendations.…”