Clinical trial NCT02817724: Integral Strategy to Supportive Care in Breast Cancer Patients
Official title: Integral Strategy to Supportive Care in Breast Cancer Patients Through Occupational Therapy and a M-health System: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: Breast Neoplasms
survivor
occupational therapy
mobile applications
Quality of Life
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2016-06-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if it is better an integral strategy, with a m-health system, when used in addition to a supervised treatment, versus the use of the m-health system alone, to improve the immediate and long-term Quality of Life of breast cancer survivors.

Detailed description: 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 (QoL) in breast cancer survivors.

Methods: This therapeutic superiority study will use a two-arm, assessor blinded parallel randomized clinical trial (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 \> 25kg/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 supervised rehabilitation (8-weeks); m-health group will use the BENECA app for 8-weeks. Study endpoints will be assessed after 8 weeks and 24 weeks. The primary outcome will be QoL 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, Trial Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); and accelerometer.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage I, II or IIIA breast cancer.
* Overweight or obese, according to the Spanish Society for the Study of Obesity.
* Basic ability to use mobile apps or living with someone who has this ability.
* Medical clearance of participants.
* Completion of adjuvant therapy except for hormone therapy.
* Some functional or Range of Motion (ROM) limitations measures by goniometry and the DASH Questionnaire.
* Have signed informed consent.

Exclusion Criteria:

* History of cancer recurrence.
* Chronic disease or orthopedic issues that would interfere with the ability to participate in the rehabilitation program.
* Uncontrolled hypertension (diastolic pressure \> 95mm Hg).

Primary outcomes:
measure: Quality of life (QLQ)
timeFrame: Participants will be followed over 8 weeks.
Secondary outcomes:
measure: Body mass Index
timeFrame: Participants will be followed over 8 weeks.
measure: Fat mass
timeFrame: Participants will be followed over 8 weeks.
measure: Abdominal adipose tissue
timeFrame: Participants will be followed over 8 weeks.
measure: Bone mineral density
timeFrame: Participants will be followed over 8 weeks.
measure: Shoulder Range of Motion (ROM)
timeFrame: Participants will be followed over 8 weeks.
measure: Upper Body Functionality
timeFrame: Participants will be followed over 8 weeks.
measure: Upper body muscular strength
timeFrame: Participants will be followed over 8 weeks.
measure: Cognitive function: attention
timeFrame: Participants will be followed over 8 weeks.
measure: Cognitive function: memory and processing speed
timeFrame: Participants will be followed over 8 weeks.
measure: Anxiety and depression
timeFrame: Participants will be followed over 8 weeks.
measure: Physical activity
timeFrame: Participants will be followed over 8 weeks.
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences. University of Granada
Study officials:
affiliation: Deparment of physiotherapy, Faculty of Health Sciences, University of Granada
name: Manuel Arroyo-Morales, PhD
role: STUDY_DIRECTOR
References:
citation: Lozano-Lozano M, Galiano-Castillo N, Martin-Martin L, Pace-Bedetti N, Fernandez-Lao C, Arroyo-Morales M, Cantarero-Villanueva I. Monitoring Energy Balance in Breast Cancer Survivors Using a Mobile App: Reliability Study. JMIR Mhealth Uhealth. 2018 Mar 27;6(3):e67. doi: 10.2196/mhealth.9669.
citation: Lozano-Lozano M, Martin-Martin L, Galiano-Castillo N, Alvarez-Salvago F, Cantarero-Villanueva I, Fernandez-Lao C, Sanchez-Salado C, Arroyo-Morales M. Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. BMC Med Inform Decis Mak. 2016 Nov 25;16(1):150. doi: 10.1186/s12911-016-0394-0.