Clinical trial NCT01801527: Telehealth System to Improve Quality of Life in Breast Cancer Survivors
Official title: E-Cuidate: Effectiveness of a Telerehabilitation System in Women Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Telehealth
Fatigue
Breast cancer
Exercise
Quality of life
Telerehabilitation
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2013-02-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Cancer is increasingly viewed as a chronic disease and therefore there is a growing need for long-term treatments. Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increases the prevalence of conditions associated to unhealthy life-style.

Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short and long-term effects telehealth program.

Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio Hospital and associations of breast cancer patients in Granada. Patients will be randomized to receive the online rehabilitation group (n=36) or usual care (control) group (n=36). Telerehabilitation group will receive an eight-week online intervention and control group receive recommendations about usual care.

Discussion: The investigators study attempts to increase the level of fitness and reduce musculoskeletal disorders in breast cancer patients through a strategy for care based on telerehabilitation to promote therapeutic exercise.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage I, II, or IIIA breast cancer
* Medical clearance of participation
* Without chronic disease or orthopaedic that would interfere with ability to participate in a physical activity program
* Access to Internet
* Basic ability to use the computer or living with a relative who has this ability
* Completion of adjuvant therapy except for hormone therapy
* No history of cancer recurrence
* Have interest in improving lifestyle: fitness/stress level
* Have signed informed consent

Primary outcomes:
measure: Quality of life
timeFrame: Participants will be followed over 8 weeks
Secondary outcomes:
measure: Algometry
timeFrame: Participants will be followed over 8 weeks
measure: The Visual Analogue Scale (VAS) for pain
timeFrame: Participants will be followed over 8 weeks
measure: Pain
timeFrame: Participants will be followed over 8 weeks
measure: Body composition
timeFrame: Participants will be followed over 8 weeks
measure: Physical measurement
timeFrame: Participants will be followed over 8 weeks
measure: Cardiorespiratory fitness
timeFrame: Participants will be followed over 8 weeks
measure: Fatigue
timeFrame: Participants will be followed over 8 weeks
measure: Anxiety and depression
timeFrame: Participants will be followed over 8 weeks
measure: Cognitive function
timeFrame: Participants will be followed over 8 weeks
measure: Accelerometry
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: Faculty of Health Sciences. University of Granada
name: Manuel Arroyo-Morales, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galiano-Castillo N, Arroyo-Morales M, Ariza-Garcia A, Fernandez-Lao C, Fernandez-Fernandez AJ, Cantarero-Villanueva I. Factors that Explain the Cancer-Related Insomnia. Breast J. 2017 Jul;23(4):387-394. doi: 10.1111/tbj.12759. Epub 2017 Jan 24.
citation: Galiano-Castillo N, Ariza-Garcia A, Cantarero-Villanueva I, Fernandez-Lao C, Diaz-Rodriguez L, Legeren-Alvarez M, Sanchez-Salado C, Del-Moral-Avila R, Arroyo-Morales M. Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial. Trials. 2013 Jun 22;14:187. doi: 10.1186/1745-6215-14-187.