Clinical trial NCT01915043: Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients
Official title: Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Prevention
Keywords: lymphedema, prevention, ehealth, cancer
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Background: The cancer-related lymphedema (BCRL) is the abnormal accumulation of fluid in the lymphatic system and can develop immediately after surgery / radiotherapy of breast cancer, or may appear months later. In the literature there are numerous educational recommendations to avoid the appearance BCRL, but there is a lack of adherence to these recommendations. With the increase of mobile technologies among adults, the mobile devices can be an effective method to meet their education.

Objective: To determine the effectiveness of therapeutic adherence a brief educational intervention through a smartphone-based application in the prevention of lymphedema in women with mastectomies.

Method: 100 women survivors of breast cancer will be randomized to a group that will receive lymphedema prevention education and an app specific for better adhesion compared to the control group will receive education only. They will be monitored for 28 weeks by specific measures of lymphedema onset, volume and perimeter arm and hand strength lymphedema disability questionnaire and other measures of fatigue, quality of life and mood related to cancer.

Discussion: The lack of adherence to health education is the main cause of failure in maintaining these brief educational interventions, whether the program is beneficial, it could be successfully implemented in clinical practice.


Eligibility criteria: Women diagnosed with breast cancer, including the Via Clinic (11) breast cancer at the Hospital Costa del Sol, Marbella, Spain.

Inclusion criteria :

* be over 18 years
* with own smartphone telephony server and mobile internet.

Exclusion criteria :

* reading problems, psychological problems, who can not read Spanish
* unwilling to participate in the study.

It also takes into account the severity of the disease, dividing criteria, conservative surgery, mastectomy, with or without lymphadenectomy, sentinel node.

Primary outcomes:
measure: volume and perimeter arm
timeFrame: baseline and 18 weeks
Secondary outcomes:
measure: hand strength
timeFrame: baseline; 18 and 28 weeks
measure: Quality of Life Breast CAncer QLQ-BR23 questionnaire
timeFrame: baseline; 18 and 28 weeks
measure: Cancer related fatigue questionnaire
timeFrame: baseline; 18 and 28 weeks
measure: volume and periemter arm
timeFrame: changes from 18 to 28 weeks
Other outcomes:
Locations:
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Malaga
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta-Vargas, PhD
role: STUDY_DIRECTOR
References: