Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients

Conditions
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Secondary Prevention

Intervention / Treatment
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* Other: health education for lymphedema prevention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: health education for lymphedema prevention<br>health education for lymphedema prevention | Other: health education for lymphedema prevention<br>* All subjects received a multimodal intervention consist in a multimodal program with an educational approach<br>|
| Experimental: application smartphone-based group<br>Health education plus Smartphone-based application sample will have a reminder to do education everyday where patients will have to select if they have done or they haven´t done compliance | Other: health education for lymphedema prevention<br>* All subjects received a multimodal intervention consist in a multimodal program with an educational approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume and perimeter arm | Water Displacement (volume) Is performed by the water displacement method, a volumeter to reference point 16 cm proximal to the olecranon, with a Tª of 21ºC. The upper limit is 65% of the distance from the olecranon to the acromion. Circumferential Measurement (Perimeter) The patient should be seated both arms on a table, shoulder in neutral rotation and in flexion of 45º, forearm in maximun supination, is measured at intervals of 5 cm along both arms, using elbow crease as starting point. | baseline and 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand strength | It´s a standardized method to evaluate the hand strengh and it´s relation to the function of the upper extremity. Is done with a Jamar hydraulic hand dynamometer, has 5 fixed grip posititons. | baseline; 18 and 28 weeks | 
| Quality of Life Breast CAncer QLQ-BR23 questionnaire | The QLQ-BR23 consist of 23 items, is divided in dimennsions as body image, sexuality, future perspective and side-effects to different treatment modalities such as surgery, chemotherapy or radiotherapy. | baseline; 18 and 28 weeks | 
| Cancer related fatigue questionnaire | Quick-Piper scale, self- administered, a 15 items. Consists of 4 subjetive dimensions. Offers the important advantage of brevity. | baseline; 18 and 28 weeks | 
| volume and periemter arm | Water Displacement (volume) Is performed by the water displacement method, a volumeter to reference point 16 cm proximal to the olecranon, with a Tª of 21ºC. The upper limit is 65% of the distance from the olecranon to the acromion. Circumferential Measurement (Perimeter) The patient should be seated both arms on a table, shoulder in neutral rotation and in flexion of 45º, forearm in maximun supination, is measured at intervals of 5 cm along both arms, using elbow crease as starting point. | changes from 18 to 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, prevention, ehealth, cancer