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

Secondary Prevention Clinical Trial

— APPCOMCAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915043
• Other study ID #: FCCSS_UMA-02-13
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: September 2017

Study information

• Verified date: March 2017
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Secondary Prevention

Intervention

Other:
• health education for lymphedema prevention
All subjects received a multimodal intervention consist in a multimodal program with an educational approach

Locations

Country	Name	City	State
Spain	Hospital Costa del Sol	Marbella	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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