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

University of Malaga

Status: Completed

Conditions: Secondary Prevention

Treatments: Other: health education for lymphedema prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT01915043

FCCSS_UMA-02-13

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

health education for lymphedema prevention

Active Comparator group

Description:

health education for lymphedema prevention

Treatment:

Other: health education for lymphedema prevention

application smartphone-based group

Experimental group

Description:

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

Treatment:

Other: health education for lymphedema prevention