Overview

This trial is active, not recruiting.

Condition secondary prevention
Treatment health education for lymphedema prevention
Sponsor University of Malaga
Start date January 2013
End date September 2016
Trial size 100 participants
Trial identifier NCT01915043, FCCSS_UMA-02-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
health education for lymphedema prevention
health education for lymphedema prevention
All subjects received a multimodal intervention consist in a multimodal program with an educational approach
(Experimental)
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
health education for lymphedema prevention
All subjects received a multimodal intervention consist in a multimodal program with an educational approach

Primary Outcomes

Measure
volume and perimeter arm
time frame: baseline and 18 weeks

Secondary Outcomes

Measure
hand strength
time frame: baseline; 18 and 28 weeks
Quality of Life Breast CAncer QLQ-BR23 questionnaire
time frame: baseline; 18 and 28 weeks
Cancer related fatigue questionnaire
time frame: baseline; 18 and 28 weeks
volume and periemter arm
time frame: changes from 18 to 28 weeks

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Malaga.