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

NCT ID: NCT01915043

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-09-30

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.

Conditions

Secondary Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

health education for lymphedema prevention

health education for lymphedema prevention

Group Type: ACTIVE_COMPARATOR

health education for lymphedema prevention

Intervention Type: OTHER

All subjects received a multimodal intervention consist in a multimodal program with an educational approach

application smartphone-based group

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

Group Type: EXPERIMENTAL

health education for lymphedema prevention

Intervention Type: OTHER

All subjects received a multimodal intervention consist in a multimodal program with an educational approach

Interventions

health education for lymphedema prevention

All subjects received a multimodal intervention consist in a multimodal program with an educational approach

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio I Cuesta-Vargas, PhD

Role: STUDY_DIRECTOR

University of Malaga

Locations

Hospital Costa del Sol

Marbella, Malaga, Spain

Countries

Spain

Other Identifiers

FCCSS_UMA-02-13

Identifier Type: -

Identifier Source: org_study_id