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

NCT01915043 | Completed DMC

• 1 other identifier: FCCSS_UMA-02-13
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Keywords

lymphedema, prevention, ehealth, cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• hand strength

  baseline; 18 and 28 weeks

• Quality of Life Breast CAncer QLQ-BR23 questionnaire

  baseline; 18 and 28 weeks

• Cancer related fatigue questionnaire

  baseline; 18 and 28 weeks

• volume and periemter arm

  changes from 18 to 28 weeks

Study Arms (2)

health education for lymphedema prevention

ACTIVE COMPARATOR

health education for lymphedema prevention

Other: health education for lymphedema prevention

application smartphone-based group

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

Other: health education for lymphedema prevention

Interventions

health education for lymphedema prevention OTHER

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

application smartphone-based group; health education for lymphedema prevention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be over 18 years
• with own smartphone telephony server and mobile internet.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Hospital Costa del Sol

Marbella, Malaga, 29620, Spain

Location

MeSH Terms

Conditions

Lymphedema; Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Antonio I Cuesta-Vargas, PhD

  University of Malaga

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: August 2, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: September 30, 2019

Record last verified: 2017-03

Locations

ES (1)