Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01915043
Other study ID # FCCSS_UMA-02-13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02197416 - Safety of Dabigatran Etexilate in Blood Clot Prevention in Children Phase 3
Completed NCT02550717 - Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN)
Recruiting NCT06025526 - Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot) N/A
Completed NCT03234023 - Secondary PRevention in Cardiovascular Disease by a Nursing Guided Program (SPRING) N/A
Completed NCT02239120 - Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS) Phase 3
Completed NCT04821518 - The Use of Samsung Health and ECG M-Trace Base II Applications in the Secondary Prevention After Stroke
Recruiting NCT04121702 - Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center N/A
Active, not recruiting NCT04893447 - Suicide Prevention Among Recipients of Care N/A
Recruiting NCT06258928 - Early Mobilisation of the Distal Radius Fracture
Active, not recruiting NCT03269708 - Improving Cardiac Secondary Prevention N/A
Active, not recruiting NCT05426863 - Domestic Violence Intervention to Reduce Psychological Distress and Violence Among Women Experiencing IPV in Nepal N/A
Recruiting NCT05942794 - Identification of Oral Lesions Through an Autofluorescence System N/A
Not yet recruiting NCT06243133 - Pair Antiplatelet THerapy in Ischemic Stroke With Intracranial Artery Stenosis Phase 4
Recruiting NCT03186729 - Study of Antithrombotic Treatment After IntraCerebral Haemorrhage Phase 4
Completed NCT02156778 - Post-Stroke Disease Management - Stroke Card N/A
Completed NCT00643019 - Project Sexual Awareness for Everyone (SAFE) Phase 3
Recruiting NCT04608851 - Preventing Urinary Tract Infections With E. Coli Nissle: Phase 4
Recruiting NCT03065543 - Hyperlipidemia Therapy TERCET Zabrze Registry N/A
Completed NCT04199663 - Socioeconomic Status, Secondary Prevention Activities and Recurrence After a Myocardial Infarction
Recruiting NCT05542719 - Mexican Registry of Dyslipidemia in Patients at High Risk and Very High Risk of Atherosclerotic Cardiovascular