Secondary PreventionAPPCOMCANNCT01915043
Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients
A study testing health education for lymphedema prevention in people with Secondary Prevention, run by University of Malaga at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Secondary Prevention
- What is being tested?
- health education for lymphedema prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 years
- with own smartphone telephony server and mobile internet.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- health education for lymphedema prevention
- Keywords
- lymphedema, prevention, ehealth, cancer
- Medical subject headings
- Lymphedema, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health education for lymphedema preventionOther
All subjects received a multimodal intervention consist in a multimodal program with an educational approach
| Study group | Role | What they receive |
|---|---|---|
| health education for lymphedema prevention | Active comparator | health education for lymphedema prevention Receives: 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 Receives: Other: health education for lymphedema prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 18 weeks
Secondary outcomes (4)
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.
Measured: baseline; 18 and 28 weeks
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.
Measured: baseline; 18 and 28 weeks
Cancer related fatigue questionnaire
Quick-Piper scale, self- administered, a 15 items. Consists of 4 subjetive dimensions. Offers the important advantage of brevity.
Measured: baseline; 18 and 28 weeks
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.
Measured: changes from 18 to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Antonio I Cuesta-Vargas, PhD, Study director, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915043
- Sponsor's protocol ID
- FCCSS_UMA-02-13
- Acronym
- APPCOMCAN
- Status last verified
- Mar 2017
- First submitted
- 23 Jul 2013
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence Healthy Lifestyle With a Smartphone Application Based After Surgery in Cancer Patients
- ClinicalTrials.gov ID
- NCT01915043
- Acronym / sponsor ID
- APPCOMCAN / FCCSS_UMA-02-13
- Conditions
- Secondary Prevention
- Keywords
- lymphedema, prevention, ehealth, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health education for lymphedema prevention | Active comparator | Other: health education for lymphedema preventionhealth education for lymphedema prevention |
| application smartphone-based group | Experimental | Other: health education for lymphedema preventionHealth 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- be over 18 years
- with own smartphone telephony server and mobile internet.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health education for lymphedema preventionAll subjects received a multimodal intervention consist in a multimodal program with an educational approach | Other | application smartphone-based group, health education for lymphedema prevention |
Primary outcome
volume and perimeter arm
Time frame: baseline and 18 weeks
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio I Cuesta-Vargas, PhD study director
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education for lymphedema prevention in people with Secondary Prevention, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume and perimeter arm (time frame: baseline and 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.