Breast NeoplasmsNCT02817724
Integral Strategy to Supportive Care in Breast Cancer Patients
A study testing BENECA System and Supervised-occupational therapy program in people with Breast Neoplasms, run by Universidad de Granada at 1 site in Spain.
Trial summary
The purpose of this study is to determine if it is better an integral strategy, with a m-health system, when used in addition to a supervised treatment, versus the use of the m-health system alone, to improve the immediate and long-term Quality of Life of breast cancer survivors. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- BENECA System and Supervised-occupational therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Jul 2019
- 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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stage I, II or IIIA breast cancer.
- Overweight or obese, according to the Spanish Society for the Study of Obesity.
- Basic ability to use mobile apps or living with someone who has this ability.
- Medical clearance of participants.
- Completion of adjuvant therapy except for hormone therapy.
- Some functional or Range of Motion (ROM) limitations measures by goniometry and the DASH Questionnaire.
- Have signed informed consent.
Who cannot join
- History of cancer recurrence.
- Chronic disease or orthopedic issues that would interfere with the ability to participate in the rehabilitation program.
- Uncontrolled hypertension (diastolic pressure > 95mm Hg).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integral Strategy to Supportive Care in Breast Cancer Patients Through Occupational Therapy and a M-health System: a Randomized Controlled Trial.
The purpose of this study is to determine if it is better an integral strategy, with a m-health system, when used in addition to a supervised treatment, versus the use of the m-health system alone, to improve the immediate and long-term Quality of Life of breast cancer survivors.
Read the detailed description
Background: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mortality). Moreover, cancer rehabilitation programs supervised by health professionals are needed due to the inherent characteristics of these breast cancer patients. Our main objective is to compare the clinical efficacy of a m-health lifestyle intervention system alone versus an integral strategy to improve Quality of Life (QoL) in breast cancer survivors.
Methods: This therapeutic superiority study will use a two-arm, assessor blinded parallel randomized clinical trial (RCT) design. Women will be eligible if: they are diagnosed of stage I, II or III-A breast cancer; are between 25 and 75 years old; have a Body Mass Index > 25kg/m2; they have basic ability to use mobile apps; they had completed adjuvant therapy except for hormone therapy; and they have some functional shoulder limitations. Participants will be randomized to one of the following groups: integral group will use a mobile application (BENECA APP) and will receive a supervised rehabilitation (8-weeks); m-health group will use the BENECA app for 8-weeks. Study endpoints will be assessed after 8 weeks and 24 weeks. The primary outcome will be QoL measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core and breast module. The secondary outcomes: body composition; upper-body functionality (handgrip, Disability of the Arm, Shoulder and Hand questionnaire, goniometry); cognitive function (Wechsler Adult Intelligence Scale, Trial Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); and accelerometer.
Discussion: This study has been designed to seek to address the new needs for support and treatment of breast cancer survivors, reflecting the emerging need to merge new low cost treatment options with much-needed involvement of health professionals in this type of patients.
- Conditions
- Breast Neoplasms
- Being tested
- BENECA System, Supervised-occupational therapy program
- Keywords
- Breast Neoplasms, survivor, occupational therapy, mobile applications, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BENECA SystemDevice
BENECA System is a mobile application whit aims to recover a healthy lifestyle in breast cancer survivors (in terms of energy balance: physical activity and dietary).
Supervised-occupational therapy programOther
It is a comprehensive program that covers most of the physical, cognitive and emotional needs of these patients after oncology treatment from occupational therapy perspective.
| Study group | Role | What they receive |
|---|---|---|
| m-Health group | Active comparator | BENECA System: The m-health group will use the BENECA app for 8 weeks. Receives: Device: BENECA System |
| Integral Group | Experimental | BENECA System and Supervised-occupational therapy program: The integral groups will use the BENECA app and they will receive a face-to-face occupational therapy rehabilitation program for 8 weeks. Receives: Device: BENECA System; Other: Supervised-occupational therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QLQ)
The primary outcome will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORT QLQ-C30) version 3.0., and with the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORT QLQ-BR23). Both are the most widely used instruments to measure Quality of Life in cancer patients.
Measured: Participants will be followed over 8 weeks.
Secondary outcomes (11)
Body mass Index
Body mass index, in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).
Measured: Participants will be followed over 8 weeks.
Fat mass
% Fat mass will also be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).
Measured: Participants will be followed over 8 weeks.
Abdominal adipose tissue
Abdominal adipose tissue will also be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).
Measured: Participants will be followed over 8 weeks.
Bone mineral density
Bone mineral density (Z-score) will also be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).
Measured: Participants will be followed over 8 weeks.
Shoulder Range of Motion (ROM)
- Shoulder ROM measurements will be obtained using a standard, two-armed goniometer which is described as the clinical gold standard.
Measured: Participants will be followed over 8 weeks.
Upper Body Functionality
The disability of the arm, shoulder and hand (DASH) questionnaire will be used to measure the upper extremity functionality. It includes 30-item disability/symptom scale.
Measured: Participants will be followed over 8 weeks.
Upper body muscular strength
Handgrip: Upper body muscular strength will be determined using digital dynamometer (TKK 5101 Grip-D; Tokyo, Japan. The precision will be 0.1 kg.
Measured: Participants will be followed over 8 weeks.
Cognitive function: attention
The trial making test (TMT) will be used to assess speed for attention, sequencing, mental flexibility, visual search and motion function.
Measured: Participants will be followed over 8 weeks.
Cognitive function: memory and processing speed
Wechsler Adult Intelligence Scale (WAIS IV) will be used to assess working memory and processing speed.
Measured: Participants will be followed over 8 weeks.
Anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression. It contains 14 items (7 items for each scale) with 4-point likert scale.
Measured: Participants will be followed over 8 weeks.
Physical activity
Participants will be asked to wear an try-axial accelerometer (ActiGraph GT3X+, Pensacola, Florida, US) to record physical activity intensity levels and patterns, as well as sleeping habits.
Measured: Participants will be followed over 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, Manuel Arroyo Morales, Universidad de Granada
- Investigators
- Manuel Arroyo-Morales, PhD, Study director, Deparment of physiotherapy, Faculty of Health Sciences, University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817724
- Sponsor's protocol ID
- PI14/01627
- Other IDs
- PI14/01627, FPU14/01069
- Status last verified
- Oct 2017
- First submitted
- 22 Jun 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
Publications
Lozano-Lozano M, Galiano-Castillo N, Martin-Martin L, Pace-Bedetti N, Fernandez-Lao C, Arroyo-Morales M, Cantarero-Villanueva I. Monitoring Energy Balance in Breast Cancer Survivors Using a Mobile App: Reliability Study. JMIR Mhealth Uhealth. 2018 Mar 27;6(3):e67. doi: 10.2196/mhealth.9669.
PubMed 29588273Lozano-Lozano M, Martin-Martin L, Galiano-Castillo N, Alvarez-Salvago F, Cantarero-Villanueva I, Fernandez-Lao C, Sanchez-Salado C, Arroyo-Morales M. Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. BMC Med Inform Decis Mak. 2016 Nov 25;16(1):150. doi: 10.1186/s12911-016-0394-0.
PubMed 27887610
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integral Strategy to Supportive Care in Breast Cancer Patients Through Occupational Therapy and a M-health System: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02817724
- Acronym / sponsor ID
- PI14/01627
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasms, survivor, occupational therapy, mobile applications, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 29 Jun 2016 (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.
The purpose of this study is to determine if it is better an integral strategy, with a m-health system, when used in addition to a supervised treatment, versus the use of the m-health system alone, to improve the immediate and long-term Quality of Life of breast cancer survivors.
Detailed description
Background: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mortality). Moreover, cancer rehabilitation programs supervised by health professionals are needed due to the inherent characteristics of these breast cancer patients. Our main objective is to compare the clinical efficacy of a m-health lifestyle intervention system alone versus an integral strategy to improve Quality of Life (QoL) in breast cancer survivors.
Methods: This therapeutic superiority study will use a two-arm, assessor blinded parallel randomized clinical trial (RCT) design. Women will be eligible if: they are diagnosed of stage I, II or III-A breast cancer; are between 25 and 75 years old; have a Body Mass Index > 25kg/m2; they have basic ability to use mobile apps; they had completed adjuvant therapy except for hormone therapy; and they have some functional shoulder limitations. Participants will be randomized to one of the following groups: integral group will use a mobile application (BENECA APP) and will receive a supervised rehabilitation (8-weeks); m-health group will use the BENECA app for 8-weeks. Study endpoints will be assessed after 8 weeks and 24 weeks. The primary outcome will be QoL measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core and breast module. The secondary outcomes: body composition; upper-body functionality (handgrip, Disability of the Arm, Shoulder and Hand questionnaire, goniometry); cognitive function (Wechsler Adult Intelligence Scale, Trial Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); and accelerometer.
Discussion: This study has been designed to seek to address the new needs for support and treatment of breast cancer survivors, reflecting the emerging need to merge new low cost treatment options with much-needed involvement of health professionals in this type of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| m-Health group | Active comparator | Device: BENECA SystemBENECA System: The m-health group will use the BENECA app for 8 weeks. |
| Integral Group | Experimental | Device: BENECA System, Other: Supervised-occupational therapy programBENECA System and Supervised-occupational therapy program: The integral groups will use the BENECA app and they will receive a face-to-face occupational therapy rehabilitation program for 8 weeks. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of stage I, II or IIIA breast cancer.
- Overweight or obese, according to the Spanish Society for the Study of Obesity.
- Basic ability to use mobile apps or living with someone who has this ability.
- Medical clearance of participants.
- Completion of adjuvant therapy except for hormone therapy.
Key exclusion criteria (3 listed)
- History of cancer recurrence.
- Chronic disease or orthopedic issues that would interfere with the ability to participate in the rehabilitation program.
- Uncontrolled hypertension (diastolic pressure > 95mm Hg).
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 |
|---|---|---|
| BENECA SystemBENECA System is a mobile application whit aims to recover a healthy lifestyle in breast cancer survivors (in terms of energy balance: physical activity and dietary). | Device | Integral Group, m-Health group |
| Supervised-occupational therapy programIt is a comprehensive program that covers most of the physical, cognitive and emotional needs of these patients after oncology treatment from occupational therapy perspective. | Other | Integral Group |
Primary outcome
Quality of life (QLQ)
Time frame: Participants will be followed over 8 weeks.
The primary outcome will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORT QLQ-C30) version 3.0., and with the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORT QLQ-BR23). Both are the most widely used instruments to measure Quality of Life in cancer patients.
11 secondary outcomes
Body mass Index
Time frame: Participants will be followed over 8 weeks.
Fat mass
Time frame: Participants will be followed over 8 weeks.
Abdominal adipose tissue
Time frame: Participants will be followed over 8 weeks.
Bone mineral density
Time frame: Participants will be followed over 8 weeks.
Shoulder Range of Motion (ROM)
Time frame: Participants will be followed over 8 weeks.
Upper Body Functionality
Time frame: Participants will be followed over 8 weeks.
Upper body muscular strength
Time frame: Participants will be followed over 8 weeks.
Cognitive function: attention
Time frame: Participants will be followed over 8 weeks.
Cognitive function: memory and processing speed
Time frame: Participants will be followed over 8 weeks.
Anxiety and depression
Time frame: Participants will be followed over 8 weeks.
Physical activity
Time frame: Participants will be followed over 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 29588273Lozano-Lozano M, Galiano-Castillo N, Martin-Martin L, Pace-Bedetti N, Fernandez-Lao C, Arroyo-Morales M, Cantarero-Villanueva I. Monitoring Energy Balance in Breast Cancer Survivors Using a Mobile App: Reliability Study. JMIR Mhealth Uhealth. 2018 Mar 27;6(3):e67. doi: 10.2196/mhealth.9669.
- Derived from this study: PubMed 27887610Lozano-Lozano M, Martin-Martin L, Galiano-Castillo N, Alvarez-Salvago F, Cantarero-Villanueva I, Fernandez-Lao C, Sanchez-Salado C, Arroyo-Morales M. Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial. BMC Med Inform Decis Mak. 2016 Nov 25;16(1):150. doi: 10.1186/s12911-016-0394-0.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Manuel Arroyo-Morales, PhD study director
Deparment of physiotherapy, Faculty of Health Sciences, University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BENECA System and Supervised-occupational therapy program in people with Breast Neoplasms, run by Universidad de Granada 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 7 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: status not confirmed, as of the sponsor's last update on 25 Oct 2017. 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?
Results are not available in the source record.
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?
Quality of life (QLQ) (time frame: Participants will be followed over 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817724, which also lists 2 linked publications.
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 25 Oct 2017.