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Trial record 1 of 1 for:    NCT02817724
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Integral Strategy to Supportive Care in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT02817724
Recruitment Status : Unknown
Verified October 2017 by Manuel Arroyo Morales, Universidad de Granada.
Recruitment status was:  Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Manuel Arroyo Morales, Universidad de Granada

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Device: BENECA System Other: Supervised-occupational therapy program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Integral Strategy to Supportive Care in Breast Cancer Patients Through Occupational Therapy and a M-health System: a Randomized Controlled Trial.
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: m-Health group
BENECA System: The m-health group will use the BENECA app for 8 weeks.
Device: BENECA System
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).

Experimental: Integral Group
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.
Device: BENECA System
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).

Other: Supervised-occupational therapy program
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Body mass Index [ Time Frame: Participants will be followed over 8 weeks. ]
    Body mass index, in kg/m2, will be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).

  2. Fat mass [ Time Frame: Participants will be followed over 8 weeks. ]
    % Fat mass will also be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).

  3. Abdominal adipose tissue [ Time Frame: Participants will be followed over 8 weeks. ]
    Abdominal adipose tissue will also be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).

  4. Bone mineral density [ Time Frame: Participants will be followed over 8 weeks. ]
    Bone mineral density (Z-score) will also be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).

  5. Shoulder Range of Motion (ROM) [ Time Frame: Participants will be followed over 8 weeks. ]
    - Shoulder ROM measurements will be obtained using a standard, two-armed goniometer which is described as the clinical gold standard.

  6. Upper Body Functionality [ Time Frame: Participants will be followed over 8 weeks. ]
    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.

  7. Upper body muscular strength [ Time Frame: Participants will be followed over 8 weeks. ]
    Handgrip: Upper body muscular strength will be determined using digital dynamometer (TKK 5101 Grip-D; Tokyo, Japan. The precision will be 0.1 kg.

  8. Cognitive function: attention [ Time Frame: Participants will be followed over 8 weeks. ]
    The trial making test (TMT) will be used to assess speed for attention, sequencing, mental flexibility, visual search and motion function.

  9. Cognitive function: memory and processing speed [ Time Frame: Participants will be followed over 8 weeks. ]
    Wechsler Adult Intelligence Scale (WAIS IV) will be used to assess working memory and processing speed.

  10. Anxiety and depression [ Time Frame: Participants will be followed over 8 weeks. ]
    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.

  11. Physical activity [ Time Frame: Participants will be followed over 8 weeks. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817724


Locations
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Spain
Faculty of Health Sciences. University of Granada
Granada, Spain, 18071
Sponsors and Collaborators
Universidad de Granada
Carlos III Health Institute
Investigators
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Study Director: Manuel Arroyo-Morales, PhD Deparment of physiotherapy, Faculty of Health Sciences, University of Granada
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manuel Arroyo Morales, PhD, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02817724    
Other Study ID Numbers: PI14/01627
PI14/01627 ( Other Grant/Funding Number: Spanish Ministry of Economy and Competitiveness, Fondo de Investigación Sanitaria del Instituto de Salud Carlos III )
FPU14/01069 ( Other Grant/Funding Number: Spanish Ministry of Education )
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Keywords provided by Manuel Arroyo Morales, Universidad de Granada:
Breast Neoplasms
survivor
occupational therapy
mobile applications
Quality of Life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases