Integral Strategy to Supportive Care in Breast Cancer Patients

Breast Neoplasms Clinical Trial

Official title:

Integral Strategy to Supportive Care in Breast Cancer Patients Through Occupational Therapy and a M-health System: a Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02817724
• Other study ID #: PI14/01627
• Secondary ID: PI14/01627FPU14/
• Status: Active, not recruiting
• Phase: N/A
• First received: June 22, 2016
• Last updated: October 24, 2017
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: October 2017
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences. University of Granada	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed over 8 weeks.
Secondary	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).	Participants will be followed over 8 weeks.
Secondary	Fat mass	% Fat mass will also be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).	Participants will be followed over 8 weeks.
Secondary	Abdominal adipose tissue	Abdominal adipose tissue will also be assessed by conducting Dual-energy X-ray absorptiometry (DXA, Discovery densitometer from HOLOGIC, QDR 4500W).	Participants will be followed over 8 weeks.
Secondary	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).	Participants will be followed over 8 weeks.
Secondary	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.	Participants will be followed over 8 weeks.
Secondary	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.	Participants will be followed over 8 weeks.
Secondary	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.	Participants will be followed over 8 weeks.
Secondary	Cognitive function: attention	The trial making test (TMT) will be used to assess speed for attention, sequencing, mental flexibility, visual search and motion function.	Participants will be followed over 8 weeks.
Secondary	Cognitive function: memory and processing speed	Wechsler Adult Intelligence Scale (WAIS IV) will be used to assess working memory and processing speed.	Participants will be followed over 8 weeks.
Secondary	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.	Participants will be followed over 8 weeks.
Secondary	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.	Participants will be followed over 8 weeks.