Integral Strategy to Supportive Care in Breast Cancer Patients

University of Granada (UGR)

Status: Unknown

Conditions: Breast Neoplasms

Treatments: Device: BENECA System; Other: Supervised-occupational therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT02817724

FPU14/01069 (Other Grant/Funding Number)

PI14/01627 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

m-Health group

Active Comparator group

Description:

BENECA System: The m-health group will use the BENECA app for 8 weeks.

Treatment:

Device: BENECA System

Integral Group

Experimental group

Description:

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.

Treatment:

Device: BENECA System

Other: Supervised-occupational therapy program