Integral Strategy to Supportive Care in Breast Cancer Patients Through Occupational Therapy and a M-health System: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of life (QLQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
m-Health group
BENECA System: The m-health group will use the BENECA app for 8 weeks.
干预措施: BENECA System (Device)
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.
干预措施: BENECA System (Device)
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.
干预措施: Supervised-occupational therapy program (Other)
结局指标
主要结局
Quality of life (QLQ)
时间窗: 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.
次要结局
- Abdominal adipose tissue(Participants will be followed over 8 weeks.)
- Bone mineral density(Participants will be followed over 8 weeks.)
- Shoulder Range of Motion (ROM)(Participants will be followed over 8 weeks.)
- Upper Body Functionality(Participants will be followed over 8 weeks.)
- Upper body muscular strength(Participants will be followed over 8 weeks.)
- Cognitive function: attention(Participants will be followed over 8 weeks.)
- Body mass Index(Participants will be followed over 8 weeks.)
- Fat mass(Participants will be followed over 8 weeks.)
- Cognitive function: memory and processing speed(Participants will be followed over 8 weeks.)
- Anxiety and depression(Participants will be followed over 8 weeks.)
- Physical activity(Participants will be followed over 8 weeks.)
研究者
Manuel Arroyo Morales
PhD
Universidad de Granada