Clinical trial NCT04641377: Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth)
Official title: A Multicomponent Exercise Intervention Using Telehealth to Improve Psychological and Physical Outcomes in Breast Cancer Patients Undergoing Primary Treatment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the present study is to determine the effects of 12 weeks of multicomponent training associated with a health education program carried out remotely, compared to a health education-only program, on psychological and physical outcomes of women in primary treatment for breast cancer. For that, 36 women will be randomized to a multicomponent training group carried out remotely associated with health education or health education group. The psychological and physical outcomes will be measured pre (week 0) and post-intervention (week 13) in both groups, always by the same investigator blinded in relation to the groups. The multicomponent training group will carry out an exercise program twice a week, and health education will also be carried out on one of the two days. In this group, the conversation on the topic of the week will take place during stretching. The sessions (on pre-established and non-consecutive days) will be held by video call (approximately 60 min) in small groups (maximum three participants) and will be given by students of the Physical Education course, previously trained to perform the intervention. The order of the multicomponent training will be joint mobilization, aerobic stimulus, balance exercise, strength exercises and stretching of the main muscles used during the training session. For the participants of the health education group, also, once a week, a material with several topics related to the management of breast cancer diagnosis and physical activity will be sent by message. In addition, two days after this material is sent, a conversation will be held with the participants of this group, at a google meet of approximately 30 minutes, about the theme sent by message. The themes will be depression, pain, fatigue, body image, symptoms in the arm and breast, vasomotor symptoms, neuropathy, arthralgia, sexual dysfunction, quality of life, physical activity and eating habits. To analyze the outcomes collected, it will be used Generalized Estimating Equations (GEE) and the Bonferroni post-hoc test.


Eligibility criteria: Inclusion Criteria:

* Women from the city of Porto Alegre and Pelotas in southern Brazil
* Women diagnosed with breast cancer in stages I-III
* Women undergoing primary treatment (adjuvant or neoadjuvant chemotherapy or only radiotherapy) of breast cancer
* Women can not be practicing periodized and systematic physical exercise programs

Exclusion Criteria:

* Women can not have reached more than 50% of the completion of chemotherapy or only radiotherapy treatment
* Women can not have the following comorbidities:

  * autonomic neuropathy or severe peripheral neuropathy, proliferative diabetic retinopathy, non-proliferative diabetic retinopathy, uncompensated heart failure, unstable angina, peripheral amputations, uncontrolled arterial hypertension, chronic renal failure, severe psychiatric disorders and musculoskeletal impairment that limits physical exercise.

Primary outcomes:
measure: Change from Baseline Cancer-related fatigue at 3 months
timeFrame: Baseline and post-intervention (week 13)
Secondary outcomes:
measure: Change from Baseline Quality of life (QoL) of Cancer Patients at 3 months
timeFrame: Baseline and post-intervention (week 13)
measure: Change from Baseline Quality of life (QoL) of Breast cancer patients specific supplement at 3 months
timeFrame: Baseline and post-intervention (week 13)
measure: Change from Cancer-related cognitive impairment at 3 months
timeFrame: Baseline and post-intervention (week 13)
measure: Change from Depressive symptoms at 3 months
timeFrame: Baseline and post-intervention (week 13)
measure: Change from Anxiety at 3 months
timeFrame: Baseline and post-intervention (week 13)
measure: Change from Functional capacity at 3 months
timeFrame: Baseline and post-intervention (week 13)
measure: Change from Level of leisure-time physical activity at 3 months
timeFrame: Baseline and post-intervention (week 13)
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: UFPel
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: UFRGS
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Pelotas
name: Stephanie S Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References: