Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth)

Federal University of Pelotas

Status: Unknown

Conditions: Breast Cancer Female

Treatments: Other: Multicomponent exercise intervention plus health education; Other: Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04641377

CAAE: 39277420.8.0000.5313

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Multicomponent exercise intervention plus health education

Experimental group

Description:

The multicomponent training will be performed twice a week, on pre-established and non-consecutive days. The sessions will be held by video call (approximately 60 min) in small groups (maximum three participants) and will be taught by students of the Physical Education course, previously trained to carry out 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. Health education will also be carried out on one of the two days. The conversation on the topic of the week will take place during stretching.

Treatment:

Other: Multicomponent exercise intervention plus health education

Health education

Active Comparator group

Description:

Once a week, participants in the health education group will be sent a message with a material with various topics related to the management of breast cancer diagnosis and physical activity. In addition, two days after this material is sent, members of ABRACE: Telehealth will have a conversation 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.

Treatment:

Other: Health Education