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

NCT04641377 | Unknown

• 1 other identifier: CAAE: 39277420.8.0000.5313
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Cancer-related fatigue at 3 months

  Fatigue will be determined using the behavioural/severity, affective, sensory, cognitive/mood, and total fatigue scores from the Piper Fatigue Scale through an interview. Its version translated into Portuguese is a reliable and valid instrument to measure fatigue in Brazilian cancer patients. This consists of 22 items numerically scaled 0 to 10 that measure the 4 dimensions of subjective fatigue as well as total fatigue.

  Baseline and post-intervention (week 13)

Secondary Outcomes (7)

• Change from Baseline Quality of life (QoL) of Cancer Patients at 3 months

  Baseline and post-intervention (week 13)

• Change from Baseline Quality of life (QoL) of Breast cancer patients specific supplement at 3 months

  Baseline and post-intervention (week 13)

• Change from Cancer-related cognitive impairment at 3 months

  Baseline and post-intervention (week 13)

• Change from Depressive symptoms at 3 months

  Baseline and post-intervention (week 13)

• Change from Anxiety at 3 months

  Baseline and post-intervention (week 13)

Study Arms (2)

Multicomponent exercise intervention plus health education

EXPERIMENTAL

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.

Other: Multicomponent exercise intervention plus health education

Health education

ACTIVE COMPARATOR

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.

Other: Health Education

Interventions

Multicomponent exercise intervention plus health education OTHER

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.

Multicomponent exercise intervention plus health education

Health Education OTHER

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.

Health education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (2)

UFPel

Pelotas, Rio Grande do Sul, 96055-630, Brazil

RECRUITING

UFRGS

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

RECRUITING

Related Publications (1)

• Henkin JS, Botton CE, Simon MS, Rocha GG, Silveira CB, Gehrke RS, Freitas GB, Trajano GS, Pinto RS, Pinto SS. Telehealth multicomponent exercise and health education in breast cancer patients undergoing primary treatment: rationale and methodological protocol for a randomized clinical trial (ABRACE: Telehealth). Trials. 2023 Jan 19;24(1):42. doi: 10.1186/s13063-022-07015-z.

  PMID: 36658611 DERIVED

Study Officials

• Stephanie S Pinto, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie S Pinto, PhD

CONTACT

+5553 32732752; tetisantana@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 23, 2020
• Study Start: February 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: March 1, 2023
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

BR (2)