Breast Cancer FemaleNCT04641377
Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth)
A study testing Multicomponent exercise intervention plus health education and Health Education in people with Breast Cancer Female, run by Federal University of Pelotas at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Multicomponent exercise intervention plus health education and Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesBrazil
- Study dates
- Feb 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
UFPel
Pelotas, Rio Grande do Sul, 96055-630
- Recruiting
UFRGS
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
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
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
- Being tested
- Multicomponent exercise intervention plus health education, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise intervention plus health educationOther
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.
Health EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention (week 13)
Secondary outcomes (7)
Change from Baseline Quality of life (QoL) of Cancer Patients at 3 months
The impact of cancer and its treatment on QoL will be estimated using the European Organization for Research and Treatment of Cancer (EORTIC) Quality of Life of Cancer Patients (QLQ-C30). The QLQ-C30 is a 30-item questionnaire assessing function and symptoms that impact QoL. It was developed as an integrated measurement system and incorporates 5 functional scales (physical, role, cognitive, emotional, and social: higher scores represent better QoL), 3 symptom scales (fatigue, pain, and nausea and vomiting: higher score corresponds to more frequent and/or more intense symptoms), and 1 global health and QoL scale (higher scores represent better QoL). Several single-item measures assess common cancer symptoms (dyspnea, loss of appetite, sleep disturbance, constipation, and diarrhea: higher score corresponds to more frequent and/or more intense symptoms) and the perceived financial impact of cancer and its treatments.
Measured: Baseline and post-intervention (week 13)
Change from Baseline Quality of life (QoL) of Breast cancer patients specific supplement at 3 months
The European Organization for Research and Treatment of Cancer (EORTIC) breast cancer specific module (QLQ-BR-23), consists of a functional and a symptom scale domains. The scoring algorithm recommended by the EORTC, was used to transform the responses to values on scale 0-100%. For the functional scale, a higher score corresponds to better functioning and HRQOL. For symptom scales, a higher score corresponds to more frequent and/or more intense symptoms. A problematic group is defined as one with a global QoL or functional scale score of 33 or less, and a symptom scale score of 66 or more on the QLQ-BR-23.
Measured: Baseline and post-intervention (week 13)
Change from Cancer-related cognitive impairment at 3 months
The FACT-Cog version 3 comprises 37 items, with four subscales created by the developers: patients' perceived cognitive impairments (CogPCI), perceived cognitive abilities (CogPCA), deficits observed or commented on by others (CogOth), and impact of cognitive changes on quality of life (CogQOL). A global or summary score is obtained by summing all item scores. Respondents indicate the frequency of each occurrence over the 7 days preceding the test on a 5-point Likert-type scale ranging from 0 (never) to 4 (several times per day) in CogPCI and CogOth. In the CogPCA and CogQOL subscales, the responses are rated on a 5-point severity scale ranging from 0 (not at all) to 4 (very much). The individual subscale scores are summed to determine the FACT-Cog total score, ranging from 0 to 132, with higher scores indicating better cognitive functioning.
Measured: Baseline and post-intervention (week 13)
Change from Depressive symptoms at 3 months
The CES-D measures symptoms of depression and is not a diagnostic tool for major depressive disorder. Participants scoring ≥16 (range 0-60) will be considered at risk for prevalent depression. Individuals will be coded as positive for depression if they have a CES-D score of ≥16 and/or had self-report of depression diagnosis at baseline. In addition to the total score, the CES-D includes 4 subscales: depressed affect (range 0-21), positive affect (range 0-12), somatic (range 0-21), and interpersonal (range 0-6).
Measured: Baseline and post-intervention (week 13)
Change from Anxiety at 3 months
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level.
Measured: Baseline and post-intervention (week 13)
Change from Functional capacity at 3 months
The 30-s chair-stand test assesses lower body strength and will be scored by the number of times the participant correctly stands within 30 s. To evaluate upper body strength the arm curl test will be employed. The participant will be instructed to perform as many elbow flexions as possible within a 30-second time limit, always with controlled movements in both the flexion and extension phases. Each complete movement performed correctly will be counted. The tests will be performed with verbal encouragement for all participants, in order to reach their best performance.
Measured: Baseline and post-intervention (week 13)
Change from Level of leisure-time physical activity at 3 months
The Godin-Shephard leisure-time physical activity questionnaire will be used in its validated version and translated into Portuguese in Brazil. Participants should report the number of times per week that they engage in vigorous, moderate and light physical activity for a period of time greater than 15 min. The frequency is multiplied the metabolic equivalent (MET). High scores indicate a higher level of physical activity during leisure.
Measured: Baseline and post-intervention (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study startFeb 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Santana Pinto, Federal University of Pelotas
- Investigators
- Stephanie S Pinto, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641377
- Sponsor's protocol ID
- CAAE: 39277420.8.0000.5313
- Status last verified
- Feb 2021
- First submitted
- 12 Nov 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36658611
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04641377
- Acronym / sponsor ID
- CAAE: 39277420.8.0000.5313
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise intervention plus health education | Experimental | Other: Multicomponent exercise intervention plus health educationThe 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. |
| Health education | Active comparator | Other: Health EducationOnce 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Women can not have reached more than 50% of the completion of chemotherapy or only radiotherapy treatment
- Women can not have the following comorbidities:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent exercise intervention plus health educationThe 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 EducationOnce 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 |
Primary outcome
Change from Baseline Cancer-related fatigue at 3 months
Time frame: Baseline and post-intervention (week 13)
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.
7 secondary outcomes
Change from Baseline Quality of life (QoL) of Cancer Patients at 3 months
Time frame: Baseline and post-intervention (week 13)
Change from Baseline Quality of life (QoL) of Breast cancer patients specific supplement at 3 months
Time frame: Baseline and post-intervention (week 13)
Change from Cancer-related cognitive impairment at 3 months
Time frame: Baseline and post-intervention (week 13)
Change from Depressive symptoms at 3 months
Time frame: Baseline and post-intervention (week 13)
Change from Anxiety at 3 months
Time frame: Baseline and post-intervention (week 13)
Change from Functional capacity at 3 months
Time frame: Baseline and post-intervention (week 13)
Change from Level of leisure-time physical activity at 3 months
Time frame: Baseline and post-intervention (week 13)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 36658611Henkin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie S Pinto, PhD principal investigator
Federal University of Pelotas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise intervention plus health education and Health Education in people with Breast Cancer Female, run by Federal University of Pelotas at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie S Pinto, PhD (+5553 32732752, tetisantana@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Cancer-related fatigue at 3 months (time frame: Baseline and post-intervention (week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04641377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.