Public trial
RBR-7k4zy9v Mental health guidance for people undergoing cancer treatment
Date of registration: 04/29/2026 (mm/dd/yyyy)Last approval date : 04/29/2026 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Mental health education: a psychoeducational guide for oncology patients undergoing treatment
pt-br
Educação em saúde mental: um guia psicoeducativo para pacientes em tratamento oncológico
es
Mental health education: a psychoeducational guide for oncology patients undergoing treatment
Trial identification
- UTN code: U1111-1339-7885
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Public title:
en
Mental health guidance for people undergoing cancer treatment
pt-br
Orientações sobre saúde mental para quem está em tratamento de câncer
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Scientific acronym:
-
Public acronym:
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Secondaries identifiers:
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7.756.876
Issuing authority: Comitê de Ética em Pesquisa da Sociedade Beneficente Israelita Brasileira Albert Einstein
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85607124.4.0000.0071
Issuing authority: Plataforma Brasil
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7.756.876
Sponsors
- Primary sponsor: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Secondary sponsor:
- Institution: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Supporting source:
- Institution: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Health conditions
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Health conditions:
en
Breast Neoplasms; Anxiety; Quality of Life
pt-br
Neoplasias da Mama; Ansiedade; Qualidade de Vida
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General descriptors for health conditions:
en
F02.418 Mental Health
pt-br
F02.418 Saúde Mental
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Specific descriptors:
en
C04.588.180 Breast Neoplasms
pt-br
C04.588.180 Neoplasias da Mama
en
F01.470.132 Anxiety
pt-br
F01.470.132 Ansiedade
en
I01.800 Quality of Life
pt-br
I01.800 Qualidade de Vida
Interventions
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Interventions:
en
This is a randomized clinical study conducted using sealed, opaque envelopes, designed with a pre- and post-test and a non-blinded control group. Intervention group: 20 women undergoing breast cancer treatment will receive a structured psychoeducational guide and will participate in four group sessions led by a trained mental health professional, each lasting approximately 60 minutes, conducted over four weeks. The sessions will address coping strategies, mental health education, and emotional support during oncological treatment. Control group: 20 women undergoing breast cancer treatment will receive usual care only, without access to the psychoeducational guide or the structured sessions during the study period
pt-br
Trata-se de um estudo clínico randomizado, por meio de envelopes lacrados e opacos, planejado com pré e pós-teste e grupo controle, não cego. Grupo intervenção: 20 mulheres em tratamento de câncer de mama receberão um guia psicoeducativo estruturado e participarão de quatro sessões em grupo conduzidas por profissional de saúde mental treinado, com duração aproximada de 60 minutos cada, realizadas ao longo de quatro semanas, abordando estratégias de enfrentamento, educação em saúde mental e suporte emocional durante o tratamento oncológico. Grupo controle: 20 mulheres em tratamento de câncer de mama receberão apenas o tratamento usual, sem acesso ao guia psicoeducativo ou às sessões estruturadas durante o período do estudo
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Descriptors:
en
H02.403.720.750.380 Health Education
pt-br
H02.403.720.750.380 Educação em Saúde
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 05/27/2025 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 40 F 18 Y 75 Y -
Inclusion criteria:
en
Women aged between 18 and 75 years, diagnosed with breast cancer, undergoing oncological treatment, able to understand Portuguese language, and who agree to participate in the study.
pt-br
Mulheres com idade entre 18 e 55 anos, com diagnóstico de câncer de mama, em tratamento oncológico, com capacidade de compreensão da língua portuguesa e que concordem em participar do estudo.
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Exclusion criteria:
en
Patients with pre-existing severe psychiatric disorders, inability to understand Portuguese language, or who have previously received similar psychoeducational intervention.
pt-br
Pacientes com transtorno psiquiátrico grave pré-existente, incapacidade de compreensão da língua portuguesa ou que já tenham recebido previamente intervenção psicoeducativa semelhante.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Parallel 2 Open Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
To identify the main emotional and psychological challenges faced by patients undergoing oncological treatment, using the FACT-B (Functional Assessment of Cancer Therapy – Breast) and the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire), comparing baseline (pre-intervention) and post-intervention assessments after four weeks of intervention in both groups
pt-br
Identificar os principais desafios emocionais e psicológicos enfrentados por pacientes em tratamento oncológico, por meio dos questionários FACT-B (Functional Assessment of Cancer Therapy – Breast) e EORTC QLQ C-30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire), comparando os momentos pré-intervenção (baseline) e após quatro semanas de intervenção em ambos os grupos
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Secondary outcomes:
en
To evaluate changes in health-related quality of life using the FACT-B (Functional Assessment of Cancer Therapy – Breast) and the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire), comparing baseline (pre-intervention) and post-intervention assessments after four weeks of intervention in both groups
pt-br
Avaliar a variação na qualidade de vida relacionada à saúde,por meio dos questionários FACT-B (Functional Assessment of Cancer Therapy – Breast) e EORTC QLQ C-30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire), comparando os momentos pré-intervenção (baseline) e após quatro semanas de intervenção em ambos os grupos
Contacts
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Public contact
- Full name: Angélica Cristiane da Cruz Britto
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- Address: Avenida Albert Einstein, 627|701, Morumbi
- City: São Paulo / Brazil
- Zip code: 05652900
- Phone: +55 (14) 998397053
- Email: angelica.cruz@einstein.br
- Affiliation: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Scientific contact
- Full name: Angélica Cristiane da Cruz Britto
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- Address: Avenida Albert Einstein, 627|701, Morumbi
- City: São Paulo / Brazil
- Zip code: 05652900
- Phone: +55 (14) 998397053
- Email: angelica.cruz@einstein.br
- Affiliation: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Site contact
- Full name: Angélica Cristiane da Cruz Britto
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- Address: Avenida Albert Einstein, 627|701, Morumbi
- City: São Paulo / Brazil
- Zip code: 05652900
- Phone: +55 (14) 998397053
- Email: angelica.cruz@einstein.br
- Affiliation: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Additional links:
Total de Ensaios Clínicos 18102.
Existem 9156 ensaios clínicos registrados.
Existem 4992 ensaios clínicos recrutando.
Existem 128 ensaios clínicos em análise.
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