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Aún no reclutaNCT07529496Registro de ClinicalTrials.gov

The Effect of Psychosocial Support on Improving Breast Cancer Patients Response to Medical Treatment

Breast Cancer - Female

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
20 años - 65 años
Sexo admitido
Femenino
Voluntarios sanos
No aceptados
Participantes
160 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The goal of this clinical trial is to evaluate the effect of psychosocial therapy on improving treatment response among breast cancer patients receiving chemotherapy. Participants will be randomized to receive standard medical treatment alone or combined with structured psychosocial therapy. Outcomes include treatment response, psychological well-being, and quality of life.

1. Do psychosocial interventions affect the response to breast cancer treatment?
2. How do societal attitudes toward psychological and social care influence the willingness of breast cancer patients in Palestine to seek psychosocial interventions?

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • age between 20-65 Being Palestinian female from west bank and Jerusalem
  • Diagnosed with stage I-III breast cancer.
  • Currently receiving active medical treatment.
  • Able to provide consent and participate in the intervention.

Exclusion Criteria:

  • being male.
  • holding other nationalities than Palestinian or living outside the westbank or Jerusalem.
  • Younger than 20 or older than 65 years old.
  • Uncooperative with interviewer
  • Terminally ill (stage IV).
  • Receiving palliative care only.

Note Regarding the Modification of the Eligibility Criteria - Age Range

Please note that one of the study eligibility criteria has been revised, specifically the age range, which has been expanded from 20-65 years for several reasons.

First, the youth age group in Palestine is defined as individuals aged 18-65 years. Second, the disease affects patients across a broad range of ages rather than being limited to a specific age group. Finally, given the political and socioeconomic challenges facing our study, which may limit the availability and recruitment of patients across different age groups, particularly younger individuals, expanding the age range was considered necessary to facilitate patient recruitment and ensure a more representative study population.

Therefore, broadening the age eligibility criteria was deemed a practical and methodologically appropriate adjustment to address these challenges while improving the feasibility of the study.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Sin enmascaramiento
Psychosocial intervention

No informado en este registro.

Behavioral: Psychosocial Therapy · Other: Standard Medical Treatment

Standard medical treatment

No informado en este registro.

Other: Standard Medical Treatment

Psychosocial Therapy BEHAVIORAL

The psychosocial therapy consists of structured, individual, in-person counseling sessions designed to provide emotional support, enhance coping skills, and address psychological and social challenges experienced by breast cancer patients during treatment. The intervention is delivered by trained mental health professionals and focuses on improving patients' psychological well-being and treatment response.

Standard Medical Treatment OTHER

Standard oncological medical treatment for breast cancer as prescribed by the treating physician, which may include chemotherapy, radiotherapy, hormonal therapy, or targeted therapy according to clinical guidelines.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Breast cancer-specific quality of life assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)

Plazo: Baseline and 6 weeks

Breast cancer-specific quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B is a 37-item instrument assessing physical, social/family, emotional, functional well-being, and additional breast cancer concerns. Total scores range from 0 to 148, with higher scores indicating better quality of life.

Medidas secundarias

Anxiety level assessed by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)

Plazo: Baseline and 6 weeks

Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire consisting of two subscales: anxiety and depression. Each subscale score ranges from 0 to 21, with higher scores indicating greater psychological distress and worse outcomes.

Health-related quality of life assessed by the 36-item short form health survey (SF-36)

Plazo: Baseline and 6 weeks

Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36). The SF-36 is a 36-item questionnaire measuring eight domains of physical and mental health. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better health-related quality of life.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Al-Quds universityEast Jerusalem, Palestinian TerritoriesEstado desconocido

Equipo y fechas

Patrocinador principal
Al-Quds University
Inicio del estudio
30 jul 2027 Estimado
Finalización primaria
15 jun 2028 Estimado
Finalización del estudio
30 dic 2028 Estimado
Primera publicación
14 abr 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Tala MZ Abu Awad, Medical student /study coordinCONTACTtalaabuawad2003@gmail.com+972 586044430
Título oficial del estudio

A Randomized Controlled Trial Assessing the Effect of Psychosocial Support on Improving Breast Cancer's Patients Response to Medical Treatment

EL PRÓXIMO PASO, CON APOYO HUMANO

Consulta a Wellness Clinical Research

Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026