- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06674499
Development and Evaluation of the Support Intervention for Head and Neck Cancer Patients (Peers)
A Randomized Controlled Clinical Trial on the Development and Evaluation of a Structured, Survivor-delivered Peer-support Intervention, Peer-led Experiential and Emotional Relief and Support (PEERS)
This randomized clinical trial evaluated the effectiveness of a structured, survivor-delivered peer-support intervention, peer-led experiential and emotional relief and support, in reducing psychological distress among patients with head and neck cancer undergoing radiotherapy.
Participants were primarily recruited from medical institutions, specifically targeting newly diagnosed patients with malignant tumors. They were randomly assigned to two different models using block randomization.
During the intervention period, trained oncology advanced practice nurses conducted questionnaire surveys for enrolled patients. During the follow-up period, these surveys were conducted every four weeks. Peripheral venous blood samples were collected at baseline and radiotherapy completion to test for biomarkers related to emotional distress.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The PEERS intervention consisted of three structured, individual, face-to-face sessions delivered by trained cancer survivor volunteers over an 8-week period. The first session, lasting 90 minutes, was conducted at radiotherapy initiation, followed by two 45-minute sessions at weeks 4 and 8. The sessions focused on preparation for radiotherapy, treatment-related emotional and practical challenges, and posttreatment adjustment. Volunteers provided emotional support and shared relevant personal experiences within predefined role boundaries.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana
- WestChina Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Pathologically diagnosed with head and neck malignancy.
- Experiencing psychological distress.
- Aged between 18 and 70 years.
- Patients scheduled to receive antitumor treatment in a day hospital or outpatient setting.
- ECOG performance status score of 0-2.
- Patients voluntarily participate, fully understand, and are able to independently complete the questionnaires.
Exclusion Criteria:
- A history of other malignancies within the past 5 years.
- A history of any mental illness, including but not limited to: generalized anxiety disorder, depressive disorder, panic disorder, schizophrenia, or bipolar disorder.
- Patients currently receiving other psychological treatments or taking psychiatric medications.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Cuidado usual
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The control group, which follows the usual care, operates under the current standard of cancer treatment and follow-up. In this model, oncology healthcare professionals provide recommendations based on the specific circumstances of the patients. |
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Experimental: PEERS intervention
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The intervention measures followed the principles and processes of cognitive-behavioral therapy. Three intervention sessions were conducted over a period of eight weeks. The first session lasted 90 minutes, while the subsequent sessions (in weeks 4 and 8) lasted 45 minutes each and were conducted face-to-face by the survivor volunteers. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Degree of improvement in emotional distress
Periodo de tiempo: From baseline to 1 month after radiotherapy completion, approximately 10.5 weeks
|
After the intervention period for the patients, the change in the HADS (Hospital Anxiety and Depression Scale) total score was assessed based on the scoring criteria, comparing the scores to the baseline. The HADS scoring ranges are as follows: Total Score Range: 0 to 42; Anxiety Subscale (HADS-A): 0 to 21; Depression Subscale (HADS-D): 0 to 21; Score Interpretation: 0-7: Normal range, typically indicating no significant anxiety or depression symptoms.; 8-10: Mild anxiety or depression, may warrant monitoring; 11-14: Moderate anxiety or depression, further assessment or intervention is advisable; 15 and above: Severe anxiety or depression, usually requiring professional mental health intervention; In summary, higher scores on the HADS indicate more severe symptoms of anxiety or depression. |
From baseline to 1 month after radiotherapy completion, approximately 10.5 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Levels of anxiety and depression
Periodo de tiempo: From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
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Anxiety and Depression: Assessed at baseline (before intervention), every two weeks during the intervention period, and every four weeks during the follow-up period, according to the scoring criteria of the HADS. Score Range Total Score Range: 0 to 42; Anxiety Subscale (HADS-A): 0 to 21; Depression Subscale (HADS-D): 0 to 21; |
From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Levels in quality of life
Periodo de tiempo: From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
|
The QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) is a tool designed to assess the quality of life in cancer patients. It consists of 30 items covering various dimensions of quality of life, including functional status, symptoms, and overall health status. Score range: Functional status: Maximum score: 100 Minimum score: 0. Symptoms: Maximum score: 100 (note: higher scores indicate worse symptoms) Minimum score: 0. Overall health status: Maximum score: 100 Minimum score: 0. |
From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
|
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Levels of supportive care needs
Periodo de tiempo: From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
|
Supportive Care Needs Level: Evaluated at baseline (before intervention), every two weeks during the intervention period, and every four weeks during the follow-up period, using the scoring criteria of the Supportive Care Needs Survey (SCNS-SF34). Scoring method: Each item is typically rated on a 4-point Likert scale (1 = no need, 2 = low need, 3 = moderate need, 4 = high need). Total score range:Minimum score: 34 (if every item is scored as 1);Maximum score: 136 (if every item is scored as 4)。 Score significance 34-68: Low need; Indicates that the patient has minimal supportive care needs. 69-102: Moderate need; Suggests that the patient has some areas where additional support or resources may be beneficial. 103-136: High need; Reflects significant supportive care needs across multiple domains, indicating that the patient may require urgent intervention and comprehensive support. |
From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
|
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Levels of peripheral stress biomarkers
Periodo de tiempo: From baseline to radiotherapy completion, approximately 6.5 weeks
|
Peripheral venous blood samples were collected from enrolled patients at baseline and radiotherapy completion. The stress biomarkers tested include the concentrations of cortisol and adrenocorticotropic hormone. The patient needs to lie on their back for 15 minutes before blood collection, and must avoid drinking alcohol and coffee for 12 hours before blood collection. After collection, the blood sample should be immediately sent to the laboratory for analysis. |
From baseline to radiotherapy completion, approximately 6.5 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-1567
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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