- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Sichuan
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Chengdu, Sichuan, China
- WestChina Hospital
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Cuidados usuais
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Degree of improvement in emotional distress
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Levels of anxiety and depression
Prazo: From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
|
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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Levels in quality of life
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2024-1567
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