- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Sichuan
-
Chengdu, Sichuan, Čína
- WestChina Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: Obvyklá péče
|
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. |
|
Experimentální: PEERS intervention
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Degree of improvement in emotional distress
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Levels of anxiety and depression
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Levels in quality of life
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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