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Development and Evaluation of the Support Intervention for Head and Neck Cancer Patients (Peers)

4. november 2026 opdateret af: Xingchen Peng

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

144

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Sichuan
      • Chengdu, Sichuan, Kina
        • WestChina Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Sædvanlig pleje

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.

Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Degree of improvement in emotional distress
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Levels of anxiety and depression
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Levels in quality of life
Tidsramme: 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
Levels of supportive care needs
Tidsramme: 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
Levels of peripheral stress biomarkers
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2024

Primær færdiggørelse (Faktiske)

31. januar 2026

Studieafslutning (Faktiske)

6. maj 2026

Datoer for studieregistrering

Først indsendt

28. oktober 2024

Først indsendt, der opfyldte QC-kriterier

3. november 2024

Først opslået (Faktiske)

5. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024-1567

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