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

November 4, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • WestChina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Usual care
Other: Usual care

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.
Experimental: PEERS intervention
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Degree of improvement in emotional distress
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Levels of anxiety and depression
Time Frame: 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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Levels in quality of life
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xingchen Peng

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-1567

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings