Head and Neck CancerPeersNCT06674499
Development and Evaluation of the Support Intervention for Head and Neck Cancer Patients
A study testing PEERS intervention in people with Head and Neck Cancer and Psychotherapy, run by Xingchen Peng at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer, Psychotherapy, Survivor
- What is being tested?
- PEERS intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer, Psychotherapy, Survivor
- Being tested
- PEERS intervention, Usual care
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEERS interventionOther
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PEERS intervention | Experimental | Not described Receives: Other: PEERS intervention |
| Usual care | Other | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of improvement in emotional distress
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.
Measured: From baseline to 1 month after radiotherapy completion, approximately 10.5 weeks
Secondary outcomes (1)
Levels of anxiety and depression
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；
Measured: From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Dec 2024
- Primary completion31 Jan 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xingchen Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674499
- Sponsor's protocol ID
- 2024-1567
- Acronym
- Peers
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06674499
- Acronym / sponsor ID
- Peers / 2024-1567
- Conditions
- Head and Neck Cancer, Psychotherapy, Survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Xingchen PengUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEERS intervention | Experimental | Other: PEERS intervention |
| Usual care | Other | Other: Usual care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEERS interventionThe 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. | Other | PEERS intervention |
| Usual careThe 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. | Other | Usual care |
Primary outcome
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.
1 secondary outcome
Levels of anxiety and depression
Time frame: From baseline to 3 months after radiotherapy completion, approximately 18.5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEERS intervention in people with Head and Neck Cancer and Psychotherapy, run by Xingchen Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of improvement in emotional distress (time frame: From baseline to 1 month after radiotherapy completion, approximately 10.5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.