An interventional study of Self-help rehabilitation model and Conventional rehabilitation model in Head and Neck Cancer, Rehabilitation and Psychotherapy, sponsored by Xingchen Peng. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Xingchen Peng · Not applicable, Interventional, and Supportive care
Participants were primarily recruited from medical institutions, specifically targeting newly diagnosed patients with malignant tumors. They were randomly assigned to two different rehabilitation models using block randomization: the cancer self-help rehabilitation model or the conventional rehabilitation model.
During the intervention period, trained oncology advanced practice nurses conducted weekly 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 at weeks 0, 4, 8, and 12 after the intervention began to test for biomarkers related to emotional distress.
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Exclusion Criteria:
Other: Self-help rehabilitation model
Other: Conventional rehabilitation model
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 therapist.
The control group, which follows the conventional rehabilitation model, 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. However, the choice of the rehabilitation model is primarily decided by the patients themselves, aligning with current clinical practice.
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.
Time frame: 16 weeks
Levels of improvement in quality of life
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. Evaluating Treatment Effects: Comparing scores before and after treatment to assess the impact on quality of life. Clinical Research: As a standard tool for assessing quality of life in cancer studies. Patient Management: Helping healthcare providers identify specific patient needs to optimize treatment plans.
Time frame: 16 weeks
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 Maximum Score: Each subscale has a maximum score of 21 (7 items × 3 points each). Minimum Score: Each subscale has a minimum score of 0 (indicating no symptoms).
Time frame: 16 weeks
Levels of Supportive care needs
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.
Time frame: 16 weeks
Levels of Peripheral stress biomarkers
Peripheral venous blood samples were collected from enrolled patients at baseline and at weeks 0, 4, 8, and 12 after intervention. The stress biomarkers tested include the concentrations of adrenaline, norepinephrine, cortisol, and adrenocorticotropic hormone. The patient needs to lie on their back for 15 minutes before blood collection, and must avoid drinking alcohol, coffee, and smoking for 12 hours before blood collection. After collection, the blood sample should be immediately sent to the laboratory for analysis.
Time frame: 16 weeks
Plan to share: No
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