Development and Evaluation of a Self-Management Model for Cancer Rehabilitation
- Conditions
- Head and Neck CancerRehabilitationPsychotherapy
- Registration Number
- NCT06674499
- Lead Sponsor
- Xingchen Peng
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Degree of improvement in emotional distress 16 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.
- Secondary Outcome Measures
Name Time Method Levels of improvement in quality of life 16 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.
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.Levels of anxiety and depression 16 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 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).Levels of Supportive care needs 16 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.
Trial Locations
- Locations (1)
WestChina Hospital
🇨🇳Chengdu, Sichuan, China