Development and Evaluation of a Self-Management Model for Cancer Rehabilitation

A Randomized Controlled Clinical Trial on the Development and Evaluation of a Self-Management Model for Cancer Rehabilitation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer; Rehabilitation; Psychotherapy
• Intervention / Treatment: Other: Self-help rehabilitation model; Other: Conventional rehabilitation model

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-help rehabilitation model	Other: Self-help 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.
Placebo Comparator: Conventional rehabilitation model	Other: Conventional rehabilitation model; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks

Collaborators and Investigators

• Sponsor: Xingchen Peng

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): January 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: November 3, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID 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
• product manufactured in and exported from the U.S.: No