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

NCT06674499 | Active Not Recruiting DMC

• 1 other identifier: 2024-1567
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Rehabilitation; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Levels of improvement in quality of life

  16 weeks

• Levels of anxiety and depression

  16 weeks

• Levels of Supportive care needs

  16 weeks

Other Outcomes (1)

• Levels of Peripheral stress biomarkers

  16 weeks

Study Arms (2)

Self-help rehabilitation model

EXPERIMENTAL

Other: Self-help rehabilitation model

Conventional rehabilitation model

PLACEBO COMPARATOR

Other: Conventional rehabilitation model

Interventions

Self-help rehabilitation model OTHER

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.

Self-help rehabilitation model

Conventional rehabilitation model OTHER

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.

Conventional rehabilitation model

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xingchen Peng: lead

Study Sites (1)

WestChina Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 5, 2024
• Study Start: December 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)