NCT06674499

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Xingchen Peng · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-01-31
• Completion: 2026-03-31
• First posted: 2024-11-05
• Last updated: 2026-03-06

Locations

1 site across 1 country: China