Development and Evaluation of a Self-Management Model for Cancer Rehabilitation
NCT06674499 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2026-03-06
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
- 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.
Sponsors & Collaborators
-
Xingchen Peng
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-01
- Primary Completion
- 2026-01-31
- Completion
- 2026-03-31
Countries
- China
Study Locations
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