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

NCT ID: NCT06674499

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Head and Neck Cancer Rehabilitation Psychotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Self-help rehabilitation model

Group Type EXPERIMENTAL

Self-help rehabilitation model

Intervention Type 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.

Conventional rehabilitation model

Group Type PLACEBO_COMPARATOR

Conventional rehabilitation model

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xingchen Peng

OTHER

Sponsor Role lead

Responsible Party

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Xingchen Peng

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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WestChina Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng

Role: CONTACT

86-19382124852

Facility Contacts

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Xingchen Peng, Ph.D

Role: primary

+8619382124852

Other Identifiers

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2024-1567

Identifier Type: -

Identifier Source: org_study_id

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