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

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Xingchen Peng

Status

Enrolling

Conditions

Rehabilitation
Psychotherapy
Head and Neck Cancer

Treatments

Other: Self-help rehabilitation model
Other: Conventional rehabilitation model

Study type

Interventional

Funder types

Other

Identifiers

NCT06674499
2024-1567

Details and patient eligibility

About

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.

Enrollment

144 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

144 participants in 2 patient groups, including a placebo group

Self-help rehabilitation model
Experimental group
Treatment:
Other: Self-help rehabilitation model
Conventional rehabilitation model
Placebo Comparator group
Treatment:
Other: Conventional rehabilitation model

Trial contacts and locations

1

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Central trial contact

Peng

Data sourced from clinicaltrials.gov

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