Development and Evaluation of a Self-Management Model for Cancer Rehabilitation (NCT06674499) | Clinical Trial Compass
CompletedNot Applicable
Development and Evaluation of a Self-Management Model for Cancer Rehabilitation
China144 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.