Actively Recruiting

Phase Not Applicable
All Genders
NCT04506359

Develop and Test the Effects of the 'Computer-Assisted OPD COPSCCP on Early Stage Lung Cancer Patients

Led by National Taiwan University Hospital · Updated on 2024-06-05

300

Participants Needed

1

Research Sites

505 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Although there is a relatively better prognosis, the 5-year survival rate for early stage lung cancer (Stage I, II, IIIA) is still relatively low compared to those other types of cancer. These patients might suffer lots from the uncertainty and substantial disease and treatment related physical changes. The investigator aims to (1) Develop and construct the contents, related patient education materials and computerized systems of the three evidence and service-based lung cancer care programs, including (a) Control as usual care (UC+ case manager care, or Control group), and (b) Computer Assisted OPD Personalized Supportive Care Program (UC+COPSCCP or Ex group); and (2) Compare the effects of Ex and care as usual (receiving usual care and case manager care) on self-report quality of life (QOL), physical symptoms, physical function and fear of cancer recurrence (FCR) in newly diagnosed early-stage lung cancer patients. Eligible patients will be newly diagnosed early stage lung cancer patients (patients in stage I, II, \& IIIA) who have received surgery. A 2-group randomized control trial (RCT) matching with cancer stages will be conducted. For the COPSCCP, patients will be intervened for 6 months from the first time during hospitalization of receiving surgery or before hospital discharge and then OPD intervention. Each patient will be followed 6 time points for 2 years (will be drop and refer to medical oncology while having recurrence, metastasis or death): baseline (pre-discharge from hospital) and 1, 3, 6, 12, and 24 months after discharge from hospital, T1-T6, respectively. The outcomes indicators will include: psychological variables, physical/disease variables, symptoms, lung function, and recurrence rate during 2 years. The estimated subjects would be 150 for each group, totally 300 subjects recruited in the beginning of the study. Results would be analyzed mainly by GEE and survival analysis. IRB approval will be received before the RCT. The investigator expects to develop and test the supportive cancer care interventions and generalize the interventions into the cancer care system after the study if prove good outcomes.

CONDITIONS

Official Title

Develop and Test the Effects of the 'Computer-Assisted OPD COPSCCP on Early Stage Lung Cancer Patients

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 20 years of age or older
  • Diagnosed with early stage lung cancer (stage I, II, or IIIA)
  • Have had tumor excision surgery
  • Able to read and speak Mandarin or Chinese
Not Eligible

You will not qualify if you...

  • Have been diagnosed with double cancer
  • Have cancer recurrence or metastasis
  • Have an unknown primary cancer
  • Have unclear consciousness

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

Y

Yeur-Hur Lai, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Develop and Test the Effects of the 'Computer-Assisted OPD COPSCCP on Early Stage Lung Cancer Patients | DecenTrialz