RecruitingNot ApplicableNCT04506359

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

Develop and Test the Effects of the 'Computer-Assisted OPD Personalized Supportive Cancer Care Program (COPSCCP)' on Early Stage Lung Cancer Patients


Sponsor

National Taiwan University Hospital

Enrollment

300 participants

Start Date

Apr 22, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria4

  • age ≥20 years
  • early stage lung cancer
  • had tumor excision surgery
  • Mandarin / Chinese-reading and speaking

Exclusion Criteria4

  • had double cancer
  • had cancer recurrence or metastasis
  • primary cancer unknown
  • conscious unclear

Interventions

OTHERExperimental Group

The Ex group is COPSCCP+ UC+ case manager care. In this group, a 6-month intervention providing for each time while subject visit their chest surgeon(s) in the OPD (from the first time before hospital discharge/T1).


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT04506359


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