Clinical trial NCT04506359: Develop and Test the Effects of the 'Computer-Assisted OPD COPSCCP on Early Stage Lung Cancer Patients
Official title: Develop and Test the Effects of the 'Computer-Assisted OPD Personalized Supportive Cancer Care Program (COPSCCP)' on Early Stage Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Personalized Supportive Cancer Care Program
Physical symptom
Fear of cancer recurrence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled clinical trial which to compare the short term and long-term effects of the COPSCCP vs. the control group as usual group on early stage lung cancer patients.

For both groups, we assessed patients' outcomes (including baseline data) for 6 times (T1=baseline/during hospitalization of receiving surgery \& before their hospital; T2 to T6 = 1, 3, 6, 12, 24 months after discharge from hospital).
Primary purpose: OTHER

Brief 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.

Detailed description: Background: 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. How to provide a feasible OPD personalized supportive care program is important.

Purpose: Main purpose of the study: (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), and (b) Computer Assisted OPD Personalized Supportive Care Program (COPSCCP) (will be developed and structured the contents and computer system in the first 4 months of this research project); and (2) Compare the effects of COPSCCP and care as usual on self-report quality of life (QOL), physical symptoms, lung function, Depression, Anxiety, fear of recurrence, Unmet Cancer Needs, recurrence rate. Each patient will be follow for 2 years. Patients with recurrence, metastasis will be dropped out from the study (and refer to medical oncology).

Method: 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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in Quality of Life EORTC QLQ C30
timeFrame: Outcome Assessments will be conducted for 6 times, the first time is at one day after tumor excision surgery (T1) and 2 weeks, 1 month, 2 months, 3 months and 6 months (T2-6) after surgery.
measure: Changes in psychological distress
timeFrame: Outcome Assessments will be conducted for 6 times, the first time is at one day after tumor excision surgery (T1) and 2 weeks, 1 month, 2 months, 3 months and 6 months (T2-6) after surgery.
measure: Changes in Fear of Recurrence
timeFrame: Outcome Assessments will be conducted for 6 times, the first time is at one day after tumor excision surgery (T1) and 2 weeks, 1 month, 2 months, 3 months and 6 months (T2-6) after surgery.
measure: Changes in Sleep Quality (SDQ)
timeFrame: Outcome Assessments will be conducted for 6 times, the first time is at one day after tumor excision surgery (T1) and 2 weeks, 1 month, 2 months, 3 months and 6 months (T2-6) after surgery.
measure: Changes in Brief Supportive Care Needs Survey (SCNS)
timeFrame: Outcome Assessments will be conducted for 6 times, the first time is at one day after tumor excision surgery (T1) and 2 weeks, 1 month, 2 months, 3 months and 6 months (T2-6) after surgery.
measure: Changes in Muscle Power
timeFrame: Outcome Assessments will be conducted for 6 times, the first time is at one day after tumor excision surgery (T1) and 2 weeks, 1 month, 2 months, 3 months and 6 months (T2-6) after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Yeur-Hur Lai, Professor
role: STUDY_CHAIR
References:
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