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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• age ≥20 years

• early stage lung cancer

• had tumor excision surgery

• Mandarin / Chinese-reading and speaking

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Yeur-Hur Lai, Professor
laiyhwk@ntu.edu.tw
886-2-23123456
Time Frame
Start Date: 2016-04-22
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 300
Treatments
No_intervention: control group
Control Group: Usual care +case manager care, UC group or Control group
Experimental: experimental group
The experimental 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) - usually patients visited hospital in 2 weeks, 1 month, 2 months, 3 months and 6 months (T2-6) after surgery. Patients will receive (a) nurse-guided touch-screen computer screening (assessment) for their psychological and physical distress and care needs during current week; (b) the screening /assessment results will immediately show as the outcome (we are developing a calculation system to sum those scores).
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov