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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506359
• Other study ID #: 201401019RINC
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: National Taiwan University Hospital
• Contact: Yeur-Hur Lai, Professor
• Phone: 886-2-23123456
• Email: laiyhwk[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Experimental 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

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. — View Citation

Chen ML, Chang HK, Yeh CH. Anxiety and depression in Taiwanese cancer patients with and without pain. J Adv Nurs. 2000 Oct;32(4):944-51. — View Citation

Chie WC, Yang CH, Hsu C, Yang PC. Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. Qual Life Res. 2004 Feb;13(1):257-62. doi: 10.1023/B:QURE.0000015295.74812.06. — View Citation

Espie CA, Brooks DN, Lindsay WR. An evaluation of tailored psychological treatment of insomnia. J Behav Ther Exp Psychiatry. 1989 Jun;20(2):143-53. doi: 10.1016/0005-7916(89)90047-5. — View Citation

Girgis A, Lambert S, Lecathelinais C. The supportive care needs survey for partners and caregivers of cancer survivors: development and psychometric evaluation. Psychooncology. 2011 Apr;20(4):387-93. doi: 10.1002/pon.1740. Epub 2010 Apr 5. — View Citation

Liao YC, Liao WY, Shun SC, Yu CJ, Yang PC, Lai YH. Symptoms, psychological distress, and supportive care needs in lung cancer patients. Support Care Cancer. 2011 Nov;19(11):1743-51. doi: 10.1007/s00520-010-1014-7. Epub 2010 Oct 15. — View Citation

Shun SC, Yeh KH, Liang JT, Huang J, Chen SC, Lin BR, Lee PH, Lai YH. Unmet supportive care needs of patients with colorectal cancer: significant differences by type D personality. Oncol Nurs Forum. 2014 Jan 1;41(1):E3-11. doi: 10.1188/14.ONF.E3-E11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Quality of Life EORTC QLQ C30	Quality of life will be assessed by the EORTC-QLQ. This Instrument is consists of 30 items to measure three subscales, includes 2 items global health status/quality of life, 15 items functional domains and 13 items cancer common related symptoms or problems. Two items in global health status use a 7-point summated scale (1 = poor; 7 = excellent) and other items are rated on 4-point Likert's Scales (1=not at all; 4=very much). The scores will be transformed to a range from 0 to 100. In global health status and functional domains, the higher scores indicate better function. In the symptoms subscale, lower scores indicate less severe symptoms (Aaronson et al., 1993). The Taiwan Chinese version has been demonstrated to be both reliable and valid (Chie et al., 2004).	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.
Primary	Changes in psychological distress	The severity of lung cancer patients' anxiety and depression will be measured by the self-reporting HADS. The 14 items of HADS consists of two subscales, include 7 items anxiety and 7 items depression. The score of all items ranges from 0 (not at all) to 3 (always) and the total score of each subscale are ranged from 0 to 21, a higher score indicates a higher level of anxiety or depression. Satisfactory psychometrics of the HADS has been shown in cancer populations in Taiwan (Chen etal. 1999).	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.
Primary	Changes in Fear of Recurrence	The FoR-C is a Chinese version of the original FoR questionnaire1-3. The FoR questionnaire consists of six statements with a five-point response scale from not at all (1), a little, sometimes (2), a lot , and all the time) and one statement with a response scale from 0 (not at all) to 10 (a great deal). The summary of FoR was range from 6 to 40. Higher score indicates a higher level of fear of recurrence. The significance of the FoR was indicated by patients' responses 'a lot' or 'all the time' for the first six statements and the score of 7-10 for the last item, in which case. Current study will use the same approach to determine the cut-off point of the FoR.	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.
Primary	Changes in Sleep Quality (SDQ)	The quality of lung cancer patients' sleep will be measured by SDQ. The 12 items of SDQ was designed to evaluate patient' insomnia experience. Respondent score use a five-point Likert's scale (1 never true, 5 very often true) to indicate how often certain statements about insomnia. Higher scores reflect more dysfunctional beliefs about the causes and correlates of insomnia (Espie et al, 1989).	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.
Primary	Changes in Brief Supportive Care Needs Survey (SCNS)	The SCNS consists of 5 domains, include psychological, health system and information, daily living, patient care and sexuality domain. Response options "No need, not applicable (1); No need, satisfied (2); Low need (3); Moderate need (4); High need (5). The sum of item scores within each domain will be calculated and the scores will be transformed to a standardized score 0 to 100, higher score indicate moreunmet needs (Girgis et al, 2011). The higher scores representing more unmet needs. The Chinese SCNS34 has acceptable psychometric properties in previous lung cancer studies (Liao et al., 2011; Shun et al., 2014).	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.
Primary	Changes in Muscle Power	Patients' muscle strength (grip strength) of right and left hands will be assessed using Jamar Plus+ Digital Hand Dynamometer. Muscle endurance of right and left upper limbs and hip flexor muscle will be assessed using MicroFET2. Both grip strength meter and microFET 2 provided good reliability and validity for measuring muscle strength in the past studies. This measures has been applied in PI's currently head and neck study and early stage lung cancer follow up study.	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.