Distress, Medication Adherence and Care Needs in Patients With CML and GIST Receiving Oral Targeted Therapy

GIST Clinical Trial

Official title:

Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880617
• Other study ID #: 201501004RIND
• Status: Completed
• Start date: March 25, 2015
• Est. completion date: August 7, 2020

Study information

• Verified date: December 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Long-term or life-long oral targeted therapy might also increase patients' distress, influencing patients' cognitive and life activity function, medication adherence and related care needs. However, very limited information has been known about patients' experiences.

Purpose: First, to examine the changes of perceived physical and psychological distress, functional status, medication adherence, and unmet care needs; and second, to identify factors related to the changes of patients' medication adherence and unmet care needs by generalized estimating equation (GEE).

Methods: This is a two-phase study. Phase I is a cross-sectional survey study, and the second phase is a 1-year follow-up prospective longitudinal study. Eligible subjects are CML and GIST patients newly taking oral targeted therapy. Patients will be assessed before taking the first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively). The patients were assessed of their (1) symptom severity, (2) psychological distress, (3) cognitive and life activity function, (4) adherence, (5) social support, (6) unmet care needs, and (7) background and disease-treatment information. Data will be analyzed mainly by GEE to identify the predictors (independent variables) of the changes in medication adherence and unmet care needs overall the 12 months, 6 time points. After the approval of IRB, research assistants in different data collection sites will be trained for maintaining the consistency and quality of data collection.

Expected Outcomes and Future Implications: Although CML and GIST are not the most prevalent cancers in Taiwan, the investigators aim to use both groups of patients groups to examine the current status and changes of distress, adherence and care needs in patients are taking long-term or life-long TKI derived oral targeted therapy. From Phase II study, the changes of newly TKI targeted therapy takers' distress, adherence and care needs would be carefully and in-depth examined. It will provide health care professionals a more comprehensive picture of the changes in patients' distress, adherence, and care needs during taking oral targeted therapy. The results will also provide as a basis and evidence for better development a timing and comprehensive care models to fit and increase patients' life quality during receiving the most advanced targeted therapy.

Description:

Prospective Panel Study, a 12-month follow-up longitudinal study. Eligible subjects are newly diagnosed CML and GIST patients who need to take targeted therapy. Patients would be assessed on the time point of before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively). Before this study conducted, the institutional review board would review the study. The research nurses will approach potential participants after their patients were initial treating oral targeted therapy and invite them to enroll in the study. Potential participants would be informed of the study purposes and interview contents. After written consent is obtained, the interview will be arranged. In order to control the quality of data collection, the investigators will train these research assistants. Research training will include ethical concerns about the collection of research data, methods of approaching eligible subjects, interviewing techniques, and pilot testing of data collection. The training will provide research assistants by the PI and Co-PI of this study. Training for research assistants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: August 7, 2020
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• newly diagnosed CML and GIST patients

• patients need to take targeted therapy

Exclusion Criteria:

• conscious unclear

• recurrence or with bone meta

Related Conditions & MeSH terms

• CML
• GIST

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hosptial	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Symptom Severity Scale (SSS)	The 43-item Symptom Severity Scale (SSS) was modified from the Symptom Distress Scale (SDS) (McCorkle & Young, 1978). The SSS aims to assess the level of symptom severity with Each item scored from 0 to 10 (0 = do not have the problem at all, 10 = the most severity that I have ever experienced). The higher the score indicated the higher the symptom severity. The SSS has been used in the previous study and had good reliability and validity (Chen, Liao, Lin, Chang, & Lai, 2009; Lai et al., 2003; Shun et al., 2008).	Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
Primary	Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale	We will use 14-item HADS to assess patients' anxiety and depression (Zigmond & Snaith, 1983). The HADS has 7 items that measure anxiety and 7 that measure depression. The total score of each subscale is ranged from 0 to 21 with a higher score indicating a higher level of anxiety and depression. The Taiwanese version of HADS has been developed and validated showed promising psychometrics (Chen et al., 2010; Cheng, Hao, Lin, & Yeh, 2000).	Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
Primary	Change in Fear of Cancer Recurrence Index-42 (FCRI-42)	The 42-item FCRI will be used to measure patients' self-reported fear of cancer recurrence (Simard & Savard, 2009) and it currently has been applied to several kinds of cancer populations (Simard & Savard, 2009). FCRI measures seven dimensions of fear of cancer recurrence. It is a five-point Likert's scale (0-4 for each item, scoring from 0 to 168 for total scale) and generally with higher scores indicates higher fear of recurrence. The Chinese version has been translated and validated in PI's on-going early-stage lung cancer study and proved to be psychometrically satisfied.	Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
Primary	Change in WHO Disability Assessment Schedule 2.0 (WHO DAS 2.0) - Cognition and Life Activity Subscales	WHODAS 2.0 has been developed based on the International Classification of Functioning, Disability, and Health (ICF) published by the World Health Organization (WHO) in 2001. In this study, we particularly apply the 6-item cognition subscale which to assess a person's cognition and thinking abilities. In addition, the 8-item life activities subscale will assess changes in life activities after having cancer and taking targeted therapy. Each scale of subscale was standardized from 0 to 100, with a higher score indicating higher limitation in daily life. The Chinese version has been tested of its psychometrics in chronic illness patients and found to be reliable (Chi et al., 2014; Chiu et al., 2014; Yen et al., 2014).	Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
Primary	Change in Medical Outcome Study Social Support Survey (MOS-SSS) - Short form	We will use the MOS-SSS to assess patient perceived social support (Sherbourne & Stewart, 1991). The 20-item MOS-SSS consists of four subscales: emotional/informational support (8 items), tangible support (4 items), affectionate 11 support (3 items), and positive social interaction (3 items), and additional item (I item). The score for each item ranges from 1 (not at all) to 5 (very much). The summed scores of each domain and the global scale are converted into standardized scores ranging from 0 to 100, with higher scores representing more support. Several previous studies have demonstrated satisfactory psychometric characteristics for this scale (Moser, Stuck, Silliman, Ganz, Clough-Gorr, 2012; Yu, Lee, Woo, 2004).	Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
Primary	Change in Supportive Care Needs Survey (SCNS-9)	The brief version of SCNS-ST9 includes 9 items identified from SCNS-34. Each item with the following response options: "No need, not applicable (1)"; "No need, satisfied (2)"; "Low need (3)"; "Moderate need (4)"; "High need (5)". The number of items with moderate/high needs was counted for each domain of the SCNS-9 and the sum of item scores was transformed to a standardized score (0-100) with higher scores indicating more unmet needs. The SCNS-ST9 had good validity and reliability (Boyes, Girgis, & Lecathelinais, 2009; Girgis, Stojanovski, Boyes, King, & Lecathelinais, 2012).	Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
Primary	Change in Background, Disease and Treatment Information Form (BDTIF)	In addition to patients' demographic information (age, gender, education). Disease and treatment-related variables include: (1) types of diagnosis, (2) Performance status (by Karnofsky Performance Index), (3) length of time diagnosis (month), (4) Duration of receiving targeted therapy (months), (5) types of targeted therapy, (6) Dosages of target therapy, (7) Times of medication taking per day, and (8) Time since cancer diagnosis.	Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)

External Links

•   National Cancer Institute (2008). Cancer Stat Facts: Leukemia - Chronic Myeloid Leukemia (CML).