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

NCT03880617 | Completed

• 1 other identifier: 201501004RIND
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CML; GIST

Keywords

Chronic myeloid leukemia; Gastrointestinal stromal tumor; Targeted therapy; Care needs; Medication adherence

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Chronic Myeloid Leukemia (CML)

For CML, the first-line targeted drug is imatinib, and then second line as nilotinib and dasatinib. In the past, the median survival of CML is around 4 to 6 years (NCI, 2008). Fortunately, the launch of the targeted therapy, the median survival is expected to approach normal life expectancy for most patients. However, limited to the less than 20 years of advent of TKI, the exact effects on survival time is not yet determined.

Gastrointestinal Stromal Tumor (GIST)

For patients with GIST, the imatinib mesylate (Glivec, Novartis Pharma, Basel, Switzerland) (Heinrich et al, 2003) is the first line drug and sunitinib as the second line drug. Sunitinib is an anti-angiogenesis agent by virtue of targeting multiple tyrosine kinases, including the vascular endothelial growth factor receptors (VEGFR). With these target drugs, the survival of advanced GIST patients is prominently prolonged (Lamba, Ambrale, Lee, Gupta, Rafiyath, \& Liu D, 2012). The median overall survival (OS) of advanced GIST patients increased from 18 to 57 months with imatinib therapy (Blanke et al, 2008).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion criteria was (1) adults diagnosed with CML or GIST; (2) awareness of their diagnosis; (3) who are new user of targeted therapy and before their first dosage; and (4) agree to participate in the study after its purposes and procedures have been explained. Exclusion criteria was: (1) Patients with CML did not have targeted therapy currently or who are receiving chemotherapy; and (2) GIST patients who only received surgery; or who did not receive targeted therapy currently. Consecutive patients will be approached and recruited from both hematological and gastroenterological OPD at a medical center in northern Taiwan.

You may qualify if:

• newly diagnosed CML and GIST patients
• patients need to take targeted therapy

You may not qualify if:

• conscious unclear
• recurrence or with bone meta

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hosptial

Taipei, Taiwan

Location

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Related Links

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

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors; Medication Adherence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Yeur-Hur Lai, Professor

  School of Nursing, College of Medicine, National Taiwan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: March 19, 2019
• Study Start: March 25, 2015
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2020
• Last Updated: August 10, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)