Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880617
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date December 3, 2018
First Posted Date March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date March 25, 2015
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2019)
  • Change in Symptom Severity Scale (SSS) [ Time Frame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively) ]
    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).
  • Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale [ Time Frame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively) ]
    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).
  • Change in Fear of Cancer Recurrence Index-42 (FCRI-42) [ Time Frame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively) ]
    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.
  • Change in WHO Disability Assessment Schedule 2.0 (WHO DAS 2.0) - Cognition and Life Activity Subscales [ Time Frame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively) ]
    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).
  • Change in Medical Outcome Study Social Support Survey (MOS-SSS) - Short form [ Time Frame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively) ]
    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).
  • Change in Morisky 8-Item Medication Adherence Scale (MMAS-8) [ Time Frame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively) ]
    The medication adherence scale aims to address patients' barriers to medication taking. It contains eight items. Each item was scored by "Yes (0)" or "No (1)". The total score was ranged from 0 to 8 with 0 indicating "high adherence", 1 or 2 indicating "medium adherence", and higher than 2 indicating "low adherence" (Morisky, Green, & Levine, 1986). The MMAS-8 was widely used to assess medication adherence in clinical setting and research (Kekale, Talvensaari, Koskenvesa, Porkka, & Airaksinen, 2014).
  • Change in Supportive Care Needs Survey (SCNS-9) [ Time Frame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively) ]
    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).
  • Change in Background, Disease and Treatment Information Form (BDTIF) [ Time Frame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively) ]
    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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Distress, Medication Adherence and Care Needs in Patients With CML and GIST Receiving Oral Targeted Therapy
Official Title Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
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.

Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • CML
  • GIST
Intervention Not Provided
Study Groups/Cohorts
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 17, 2019)
330
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • conscious unclear
  • recurrence or with bone meta
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Yeur-Hur Lai, Professor 886-2-23123456 ext 88429 laiyhwk@ntu.edu.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03880617
Other Study ID Numbers 201501004RIND
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Study Chair: Yeur-Hur Lai, Professor School of Nursing, College of Medicine, National Taiwan University
PRS Account National Taiwan University Hospital
Verification Date November 2018