Clinical trial NCT03880617: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CML
GIST
Keywords: Chronic myeloid leukemia
Gastrointestinal stromal tumor
Targeted therapy
Care needs
Medication adherence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 297
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Symptom Severity Scale (SSS)
timeFrame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
measure: Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale
timeFrame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
measure: Change in Fear of Cancer Recurrence Index-42 (FCRI-42)
timeFrame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
measure: Change in WHO Disability Assessment Schedule 2.0 (WHO DAS 2.0) - Cognition and Life Activity Subscales
timeFrame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
measure: Change in Medical Outcome Study Social Support Survey (MOS-SSS) - Short form
timeFrame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
measure: Change in Supportive Care Needs Survey (SCNS-9)
timeFrame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
measure: Change in Background, Disease and Treatment Information Form (BDTIF)
timeFrame: Patients will be assessed before taking first targeted therapy and 1st, 2nd, 3rd, 6th, 12th month (T1-T6, respectively)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hosptial
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Yeur-Hur Lai, Professor
role: STUDY_CHAIR
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