Neoplasms

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Quality of Life

Soft Tissue Sarcoma

Vicky Soomers, MSc, MD

Vicky Soomers

Winette van der Graaf, Prof, MD

Background:

The prognosis of patients with rare cancers in general and sarcomas in particular suffers from delay in diagnosis. Routes to diagnosis for sarcoma need to be quicker and more streamlined, but have neither been studied in detail in larger numbers before, nor in a direct comparison between two countries with different health systems. Comprehensive assessment of diagnostic delays and its determinants, including demographic, clinical, psychosocial and health care system factors, is necessary to improve referral pathways and come to best practice and patient reported outcomes for sarcoma patients.

Research questions to be answered:

This study aims to quantify diagnostic delay (including patient, general practitioner and system delay) and evaluates routes to diagnosis and referral to sarcoma expert centres in the Netherlands and England; to comprehensively evaluate risk factors of diagnostic delay; determine the association between diagnostic delay and outcomes (health-related quality of life, quality-adjusted life years, patient satisfaction, TNM classification, time to local/distant relapse and overall survival); and to assess differences between both countries. This should lead to advices about faster referral where possible.

The researchers will conduct a longitudinal cohort study among all sarcoma patients (≥18 years of age) that will be newly diagnosed in 1.5 years period from October 1st 2017 to March 30st 2019 in one of the participating study centers (5 centers in The Netherlands, 3 centers in England).

Patients will be invited before the start of treatment (with a two months eligibility window) and receive a questionnaire on diagnostic delay, risk factors and patient-reported outcomes. The questionnaire on patient-reported outcomes will be completed again 3 months, 6 months, 1-year and 2 years later.

Data collection will be done within PROFILES, an international registry for cancer patient reported outcomes (www.profilesregistry.nl). Clinical data will be collected through cancer registries and the junior investigator will collect extra data from patients' records.

QUEST: QUality of Life and Experiences of Sarcoma Trajectories

Risk factors to experience a long diagnostic interval

several measures will be taken into account, such as HADS etc

Radboud University Medical Center

Blood and Lymph Conditions

Digestive System Diseases

Symptoms and General Pathology

Leukemia

Gastrointestinal Stromal Tumors

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Amino Acids

Angiogenesis Inhibitors

Nilotinib

Endothelial Growth Factors

Mitogens

Sunitinib

Dasatinib

Imatinib Mesylate

Lactitol

Tyrosine

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.

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).

Yeur-Hur Lai, Professor

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.

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.

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

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

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).

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).

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.

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).

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).

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).

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.

Study title	NCT ID	Conditions	Eligibility	Organization
QUEST: QUality of Life and Experiences of Sarcoma Trajectories	NCT03441906	Quality of Life Sarcoma Diagnostic Inte... Diagnostic Path... Care Needs	18 Years -	Radboud University Medical Center
Distress, Medication Adherence and Care Needs in Patients With CML and GIST Receiving Oral Targeted Therapy	NCT03880617	CML GIST	-	National Taiwan University Hospital
Distress, Medication Adherence and Care Needs in Patients With CML and GIST Receiving Oral Targeted Therapy	NCT03880617	CML GIST	-	National Taiwan University Hospital
QUEST: QUality of Life and Experiences of Sarcoma Trajectories	NCT03441906	Quality of Life Sarcoma Diagnostic Inte... Diagnostic Path... Care Needs	18 Years -	Radboud University Medical Center

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Spots Global Cancer Trial Database for care needs

Every month we try and update this database with for care needs cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for care needs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.