Design
A prospective cross-sectional survey design was used. This study was part of an international multicenter study in which Jordan was among 11 countries [9].
Sample
The sample comprised patients with advanced cancer who were referred to the palliative care clinic at a tertiary cancer center. We included patients who were 18 years or older, diagnosed with advanced cancer (metastatic, locally advanced, or recurrent cancers), had at least one consultation encounter with the palliative care team and had no cognitive impairment as assessed by the clinicians using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV), were able to understand and speak Arabic or English, and were willing to participate in the study.
Settings
The study was conducted at a tertiary cancer center in Amman, Jordan. The center provides cancer care to Jordanians and non-Jordanians from neighboring countries like Syria, Iraq, Palestine, Yemen, Libya, Sudan, and others [15]. The center treats more than 60% of cancer cases in Jordan, and provides all cancer care modalities including surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, in addition to bone marrow transplantation for adults and pediatrics.
The center contains the region's largest oncology palliative care program, offering all models of care, including an acute palliative care unit, ambulatory palliative care clinics, in-patient palliative care consultation service, hospice, and palliative home care services. The care is delivered through an interdisciplinary team and follows international standards and guidelines adapted to patient needs [16].
Questionnaires
Four questionnaires were used to collect data in this study:
- A demographic data sheet that was designed to collect patients’ demographical characteristics, including age; gender; level of education; employment; religion, and marital status, and patients ‘clinical data regarding cancer diagnosis and the received treatment modality (radiation, chemotherapy, immunotherapy, surgery and targeted treatment).
- Control Preferences Scale (CPS)
Participation preferences were measured by the CPS, developed and validated by Denger and colleagues [17, 18]. The tool was used in many studies to assess decisional control preferences of patients with cancer; it is composed of four questions. The first question is about the preferred decisional control for patient care by asking patients how the decisions regarding their care should be made. Patients were asked to choose only one option from the 15 given answers that were listed below the question. Based on the answers, the patients had passive, active, or shared decisional control. Patients who selected any options from 1 to 4 opted for an active role, 5-12 opted for passive, and 13-15 opted for shared decisional control (appendix 1) [9, 17, 18].
The second question assesses the actual decisional control by asking patients how the decisions about their care were taken. Patients were allowed to choose only one answer from the 15 options listed. Based on patients’ answers, the actual decision-making process was later described as shared, passive, or active decisional control. Patients who answered 1-4 were active, answers from 5-12 were passive (from 5-8 family took the decision and from 9-12 it was taken by the doctor), while answers from 13-15 indicated shared decisional control; if patients chose number 13, the decision was shared between doctor and patient, for answer 14, the decisional control was shared between patient and family, and for answer 15 the decisional control was shared between the family, patient, and doctor. Appendix 2.
The third and fourth questions were used to examine patients’ preferences regarding the physician’s or family’s involvement in their decision-making process. Each question has 5 options from 1-5. The patients were asked to choose one option only. Accordingly, the patients who chose option 1 or 2 were categorized as active, option 3 for shared, and option 4 or 5 for passive decisional control preferences (Appendix 3 and 4) [9, 17, 18].
- Satisfaction with Decision Scale (SWDS)
The SWDS was usedto assess the degree of patients’ satisfaction with the information they received about their care, how decisions about their care were made, and with the decisions themselves. It was originally developed by Holmes-Rovner, Margaret, et al., 1996. It contains six Likert-type scale items. It is a reliable (Cronbach's alpha = 0.86) and valid scale. Its content, criterion, and discriminative validity was established [19]. Patients were asked to rate their response from 0; strongly disagree, to 4; strongly agree. Patients were unsatisfied if they chose options 0 or 1, satisfied if they chose 3 or 4, and undecided if they chose 2 (Appendix 5).
- Karnofsky Performance Scale (KPS)
KPS is a valid and reliable tool developed in 1949 by Dr. Bruchenal and Dr. Karnofsky. It was used broadly by healthcare providers and in many studies to assess cancer patients’ performance status by covering 11 stages from 100% (normal health) to 0% (death), decreasing 10 points at each stage. Patients with 80%-100% performance meant that they had normal performance; they could do their daily activity with no need for help from others, 50%-70% meant that they needed help in daily activity, while ≤40% meant that they needed continuous assistance and might deteriorate to reach death more rapidly (Appendix 6) [20].
Instruments translation
The CPS and SWDS were translated to Arabic by two bilingual research team members. Then they were back-translated to English by another two independent local translators to determine the linguistic and semantic equivalence by comparing the Arabic and the English versions. Furthermore, the approved Arabic version was subjected to an expert panel for final approval. Finally, the agreed-on version was used in this study.
Data Collection Procedure
The research team screened patients visiting palliative outpatient clinics for eligibility criteria. All eligible participants were approached in person to explain the study's purpose and requirements. Then if they agreed to participate in the study, they were asked to sign the consent form and fill the required questionnaires with the help of the research team in a designated clinic room to ensure patient comfort and privacy.
Ethical Considerations
Before embarking on the study, it was approved by the KHCC institutional review board (proposal No. 13 KHCC 62).
Data Analysis
Data was entered and analyzed using Statistical Analysis Software (SAS 9.3) and R-3.1.1. Descriptive statistics such as mean, standard deviation, median, frequencies, percentages, and interquartile ranges (IQR) were used. Cohen’s kappa statistic was used to assess the agreement between decision-control preferences and actual decision-making. Finally, Bivariate analysis was used to examine the association between demographical and clinical characteristics of the participants (i.e., age, gender, employment, level of education, treatment modality, and KPS) and the participants’ decision-control preferences among Jordanian patients with advanced cancer.
For the primary objective of the original international muti-center study, the MD Anderson research team estimated the proportion of passive decisional control preference and the 95% CI for each country. Each country should have a minimum of 100 patients allowing a 95% CI +- 9%. For example, a country for which they calculated a proportion of 30% passive decision would have a 95% CI of (21%, 39%). A total of 1490 patients were enrolled from all sites. In KHCC, the Jordan site, we planned to enroll ≥ 200 participants to allow site-specific analysis.