Study design and participants
A cross-sectional, correlational design was used. Data were collected from questionnaires, scales, and medical records. The study was conducted from December 20, 2017, to August 6, 2018, at a gastroenterology ward of a medical center in Northern Taiwan. A convenience sampling method was used to recruit the study sample. The inclusion criteria were patients who (1) had primary liver cancer, (2) knew about their diagnoses, (3) were only receiving TACE during their admissions, (4) could communicate in Mandarin, and (5) were aged 20 years or older. The exclusion criterion was the occurrence after TACE of severe complications such as bleeding.
The sample size was estimated using G*Power version 3.1 [24]; an effect size of 0.15, (medium effect size) [25], a significance level of 0.05, a power of 0.8, and regression-based statistical analysis were chosen. Ninety-eight participants were required.
Measurements
Demographic and disease-related information
The demographic data included age, sex, education level, marital status, employment, monthly income, and religion. The disease-related characteristics included Barcelona Clinic Liver Cancer (BCLC) stage, first-time TACE treatment, duration of liver cancer diagnosis (months), number of TACE treatments received, and length of hospital stay (days). A questionnaire about basic demographic information and disease-related characteristics was developed by the authors. Five clinical experts (two physicians and three senior clinical nurses) were invited to evaluate its content validity. The content validity index ranged from 0.8 to 1 for single items, and the content validity index was 0.98 for the total questionnaire.
Symptom distress
The Symptom Distress Scale-Chinese Modified Form (SDS-CMF) was used to measure SDs after TACE [26, 27]. Permission to use this scale was obtained. There were 25 symptoms listed that were common in patients with liver cancer who received cancer-related treatment. Each symptom was scored on a Likert scale ranging from 1 (never bothered) to 5 (severely bothered). Possible scores ranged from 25 to 125, with a higher score indicating a higher level of SDs. The internal consistency reliability (Cronbach’s α) of the SDS-CMF in this study was 0.66.
Hope
The Chinese version of the Herth Hope Index (HHI) was used to measure hope [28]. Permission to use this scale was obtained. The HHI has been used worldwide [20] in studies of individuals in both hospital and community settings who experienced varying health conditions. The Chinese version comprises 10 items. Each item was scored on a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Possible scores ranged from 10 to 40, with a higher score indicating a higher level of hope. The internal consistency reliability (Cronbach’s α) of the HHI in this study was 0.89. We used exploratory factor analysis, principal component followed by varimax rotation to examine the validity of this scale in this study [29]. A two-factor structure for the 10-item HHI scale was identified. The percentage of variance explained was 63.75%, which indicated an acceptable validity.
QOL
The Chinese version of the Functional Assessment of Cancer Therapy–General (FACT-G) was used to measure the QOL of patients with liver cancer after TACE; it was developed from the Functional Assessment of Chronic Illness Therapy [17, 30]. Permission to use this scale was obtained. The scale contains 27 items and measures physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). The possible FACT-G scores ranged from 0 to 108, with a higher score indicating a higher QOL. The Cronbach’s α of the FACT-G total scale and the physical, social/family, emotional, and functional subscales in this study were 0.95, 0.89, 0.84, 0.95, and 0.93, respectively.
Data collection
After the study hospital’s institutional review board approved the study, the purpose and procedures were explained thoroughly to the participants and written consent was obtained from them. A set of questionnaires was used to collect the data. Basic demographic and disease-related data were collected upon admission. Questionnaires about SDs, hope, and QOL were collected on the discharge day.
Data analysis
Data were analyzed using SPSS version 22.0 (IBM Corporation, Armonk, NY, USA). Mean, standard deviation (SD), count, and percentage were used to describe the distribution of the study variables. Pearson’s correlations, independent t-tests, and a one-way analysis of variance (ANOVA) were used to analyze the relationships among basic demographic variables, disease-related variables, and QOL. Significant demographic and disease-related variables were controlled for in the mediation model, which was analyzed using the mediation package PROCESS (version 3.5 by Professor Andrew F. Hayes for SPSS [31]). Statistical significance was set at p < .05. The mediating effect (indirect effect) was tested with bias-corrected bootstrapping (N = 5,000) and 95% confidence intervals (CIs) for the indices. When a 95% bootstrapped CI did not include zero, the indirect effect was statistically significant [31].