Patients in phase 1 cancer trials: psychological distress and understanding of trial information

Figures & data

Figure 1. Flow diagram of the inclusion of patients in the present study. Among referred patients, 83% were eligible; a total of 75% filled in the questionnaire at referral. Note: Other reasons for exclusion were referral for genomic profiling for causes other than possible enrollment in a phase 1 cancer trial.

Table 1. Patient characteristics based on self-reported information and patient chart reviews for referred patients (N = 229).

Characteristics	N (%)
Number of patients	229 (100)
Gender
Female	115 (50)
Male	114 (50)
Age (median [IQR])	63 [54, 71]
Cohabitation
Living with partner	174 (76)
Living without partner	54 (24)
Cohabitation missing	1 (0)
Children
No children living at home	182 (79)
Children living at home	47 (21)
Education
Short education	50 (22)
Medium education	29 (13)
Long education	148 (65)
Education level missing	2 (1)
Work
Within workforce	138 (60)
Outside workforce	89 (39)
Work status missing	2 (1)
Cancer disease
Head and neck	11 (5)
Gastrointestinal including digestive organs	83 (36)
Lung and thymus	34 (15)
Bones, connective tissue and melanoma	12 (5)
Breast	20 (9)
Female genital	37 (16)
Male genital	15 (7)
Urinary tract	7 (3)
Glands, lymphatic and ill-defined cancers	10 (4)
Number of previous treatments
0–1 previous treatments	30 (13)
2–4 previous treatments	160 (70)
≥5 previous treatments	33 (14)
Prior treatments missing	6 (3)
Comorbidity
Charlson Comorbidity Index 0	186 (81)
Charlson Comorbidity Index 1	35 (15)
Charlson Comorbidity Index ≥2	7 (3)
Status of comorbidity missing	1 (0)

IQR: interquartile range.

Table 2. Distribution of the severity of stress, anxiety, and depression among patients at first visit (N = 229).

	N (%)
Number of patients	229 (100)
Mean stress (PSS) score [SD]	12.7 [6.0]
Anxiety (GAD-7)
Median score [IQR]	3 [1, 6]
Mean score [SD]	4.0 [3.8]
Score 0–4	144 (63)
Score 5–9	59 (26)
Score ≥10	20 (9)
Score missing	6 (3)
Depression (PHQ-9)
Median score [IQR]	4 [2, 7]
Mean score [SD]	5.0 [4.0]
Score 0–4	125 (55)
Score 5–9	68 (30)
Score ≥10	26 (11)
Score missing	10 (4)

Scores 0–4 indicate minimal symptoms; scores 5–9 mild symptoms; scores ≥10 moderate to severe.

PSS: Perceived Stress Scale; IQR: interquartile range; GAD-7: Generalized Anxiety Disorder Assessment; PHQ-9: Patient Health Questionnaire.

Figure 2. Mean scores of objective understanding of trial information measured with the Quality of Informed Consent Questionnaire, presented for each domain, among enrolled patients (N = 46).

Figure 3. Proportion of patients (N = 46) responding correctly to each statement in the Quality of Informed Consent Questionnaire. Best: Q1. When I signed the consent form for my current cancer therapy, I knew that I was agreeing to participate in a clinical trial (correct answer: agree). Q12. By participating in this clinical trial, I am helping the researchers learn information that may benefit future cancer patients (correct answer: agree). Q16. If I had not wanted to participate in this clinical trial, I could have declined to sign the consent form (correct answer: agree). Q15. The consent form I signed lists the name of the person (or persons) whom I should contact if I have any questions or concerns about the clinical trial (correct answer: agree). Q5. In my clinical trial, one of the researchers’ major purposes is to test the safety of a new drug or treatment (correct answer: agree). Worse: Q4. All the treatments and procedures in my clinical trial are standard for people with my type of cancer (correct answer: disagree). Q7. The treatment being researched in my clinical trial has been proven to be the best treatment for my type of cancer (correct answer: disagree). Q8. In my clinical trial, each group of patients receives a higher dose of the treatment than the group before, until some patients have serious side effects (correct answer: agree). Q10. Compared with standard treatments for my type of cancer, my clinical trial does not carry any additional risks or discomforts (correct answer: disagree). Q14. My doctors did not offer me any alternatives besides treatment in this clinical trial (correct answer: disagree). Q: question.

Data availability statement

Examples of questionnaires, statistical codes, and deidentified participant data are available upon reasonable request.