Audio-recorded information to patients considering participation in cancer clinical trials – a randomized study

Figures & data

Figure 1. Participants CONSORT flow chart.

Table I. Patients’ clinical and demographic characteristics.

	Patient allocation:
Characteristic	Group I [CD+] N = 67	Group C [CD-] N = 63
Age: < 45 45–64 > 65 Mean [SD]	10 (15) 47 (70) 10 (15) 55 (10.3)	11 (18) 41 (65) 11 (18) 54 (10.8)
Gender: Males Females	13 (19) 54 (81)	10 (16) 53 (84)
Education: Compulsory school (1–9 years) Senior high school (10–12 years) University education (13–16 years) Higher university education (> 16 years) Data missing	9 (13) 8 (12) 5 (8) 26 (39) 19 (28)	9 (14) 12 (19) 9 (14) 22 (35) 11 (18)
Marital status: Married/living with partner Divorced/separated Never married Widowed Data missing	35 (52) 3 (5) 9 (13) 1 (2) 19 (28)	35 (56) 6 (10) 11 (18) 0 (0) 11 (18)
Diagnosis: Breast Gastro-intestinal Prostate	51 (76) 11 (16) 5 (8)	50 (79) 8 (13) 5 (8)
Participation in the clinical drug trial: No Yes Not asked for participation	19 (29) 46 (69) 2 (3)	15 (24) 45 (71) 3 (5)
Study phase: Phase III Phase II (randomized) Phase II (single-arm)	41 (61) 10 (15) 16 (24)	38 (60) 16 (25) 9 (14)

Figure 2. Proportion of correct responses to items about knowledge (QuIC) by randomization group.

Figure 3. Mean scale scores by randomization group for perceived understanding (QuIC).

Table II. Knowledge and understanding in the Quality of Informed Consent (QuIC) questionnaire by element and randomization group.

	QuIC: Knowledge			QuIC: Perceived understanding
	Group I [CD+]	Group C [CD+]		Group I [CD+]	Group C [CD+]
Element 1–8	Mean (SD)	Mean (SD)	P-value^a	Mean (SD)	Mean (SD)	P-value^a
Research purpose and procedures, duration, experimental procedures	77 (19.9)	75 (18.7)	0.54	86 (13.7)	87 (15.8)	0.58
Potential risks or comforts	42 (49.8)	28 (45.5)	0.21^b	80 (24.2)	79 (24.7)	0.85
Benefits to self and other	80 (19.7)	75 (20.8)	0.28	87 (14.6)	84 (19.9)	0.81
Alternatives to participation	81 (39.4)	81 (39.8)	1.00^b	88 (22.6)	91 (23.6)	0.31
Confidentiality	44 (50.1)	53 (50.4)	0.45^b	84 (25.7)	85 (23.2)	0.85
Procedures in the event of research injury	44 (50.0)	54 (50.3)	0.33^b	61 (37.5)	66 (37.7)	0.46
Study contacts	85 (35.7)	91 (29.5)	0.54^b	90 (20.6)	96 (11.4)	0.10
Voluntary nature of participation	96 (17.4)	97 (15.2)	0.58	98 (8.8)	100 (3.4)	0.25
Summary score	72 (15.9)	71 (14.5)	0.82	85 (12.0)	86 (12.6)	0.49

^aMann-Whitney test; ^bFisher's exact test.

Table III. Responses to items asking about the audio-recording among those 35 patients who reported having listened.

	Not at all N (%)	A little N (%)	Quite a bit N (%)	Very much N (%)
Helpful in understanding information about the clinical drug trial	0	11 (32)	16 (46)	8 (23)
Helpful in increasing knowledge about the clinical drug trial	2 (6)	15 (43)	16 (46)	2 (6)
Listening to the recording evoke more questions about the clinical drug trial	16 (46)	19 (54)	0	0
Worrying to listen to the recording	29 (83)	4 (11)	1 (3)	1 (3)
Helpful in informing relatives	5 (14)	14 (40)	10 (29)	6 (17)
Beneficial to you	0	8 (23)	17 (49)	10 (29)