Efficacy of a telephone outcall program to reduce caregiver burden among caregivers of cancer patients [PROTECT]: a randomised controlled trial

Leila Heckel; Kate M. Fennell; John Reynolds; Anna Boltong; Mari Botti; Richard H. Osborne; Cathrine Mihalopoulos; Jacquie Chirgwin; Melinda Williams; Cadeyrn J. Gaskin; David M. Ashley; Patricia M. Livingston

doi:10.1186/s12885-017-3961-6

Table 2 -Time (BL = Baseline, M1 = Month 1, M6 = Month 6) by treatment means for outcome variables for caregiver

From: Efficacy of a telephone outcall program to reduce caregiver burden among caregivers of cancer patients [PROTECT]: a randomised controlled trial

Outcome	Control			Intervention			∆ = Intervention - Control
Outcome	Mean	SE^a	n (or P-value)^b	Mean	SE	n (or P-value)	∆	SED^c	P_value
ZBI^e
BL	18.05	1.17	108	18.99	1.17	107	0.95	1.65	0.568
M1	17.81	1.31	73	19.39	1.27	82	1.58	1.82	0.386
M6	17.20	1.33	69	18.46	1.31	73	1.26	1.87	0.500
M1-BL	−0.24	1.13	0.835	0.40	1.09	0.713
M6-BL	−0.85	1.16	0.464	−0.53	1.14	0.639
M6-M1	−0.61	1.23	0.620	−0.93	1.16	0.422			0.921^d
CRA^f Total
BL	30.07	0.44	108	30.80	0.44	105	0.73	0.62	0.243
M1	29.80	0.50	73	29.58	0.49	80	−0.22	0.70	0.750
M6	29.76	0.52	66	29.66	0.51	70	−0.09	0.73	0.897
M1-BL	−0.27	0.49	0.578	−1.22	0.48	0.012
M6-BL	−0.31	0.51	0.538	−1.13	0.50	0.025
M6-M1	−0.04	0.54	0.940	0.09	0.52	0.867			0.320
SCNS-P&C^g (√ transformed)
BL	1.14	0.13	108	1.63	0.13	108	0.49	0.18	0.007
M1	1.01	0.15	75	0.92	0.14	83	−0.09	0.20	0.659
M6	0.41	0.15	68	0.53	0.15	73	0.12	0.21	0.577
M1-BL	−0.13	0.15	0.401	−0.71	0.15	<0.001
M6-BL	−0.73	0.16	<0.001	−1.10	0.16	<0.001
M6-M1	−0.60	0.17	0.001	−0.39	0.16	<0.001			0.023
CES-D^h Total
BL	11.46	0.91	107	13.24	0.91	108	1.79	1.29	0.168
M1	10.98	1.02	75	12.32	0.99	82	1.34	1.42	0.347
M6	10.62	1.04	68	12.04	1.02	73	1.42	1.46	0.334
M1-BL	−0.48	0.89	0.592	−0.93	0.85	0.280
M6-BL	−0.83	0.92	0.369	−1.20	0.89	0.180
M6-M1	−0.36	0.97	0.715	−0.27	0.92	0.765			0.926
heiQⁱ Dom1 HDB
BL	2.90	0.07	107	2.83	0.07	108	−0.06	0.10	0.548
M1	3.05	0.08	75	2.81	0.08	82	−0.24	0.11	0.034
M6	2.96	0.08	68	2.92	0.08	73	−0.04	0.12	0.749
M1-BL	0.15	0.07	0.026	−0.03	0.07	0.680
M6-BL	0.06	0.07	0.379	0.09	0.07	0.202
M6-M1	−0.09	0.07	0.224	0.11	0.07	0.105			0.080
heiQ Dom2 PAEL
BL	3.15	0.05	108	3.05	0.05	108	−0.10	0.07	0.157
M1	3.18	0.06	75	3.02	0.05	82	−0.17	0.08	0.035
M6	3.22	0.06	68	3.06	0.06	73	−0.16	0.08	0.053
M1-BL	0.03	0.05	0.464	−0.03	0.05	0.509
M6-BL	0.07	0.05	0.166	0.01	0.05	0.782
M6-M1	0.03	0.05	0.518	0.04	0.05	0.377			0.564
heiQ Dom3 ED
BL	1.70	0.06	106	1.78	0.06	106	0.09	0.08	0.303
M1	1.73	0.07	75	1.95	0.06	82	0.22	0.09	0.015
M6	1.68	0.07	67	1.91	0.07	73	0.23	0.10	0.016
M1-BL	0.03	0.06	0.653	0.17	0.06	0.005
M6-BL	−0.02	0.06	0.766	0.13	0.06	0.036
M6-M1	−0.05	0.07	0.488	−0.04	0.06	0.537			0.144
heiQ Dom4 SMI
BL	3.17	0.04	106	3.16	0.04	108	−0.01	0.06	0.859
M1	3.13	0.05	75	3.07	0.04	82	−0.06	0.06	0.354
M6	3.22	0.05	68	3.14	0.05	73	−0.08	0.07	0.209
M1-BL	−0.04	0.04	0.418	−0.08	0.04	0.047
M6-BL	0.06	0.05	0.199	−0.01	0.04	0.749
M6-M1	0.09	0.05	0.051	0.07	0.05	0.124			0.489
heiQ Dom5 CAA
BL	3.38	0.05	105	3.31	0.05	104	−0.07	0.06	0.268
M1	3.30	0.05	75	3.20	0.05	82	−0.11	0.07	0.124
M6	3.38	0.05	67	3.25	0.05	72	−0.13	0.07	0.083
M1-BL	−0.08	0.05	0.117	−0.12	0.05	0.016
M6-BL	0.00	0.05	0.980	−0.06	0.05	0.256
M6-M1	0.08	0.05	0.145	0.06	0.05	0.248			0.701
heiQ Dom6 STA
BL	3.17	0.04	102	3.15	0.04	103	−0.02	0.06	0.794
M1	3.04	0.05	74	3.01	0.05	83	−0.04	0.07	0.560
M6	3.17	0.05	66	3.09	0.05	73	−0.08	0.07	0.262
M1-BL	−0.12	0.05	0.015	−0.15	0.05	0.002
M6-BL	0.00	0.05	0.997	−0.06	0.05	0.202
M6-M1	0.12	0.05	0.026	0.08	0.05	0.108			0.672
heiQ Dom7 SIS
BL	3.23	0.05	106	3.12	0.05	104	−0.11	0.07	0.114
M1	3.08	0.05	75	2.98	0.05	83	−0.10	0.08	0.212
M6	3.24	0.06	68	3.05	0.06	73	−0.19	0.08	0.016
M1-BL	−0.15	0.05	0.003	−0.13	0.05	0.006
M6-BL	0.01	0.05	0.778	−0.07	0.05	0.191
M6-M1	0.16	0.05	0.003	0.07	0.05	0.193			0.392
heiQ Dom8 HSN
BL	3.27	0.05	105	3.17	0.05	103	−0.10	0.07	0.153
M1	3.23	0.05	75	3.07	0.05	83	−0.16	0.08	0.034
M6	3.39	0.06	67	3.15	0.05	73	−0.24	0.08	0.003
M1-BL	−0.04	0.05	0.409	−0.10	0.05	0.032
M6-BL	0.12	0.05	0.015	−0.02	0.05	0.753
M6-M1	0.16	0.05	0.002	0.09	0.05	0.086			0.144
HLQ^j S1
BL	3.24	0.05	105	3.11	0.05	103	−0.13	0.07	0.083
M1	3.25	0.06	73	3.15	0.06	83	−0.10	0.08	0.208
M6	3.30	0.06	67	3.17	0.06	73	−0.13	0.08	0.109
M1-BL	0.01	0.05	0.913	0.03	0.05	0.492
M6-BL	0.06	0.05	0.220	0.06	0.05	0.239
M6-M1	0.06	0.05	0.288	0.03	0.05	0.604			0.892
HLQ S2
BL	3.15	0.04	106	3.10	0.04	105	−0.05	0.06	0.388
M1	3.15	0.05	74	3.09	0.05	83	−0.06	0.07	0.392
M6	3.23	0.05	67	3.19	0.05	73	−0.04	0.07	0.552
M1-BL	−0.01	0.05	0.880	−0.01	0.04	0.785
M6-BL	0.08	0.05	0.107	0.09	0.05	0.058
M6-M1	0.08	0.05	0.097	0.10	0.05	0.034			0.970
HLQ S3
BL	2.96	0.05	107	2.89	0.05	105	−0.07	0.07	0.282
M1	2.95	0.05	74	2.91	0.05	83	−0.04	0.07	0.616
M6	2.99	0.05	67	2.91	0.05	72	−0.08	0.08	0.286
M1-BL	−0.02	0.05	0.758	0.02	0.05	0.692
M6-BL	0.03	0.05	0.558	0.02	0.05	0.695
M6-M1	0.05	0.05	0.405	0.00	0.05	0.987			0.815
HLQ S4
BL	3.19	0.05	106	3.04	0.05	105	−0.16	0.07	0.019
M1	3.12	0.05	74	3.02	0.05	83	−0.10	0.07	0.166
M6	3.23	0.05	68	3.04	0.05	73	−0.19	0.07	0.010
M1-BL	−0.07	0.05	0.119	−0.02	0.04	0.721
M6-BL	0.04	0.05	0.382	0.00	0.05	0.940
M6-M1	0.11	0.05	0.024	0.02	0.05	0.682			0.381
HLQ S5
BL	2.90	0.05	104	2.86	0.05	104	−0.04	0.07	0.587
M1	2.89	0.06	73	2.88	0.05	83	−0.01	0.08	0.878
M6	2.95	0.06	67	2.91	0.06	73	−0.04	0.08	0.587
M1-BL	−0.01	0.05	0.802	0.01	0.05	0.788
M6-BL	0.05	0.05	0.372	0.04	0.05	0.412
M6-M1	0.06	0.06	0.282	0.03	0.05	0.578			0.903
HLQ S6
BL	4.22	0.06	106	4.23	0.06	104	0.01	0.09	0.863
M1	4.19	0.07	74	4.28	0.07	83	0.10	0.10	0.322
M6	4.28	0.07	68	4.18	0.07	73	−0.10	0.10	0.331
M1-BL	−0.03	0.07	0.626	0.05	0.07	0.470
M6-BL	0.06	0.07	0.388	−0.05	0.07	0.454
M6-M1	0.09	0.07	0.207	−0.10	0.07	0.158			0.168
HLQ S7
BL	4.14	0.06	104	4.12	0.06	104	−0.03	0.09	0.772
M1	4.10	0.07	73	4.21	0.07	83	0.11	0.10	0.259
M6	4.19	0.07	68	4.14	0.07	73	−0.05	0.10	0.629
M1-BL	−0.04	0.06	0.498	0.09	0.06	0.143
M6-BL	0.05	0.07	0.488	0.02	0.06	0.717
M6-M1	0.09	0.07	0.200	−0.07	0.06	0.306			0.192
HLQ S8
BL	4.15	0.06	105	4.13	0.06	104	−0.03	0.09	0.774
M1	4.08	0.07	73	4.18	0.07	83	0.09	0.10	0.341
M6	4.19	0.07	68	4.13	0.07	73	−0.05	0.10	0.614
M1-BL	−0.07	0.07	0.333	0.05	0.07	0.473
M6-BL	0.03	0.07	0.657	0.01	0.07	0.928
M6-M1	0.10	0.08	0.192	−0.04	0.07	0.559			0.336
HLQ S9
BL	4.31	0.05	104	4.30	0.05	104	−0.01	0.08	0.916
M1	4.27	0.06	74	4.37	0.06	83	0.10	0.08	0.234
M6	4.32	0.06	68	4.37	0.06	73	0.05	0.09	0.563
M1-BL	−0.04	0.06	0.512	0.07	0.06	0.197
M6-BL	0.00	0.06	0.948	0.06	0.06	0.279
M6-M1	0.04	0.06	0.504	−0.01	0.06	0.884			0.390

^a SE Standard Error of the Mean or a difference in Time Means
^b Sample sizes (n) for means and p-values for time differences within treatment groups
^c SED Standard Error of the Difference in Treatment group means within a Time
^d P-value for the 2 degree-of-freedom test for a Time by Treatment group interaction
^e ZBI Zarit Burden Interview
^f CRA Caregiver Reaction Assessment
^g SCNS – P&C Supportive Care Needs Survey – Partner & Caregivers
^h CES-D Centre for Epidemiologic Studies – Depression
ⁱ heiQ health education impact Questionnaire: Domain 1 – health directed behaviour (HDB), Domain 2 – positive and active engagement in life (PAEL), Domain 3 – emotional distress (ED), Domain 4 – self monitoring and insight (SMI), Domain 5 – constructive attitudes and approaches (CAA), Domain 6 – skills and technique acquisition (STA), Domain 7 – social integration and support (SIS), Domain 8 – health service navigation (HSN)
^j HLQ Health Literacy Questionnaire: S1 – feeling understood and supported by healthcare providers, S2 – having sufficient information to manage my health, S3 – actively managing my health, S4 – social support for health, S5 – appraisal of health information, S6 – ability to actively engage with health care providers, S7 – navigating the health care system, S8 – ability to find good health information, S9 – understanding health information well enough to know what to do

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