Background
Methods
Research design
Participants
Cancer council 13 11 20 information and support service
Randomisation and group allocation
Measures
Sample size calculation
Data analysis
Results
Caregiver and patient sample
Characteristics | Control | Intervention |
P
|
---|---|---|---|
Patient demographics | |||
Age, mean (SD), years | 59.8 (12.4) | 58.8 (12.1) | .58 |
Gender, n (%) | .58 | ||
Male | 49 (45.4) | 45 (41.7) | |
Female | 59 (54.6) | 63 (58.3) | |
Clinical data | |||
Type of Cancer, n (%) | .21 | ||
Solid | 92 (85.2) | 98 (90.7) | |
Haematological | 16 (14.8) | 10 (9.3) | |
Treatment regimen, n (%) | .85 | ||
Chemotherapy | 40 (37.0) | 42 (38.9) | |
Radiotherapy | 38 (35.2) | 34 (31.5) | |
Chemo/Radio combined | 30 (27.8) | 32 (29.6) | |
Caregiver demographics | |||
Age, mean (SD), years | 56.3 (14.2) | 57.2 (11.6) | .59 |
Gender, n (%) | .27 | ||
Male | 42 (38.9) | 50 (46.3) | |
Female | 66 (61.1) | 58 (53.7) | |
Indigeneity- Aboriginal/Torres Strait Islander, n (%) | – | ||
Yes | 0 (0) | 0 (0) | |
No | 104 (100.0) | 92 (100.0) | |
Country of birth, n (%) | .46 | ||
Australia | 84 (80.8) | 83 (84.7) | |
Other | 20 (19.2) | 15 (15.3) | |
Lives with patient, n (%) | .85 | ||
Yes | 90 (83.3) | 91 (84.3) | |
No | 18 (16.7) | 17 (15.7) | |
Relationship to patient, n (%) | .87 | ||
Spouse/partner | 85 (78.7) | 86 (79.6) | |
Other (e.g. parent, adult child, friend) | 23 (21.3) | 22 (20.4) | |
Household size, mean (SD) | |||
Number of people ≥18 years | 2.2 (0.7) | 2.2 (0.7) | .85 |
Number of people <18 years | 0.4 (0.9) | 0.4 (0.9) | .88 |
Total household size | 2.6 (1.1) | 2.6 (1.2) | .81 |
Education status, n (%) | .85 | ||
Primary/secondary school | 48 (44.9) | 47 (43.5) | |
Certificate/Diploma | 27 (25.2) | 25 (23.1) | |
University Degree | 32 (29.9) | 36 (33.3) |
Caregiver outcomes
Outcome | Control | Intervention | ∆ = Intervention - Control | ||||||
---|---|---|---|---|---|---|---|---|---|
Mean | SEa | n (or P-value)b | Mean | SE | n (or P-value) | ∆ | SEDc | P_value | |
ZBIe | |||||||||
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 | 0.921d | ||
CRAf 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&Cg (√ 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-Dh 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 | ||
HLQj 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 |
Caregiver burden
Caregiver unmet needs
Caregiver self-empowerment (heiQ) and health literacy
Caregiver self-esteem
Depressive symptoms and caregivers at risk for depression
Characteristics | Control | Intervention |
P
|
---|---|---|---|
Patient demographics | |||
Age, mean (SD), years | 59.1 (12.9) | 57.7 (11.6) | .63 |
Gender, n (%) | .81 | ||
Male | 15 (48.4) | 19 (51.4) | |
Female | 16 (51.6) | 18 (48.6) | |
Clinical data | |||
Type of Cancer, n (%) | .09 | ||
Solid | 24 (77.4) | 34 (91.9) | |
Haematological | 7 (22.6) | 3 (8.1) | |
Treatment regimen, n (%) | .17 | ||
Chemotherapy | 14 (45.2) | 13 (35.1) | |
Radiotherapy | 11 (35.5) | 9 (24.3) | |
Chemo/Radio combined | 6 (19.4) | 15 (40.5) | |
Caregiver demographics | |||
Age, mean (SD), years | 53.6 (12.9) | 52.3 (12.3) | .67 |
Gender, n (%) | .67 | ||
Male | 11 (35.5) | 15 (40.5) | |
Female | 20 (64.5) | 22 (59.5) | |
Indigeneity- Aboriginal/Torres Strait Islander, n (%) | – | ||
Yes | 0 (0) | 0 (0) | |
No | 31 (100.0) | 37 (100.0) | |
Country of birth, n (%) | .21 | ||
Australia | 23 (79.3) | 29 (90.6) | |
Other | 6 (20.7) | 3 (9.4) | |
Lives with patient, n (%) | .52 | ||
Yes | 26 (83.9) | 33 (89.2) | |
No | 5 (16.1) | 4 (10.8) | |
Relationship to patient, n (%) | .33 | ||
Spouse/partner | 23 (74.2) | 31 (83.8) | |
Other (e.g. parent, adult child, friend) | 8 (25.8) | 6 (16.2) | |
Household size, mean (SD) | |||
Number of people ≥18 years | 2.3 (0.8) | 2.2 (0.6) | .65 |
Number of people <18 years | 0.6 (1.0) | 0.6 (1.2) | .97 |
Total household size | 2.9 (1.3) | 2.8 (1.3) | .84 |
Education status, n (%) | .99 | ||
Primary/secondary school | 11 (36.7) | 13 (35.1) | |
Certificate/Diploma | 10 (33.3) | 13 (35.1) | |
University Degree | 9 (30.0) | 11 (39.7) |
Characteristics | Caregivers not at risk (n = 147) | Caregivers at risk (n = 68) |
P
|
---|---|---|---|
Patient demographics | |||
Age, mean (SD), years | 59.6 (12.3) | 58.3 (12.1) | .47 |
Gender, n (%) | .18 | ||
Male | 59 (40.1) | 34 (50.0) | |
Female | 88 (59.9) | 34 (50.0) | |
Clinical data | |||
Type of Cancer, n (%) | .42 | ||
Solid | 131 (89.1) | 58 (85.3) | |
Haematological | 16 (10.9) | 10 (14.7) | |
Treatment regimen, n (%) | .74 | ||
Chemotherapy | 55 (37.4) | 27 (39.7) | |
Radiotherapy | 51 (34.7) | 20 (29.4) | |
Chemo/Radio combined | 41 (27.9) | 21 (30.9) | |
Caregiver demographics | |||
Age, mean (SD), years | 58.4 (12.8) | 52.9 (12.5) | .003 |
Gender, n (%) | .36 | ||
Male | 66 (44.9) | 26 (38.2) | |
Female | 81 (55.1) | 42 (61.8) | |
Indigeneity- Aboriginal/Torres Strait Islander, n (%) | – | ||
Yes | 0 (0) | 0 (0) | |
No | 147 (100.0) | 68 (100.0) | |
Country of birth, n (%) | .51 | ||
Australia | 114 (81.4) | 52 (85.2) | |
Other | 26 (18.6) | 9 (14.8) | |
Lives with patient, n (%) | .41 | ||
Yes | 121 (82.3) | 59 (86.8) | |
No | 26 (17.7) | 9 (13.2) | |
Relationship to patient, n (%) | .93 | ||
Spouse/partner | 116 (78.9) | 54 (79.4) | |
Other (i.e. parent, adult child, friend) | 31 (21.1) | 14 (20.6) | |
Household size, mean (SD) | |||
Number of people ≥18 years | 2.2 (0.8) | 2.3 (0.7) | .35 |
Number of people <18 years | 0.4 (0.7) | 0.6 (1.1) | .10 |
Total household size | 2.5 (1.0) | 2.9 (1.3) | .04 |
Education status, n (%) | .06 | ||
Primary/secondary school | 70 (47.6) | 24 (35.8) | |
Certificate/Diploma | 29 (19.7) | 23 (34.3) | |
University Degree | 48 (32.7) | 20 (29.9) |