Table 2.
Between-group differences in mean change from baseline to follow-up.
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T0 | T1 | T2 | T3 | Between-group difference, T0-T1 | Between-group difference, T0-T2 | Between-group difference, T0-T3 | |||||||||||||||||||||||||||
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n | Value, mean (SD) | n | Value, mean (SD) | n | Value, mean (SD) | n | Value, mean (SD) | Value, mean change (SE) | P value | Value, mean change (SE) | P value | Value, mean change (SE) | P value | ||||||||||||||||||||
| Psychological distress (HADSa total; P=.94b) | ||||||||||||||||||||||||||||||||||
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CAUc | 77 | 7.03 (7.10) | 62 | 6.98 (7.48) | 54 | 6.06 (6.09) | 34 | 6.94 (6.70) | N/Ad | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PROe results | 74 | 6.59 (5.26) | 60 | 6.43 (6.21) | 53 | 6.18 (5.61) | 28 | 7.11 (8.26) | 0.04 (0.68) | .96 | 0.20 (0.71) | .77 | –0.71 (0.88) | .42 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 5.75 (5.04) | 64 | 5.78 (4.99) | 59 | 5.68 (5.62) | 35 | 5.34 (5.78) | 0.02 (0.67) | .98 | 0.12 (0.69) | .86 | –0.87 (0.83) | .30 | |||||||||||||||||||
| Self-management skills (HeiQ positive and active engagement in lifef; P=.52b) | ||||||||||||||||||||||||||||||||||
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CAU | 76 | 3.16 (0.52) | 62 | 3.15 (0.52) | 53 | 3.25 (0.49) | 34 | 3.16 (0.48) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 3.22 (0.46) | 62 | 2.23 (0.50) | 53 | 3.23 (0.51) | 29 | 3.17 (0.65) | 0.02 (0.07) | .81 | –0.11 (0.07) | .12 | –0.04 (0.09) | .66 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 3.22 (0.44) | 64 | 3.26 (0.52) | 59 | 3.22 (0.48) | 35 | 3.24 (0.41) | 0.07 (0.07) | .34 | –0.07 (0.07) | .33 | 0.02 (0.09) | .82 | |||||||||||||||||||
| HeiQ health-directed behavior (P=.80b) | ||||||||||||||||||||||||||||||||||
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CAU | 77 | 3.34 (0.62) | 62 | 3.28 (0.56) | 55 | 3.35 (0.64) | 34 | 3.16 (0.57) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 3.27 (0.53) | 62 | 3.29 (0.59) | 53 | 3.28 (0.49) | 29 | 3.19 (0.47) | 0.08 (0.09) | .33 | 0.00 (0.09) | .69 | 0.15 (0.11) | .19 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 3.22 (0.58) | 64 | 3.23 (0.65) | 59 | 3.26 (0.63) | 35 | 3.21 (0.66) | 0.09 (0.09) | .27 | 0.04 (0.09) | .97 | 0.12 (0.11) | .28 | |||||||||||||||||||
| HeiQ skill and technique acquisition (P=.90b) | ||||||||||||||||||||||||||||||||||
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CAU | 76 | 2.94 (0.53) | 62 | 2.97 (0.46) | 53 | 3.02 (0.49) | 34 | 3.05 (0.45) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 2.94 (0.44) | 61 | 2.98 (0.43) | 53 | 3.05 (0.49) | 29 | 3.04 (0.55) | 0.01 (0.08) | .88 | –0.00 (0.08) | .97 | 0.00 (0.10) | .96 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 2.97 (0.53) | 64 | 2.95 (0.50) | 58 | 2.98 (0.47) | 35 | 2.94 (0.40) | -0.05 (0.07) | .53 | –0.05 (0.08) | .50 | –0.11 (0.09) | .22 | |||||||||||||||||||
| HeiQ constructive attitudes and approaches (P=.36b) | ||||||||||||||||||||||||||||||||||
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CAU | 76 | 3.26 (0.52) | 62 | 3.16 (0.51) | 55 | 3.31 (0.50) | 34 | 3.29 (0.47) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 3.27 (0.51) | 61 | 3.30 (0.49) | 53 | 3.35 (0.44) | 29 | 3.26 (0.60) | 0.13 (0.07) | .06 | –0.01 (0.07) | .93 | 0.03 (0.09) | .73 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 3.33 (0.43) | 64 | 3.30 (0.49) | 58 | 3.31 (0.45) | 35 | 3.34 (0.44) | 0.07 (0.07) | .28 | –0.06 (0.07) | .41 | –0.06 (0.09) | .52 | |||||||||||||||||||
| HeiQ self-monitoring and insight (P=.82b) | ||||||||||||||||||||||||||||||||||
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CAU | 77 | 3.08 (0.45) | 62 | 3.17 (0.32) | 55 | 3.15 (0.40) | 34 | 3.04 (0.53) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 3.05 (0.39) | 62 | 3.11 (0.40) | 53 | 3.13 (0.42) | 29 | 3.14 (0.35) | 0.06 (0.07) | .36 | –0.02 (0.07) | .78 | 0.09 (0.09) | .31 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 3.00 (0.42) | 64 | 3.05 (0.38) | 59 | 3.11 (0.39) | 35 | 3.05 (0.40) | 0.07 (0.07) | .30 | 0.02 (0.07) | .75 | 0.08 (0.08) | .33 | |||||||||||||||||||
| HeiQ health services navigation (P=.26b) | ||||||||||||||||||||||||||||||||||
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CAU | 76 | 3.30 (0.45) | 62 | 3.22 (0.44) | 55 | 3.30 (0.47) | 34 | 3.29 (0.42) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 3.28 (0.39) | 61 | 3.26 (0.40) | 53 | 3.38 (0.43) | 29 | 3.33 (0.44) | 0.06 (0.06) | .35 | 0.07 (0.07) | .30 | 0.04 (0.08) | .61 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 3.22 (0.49) | 64 | 3.19 (0.50) | 58 | 3.22 (0.41) | 35 | 3.15 (0.36) | 0.05 (0.06) | .40 | 0.02 (0.07) | .75 | –0.13 (0.08) | .11 | |||||||||||||||||||
| HeiQ social integration and support (P=.68b) | ||||||||||||||||||||||||||||||||||
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CAU | 76 | 3.15 (0.57) | 62 | 3.07 (0.54) | 55 | 3.12 (0.51) | 34 | 3.13 (0.50) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 3.12 (0.46) | 61 | 3.13 (0.50) | 53 | 3.15 (0.47) | 29 | 3.16 (0.41) | 0.06 (0.07) | .38 | 0.02 (0.07) | .82 | 0.04 (0.090) | .65 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 3.22 (0.47) | 64 | 3.20 (0.46) | 58 | 3.16 (0.49) | 35 | 3.19 (0.38) | 0.06 (0.07) | .38 | -0.02 (0.07) | .76 | –0.08 (0.09) | .33 | |||||||||||||||||||
| HeiQ emotional wellbeing (P=.90b) | ||||||||||||||||||||||||||||||||||
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CAU | 76 | 1.82 (0.62) | 62 | 1.88 (0.65) | 55 | 1.72 (0.55) | 34 | 1.80 (0.50) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 1.83 (0.52) | 62 | 1.82 (0.53) | 53 | 1.73 (0.53) | 29 | 1.88 (0.68) | –0.06 (0.07) | .45 | 0.02 (0.08) | .76 | –0.02 (0.10) | .81 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 1.71 (0.48) | 64 | 1.72 (0.51) | 59 | 1.65 (0.49) | 35 | 1.64 (0.53) | –0.05 (0.07) | .53 | 0.02 (0.08) | .82 | –0.08 (0.09) | .36 | |||||||||||||||||||
| Satisfaction with information provision (ISFg total information provision; P=.66b) | ||||||||||||||||||||||||||||||||||
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CAU | 76 | 3.86 (0.78) | 63 | 3.73 (0.79) | 57 | 3.88 (0.76) | 34 | 3.85 (0.82) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 3.91 (0.72) | 62 | 3.95 (0.71) | 53 | 4.02 (0.57) | 28 | 3.79 (0.79) | 0.19 (0.13) | .14 | 0.10 (0.13) | .44 | –0.01 (0.16) | .97 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 3.86 (0.80) | 65 | 3.68 (0.94) | 59 | 3.80 (0.76) | 35 | 3.80 (0.68) | –0.02 (0.12) | .88 | –0.02 (0.13) | .85 | 0.02 (0.15) | .92 | |||||||||||||||||||
| Health care use (contacts with general practitioner in past 12 months; P=.17b) | ||||||||||||||||||||||||||||||||||
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CAU | 74 | 4.70 (3.92) | 63 | 3.16 (2.57) | 57 | 3.63 (4.51) | 34 | 3.38 (3.09) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 4.78 (4.17) | 62 | 4.40 (4.97) | 53 | 3.68 (5.27) | 29 | 4.90 (6.21) | 1.04 (0.66) | .11 | –0.15 (0.69) | .83 | 0.29 (0.85) | .73 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 76 | 4.89 (4.32) | 65 | 3.34 (3.25) | 59 | 3.17 (3.24) | 35 | 2.57 (3.00) | –0.16 (0.65) | .81 | –0.97 (0.68) | .15 | –1.45 (0.82) | .08 | |||||||||||||||||||
| Contacts with medical specialist in past 12 months (P=.80b) | ||||||||||||||||||||||||||||||||||
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CAU | 76 | 10.09 (6.27) | 63 | 7.00 (4.12) | 56 | 6.66 (5.92) | 34 | 5.44 (4.54) | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||||||||||
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Return of PRO results | 74 | 10.42 (6.72) | 61 | 6.70 (4.73) | 53 | 5.70 (5.54) | 29 | 5.21 (5.84) | –0.33 (1.10) | .77 | –1.20 (1.15) | .30 | –1.59 (1.41) | .26 | |||||||||||||||||||
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Return of PRO results + Living with lymphoma | 74 | 10.46 (7.18) | 63 | 7.30 (5.43) | 58 | 5.97 (3.79) | 35 | 5.26 (6.34) | 0.18 (1.10) | .87 | –1.05 (1.14) | .35 | –1.52 (1.36) | .26 | |||||||||||||||||||
aHADS: Hospital Anxiety and Depression Scale (psychological distress subscale range, 0-42, with higher scores indicating more psychological distress).
bP value of the overall time-by-group interaction.
cCAU: care as usual (control group; reference category).
dN/A: not applicable.
ePRO: patient-reported outcome (T0, baseline assessment; T1, short-term follow-up assessment at 4 months postrandomization; T2, follow-up assessment at 12 months postrandomization; T3, follow-up assessment at 24 months postrandomization).
fHeiQ: Health Education Impact Questionnaire (self-management ability subscales range, 0-4, with higher scores indicating higher levels of self-management ability).
gISF: Information Satisfaction Questionnaire (information satisfaction subscale range, 0-5, with higher scores indicating more satisfaction with perceived information).