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There has been a cultural shift toward patient engagement in health, with a growing demand from patients to access their results.
The Lymphoma Intervention (LIVE) trial is conducted to examine the impact of return of individual patient-reported outcome (PRO) results and a web-based self-management intervention on psychological distress, self-management, satisfaction with information, and health care use in a population-based setting.
Return of PRO results included comparison with age- and sex-matched peers and was built into the Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry. The self-management intervention is an adaptation of a fully automated evidence-based intervention for breast cancer survivors. Patients with lymphoma who completed the web-based questionnaire were equally randomized to care as usual, return of PRO results, and return of PRO results plus self-management intervention. Patients completed questionnaires 9 to 18 months after diagnosis (T0; n=227), 4 months (T1; n=190), 12 months (T2; n=170), and 24 months (T3; n=98).
Of all invited patients, 51.1% (456/892) responded and web-based participants (n=227) were randomly assigned to care as usual (n=76), return of PRO results (n=74), or return of PRO results and access to Living with lymphoma (n=77). Return of PRO results was viewed by 76.7% (115/150) of those with access. No statistically significant differences were observed for psychological distress, self-management, satisfaction with information provision, and health care use between patients who received PRO results and those who did not (
Return of individual PRO results seems to meet patients’ wishes but had no beneficial effects on patient outcome. No negative effects were found when individual PRO results were disclosed, and the return of individual PRO results can therefore be safely implemented in daily clinical practice.
Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790
RR2-10.1186/s13063-017-1943-2
Patients with lymphoma are at risk of experiencing adverse effects of cancer and its treatment, such as fatigue, cognitive problems, and neuropathy [
Since the past decade, there has been a cultural shift toward patient engagement in health, with a growing demand from patients to access their individual results [
To improve health outcomes, subsequent steps such as self-management interventions are expected to be necessary in addition to monitoring and returning PRO results [
To investigate the effect of (1) return of individual PRO research results, including comparison with peers [
This RCT was embedded in the population-based Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship (PROFILES) registry [
Between October 2015 and February 2019, patients diagnosed with lymphoma (Hodgkin lymphoma, non-Hodgkin lymphoma, or chronic lymphocytic leukemia), as defined by the International Classification of Diseases for Oncology-3 codes [
Randomization was performed using block randomization to ensure a balance in sample size across arms over time [
In arm 1, patients received CAU from their hemato-oncologists and oncology nurses. In general, they provided verbal information to their patients and provided leaflets regarding the diagnosis and treatment they received.
In arms 2 and 3, in addition to CAU, individual PRO research results were disclosed to patients. This feedback was automatically generated after the completion of the questionnaire. On the basis of respect for autonomy, patients had the choice as to whether they wanted to receive the results [
Detailed information about the return of PRO results (also known as PRO feedback) has been described elsewhere [
In addition to the return of PRO results, patients in arm 3 had access to a web-based self-management intervention—Living with lymphoma. A detailed description of Living with lymphoma has been described elsewhere [
Sociodemographic characteristics (age and sex) and detailed clinical information (date of diagnosis, cancer type, and primary treatment) were obtained from the NCR. NCR data were available for both RCT participants and nonparticipants. Information on educational level and marital status was assessed in the questionnaire (data only available for RCT participants).
Comorbidities at the time of questionnaire completion were assessed using an adapted version of the Self-Administered Comorbidity Questionnaire [
Personality traits were assessed using the Big Five Inventory [
The 40-item Mental Adjustment to Cancer scale was used to assess adjustment to cancer in terms of coping strategies [
Health-related quality of life was assessed using the 30-item Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer [
Self-management skills were assessed using the Health Education Impact Questionnaire, which contains 40 items across 8 scales—positive and active engagement in life, health-directed activities, skill and technique acquisition, constructive attitudes and approaches, self-monitoring and insight, health service navigation, social integration and support, and emotional distress [
Satisfaction with overall information provision was assessed using an adapted version of the 9-item Information Satisfaction Questionnaire [
Psychological distress was assessed using the 14-item Hospital Anxiety and Depression Scale [
Two open questions were asked to assess health care use: (1) “How often did you contact a general practitioner in the past 12 months?” and (2) “How often did you visit a medical specialist in the past 12 months?”
Sociodemographic and clinical characteristics between the three arms were compared using univariable analyses of variance and chi-square tests. If at least half of the items from a subscale were completed, the missing items were replaced by the average of those that were present for the participant.
To model between-group differences in change from baseline (T0) to follow-up (T1-T3), mixed-effects models were used with an unstructured covariance structure and a restricted maximum likelihood solution [
Baseline characteristics of participants according to randomized controlled trial (RCT) arm and of nonparticipants.
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CAUa (n=77) | Return of PROb results (n=74) | Return of PRO results + living with lymphoma (n=76) | Total RCT participants (n=227) | Nonparticipants (n=666) | |||||||||||||||
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Age at time of questionnaire (years), mean (SD) | 61.3 (12.9) | 60.0 (13.4) | 60.8 (14.0) | .83 | 60.7 (13.4) | 65.3 (15.7) | <.001 | ||||||||||||
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.73 |
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<.001 | |||||||||||||||
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Male | 53 (68.8) | 55 (74.3) | 53 (69.7) |
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161 (70.9) | 377 (56.6) |
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Female | 24 (31.2) | 19 (25.7) | 23 (30.3) |
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66 (29.1) | 289 (43.4) |
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.71 |
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—g | |||||||||||||||
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Low | 1 (1.3) | 2 (2.7) | 3 (3.9) |
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6 (2.6) | N/Af |
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Medium | 33 (42.9) | 38 (51.4) | 35 (46.1) |
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106 (46.7) | N/A |
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High | 42 (54.5) | 34 (45.9) | 38 (50) |
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114 (50.2) | N/A |
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Partner (yes), n (%) | 62 (80.5) | 65 (87.8) | 63 (82.9) | .46 | 190 (83.7) | N/A | — | ||||||||||||
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Months since diagnosis: mean (SD) | 14.0 (3.1) | 14.0 (3.6) | 13.9 (3.0) | .94 | 14.0 (3.2) | 14.0 (3.5) | .80 | ||||||||||||
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Hodgkin lymphoma | 10 (12.9) | 8 (10.8) | 9 (11.8) | .99 | 27 (11.9) | 75 (11.3) | .95 | |||||||||||
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NHL-HGh | 41 (53.2) | 41 (55.4) | 42 (55.3) |
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125 (55.1) | 359 (53.9) |
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NHL-LGi | 18 (23.4) | 19 (25.7) | 19 (25) |
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56 (24.7) | 169 (25.4) |
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CLLj | 8 (10.4) | 6 (8.1) | 6 (7.9) |
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19 (8.4) | 63 (9.5) |
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.10 |
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.13 | |||||||||||||||
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Active surveillance | 23 (29.9) | 18 (24.3) | 12 (15.8) |
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53 (23.3) | 199 (28.5) |
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Received active treatment | 52 (67.5) | 56 (75.7) | 64 (84.2) |
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172 (75.8) | 458 (68.8) |
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Chemotherapy | 37 (48.1) | 46 (62.2) | 54 (71.1) |
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137 (60.4) | 357 (54) |
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Radiotherapy | 5 (6.5) | 4 (5.4) | 3 (3.9) |
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12 (5.3) | 60 (8.1) |
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Stem cell transplantation | 8 (10.4) | 3 (4.1) | 3 (3.9) |
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14 (6.2) | 4 (0.6) |
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Other | 2 (2.6) | 3 (4.1) | 4 (5.3) |
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9 (3.9) | 37 (5.6) |
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.81 |
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.30 | |||||||||||||||
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Stage I, n (%) | 6 (7.8) | 8 (10.8) | 15 (19.7) |
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29 (12.8) | 112 (16.8) |
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Stage II, n (%) | 8 (10.4) | 13 (17.6) | 15 (19.7) |
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36 (15.8) | 95 (14.3) |
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Stage III, n (%) | 11 (14.3) | 9 (12.2) | 10 (13.2) |
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30 (13.2) | 97 (14.6) |
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Stage IV, n (%) | 30 (38.9) | 30 (40.5) | 26 (34.2) |
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86 (37.9) | 194 (29.1) |
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Not determined (CLL) or missing, n (%) | 22 (28.6) | 14 (18.9) | 10 (13.2) |
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46 (20.3) | 168 (25.2) |
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Number of self-reported comorbidities: mean (SD) | 1.3 (1.2) | 1.2 (1.1) | 1.0 (1.0) | .22 | 1.1 (1.1) | N/A |
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Psychological distress | 17 (22.1) | 9 (12.2) | 8 (10.5) | .09 | 34 (14.9) | N/A | — |
aCAU: care as usual.
bPRO: patient-reported outcome.
cReports comparisons between the intervention arms and the care as usual arm.
dReports comparisons between randomized controlled trial participants and nonparticipants.
eEducation levels were low=none or primary school; medium=lower general secondary education or vocational training; or high=preuniversity education or high-level vocational training or university.
fN/A: not applicable.
gNot available.
hNHL-HG: high-grade non-Hodgkin lymphoma.
iNHL-LG: low-grade non-Hodgkin lymphoma.
jCLL: chronic lymphocytic leukemia.
With more than 74 participants per study arm, the study had 90% power to detect an ES of 0.50 with a two-tailed
In total, 1193 patients were selected from the NCR and 892 patients were invited to participate. Of these, 51.1% (456/892) participated, of which 25.7% (229/892) were excluded for the RCT as they completed the questionnaire on paper (CONSORT [Consolidated Standards of Reporting Trials] diagram;
Overall, 25.4% (227/892) completed the web-based questionnaire and were included in the RCT. They were randomly assigned to CAU (control group; n=76), return of PRO results (n=74), or return of PRO results and access to Living with lymphoma (n=77). Completion rates of follow-up questionnaires were 84.1% (191/227) on T1, 74.9% (143/191) on T2, and 68.5% (98/143) on T3, and did not differ significantly among groups.
Those who declined participation or completed the questionnaire on paper were analyzed as nonparticipants in this study. All participants provided written informed consent.
RCT participants were younger than nonparticipants (60.7 vs 65.3 years;
CONSORT (Consolidated Standards of Reporting Trials) flow diagram of the progress of the patients with lymphoma through the phases of the Lymphoma Intervention (LIVE) trial. CAU: care as usual (control group); NCR: Netherlands Cancer Registry; PRO: patient-reported outcome.
The use of self-management intervention was very low (3/76, 4%). Therefore, the effects of
As we observed that adherence to Living with lymphoma intervention was very low one year after starting patient inclusion, research assistants sent an email for inquiry. A random sample of 5 patients who had access to the intervention and signed up were asked to respond without any obligation and were asked for their reasons for nonadherence. Two patients responded that they felt well and still had regular appointments with their hematologist, and therefore were not in need of an intervention:
In the first place, I feel very well, both physically and mentally. Secondly, I have regular appointments with my treating haematologist. Furthermore, I do not always want to be confronted with my disease.
I am not really concerned about the fact that I have had cancer. I am in remission for one year now, and that is how I feel. Every three months, I still have checkup appointments, but other than that I live my life the way I did before I had cancer. I feel fine, I have no limitations, and therefore I do not need information about a disease from the past.
No statistically significant differences were observed for psychological distress, self-management subscales, and satisfaction with information provision between patients who received their individual PRO results and those who did not (
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) | Value, mean change (SE) | Value, mean change (SE) | |||||||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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 | |||||||||||||||||||
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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 + |
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).
b
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).
Of the 150 patients who were randomized to arm 2 or 3 and had access to individual PRO results, 115 (76.7%) patients viewed their PRO results. The majority (79/115, 68.7%) viewed their PRO results more than once, and 16% (13/79) viewed it more than 5 times.
Patients with lymphoma who viewed their PRO results were more recently diagnosed (13.6 vs 15.0 months;
Of those who viewed the PRO results, 91.3% (105/115) wished to compare their individual results to other patients with lymphoma and 80.8% (93/115) to a normative population without cancer. Only 7.8% (9/115) solely wanted to view their individual results.
Baseline characteristics of patients who viewed their individual patient-reported outcome (PRO) results and those who did not.
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Those who viewed their PRO results (N=115) | Those who did not view their PRO results (N=35) | |||||||
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Age at time of questionnaire (years), mean (SD) | 60.1 (13.6) | 61.4 (14.0) | .64 | |||||
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.93 | |||||||
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Male | 83 (72.2) | 25 (71.4) |
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Female | 32 (27.8) | 10 (28.6) |
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.16 | |||||||
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Low | 4 (3.5) | 1 (2.9) |
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Medium | 51 (44.3) | 22 (62.9) |
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High | 60 (52.2) | 12 (34.3) |
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Partner (yes), n (%) | 14 (12.2) | 8 (22.9) | .12 | |||||
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Months since diagnosis, mean (SD) | 13.6 (3.3) | 15.0 (3.3) | .03 | |||||
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.21 | |||||||
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Hodgkin lymphoma | 10 (8.7) | 7 (20) |
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NHL-HGc | 67 (58.3) | 16 (45.7) |
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NHL-LGd | 30 (26.1) | 8 (22.9) |
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CLLe | 8 (6.9) | 4 (11.4) |
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.63 | |||||||
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Active treatment received | 91 (79.1) | 29 (82.9) |
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Active surveillance | 24 (20.9) | 6 (17.1) |
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Number of self-reported comorbidities, mean (SD) | 1.1 (1.1) | 1.1 (1.2) | .94 | |||||
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Openness | 3.5 (0.6) | 3.4 (0.6) | .43 | ||||
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Conscientiousness | 3.8 (0.4) | 3.6 (0.5) | .01 | ||||
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Extraversion | 3.6 (0.6) | 3.5 (0.5) | .66 | ||||
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Agreeableness | 3.8 (0.4) | 3.7 (0.4) | .14 | ||||
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Neuroticism | 2.4 (0.6) | 2.4 (0.6) | .78 | ||||
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Fighting spirit | 3.0 (0.4) | 3.0 (0.4) | .47 | ||||
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Anxious preoccupation | 2.3 (0.4) | 2.2 (0.4) | .07 | ||||
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Helplessness or hopelessness | 1.6 (0.4) | 1.6 (0.5) | .87 | ||||
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Fatalism | 2.1 (0.4) | 2.2 (0.3) | .02 | ||||
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Avoidance | 1.7 (0.7) | 1.6 (0.6) | .47 | ||||
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Psychological distress (yes), n (%) | 101 (87.8) | 32 (91.4) | .56 | |||||
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Self-monitoring and insight, mean (SD) | 3.1 (0.4) | 2.9 (0.4) | .01 | |||||
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Satisfaction with information provision, mean (SD) | 3.9 (0.8) | 3.9 (0.7) | .76 |
a
bEducational levels were defined as follows: low=none or primary school; medium=lower general secondary education or vocational training; or high=preuniversity education or high-level vocational training or university.
cNHL-HG: high-grade non-Hodgkin lymphoma.
dNHL-LG: low-grade non-Hodgkin lymphoma.
eCLL: chronic lymphocytic leukemia.
The results of this RCT demonstrated that patients were neither in a better nor in a worse situation when their individual PRO results were disclosed, as no effects of return of PRO results were found on psychological distress, self-management skills, and satisfaction with information provision. In addition, patients who received their PRO results did not report more contact with their general practitioner or medical specialist compared with those receiving CAU.
Return of individual PRO research results seems to meet patients’ wishes, as the majority of those with access viewed their individual results, of whom two-thirds viewed it more than once. The possibility of comparing their scores with peers was most often chosen, indicating the importance of including normative data to place outcomes in perspective. Almost a quarter chose not to receive their results. Therefore, patients should have the choice as to whether they would like to receive their outcomes [
We observed little statistical differences in characteristics of patients who did view their PRO results and those who did not. Patients who viewed their PRO results more frequently wanted to receive all available information about the disease compared with those who did not view their results. This is in line with the literature that patients with a monitoring (information seeking) coping style tend to benefit from more provided information, whereas patients with a blunting (information avoiding) coping style benefit from less information [
There is increasing interest in integrating the collection of PROs in routine practice to enhance clinical care [
We could not compare our results to the evidence-based BREATH intervention for breast cancer [
With respect to the
This is the first RCT to study the effect of the return of individual PRO results to patients with lymphoma or to patients with cancer in general. The strengths of this study include the design and linkage of PROs with clinical data from the NCR. Owing to the design of our RCT, within a population-based observational cohort, we had access to sociodemographic information about nonparticipants. This provides a unique opportunity to make clear statements about the representativeness of the sample. Participants of the RCT were younger, more often male, and more often highly educated [
In conclusion, the return of individual PRO results seems to meet patients’ wishes, even though it had no beneficial effects on patient outcomes; it did not have negative effects either. Therefore, we decided to include and implement the return of individual PRO results in the PROFILES registry. In addition, at this moment, the return of individual PRO results is extended to other cancer types, such as colorectal cancer, and is used in daily clinical practice. No conclusions could be drawn about the effectiveness of the self-management intervention because the uptake was too limited.
CONSORT-eHEALTH checklist (V 1.6.1).
Breast Cancer eHealth
care as usual
Consolidated Standards of Reporting Trials
effect size
health-related quality of life
Lymphoma Intervention
Netherlands Cancer Registry
patient-reported outcome
Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship
randomized controlled trial
This randomized controlled trial was financially supported by the Jonker-Driessen Foundation. The Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship registry was funded by an investment grant (480-08-009) of the Netherlands Organization for Scientific Research (The Hague, The Netherlands). Both funding agencies had no further role in study design; in the collection, analysis, and interpretation of data; in the writing of this paper; and in the decision to submit the paper for publication.
SO was responsible for data collection, data analysis, and drafting of the manuscript. LPJA was responsible for patient recruitment, data collection, data analysis, and drafting of the manuscript. JMK was responsible for data analysis and contributed to the writing of this manuscript. JP designed the intervention that was originally developed for breast cancer patients and wrote the intervention content. MH, MVDP, AK, CL, WS, DI, JP, MO, RVDG, MN, LT, and EP were responsible for data collection and contributed to writing this manuscript. LVDPF was the project leader and was a major contributor in drafting this manuscript. All authors read and approved the final manuscript.
None declared.