This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
Patients often seek other patients’ experiences with the disease. The Internet provides a wide range of opportunities to share and learn about other people’s health and illness experiences via blogs or patient-initiated online discussion groups. There also exists a range of medical information devices that include experiential patient information. However, there are serious concerns about the use of such experiential information because narratives of others may be powerful and pervasive tools that may hinder informed decision making. The international research network DIPEx (Database of Individual Patients’ Experiences) aims to provide scientifically based online information on people’s experiences with health and illness to fulfill patients’ needs for experiential information, while ensuring that the presented information includes a wide variety of possible experiences.
The aim is to evaluate the colorectal cancer module of the German DIPEx website krankheitserfahrungen.de with regard to self-efficacy for coping with cancer and patient competence.
In 2015, a Web-based randomized controlled trial was conducted using a two-group between-subjects design and repeated measures. The study sample consisted of individuals who had been diagnosed with colorectal cancer within the past 3 years or who had metastasis or recurrent disease. Outcome measures included self-efficacy for coping with cancer and patient competence. Participants were randomly assigned to either an intervention group that had immediate access to the colorectal cancer module for 2 weeks or to a waiting list control group. Outcome criteria were measured at baseline before randomization and at 2 weeks and 6 weeks
The study randomized 212 persons. On average, participants were 54 (SD 11.1) years old, 58.8% (124/211) were female, and 73.6% (156/212) had read or heard stories of other patients online before entering the study, thus excluding any influence of the colorectal cancer module on krankheitserfahrungen.de. No intervention effects were found at 2 and 6 weeks after baseline.
The results of this study do not support the hypothesis that the website studied may increase self-efficacy for coping with cancer or patient competencies such as self-regulation or managing emotional distress. Possible explanations may involve characteristics of the website itself, its use by participants, or methodological reasons. Future studies aimed at evaluating potential effects of websites providing patient experiences on the basis of methodological principles such as those of DIPEx might profit from extending the range of outcome measures, from including additional measures of website usage behavior and users’ motivation, and from expanding concepts, such as patient competency to include items that more directly reflect patients’ perceived effects of using such a website.
Clinicaltrials.gov NCT02157454; https://clinicaltrials.gov/ct2/show/NCT02157454 (Archived by WebCite at http://www.webcitation.org/6syrvwXxi)
Activating patients to become partners in their care has been a priority in health policy in many Western countries over the past years [
Although medical information on diseases, treatments, and outcomes that is based on available quality criteria [
Against this background, this study asks whether a website that provides experiential information on living with colorectal cancer based on scientifically rigorous data collection and analysis positively influences self-efficacy for coping with cancer [
The study used a randomized two-group between-subjects design with repeated measures; participants were randomly assigned either to an intervention group that had immediate access to the colorectal cancer module for 2 weeks or to a waiting list control group that was given access to the module after completion of the study 6 weeks after randomization. Coping self-efficacy served as the primary outcome; patient competencies constituted the secondary outcome. Outcome criteria were measured in both groups at baseline before randomization and at 2 weeks (time 1). At 6 weeks after baseline (time 2), follow-up measures were taken to test for the short-term stability of the intervention. The trial was conducted before the website became available to the general public.
The study protocol was approved by the Charité Universitätsmedizin Berlin ethics committee (EA4/053/12) and was registered (clinicaltrials.gov NCT02157454). This trial is reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement and the CONSORT-EHEALTH extension.
The intervention of the study consisted of a website providing information of experiences by men and women diagnosed with colorectal cancer. The website is a section (module) of a German website krankheitserfahrungen.de, which aims to provide scientifically collected and analyzed experiences of health and illness to patients, health care providers, and the wider public. The project team DIPEx Germany that runs the website is a member of the international research network DIPEx (Database of Individual Patients’ Experiences) [
The content of the modules of the DIPEx website can be accessed via thematic pages (eg, “stoma” or “living with colorectal cancer”) or by interviewed persons (person pages). The person pages can be searched applying a filter (eg, age or gender) for ease of navigation. These features of the website are positively viewed by users [
In determining the necessary sample size for the trial, it was assumed that given a standard deviation of 18 [
Potential participants were considered eligible if they were German-speaking, 18 years of age or older, and had either been diagnosed with colorectal cancer within the past 3 years before enrollment or—independent of time since diagnosis—had metastasized colorectal cancer and/or a relapse of the disease, and who consented to participate online on the study website. Potential participants who indicated on the survey that the time since their diagnosis was more than 3 years and who indicated that they had no recurrence or metastases were excluded from the study.
A wide range of recruitment strategies was used. Many major websites related to colorectal cancer, such as felix-burda-stiftung.de and lebensblicke.de, were informed about the study and provided a link to the study website. Information on the study was posted regularly on a colorectal cancer Facebook group and on online colorectal cancer discussion groups. The study was presented in-person to support groups, in rehabilitation clinics, and to hospital staff for them to aid in recruitment. Some colorectal cancer centers also informed their patients about the study. Finally, the project was presented at information events for patients at hospitals and cancer meetings. Recruitment started in June 2014 and ended in August 2015.
Study participants had to enroll themselves through the study website, which also provided detailed information about the study. If participants then chose to enroll, this was considered as giving consent because they had previously been informed. After enrollment, participants were first asked to complete the baseline measures and were then randomized.
Online data collection at the three measurement points required patients to complete validated questionnaire measures of self-efficacy for coping with cancer, patient competence, depression, social support, health-related quality of life, and medical information received (
Self-efficacy for coping with cancer may be defined as a patient’s confidence in his or her ability to perform coping behaviors in the context of cancer [
Data collection: measurements and time points.
Variables measureda | Baseline | 2 weeks into study |
6 weeks after |
Sociodemographics; illness and treatment characteristics; Internet use behavior | X | ||
Depression: PHQ-2 | X | ||
Social support: SSUK-8 | X | ||
Self-efficacy for coping with cancer: CBI-B-D (primary outcome) | X | X | X |
Self-ratings of patient competencies: FEPK 2-57 (secondary outcome) | All 8 subscales | 4 subscales | 4 subscales |
Information: EORTC QLQ-INFO25 | X | ||
Ratings of personal reports of those affected by cancer | X | X | |
Quality of life: EORTC QLQ-C30 | X |
aCBI-B-D: German version of brief form of Cancer Behavior Inventory; EORTC QLQ-C30: questionnaire to assess the quality of life of cancer patients by the European Organisation for Research and Treatment of Cancer; EORTC QLQ-INFO25: questionnaire to assess information given to cancer patients; FEPK 2-57: 57-item questionnaire on patient competence using five problem-focused and three emotion-focused subscales; PHQ-2: two-item Patient Health Questionnaire; SSUK-8: German brief version of the illness-specific Social Support Scale.
Following Giesler and Weis [
The competencies measured at baseline and weeks 2 and 6 were “self-regulation” (ability to negotiate needed support and to allow for resting periods during the course of the day when needed), “managing distressing emotions” (ability to deal with cancer-related fears), “dealing explicitly with the threat posed to life by cancer” (being able to confront the idea that one might die), and “(low) avoidance” (ability not to engage in ruminating thoughts and avoidance behaviors) [
To allow a more comprehensive characterization of the participants, depression, social support, quality of life, and satisfaction with information received on the condition and its treatment were measured. Depression was measured at baseline using the two-item Patient Health Questionnaire (PHQ-2) [
Data analysis was performed using IBM SPSS versions 23 and 24. Baseline differences between the intervention and the waiting list group were analyzed by means of chi-square statistics for categorical variables or one-way analyses of variance (ANOVAs) in the case of continuous variables based on all participants with nonmissing data for a given variable. Effect sizes were estimated by computing phi coefficients or eta squared. Following Cohen [
For testing the hypothesized intervention effect on the primary and secondary outcomes, we preformed separate regression analyses of the postintervention (week 2) and follow-up (week 6) scores with the intervention dummy coded (intervention=0, control=1) and the respective pretest scores as an additional predictor, which is equivalent to a traditional analysis of covariance. These analyses were based on all randomized participants, using multiple imputation of missing values at baseline and at 2 and 6 weeks. We ran 10 multiple imputations with the full information maximum likelihood method when data were missing in single items or scales. Multiple imputation creates multiple datasets, in which the missing observations are imputed, using a stochastic algorithm that estimates values based on given information and creates different imputed values in each dataset. Statistics are performed separately for these datasets and coefficients are combined after having finished the analyses [
The sample consisted of 212 randomized participants who completed the baseline survey.
The mean age of participants was 54.1 (SD 11.1) years and 58.8% (124/211) were female. Approximately 73.6% (156/212) of the study sample had read or heard stories and experiences of other patients online before that were unrelated to the intervention provided in the study. Most participants were recruited via the Internet (123/212, 58.0%), 33 (15.6%) were referred to the website by their physician, 25 (11.8%) were recruited via flyers, 8 (3.8%) had been informed by friends, and 23 (10.8%) provided no information about their recruitment path.
Flowchart of study participation.
Sociodemographic characteristics of participants in the intervention and control groups at baseline (N=212).
Sociodemographic characteristics | Intervention |
Control |
||
.17 | ||||
Female | 55 (53.9) | 69 (63,3) | ||
Male | 47 (46.1) | 40 (36.7) | ||
Age in years, mean (SD) | 54.5 (11.8) | 53.6 (10.5) | .57 | |
.19 | ||||
With partner | 85 (82.5) | 82 (75.2) | ||
No partner | 18 (17.5) | 27 (24.8) | ||
.70 | ||||
Yes | 78 (75.7) | 80 (73.4) | ||
No | 25 (24.3) | 29 (26.6) | ||
.96 | ||||
≥13 | 53 (52.0) | 57 (53.3) | ||
10 | 39 (38.2) | 39 (36.4) | ||
9 | 10 (9.8) | 11 (10.3) | ||
.06 | ||||
No degree | 8 (7.8) | 1 (0.9) | ||
Vocational training | 55 (53.9) | 53 (49.5) | ||
University degree | 33 (32.4) | 44 (41.1) | ||
Other | 6 (5.9) | 9 (8.4) | ||
.41 | ||||
Employed | 30 (29.4) | 34 (31.2) | ||
Unemployed | 4 (3.9) | 2 (1.8) | ||
Sick leave | 22 (21.6) | 31 (28.4) | ||
Retired | 29 (28.4) | 32 (29.4) | ||
Homemaker | 10 (9.8) | 4 (3.7) | ||
Other | 7 (6.9) | 6 (5.5) | ||
.83 | ||||
<100,000 | 71 (68.9) | 74 (67.9) | ||
100,000-1,000,000 | 16 (15.5) | 20 (18.3) | ||
>1,000,000 | 16 (15.5) | 15 (13.8) |
a
As shown in
Illness and treatment characteristics of participants in the intervention and control groups at baseline (N=212).
Illness and treatment characteristics | Intervention, n (%) |
Control, n (%) |
||
.07 | ||||
<2 years before survey | 62 (60.2) | 61 (56.0) | ||
2-3 years before survey | 28 (27.2) | 42 (38.5) | ||
≥4 years before survey | 13 (12.6) | 6 (5.5) | ||
.37 | ||||
Yes | 25 (24.8) | 33 (30.3) | ||
No | 76 (75.2) | 76 (69.7) | ||
.92 | ||||
Yes | 48 (46.6) | 48 (44.0) | ||
No | 52 (50.5) | 58 (53.2) | ||
Do not know | 3 (2.9) | 3 (2.8) | ||
.72 | ||||
Yes | 12 (11.7) | 11 (10.1) | ||
No | 91 (88.3) | 98 (89.9) | ||
.33 | ||||
Yes | 40 (38.8) | 35 (32.4) | ||
No | 63 (61.2) | 73 (67.6) | ||
.91 | ||||
Completed | 53 (58.9) | 61 (60.4) | ||
Ongoing | 29 (32.2) | 29 (28.7) | ||
Planned or uncertain | 5 (5.6) | 6 (5.9) | ||
Not received | 3 (3.3) | 5 (5.0) | ||
.88 | ||||
Completed | 33 (63.5) | 43 (67.2) | ||
Ongoing | 2 (3.8) | 2 (3.1) | ||
Planned or uncertain | 2 (3.8) | 1 (1.6) | ||
Not received | 15 (28.8) | 18 (28.1) | ||
.60 | ||||
Completed | 88 (89.8) | 96 (93.2) | ||
Ongoing | 1 (1.0) | 1 (1.0) | ||
Planned or uncertain | 8 (8.2) | 4 (3.9) | ||
Not received | 1 (1.0) | 2 (1.9) |
a
Health information-seeking characteristics and mean scores for patient competence, social support, and depression of participants in the intervention and control groups at baseline (N=212).
Patient characteristics | Intervention | Control | |||
n=71-103 | n=83-109 | ||||
.59 | |||||
Yes | 39 (43.8) | 35 (39.8) | |||
No | 50 (56.2) | 53 (60.2) | |||
.46 | |||||
Yes | 12 (16.9) | 18 (21.7) | |||
No | 59 (83.1) | 65 (78.3) | |||
.62 | |||||
Yes | 96 (97.0) | 101 (98.1) | |||
No | 3 (3.0) | 2 (1.9) | |||
.81 | |||||
Yes | 76 (73.8) | 82 (75.2) | |||
No | 27 (26.2) | 27 (24.8) | |||
.74 | |||||
Yes | 19 (23.5) | 19 (21.3) | |||
No | 62 (76.5) | 70 (78.7) | |||
.87 | |||||
Yes | 76 (74.5) | 80 (75.5) | |||
No | 26 (25.5) | 26 (24.5) | |||
Self-efficacy for coping with cancer, mean (SD)b | 99.74 (17.20) | 96.27 (19.71) | .20 | ||
n=96-103 | n=103-108 | ||||
Seeking information | 4.00 (0.79) | 4.04 (0.78) | .73 | ||
Self-regulation | 3.61 (0.51) | 3.48 (0.75) | .18 | ||
Patient-physician interaction | 4.09 (0.71) | 4.00 (0.78) | .40 | ||
Autonomous decision | 2.92 (0.82) | 2.84 (0.89) | .51 | ||
Interest in social benefits | 3.98 (1.42) | 3.92 (1.38) | .76 | ||
n=58-86 | n=61-94 | ||||
Coping with distress | 3.54 (0.88) | 3.32 (0.77) | .14 | ||
Dealing with threat | 3.78 (0.56) | 3.70 (0.72) | .53 | ||
Low avoidance | 3.39 (0.78) | 3.35 (0.80) | .74 | ||
Depression, mean (SD)c | 1.58 (1.55) | 1.81 (1.51) | .29 | ||
n=103-109 | n=102-106 | ||||
Positive support | 4.43 (0.62) | 4.22 (0.78) | .04 | ||
Distressing interaction | 2.00 (0.77) | 1.92 (0.70) | .48 |
a
bIntervention: n=94; control: n=97.
cIntervention: n=101; control: n=105.
On average, participants in the intervention group visited the intervention website for mean 42.21 (SD 45.64, median 26) minutes in total. The mean number of sessions at the site was 3.43 (SD 2.94, median 3). A mean 40.15 (SD 42.14, median 26) clicks across all sessions suggests that the intervention participants accessed a moderately large number of subpages.
Results of regression analyses of group effects on primary and secondary outcomes at 2 weeks including the respective baseline score as additional predictor.
Outcomes | Participants, mean (SE)a | Group effecta | Baseline predictora | |||||||||
Intervention |
Control |
Total |
b | beta (range) | b | beta (range) | ||||||
–2.25 | .21 | –0.07, –0.05 | 0.79 | <.001 | 0.74, 0.76 | |||||||
Baseline | 98.35 (1.66) | 94.45 (1.94) | 96.34 (1.29) | |||||||||
Week 2 | 96.06 (1.68) | 90.71 (2.09) | 93.31 (1.36) | |||||||||
–0.03 | .60 | –0.03, –0.01 | 0.83 | <.001 | 0.76, 0.80 | |||||||
Baseline | 3.58 (0.06) | 3.48 (0.07) | 3.53 (0.05) | |||||||||
Week 2 | 3.49 (0.06) | 3.37 (0.08) | 3.43 (0.05) | |||||||||
–0.13 | .07 | –0.12, –0.07 | 0.64 | <.001 | 0.68, 0.72 | |||||||
Baseline | 3.62 (0.08) | 3.42 (0.07) | 3.52 (0.05) | |||||||||
Week 2 | 3.53 (0.06) | 3.27 (0.07) | 3.39 (0.05) | |||||||||
–0.05 | .52 | –0.07, –0.03 | .50 | <.001 | 0.49, 0.54 | |||||||
Baseline | 3.74 (0.06) | 3.73 (0.07) | 3.74 (0.04) | |||||||||
Week 2 | 3.72 (0.06) | 3.67 (0.06) | 3.69 (0.04) | |||||||||
0.03 | .68 | 0.01, 0.04 | 0.66 | <.001 | 0.66, 0.71 | |||||||
Baseline | 3.40 (0.08) | 3.38 (0.08) | 3.39 (0.05) | |||||||||
Week 2 | 3.24 (0.07) | 3.25 (0.07) | 3.25 (0.05) |
aResults based on 10 multiple imputations, b coefficient combined (mean), beta coefficients as effect size, minimum and maximum across imputations, group dummy coded with intervention=0, control=1.
Results of regression analyses of group effects on primary and secondary outcomes at 6 weeks including respective baseline scores as additional predictor.
Outcomes | Participants, mean (SE)a | Group effecta | Baseline predictora | |||||||||
Intervention |
Control |
Total |
b | beta (range) | b | beta (range) | ||||||
–0.00 | .99 | –0.01, 0.01 | 0.62 | <.001 | 0.61, 0.64 | |||||||
Baseline | 98.35 (1.66) | 94.45 (1.94) | 96.34 (1.29) | |||||||||
Week 6 | 93.73 (1.62) | 91.29 (2.01) | 92.48 (1.30) | |||||||||
0.09 | .23 | 0.04, 0.08 | 0.62 | <.001 | 0.63, 0.70 | |||||||
Baseline | 3.58 (0.06) | 3.48 (0.07) | 3.53 (0.05) | |||||||||
Week 6 | 3.46 (0.06) | 3.48 (0.07) | 3.47 (0.05) | |||||||||
–0.01 | .86 | –0.03, 0.02 | .53 | <.001 | 0.59, 0.65 | |||||||
Baseline | 3.62 (0.08) | 3.42 (0.07) | 3.52 (0.05) | |||||||||
Week 6 | 3.50 (0.06) | 3.38 (0.06) | 3.44 (0.04) | |||||||||
–0.02 | .75 | –0.05, 0.01 | 0.47 | <.001 | 0.46, 0.54 | |||||||
Baseline | 3.74 (0.06) | 3.73 (0.07) | 3.74 (0.04) | |||||||||
Week 6 | 3.73 (0.06) | 3.70 (0.06) | 3.71 (0.04) | |||||||||
–0.04 | .62 | –0.07, 0.01 | 0.61 | <.001 | 0.61, 0.67 | |||||||
Baseline | 3.40 (0.08) | 3.38 (0.08) | 3.39 (0.05) | |||||||||
Week 6 | 3.24 (0.08) | 3.18 (0.07) | 3.21 (0.05) |
aResults based on 10 multiple imputations, b coefficient combined (mean), beta coefficients as effect size, minimum and maximum across imputations, group dummy coded with intervention=0, control=1.
This randomized controlled trial investigated the effects of a website presenting systematically collected and organized patients’ experiences of living with colorectal cancer on self-efficacy for coping with the disease and on patient competencies such as coping with emotional distress or dealing with the life threatening nature of cancer [
In what follows, we will briefly discuss possible explanations for each of these observations. Insofar as these explanations involve factors relating to characteristics of the new website module itself or to its use by participants, they will primarily be discussed in the section comparing these results to prior work. In contrast, explanations that involve methodological factors will be discussed in the limitations section. Considering these factors in more detail may help improve the design of future studies that aim at evaluating websites providing patient narratives on living with (colorectal) cancer. This appears especially important if one shares the conviction that such narratives contain elements that are relevant for empowering cancer patients and helping them develop their coping competencies and coping self-efficacy.
Regarding the slight, but significant, decrease of self-efficacy for coping with cancer and three patient competence scales across time observed in this study, a possible explanation may lie in assuming the operation of a response shift [
A major limitation of this study may be that its participants were much younger on average (mean 54.1, SD 11.1 years) than patients with colorectal cancer in Germany in general (mean 71 years) [
Another important limitation may be the fact that far fewer participants could be recruited for the study than suggested by the initial determination of the necessary sample size. This inevitably reduced the power of the trial to detect a treatment effect, if it in fact existed. It would certainly have been preferable to extend the recruitment phase of the study. Unfortunately, this was not possible because of the timeline of the study and the intention to make the newly constructed website available to the public in due time. Nevertheless, achieving the targeted sample size would by no means have guaranteed to establish the hypothesized effect.
Traditional face-to-face psychoeducational interventions in cancer patients have been shown to yield small-to-medium positive effects on distress and quality of life, although problems with study quality and heterogeneity have to be acknowledged [
Regarding self-efficacy for coping with cancer and patient competence, this study found that having access to a new website presenting illness narratives of colorectal cancer patients that have been systematically collected on a scientific basis has no effect compared to a control condition. Possible explanations of this finding may be seen in specific features of the website itself and in features of patients’ on-site usage behavior that might operate as a moderator of online intervention effects on coping self-efficacy and patient competence and other patient-reported outcomes. As a consequence, it may be of importance to analyze patients’ usage behavior in more detail in future research. Furthermore, future research should extend the range of outcome criteria and include measures that more directly reflect patients’ perceived effects of using such a website.
Cancer Behavior Inventory
Consolidated Standards of Reporting Trials
Database of Individual Patients’ Experiences
European Organisation for Research and Treatment of Cancer
Patient Health Questionnaire
Illness-specific Social Support Scale
We want to thank everyone who helped to recruit participants for the study. We also thank the patients interviewed for krankheitserfahrungen.de for their patience in waiting to see the website go live. Finally, we want to thank all our study participants.
The study was funded by the German Ministry of Health (grant number: NKP-332-041). The ministry played no role in the study.
None declared.
CONSORT-EHEALTH (v.1.6.1).