Web-Based Self-Management for Patients With Lymphoma: Assessment of the Reach of Intervention of a Randomized Controlled Trial

Abstract

Background Randomized controlled trials (RCTs) often provide accurate estimates of the internal validity of an intervention but lack information on external validity (generalizability). We conducted an RCT on the effectiveness of a self-management intervention among patients with lymphoma in a population-based setting. Objective The objectives of the current study were to describe the proportion of RCT participants compared to all patients invited to participate, and compare sociodemographic and clinical characteristics of RCT participants with all respondents, all patients invited to participate, and all patients selected from the Netherlands Cancer Registry (NCR) to determine the reach of the intervention. An additional objective was to assess differences on RCT outcome variables between RCT and paper respondents. Methods Patients with lymphoma or chronic lymphocytic leukemia ≥18 years old at diagnosis from 13 hospitals in the Netherlands were selected from the population-based NCR, which routinely collects data on sociodemographic and clinical characteristics. Eligible patients were invited to participate in an RCT and complete a questionnaire. Web-based completion determined RCT enrollment, whereas paper respondents were followed observationally. Results A total of 1193 patients were selected from the NCR, 892 (74.77%) of whom were invited to participate in the trial by their hematologist after verifying eligibility. Among those invited, 25.4% (227/892) completed the web-based questionnaire and were enrolled in the RCT. The RCT participants were younger and there was a higher proportion of men than nonparticipants (P<.001). In addition, 25.7% (229/892) of those invited opted to participate in the paper-based observational follow-up study. Compared with paper respondents, RCT participants were younger (P<.001), with a higher proportion of men (P=.002), and had higher education levels (P=.02). RCT participants more often wanted to receive all available information on their disease (P<.001), whereas paper respondents reported higher levels of emotional distress (P=.009). Conclusions From a population-based sample of eligible patients, the participation rate in the RCT was approximately 25%. RCT participants may not be representative of the target population because of different sociodemographic and clinical characteristics. Since RCT participants represent a minority of the target population, RCT results should be interpreted with caution as patients in the RCT may be those least in need of a self-management intervention. Trial Registration Netherlands Trial Register NTR5953; https://www.trialregister.nl/trial/5790

The effect of web‐based intervention programs on self‐management and symptom management in patients with lymphoma: A systematic review of randomized controlled trials

“…A decrease was observed in anxiety and depression levels following web-based applications in the intervention group (p = .01). However, it was reported that the results would not represent the target population as the participation rate was 25% (Arts et al, 2020). In their study on the effects of e-health self-management application…”

“…In randomized controlled trials, analysis is required for therapeutic purposes, but in most studies, an "intention-to-treat (ITT) analysis" was not performed. The completed ITT and the number of patients lost during follow-up were clearly reported in five studies (Arts et al, 2020;Cheville et al, 2018;Ruland et al, 2010;Stevenson et al, 2020;van der Hout et al, 2020b). The results of the ITT analysis were not reported in only one study (van der Hout et al, 2020a).…”

“…Three of the studies were conducted in the Netherlands and others in the USA, the UK, and Sweden. While one study had a threegroup design (Cheville et al, 2018), the other five studies were found to use a two-group design (Arts et al, 2020;Ruland et al, 2010;Stevenson et al, 2020;van der Hout et al, 2020avan der Hout et al, , 2020b. Also, the studies reviewed were found to focus on the adult population (individuals aged 18 or above).…”

“…Three of the studies reviewed included mixed patient groups (breast, lung, colorectal, etc.) (Cheville et al, 2018;van der Hout et al, 2020avan der Hout et al, , 2020b, while the majority of the participants in the other three studies were patients with lymphoma (Arts et al, 2020;Ruland et al, 2010;Stevenson et al, 2020). Three of the six studies involved self-management interventions (Arts et al, 2020;van der Hout et al, 2020avan der Hout et al, , 2020b, while other studies involved symptom management (Cheville et al, 2018;Ruland et al, 2010;Stevenson et al, 2020).…”

“…The status of blinding was clearly stated. Since the blinding status was not clearly stated in two of the studies, it was decided that they carried an uncertain risk of bias (Arts et al, 2020;van der Hout et al, 2020a). In all studies, missing outcome data were considered low risk.…”