|- candidate number||14095|
|- NTR Number||NTR3779|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-dec-2012|
|- Secondary IDs||NIVEL 2010-4747 / 38333.091.11 KWF / METC St Radboud|
|- Public Title||Enhancing patient communication in oncology consultations.|
|- Scientific Title||Enhancing patient communication during oncology follow-up visits: The design and testing of a computer-tailored pre-visit patient education program.|
|- Healt Condition(s) or Problem(s) studied||E-health, Web-based tailored , Malignant lymphoma, Patient-caregiver communication|
|- Inclusion criteria||1. Diagnosed with malignant lymphoma;|
2. Age 18 or older;
3. Having internet access at home;
4. At least one (follow up) consultation per year.
|- Exclusion criteria||1. Age under 18;|
2. Not having internet access at home;
3. Less than one (follow up) consultation per year.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2013|
|- planned closingdate||1-mrt-2015|
|- Target number of participants||100|
|- Interventions||The intervention is an online communication training for patients, focused on communicating with their health care provider. The goal of the training is the support patients to prepare their consultations. The training is computer-tailored to patientsí efficacy for communication with health care providers, to their communication goals, to whether they attend their consultations alone or with a companion and to their health status. The training includes information, advice and video fragments of simulated consultations to model adequate communication behaviour. Additionally, the intervention includes a QPS (question prompt sheet). Patients can print this sheet to take it to the consultation. The intervention group receives access to the online communication training one week before every consultation during the year of measurement. In this week the participants will be asked to visit the training before they enter the consultation. The participants can access the training from their own computer, at the time they prefer and as many times as they want during that week.
The control group will receive access to the program after the data-collection period has finished.
|- Primary outcome||Perceived and experienced efficacy for communication (QT0, QT3).|
|- Secondary outcome||Evaluation of achievement of the communication goals (QT0, QT1), patient satisfaction with the control visit (QT1,QT2), patient expression of questions, cues and concerns (analysis of audio recordings), anxiety (QT0,QT1), information recall (QT1,QT2, analysis of audio recordings) and cancer worry (QT0,QT3).|
|- Timepoints||Patients will be asked to complete an online questionnaire at inclusion (QTi), before (QT0) and after (QT1) their first consultation during the year of data collection. Subsequently, they will be asked to complete an online questionnaire after each following consultation (QT2) and three months after their last consultation during the year of data collection (QT3). |
|- Trial web site||www.patientTIME.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Ir. I.R. Bruinessen, van|
|- CONTACT for SCIENTIFIC QUERIES||Ir. I.R. Bruinessen, van|
|- Sponsor/Initiator ||NIVEL, Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society|
|- Brief summary||OBJECTIVE: |
The aim of the study is to test the effects of an online communication training to enhance cancer patients' utterance of questions, cues and concerns during oncology (follow-up) visits and their evaluation of the communication. The secondary aim of the study is to examine the feasibility of granting patients more control in the execution of a research project by asking them to collect audio recordings of their own follow-up visits.
Using a randomised controlled trial, this study examines the effectiveness of an online communication training for patients diagnosed with malignant lymphoma. Patients will be randomly assigned to receive the online communication training or to receive access at the end of the study. Both intervention and control group patients will be asked to fill in questionnaires. Part of the participants will be provided with audio equipment to audiotape their consultations.
|- Main changes (audit trail)||14-May-2013: Text regarding timepoints has been adjusted - NM|
New text: Patients will be asked to complete an online questionnaire at inclusion (QTi), before (QT0) and after (QT1) their first consultation during the year of data collection (with a maximum of 3 consultations). Subsequently, they will be asked to complete an online questionnaire after each following consultation (QT2) and three months after their last measured consultation (QT3).
|- RECORD||14-dec-2012 - 19-nov-2014|