Effective Information Provision About the Side Effects of Treatment for Malignant Lymphoma: Protocol of a Randomized Controlled Trial Using Video Vignettes

Abstract

Background Informing patients with cancer about the possible implications of prospective treatment is a crucial yet challenging task. Unfortunately, patients’ recall of medical information is generally poor and their information needs are not met. Effective information giving entails that oncologists help patients understand and recall the implications of their treatment, meanwhile fostering a trusting physician-patient relationship. Communication strategies that are often suggested to be effective are structuring and tailoring (cognition-oriented) but also are oncologists’ expressions of caring or empathy (affect-oriented). Objective The aim of this study is to provide evidence concerning the pathways linking physician communication to (improved) consultation outcomes for patients. More specifically, the aim is to determine the effects of information structuring and information tailoring , combined with physician caring , on information recall, satisfaction with information, and trust in the physician (primary objective) and on symptom distress (secondary objective). Methods A randomized controlled trial, systematically testing the effects of information structuring and information tailoring , each combined with caring , in 2 video-vignette experiments (2×2 and 2×2×2 design). Using an online survey platform, participants will be randomly allocated (blinded) to 1 of 12 conditions in which they are asked to view a video vignette (intervention) in which an oncologist discusses a treatment plan for malignant lymphoma with a patient. The independent variables of interest are systematically varied across conditions. The outcome measures are assessed in a survey, using validated instruments. Study participants are (former) patients with cancer and their relatives recruited via online panels and patient organizations. This protocol discusses the trial design, including the video-vignette design, intervention pretesting, and a pilot study. Results Data collection has now been completed, and preliminary analyses will be available in Spring 2019. A total of 470 participants completed the first part of the survey and were randomized to receive the intervention. Conclusions The results of the proposed trial will provide evidence concerning the pathways linking physician information, giving skills to (improved) consultation outcomes for patients. Trial Registration Netherlands Trial Register NTR6153; https://www.trialregister.nl/trial/6022 (Archived by Webcite at http://www.webcitation.org/76xVV9xC8). International Registered Report Identifier (IRRID) DERR1-10.2196/12453

Possible alleviation of symptoms and side effects through clinicians’ nocebo information and empathy in an experimental video vignette study

“…(a) General side-effect expectations, (b) general side-effect experiences 16 , 42 , (c) current side effects (0–100 VAS ‘not at all ‘to ‘very much’), all adapted from previous studies 16 , 43 .…”

“…For a list of 13 pre-defined side effects (determined in collaboration with the oncologists involved and divided into the groups ‘specific’ (i.e., hair loss, nausea, diarrhea, impaired immune system functioning, neuropathy), ‘non-specific’ (i.e., loss of interest/apathy, insomnia, being abrupt/irritability) and ‘partially specific/non-specific’ (i.e. cognitive impairment, fatigue, headache, concentration problems, rash), we assessed participants’ expectations regarding: (a) probability: probable occurrence of side effects (0–10 NRS scale, ‘not probable at all’ to ‘very probable’, self-created question adapted from 16 , 43 , (b) intensity: intensity (severity) of side effects (0–10 NRS scale, ‘not at all intense’ to ‘very intense’ using a modified version of the GASE 44 , adapted from 15 ), (c) Coping: coping with side effects (0–10 NRS scale, ‘not handling at all’ ‘handling very well’, using a modified version of the GASE 44 adapted from 15 ).…”

Provider caring and structuring treatment information to improve cancer patients’ recall: Does it help?

“…Some participants indicated that too much information was discussed in our vignettes, and negative effects of providing too much information have indeed been reported previously [11]. Nevertheless, our video consultations closely resembled real-life situations in terms of length and type/amount of information, and were developed together with oncology care providers to enhance validity [56].…”

“…This study was part of a larger experimental protocol (Fig. 1) and additional details about the study protocol and development of video vignettes have been published elsewhere [56]. Our video vignettes showed a patient-provider conversation about the intended treatment plan of a recently diagnosed lymphoma patient (e.g., rounds of chemotherapy, potential side effects).…”

“…Two aspects of recall, that is active recall and recognition, were measured in this study. Both were based on the Netherlands Patient Information Recall Questionnaire [38] and their development was described in the full study protocol [56]. Active recall was measured with 14 open-ended questions inquiring about information presented in the video vignette (e.g., patient's type of cancer, type of treatment, potential side effects).…”