Project Title: CANPRIM – BEYOND ONCOLOGY INTO PRIMARY CARE CANCER DISTRESS FOLLOW-UP STUDY AMONG OUTPATIENTS
Project code: PN-III-P1-1.1-TE-2019-0097
Single Stage: September-December 2020
In opening the 2020 report, we briefly present the objectives of the first single stage of this project.
(1.1) Building and implementing meeting and working visit protocols; (1.1.1) Weekly sessions/meetings with all the team members; (1.1.2) Preparation of weekly reports resulting from meetings; Implementation of a work plan by each member of the team, aiming at each task to be performed and the scheduled date for its completion; (1.1.3) Obtaining the ethical approval for CANPRIM research;
(1.2) Construction of the CANPRIM questionnaire in Romanian language; (1.2.1) Establish how each team member will contribute to its construction and translation; (1.2.2) Translation of some questionnaires from English language into Romanian language; (1.2.3) Sending the whole/entire questionnaire for checking and completion by the project team; (1.2.4) Sending the questionnaire to the IT team that will introduce it in the CANPRIM application and on the project’s web platform.
(1.3) Construction/Creating the semi-structured interview guide in Romanian; (1.3.1) Establish by mutual agreement the questionnaires and questions that will make up the semi-structured interview; (1.3.2) Translation of some questionnaires from English into Romanian; (1.3.3) Final construction and completion of the semi-structured interview;
(1.4) CANPRIM application for data collection; (1.4.1) Application components; (1.4.2) Application testing and verification;
(1.5) List of participating GP medical offices; (1.5.1) Obtaining support from the National Society of Family Physicians – SNMF; (1.5.2) Establishing the counties/districts where we will send the invitation to GPs, family doctors; (1.5.3) Collecting the contacts of GPs, family doctors from each county; (1.5.4) Creating the data collection table; (1.5.5) Determining the protocol of and frequency of contacting doctors; (1.5.6) Contacting patients with the help of GPs, family doctors;
(1.6) Web page of the CANPRIM project – http://www.canprim.psychooncology.ro.
(1.1) The first objective of this unique stage was to establish the protocols of meetings and working visits. This objective was achieved by the fact that the team set together a weekly date for the joint meeting in which the necessary steps for the implementation of the project were discussed as well as the tasks related to each team member and the constant monitoring of the progress. (1.1.1) After each joint meeting, the activity reports were made regarding the topics discussed during the meeting that took place and the tasks to be performed, this being recorded in a collaborative document on GDRIVE. (1.1.2) The project director provided training to protect research participants as well as the importance of GDPR. The field researchers underwent a training on the protection of personal data and human subjects, after which they obtained a certificate of research ethics. They went through the JHSPH Human Subjects Research Ethics Guide, after which they had to complete a test in order to receive the ethical certification; they also went through Ethics for researchers from the European Commission and Romanian and European Union legislation on GDPR. The Informed Consent Form and the GDPR Form for research participants were also completed. (1.1.3) On 30.10.2020, the ethical approval with no. 16.260 for CANPRIM research from the Scientific Council of UBB was obtained. Available here: https://cutt.ly/EhgEL3D.
(1.2) With regard to the second objective of this single stage, the first subsection was to determine how each team member would contribute to the translation of the questionnaire. (1.2.1) Thus, the members of the CANPRIM project team established that the field researchers Alexandra Rebeca Mihoc and Pustianu Valeria Daniela to translate the necessary tools from English into Romanian for the first time, after which they were sent to the project director Dégi László Csaba who translated them back in English. He then sent them to Mrs. Éva Kállay who translated them back into Romanian and made their final check. (1.2.2) Some scales included in this questionnaire have already been translated into Romanian, namely GAD7, PHQ9 and EORTC QLQ-C30. The translated scales were incorporated with those translated from English to Romanian. The questionnaire consists of 4 parts: the first part (first page of the questionnaire) is based on the Emotional and Impact Thermometers that monitor the patient’s cancer distress in the last week and how much help and respectively, how much impact these emotions felt on him/her; the second part (Part A) consists of personal data about the patient; the third part (Part B) tracks patient health data and the last part (Part C) contains instruments for measuring psychological factors such as: PHQ9-which is a tool for screening and measuring the level and severity of depressive symptoms; EORTC QLQ-C30-which measures patients’ quality of life; FoP-Q-SF-which measures the fear of recurrence of the disease; PCI-which is a screening tool for the problems that patients may face; EORTC QLQ-INFO25-which assesses the level of information that patients received following consultations; GAD7-which assesses patients’ level of concern, anxiety. (1.2.3) The verified final version of the questionnaire was completed and uploaded on 18.11.2020. (1.2.4) The last step regarding the CANPRIM questionnaire for patients was to send it to the IT team which is responsible for developing the CANPRIM application.
(1.3) Objective three of this first single stage aimed at creating the semi-structured interview guide in Romanian for GPs, medical staff. The first step in its realization (by the project team) was to establish the content of the semi-structured interview. (1.3.1) The project director, Mr. Dégi László Csaba, sent to the field researchers a series of tools to be translated from English into Romanian, namely a series of questions from an article: Zebrack, B., Kayser, K., Nelson, K., & Sundstrom, L. (2016). Enhancing Institutional Capacity to Deliver Psychosocial Care: A Report from AOSW’s Project to Assure Quality Cancer Care (APAQCC) JOURNAL OF PSYCHOSOCIAL ONCOLOGY (Vol. 34, pp. 134-135); a short questionnaire adapted to primary health care in Romania, which addressed the changes brought by the coronavirus pandemic, from the article – ”No turning back ”Psycho-oncology in the time of COVID-19: Insights from a survey of UK professionals, Archer S., Holch P., Armes Jo., Calman L., Foster C., Gelcich S., MacLennan SJ., Absolom K., 2020. These questions were added to a number of questions about their personal data, their opinion on psycho-oncology needs in primary care in Romania and some questions proposed by field researchers Alexandra Rebeca Mihoc and Pustianu Valeria-Daniela. (1.3.2) Field researchers translated the tools/questions from English into Romanian and adapted them to evidence primary health care needs in Romania regarding quality cancer care. The project director, Mr. Dégi László Csaba, verified this translation and made the necessary changes. (1.3.3) The final version of the interview guide consists of four parts. The first part consists of 5 questions that have been formulated by the project team; the second part (A) contains personal data; the third part (B) consists of questions about psycho-oncology needs in Romania and the last part (C) is based on questions about cancer and the coronavirus pandemic.
(1.4) The CANPRIM application was developed through services with third parties’ services by an IT team. The mobile application for Android system has been implemented and delivered CANPRlM.apk along with the corresponding source code. (1.4.1) The CANPRIM research application includes the following functions: mobile application user authentication; displaying to the Android application users the questionnaires that are part of the CANPRIM study; connecting the answers of persons with cancer to the questionnaires in the study as well as saving on the CANPRIM server the responses of persons affected by cancer. The CANPRIM web application was also implemented and delivered along with the source code for it. The web application includes the following: the application is published at: https://psychooncology.ro/CANPRIM/; the application allows the introduction, modification and maintenance of questions that are part of the CANPRIM study; the application allows for the coded introduction of persons with cancer which are part of the study, the assignment of questionnaires to which patients included in the CANPRIM study will respond, the saving of responses provided in the mobile application and the data management of the responses provided in the study. (1.4.2) In vivo testing and verification of the CANPRIM application was carried out by the project team.
(1.5) Approach was established to contact GPs, family doctors, and the keywords to be included and emphasized in the conversation were discussed. Together with the field research coordinator the custom presentation text as well as the communication protocol named Standard way of contacting family doctors was carried out. (1.5.1) At the meeting on 19.10.2020 we also discussed the affirmative answer of Mr. Mergeani (President of the National Society of Family Medicine in Romania) with the help of which the official invitation of the CANPRIM project was published on the official website of the SNMF and on its social media platforms. He highlighted the specialized terms that it would be desirable to adopt and use both on the field research and in our project, in terms of primary care. In this context, the working emails of researcher Alexandra Rebeca Mihoc | email@example.com and Pustianu Valeria-Daniela | firstname.lastname@example.org was set up to carry out contact and collaboration. (1.5.2) Together with the field coordinator, Mihoc Alexandra, we have also established to plan for the first phase of data collection in the following counties: Cluj, Arad, Timiş, Bistrița, Hunedoara, Covasna, Botoşani, Neamț, Mureş, Iasi, Satu Mare, Suceava, Braşov and Harghita, these constituting about a quarter of the counties in Romania. (1.5.3) We have established that in order to contact the GPs, family doctors we use the lists of primary care providers available on the county websites of the National Health Insurance House, which contain their contact details. GPs, family doctor lists have been updated and uploaded to the drive in Excel format, to which we have added a table that helps us manage data collection. (1.5.4) The making of this customized table was set up with the help of the project team. The table contains how to contact family doctors (by email/phone), their response (affirmative/negative), designated patients (name along with the application code), recommendation of another GP, doctor, if applicable, and other details are presented at the end. We also established a caption that contains three colors to help visualize the situation by county: the red color represents the doctor’s refusal to participate in the project, the yellow color means that the email was sent to the family doctor/he was contacted by phone and did not answer the call and a response is expected, and the green color indicates his acceptance to participate in the project. (1.5.5) In our protocol of contacting family doctors we decided to send them three times an email with the project invitation, followed up by a telephone contact, and if no answer is given to this invitation, we will leave a text message with the project invitation. (1.5.6) Contacting patients will be done with the help of GPs, family doctors. The first step is to contact and inform the family doctor about the CANPRIM project, and then discuss with him/her about the semi-structured interview and patient contacts. The only field contact, delegation in the reported period was in Harghita county.
(1.6) Here is the interface of the CANPRIM web page – http://www.canprim.psychooncology.ro – that has been built with the following main menu: Activities, Team, Collaborators, Results, Publications and Contact. It also includes an invitation to participate in the CANPRIM research and its short description, linking to a more detailed presentation. The GPs, doctors’ questionnaire will be accessible on the website, too. Our web page contains all required content.