Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

All Drugs and Chemicals

Hormones

Women older than 18 years of age who have suffered from hormonally dependent breast cancer stages 0-III (from "in situ" to locally advanced breast cancer) according to the American Joint Committee on Cancer (AJCC) classification and have been undergoing adjuvant endocrine therapy for more than 3 months.

An observational study conducted in a cross-sectional manner using a questionnaire.

Survey using a questionnaire.

Iva Mucalo

Faculty of Pharmacy and Biochemistry

Centre for Applied Pharmacy

Breast cancer is the most common type of cancer and the leading cause of cancer death in women. Adjuvant endocrine therapy (AET) reduces the risk of disease recurrence and mortality in women with hormone-dependent breast cancer. This cross-sectional study aims to investigate adherence to AET and identify factors associated with adherence in the Republic of Croatia. The level of adherence, beliefs about medicines, and quality of life with AET will be investigated with validated instruments in the form of an anonymous survey. Given the available data on suboptimal adherence to AET in Europe and globally, it is clear that there is a need for investigating adherence in Croatia which hasn't been done so far. Each country, population, and health system has its own characteristics, and understanding the experience of using AET and identifying associated psychosocial factors could help in developing specific interventions supporting women and improving AET adherence.

Factors Influencing Adherence to Adjuvant Endocrine Therapy

Factors Influencing Adherence to Adjuvant Endocrine Therapy in Women With Early Breast Cancer in Croatia

The overall aim of the study is to determine the proportion of women adherent to oral adjuvant endocrine therapy (AEL) after the diagnosis of breast cancer in Croatia, as well as to investigate the association between AEL adherence, medication beliefs, quality of life, sociodemographic, and clinical factors.

Investigate medication beliefs using the Medication Beliefs Questionnaire (BMQ).

Examine the quality of life using the Quality of Life Questionnaire with endocrine symptoms (FACT-ES).

University of Zagreb

Associate professor at the Center for Applied Pharmacy.

Blood and Lymph Conditions

Rare Diseases

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Myeloproliferative Disorders

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Chronic Myeloproliferative Disorders

The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The main purpose is to assess adherence to ruxolitinib using the ARMS questionnaire. Each individual patient will be administered the questionnaire at the first convenient opportunity, regardless of when ruxolitinib is started, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement.

The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histologic, cytogenetic, molecular, and radiologic investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular, data related to systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. These data will be collected at the first administration of the ARMS questionnaire and again after 12, 24, and 48 weeks. If performed, any additional assessments will also be recorded. Each individual patient will be administered the questionnaire (ARMS) at the first convenient opportunity, regardless of the time of initiation of ruxolitinib, and again after 4, 8, 12, 24, and 48 weeks, in conjunction with drug procurement. If in-person data collection is not possible, the mode of data collection by telephone interview will be adopted. The minimum expected duration of individual patient observation is 48 weeks.

Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence

Emotional distress is measured based on a visual analogue scale with the distress thermometer, a simple and quick (3-4 minutes) tool that investigates the areas most involved in distress (minimum value: 0, lower distress; maximum value: 10, higher distress)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients in this group will be encouraged to prepare each of the four medical encounters targeted in the trajectory in radiation oncology using Let's Discuss Health website, which are the initial visit, the mid-treatment visit, the end-of-treatment visit and the 3-month post-treatment visit.

Patients in this group will received the usual care in the radiation oncology care pathway.

Use of the Let's Discuss Health website to prepare four medical encounters with the radiation oncologist throughout the radiation care trajectory.

Let's Discuss Health Group

Marie-Thérèse Lussier, MD, MSc

Marie-Eve Lavoie, PhD

Marie-Andrée Fortin, MD

Moein Alizadeh, MD

Israël Fortin, MD

William Foster, MD

Isabelle Germain, MD

In Canada, the prevalence of cancer is growing and contributes significantly to health costs. The prevention and treatment of cancer is a major concern of our health system. Many men with prostate cancer develop psychological distress. The emotional consequences of a cancer diagnosis and its treatments can prevent patients from communicating effectively with their healthcare team. It is recognized that the quality of communication between cancer patients and their caregivers plays an important role in the management of their disease. However, few tools are being developed to help clinicians and patients better communicate and decrease patients' psychological distress. Let's Discuss Health (www.discutonssante.ca) is a French-language website that offers several tools to support collaboration between caregivers and cancer patients.

The objectives of this research project are to assess the experience of using the Let's Discuss Health website and the impact of its use on the quality of communication between radiation oncologists and patients, the level of distress of patients with prostate cancer, recall of the information discussed as well as adherence to the trajectory in radiation oncology.

The project will take place in three radiation oncology centers in Quebec. Two groups of prostate cancer patients will be recruited. Patients in the first group will be assessed on the basis of regular consultations and those in the second group will be encouraged to prepare for their medical visits using the Let's Discuss Health website. Patients and their caregivers will answer short questionnaires before and after four targeted consultations (initial visit, mid-treatment visit, end-of-treatment visit and 3-month post-treatment visit). Focus groups will also be organized to explore the impact of the website.

This project offers the potential to transform clinical practices in radiation oncology to reduce the burden of cancer and improve the quality of care offered to patients with cancer.

Comparative study in which two distinct groups of patients will be formed, sequentially. Patients from both groups will be assessed by the same radiation oncologists recruited from each of the three centers. In each center, recruited patients will initially be assigned to Group 1 (Usual Care) until 50 patients will be included in the study (for a total of 150 patients in this group). Recruitment will then pursue and patients will be assigned to Group 2 (Intervention) until 50 patients will be included in the study (for a total of 150 patients in this group).

Patients in Group 1 (Usual Care) will be assessed during regular consultations of the radiation oncology care pathway. Those in Group 2 (Intervention) will be encouraged to prepare each of the four medical encounters targeted in the usual trajectory in radiation oncology using Let's Discuss Health website. For Group 2, the radiation oncologists will have participated in an workshop on the Let's Discuss Health website.

ComCancer: Use of Let's Discuss Health Website by Patients With Prostate Cancer Undergoing Radiation Oncology Treatment

ComCancer - Integration Into the Radiation Oncology Care Trajectory of the Let's Discuss Health Website and Evaluation of Its Effects in Patients With Prostate Cancer

Proportion of patients in the Intervention Group who complete the Let's Discuss Health summary sheet at each of the four targeted visits.

Using Medicode, the exchanges during the medical encounters will be qualified as dialogue or monologue for each of the topics covered in the discussion of cancer itself and each of the treatment options discussed according to the following themes: designation, dosage, main effect observed, main effect anticipated, side effects observed, possible side effects, indication to consult again, attitudes and emotions and warnings.

The dialogic rate (DR) will be generated. It is determined by the proportion of exchanges on a topic that is a dialogue, i.e., a contribution to the content exchanged by each of the interlocutors, and the proportion that is a monologue, i.e., a contribution to the content by a single interlocutor. The DR score ranged between 0 (monologue) and 1 (dialogue). An overall DR score per targeted treatment option will be calculated by aggregating the scores for each of the topics discussed in relation to that treatment.

The psychological distress before the medical encounters throughout the care trajectory will be assessed using the distress thermometer developed by the National Comprehensive Cancer Network. The level of emotional distress will be self-rated using a visual analog scale from 0 \[no distress\] to 10 \[extreme distress\].

Appropriate patient recall of the information discussed during the medical encounter will be assessed using a home-made questionnaire. Dimensions assessed include severity of the disease, treatment options, side effects, and perceived risk of the disease itself or its treatment. The questionnaire asks patients to indicate whether an information was discussed using a 3-point rating scale (yes, no, I don't remember). For each "yes" answer, patients are asked to provide the information discussed. The answers will be compared to the information coded using MEDICODE. Percentage of correct answers will be reported.

Appropriate patient recall of the information discussed during the medical encounter will be assessed using a home-made questionnaire. Dimensions assessed include side effects and their management, when being cured, chances of survival following the treatment, probability of cancer recurrence, and follow-up. The questionnaire asks patients to indicate whether an information was discussed using a 3-point rating scale (yes, no, I don't remember). For each "yes" answer, patients are asked to provide the information discussed. The answers will be compared to the information coded using MEDICODE. Percentage of correct answers will be reported.

Measurements of: 1) total number of treatments received compared to what was planned; 2) documented absences from scheduled appointments and reasons; 3) treatment delays and reasons if documented. Data will be extracted from the participant's medical chart and follow-up notes of the nurse.

Following the medical encounter, perception of usefulness of Let's Discuss Health website to prepare the visit will be assessed in patients of the Intervention Group only. Each item asks the patient to rate its level of agreement using a 4-point Likert scale (strongly disagree, disagree, agree, strongly agree).

Patient perception of the quality of the communication with the radiation oncologist (RO) will be assessed using the Communication Assessment Tool (CAT) developed and validated by Makoul et al. The CAT asks patients to rate different dimensions of the communication and interpersonal skills of the RO using a 5-point rating scale (1=poor, 2=fair, 3=good, 4=very good, 5=excellent). Means and percentage of items rated as excellent will be reported.

Following the medical encounter with the participating patient, radiation oncologist (RO) will assess its appreciation of the quality of the communication regarding six items (whether the patient was well prepared, well informed about the cancer, expressed concerns, asked questions, verified its understanding, and whether the RO is satisfied with the discussion). Each item asks the RO to rate its level of agreement with the sentence on a scale of 0 (strongly disagree) to 10 (strongly agree).

Content of the audio-recorded medical encounters will be analysed using Medicode, a validated medical interview coding system that is particularly well suited to discussion on treatments. It allows the description of the exchanged content. The frequency of the topics covered in the discussion of cancer itself and each of the treatment options discussed will be described according to the following themes: designation, dosage, main effect observed, main effect anticipated, side effects observed, possible side effects, indication to consult again, attitudes and emotions and warnings.

Using Medicode, the exchanges during the audio-recorded medical encounters will be qualified as who initiated the discussion (patient or radiation oncologist) for each of the topics covered in the discussion of cancer itself and each of the treatment options discussed according to the following themes: designation, dosage, main effect observed, main effect anticipated, side effects observed, possible side effects, indication to consult again, attitudes and emotions and warnings.

The preponderance of initiative (PI) will be generated. It determines to what extent the exchanges about each theme are initiated by the physician or the patient. The PI score for each topic discussed ranges from -1 (always the patient) to +1 (always the doctor).

Using Medicode, the exchanges during the medical encounters will be qualified as who initiated the discussion (patient or radiation oncologist) for each of the topics covered in the discussion of cancer itself and each of the treatment options discussed according to the following themes: designation, dosage, main effect observed, main effect anticipated, side effects observed, possible side effects, indication to consult again, attitudes and emotions and warnings.

The preponderance of initiative (PI) will be generated. It determines to what extent the exchanges about each theme are initiated by the physician or the patient. The PI score for each topic discussed ranges from -1 (always the patient) to +1 (always the doctor).

Level of emotional distress will be assessed before and after medical encounters using the distress thermometer developed by the National Comprehensive Cancer Network. The level of emotional distress will be self-rated using a visual analog scale from 0 \[no distress\] to 10 \[extreme distress\]. Change in the level will be calculate as the difference between the value post-consultation and pre-consultation.

Focus groups with patients to explore their appreciation of Let's Discuss Health use during their care trajectory in radiation oncology and identify facilitators and barriers to its implementation. Emergent themes will be identified.

Focus groups with radiation oncologists to explore the appreciation of Let's Discuss Health tools' use and integration into clinical-administrative routines and identify facilitators and barriers to its implementation. Emergent themes will be identified.

The presence of problems related to the cancer reported by patients will be determined by the Canadian Problem Checklist, a tool developed by the National Comprehensive Cancer Network. The number of problems will be reported.

The intensity of symptoms related to cancer will be assessed by the revised Edmonton Symptom Assessment System (ESAS-r), a tool developed by the National Comprehensive Cancer Network. The intensity of each of the ten symptoms (pain, fatigue, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, sleep disturbance, well-being) will be self-reported on a scale of 0 (absence) to 10 (maximum intensity).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Factors Influencing Adherence to Adjuvant Endocrine Therapy	NCT06192446	Adherence, Trea...	Survey using a ...	18 Years -	University of Zagreb
Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera	NCT06078319	Adherence, Pati... Adherence, Trea...		18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
ComCancer: Use of Let's Discuss Health Website by Patients With Prostate Cancer Undergoing Radiation Oncology Treatment	NCT05787145	Prostatic Neopl... Psychological D... Physician-Patie... Communication Patient Partici... Adherence, Trea... Men	Let's Discuss H...	18 Years -	Ciusss de L'Est de l'Île de Montréal
Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera	NCT06078319	Adherence, Pati... Adherence, Trea...		18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna

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