Clinical trial NCT05787145: ComCancer: Use of Let's Discuss Health Website by Patients With Prostate Cancer Undergoing Radiation Oncology Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostatic Neoplasms
Psychological Distress
Physician-Patient Relations
Communication
Patient Participation
Adherence, Treatment
Men
Keywords: Prostate Cancer
Patient-Physician Communication
Patient Recall of Information
Adult
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Hopital Cité de la Santé
name: CHU de Quebec-Universite Laval
First posted: 2023-03-28
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* have a diagnosis of prostate cancer
* understand, speak and read French
* report being comfortable using the Internet
* have access to a computer, tablet or smartphone or know someone who does and is willing to accompany them

Exclusion Criteria:

* being considered unfit to give free and informed consent (e.g. dementia, severe psychiatric condition)
* any other clinical reason (poor health of the patient at the time of the consultation) that the clinician deems relevant

Primary outcomes:
measure: Patient use of Let's Discuss Health tools
timeFrame: Through study completion, an average of 8 months
measure: Dialogic rate in the exchanges during the initial patient-radiation oncologist encounter
timeFrame: Baseline (0 week)
measure: Dialogic rate of the conversations during the end-of-treatment patient-radiation oncologist encounter
timeFrame: Up to 5 months
measure: Pre-consultation patient emotional distress during the care trajectory
timeFrame: Through study completion, an average of 8 months
measure: Patient recall of information after the initial encounter
timeFrame: Baseline (0 week)
measure: Patient recall of information after the end-of-treatment encounter
timeFrame: Up to 5 months
measure: Adherence to the care pathway
timeFrame: Through care pathway completion, an average of 5 weeks
Secondary outcomes:
measure: Patient appreciation of the use of the Let's Discuss Health website
timeFrame: Through study completion, an average of 8 months
measure: Patient perception of the quality of the communication with the radiation oncologist
timeFrame: Through study completion, an average of 8 months
measure: Radiation oncologist's perception of the quality of the consultation
timeFrame: Through study completion, an average of 8 months
measure: Frequency of themes discussed during the initial patient-radiation oncologist encounter
timeFrame: Baseline (0 week)
measure: Frequency of themes discussed during the end-of-treatment patient-radiation oncologist encounter
timeFrame: Up to 5 months
measure: Preponderance of initiative in the discussion during the initial patient-radiation oncologist encounter
timeFrame: Baseline (0 week)
measure: Preponderance of initiative in the discussion during the end-of-treatment patient-radiation oncologist encounter
timeFrame: Up to 5 months
measure: Change in emotional distress following the medical encounter
timeFrame: Through study completion, an average of 8 months
measure: Qualitative patient appreciation of the use of Let's Discuss Health
timeFrame: At the end of the study, up to 1.5 years
measure: Radiation oncologist appreciation of Let's Discuss Health implementation in clinical routines in radiation oncology
timeFrame: At the end of the study, up to 1.5 years
measure: Number of problems related to the cancer during the care trajectory
timeFrame: Through study completion, an average of 8 months
measure: Intensity of symptoms during the care trajectory
timeFrame: Through study completion, an average of 8 months
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Centre intégré de cancérologie de Laval
state: Quebec
city: Montréal
country: Canada
facility: Ciusss de l'Est de l'Île de Montréal
state: Quebec
city: Québec
country: Canada
facility: Centre hospitalier universitaire de Québec
Study officials:
affiliation: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: Marie-Thérèse Lussier, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre intégré de cancérologie de Laval
name: Marie-Andrée Fortin, MD
role: PRINCIPAL_INVESTIGATOR
References: