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

NCT05787145 | Unknown

• 1 other identifier: MP-12-2021-2328
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (7)

• Patient use of Let's Discuss Health tools

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

  Through study completion, an average of 8 months

• Dialogic rate in the exchanges during the initial patient-radiation oncologist encounter

  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.

  Baseline (0 week)

• Dialogic rate of the conversations during the end-of-treatment patient-radiation oncologist encounter

  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.

  Up to 5 months

• Pre-consultation patient emotional distress during the care trajectory

  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 \[extreme distress\].

  Through study completion, an average of 8 months

• Patient recall of information after the initial encounter

  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.

  Baseline (0 week)

• Patient recall of information after the end-of-treatment encounter

  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.

  Up to 5 months

• Adherence to the care pathway

  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.

  Through care pathway completion, an average of 5 weeks

Secondary Outcomes (12)

• Patient appreciation of the use of the Let's Discuss Health website

  Through study completion, an average of 8 months

• Patient perception of the quality of the communication with the radiation oncologist

  Through study completion, an average of 8 months

• Radiation oncologist's perception of the quality of the consultation

  Through study completion, an average of 8 months

• Frequency of themes discussed during the initial patient-radiation oncologist encounter

  Baseline (0 week)

• Frequency of themes discussed during the end-of-treatment patient-radiation oncologist encounter

  Up to 5 months

Study Arms (2)

Let's Discuss Health Group

EXPERIMENTAL

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.

Behavioral: Let's Discuss Health Group

Usual Care Group

NO INTERVENTION

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

Interventions

Let's Discuss Health Group BEHAVIORAL

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

Also known as: Pre-consultation patient's preparedness

Let's Discuss Health Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Hopital Cité de la Santé: collaborator
• CHU de Quebec-Universite Laval: collaborator

Study Sites (3)

Centre intégré de cancérologie de Laval

Laval, Quebec, H7M 3L9, Canada

RECRUITING

Ciusss de l'Est de l'Île de Montréal

Montreal, Quebec, Canada

RECRUITING

Centre hospitalier universitaire de Québec

Québec, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Communication; Patient Participation; Treatment Adherence and Compliance; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior; Patient Acceptance of Health Care; Health Behavior; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Marie-Thérèse Lussier, MD, MSc

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

• Marie-Andrée Fortin, MD

  Centre intégré de cancérologie de Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Thérèse Lussier, MD, MSc

CONTACT

514-966-4615; marie.therese.lussier@umontreal.ca

Marie-Eve Lavoie, PhD

CONTACT

514-966-4615; marie.eve.lavoie.cissslav@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: March 28, 2023
• Study Start: March 10, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

CA (3)