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

March 24, 2023 updated by: Ciusss de L'Est de l'Île de Montréal

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Québec, Canada
        • Recruiting
        • Centre Hospitalier Universitaire de Quebec
        • Contact:
        • Principal Investigator:
          • William Foster, MD
        • Sub-Investigator:
          • Isabelle Germain, MD
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Recruiting
        • Centre intégré de cancérologie de Laval
        • Contact:
        • Principal Investigator:
          • Marie-Andrée Fortin, MD
        • Sub-Investigator:
          • Moein Alizadeh, MD
      • Montréal, Quebec, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Let's Discuss Health Group
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
Use of the Let's Discuss Health website to prepare four medical encounters with the radiation oncologist throughout the radiation care trajectory.
Other Names:
  • Pre-consultation patient's preparedness
No Intervention: Usual Care Group
Patients in this group will received the usual care in the radiation oncology care pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient use of Let's Discuss Health tools
Time Frame: Through study completion, an average of 8 months
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
Time Frame: Baseline (0 week)

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
Time Frame: Up to 5 months

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
Time Frame: Through study completion, an average of 8 months
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
Time Frame: Baseline (0 week)
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
Time Frame: Up to 5 months
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
Time Frame: Through care pathway completion, an average of 5 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient appreciation of the use of the Let's Discuss Health website
Time Frame: Through study completion, an average of 8 months
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).
Through study completion, an average of 8 months
Patient perception of the quality of the communication with the radiation oncologist
Time Frame: Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months
Radiation oncologist's perception of the quality of the consultation
Time Frame: Through study completion, an average of 8 months
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).
Through study completion, an average of 8 months
Frequency of themes discussed during the initial patient-radiation oncologist encounter
Time Frame: Baseline (0 week)
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.
Baseline (0 week)
Frequency of themes discussed during the end-of-treatment patient-radiation oncologist encounter
Time Frame: Up to 5 months
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.
Up to 5 months
Preponderance of initiative in the discussion during the initial patient-radiation oncologist encounter
Time Frame: Baseline (0 week)

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).
Baseline (0 week)
Preponderance of initiative in the discussion during the end-of-treatment patient-radiation oncologist encounter
Time Frame: Up to 5 months

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).
Up to 5 months
Change in emotional distress following the medical encounter
Time Frame: Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months
Qualitative patient appreciation of the use of Let's Discuss Health
Time Frame: At the end of the study, up to 1.5 years
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.
At the end of the study, up to 1.5 years
Radiation oncologist appreciation of Let's Discuss Health implementation in clinical routines in radiation oncology
Time Frame: At the end of the study, up to 1.5 years
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.
At the end of the study, up to 1.5 years
Number of problems related to the cancer during the care trajectory
Time Frame: Through study completion, an average of 8 months
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.
Through study completion, an average of 8 months
Intensity of symptoms during the care trajectory
Time Frame: Through study completion, an average of 8 months
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).
Through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborators

CHU de Quebec-Universite Laval
Hopital Cité de la Santé

Investigators

  • Principal Investigator: Marie-Thérèse Lussier, MD, MSc, Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
  • Principal Investigator: Marie-Andrée Fortin, MD, Centre intégré de cancérologie de Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-12-2021-2328

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Neoplasms

Clinical Trials on Let's Discuss Health Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe