Prostatic NeoplasmsNCT05787145
ComCancer: Use of Let's Discuss Health Website by Patients With Prostate Cancer Undergoing Radiation Oncology Treatment
A study testing Let's Discuss Health Group in people with Prostatic Neoplasms and Psychological Distress, run by Ciusss de L'Est de l'Île de Montréal at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Psychological Distress, Physician-Patient Relations
- What is being tested?
- Let's Discuss Health Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesCanada
- Study dates
- 10 Mar 2021to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Centre intégré de cancérologie de Laval
Laval, Quebec, H7M 3L9
Marie-Eve Lavoie, PhD, 514-966-4615, marie.eve.lavoie.cissslav@ssss.gouv.qc.ca
Marie-Andrée Fortin, MD
- Recruiting
Ciusss de l'Est de l'Île de Montréal
Montreal, Quebec
Marie-Eve Lavoie, PhD, 514-966-4615, marie.eve.lavoie.cissslav@ssss.gouv.qc.ca
Israël Fortin, MD
- Recruiting
Centre hospitalier universitaire de Québec
Québec
Marie-Eve Lavoie, PhD, 514-966-4615, marie.eve.lavoie.cissslav@ssss.gouv.qc.ca
William Foster, MD
About this study
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
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.
Read more
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
- Being tested
- Let's Discuss Health Group
- Keywords
- Prostate Cancer, Patient-Physician Communication, Patient Recall of Information, Adult
- Medical subject headings
- Prostatic Neoplasms, Communication, Patient Participation, Treatment Adherence and Compliance, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Discuss Health GroupBehavioural
Also called Pre-consultation patient's preparedness
Use of the Let's Discuss Health website to prepare four medical encounters with the radiation oncologist throughout the radiation care trajectory.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through care pathway completion, an average of 5 weeks
Secondary outcomes (12)
Patient appreciation of the use of the Let's Discuss Health website
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).
Measured: Through study completion, an average of 8 months
Patient perception of the quality of the communication with the radiation oncologist
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.
Measured: Through study completion, an average of 8 months
Radiation oncologist's perception of the quality of the consultation
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).
Measured: Through study completion, an average of 8 months
Frequency of themes discussed during the initial patient-radiation oncologist encounter
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.
Measured: Baseline (0 week)
Frequency of themes discussed during the end-of-treatment patient-radiation oncologist encounter
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.
Measured: Up to 5 months
Preponderance of initiative in the discussion during the initial patient-radiation oncologist encounter
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).
Measured: Baseline (0 week)
Preponderance of initiative in the discussion during the end-of-treatment patient-radiation oncologist encounter
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).
Measured: Up to 5 months
Change in emotional distress following the medical encounter
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.
Measured: Through study completion, an average of 8 months
Qualitative patient appreciation of the use of Let's Discuss Health
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.
Measured: 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
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.
Measured: At the end of the study, up to 1.5 years
Number of problems related to the cancer during the care trajectory
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.
Measured: Through study completion, an average of 8 months
Intensity of symptoms during the care trajectory
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).
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start10 Mar 2021
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Cité de la Santé, CHU de Quebec-Universite Laval
- Responsible party
- Sponsor
- Investigators
- Marie-Thérèse Lussier, MD, MSc, Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de MontréalMarie-Andrée Fortin, MD, Principal investigator, Centre intégré de cancérologie de Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787145
- Sponsor's protocol ID
- MP-12-2021-2328
- Status last verified
- Mar 2023
- First submitted
- 14 May 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05787145
- Acronym / sponsor ID
- MP-12-2021-2328
- Conditions
- Prostatic Neoplasms, Psychological Distress, Physician-Patient Relations, Communication, Patient Participation, Adherence, Treatment
- Keywords
- Prostate Cancer, Patient-Physician Communication, Patient Recall of Information, Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Hopital Cité de la Santé, CHU de Quebec-Universite Laval
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Let's Discuss Health Group | Experimental | Behavioral: Let's Discuss Health GroupPatients 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. |
| Usual Care Group | No intervention | –Patients in this group will received the usual care in the radiation oncology care pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let's Discuss Health GroupAlso: Pre-consultation patient's preparednessUse of the Let's Discuss Health website to prepare four medical encounters with the radiation oncologist throughout the radiation care trajectory. | Behavioural | Let's Discuss Health Group |
Primary outcome
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.
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.
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.
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].
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.
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.
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.
12 secondary outcomes
Patient appreciation of the use of the Let's Discuss Health website
Time frame: 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
Radiation oncologist's perception of the quality of the consultation
Time frame: Through study completion, an average of 8 months
Frequency of themes discussed during the initial patient-radiation oncologist encounter
Time frame: Baseline (0 week)
Frequency of themes discussed during the end-of-treatment patient-radiation oncologist encounter
Time frame: Up to 5 months
Preponderance of initiative in the discussion during the initial patient-radiation oncologist encounter
Time frame: Baseline (0 week)
Preponderance of initiative in the discussion during the end-of-treatment patient-radiation oncologist encounter
Time frame: Up to 5 months
Change in emotional distress following the medical encounter
Time frame: 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
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
Number of problems related to the cancer during the care trajectory
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Thérèse Lussier, MD, MSc principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Marie-Andrée Fortin, MD principal investigator
Centre intégré de cancérologie de Laval
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Discuss Health Group in people with Prostatic Neoplasms and Psychological Distress, run by Ciusss de L'Est de l'Île de Montréal at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Thérèse Lussier, MD, MSc (514-966-4615, marie.therese.lussier@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient use of Let's Discuss Health tools (time frame: Through study completion, an average of 8 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.