Brain TumorNCT01866228
Clinical Trial of the Impact of Treatment Consultation Recordings on Cancer Patient Outcomes
A study testing Consultation Recording in people with Brain Tumor and Neuroendocrine Cancer, run by University of Manitoba at 3 sites in Canada.
Trial summary
The time period from diagnosis through to the end of treatment is challenging for patients. Patients need information, assistance with decision making, and emotional and social support to help cope with their diagnosis and treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Neuroendocrine Cancer
- What is being tested?
- Consultation Recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2013to Dec 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presenting with a primary diagnosis of non-recurrent or metastatic brain, or neuroendocrine cancer
- 18 years of age or older
- able to read and communicate using the English language
- access to a computer to enable consultation playback
Who cannot join
- deemed by a treating clinician (or primary nurse for the treating clinician) to have any severe psychiatric condition or cognitive dysfunction that precludes provision of free and informed consent to participate
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
British Columbia Cancer Agency
Vancouver, British Columbia
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: Impact of Treatment Consultation Recordings on Cancer Patient Outcomes: A Prospective, Parallel, Randomized Controlled Trial
The time period from diagnosis through to the end of treatment is challenging for patients. Patients need information, assistance with decision making, and emotional and social support to help cope with their diagnosis and treatment. The first meeting with the cancer doctor is especially anxiety-provoking for patients who will learn, for the first time, their treatment options and likelihood of being cured. This anxiety causes many patients to have difficulty remembering the important pieces of information that their cancer doctor tells them during this consultation. The main goal of this study is to demonstrate the benefits of giving cancer patients an audio-recording of their first consultation with their cancer doctor. The investigators will include newly diagnosed patients from cancer centres in Winnipeg and Calgary. The types of cancer that will be included in this study are brain and neuroendocrine. Patients with these types of cancer are more likely to have confused thinking, and therefore may have the most to gain from receiving their consultation recordings. The study will include 244 patients, and those who sign consent forms to participate will be assigned by chance to either receive their treatment consultation recording or not. Patients will receive their recording immediately after their consultation, and will be able to listen to the recording at any time either alone, or with family and friends. To figure out whether the consultation recording provides patients with benefits, the investigators will administer some questionnaires to patients at 1 week after the consultation, and again at 3 and 6 months after the consultation. These questionnaires will assess the following patient outcomes: i) anxiety and depression, ii) perception of being informed about the disease and treatment, iii) satisfaction with cancer care, iv) satisfaction with the doctor, and v) the extent to which patients are satisfied with their degree of involvement in treatment decision making. The investigators hypothesize that patients who receive their consultation recording will experience more benefits than patients who do not receive their consultation recording.
- Conditions
- Brain Tumor, Neuroendocrine Cancer
- Being tested
- Consultation Recording
- Keywords
- Consultation Recording, Brain Tumor, Neuroendocrine Cancer, Quality of Life, Patient Satisfaction
- Medical subject headings
- Brain Neoplasms, Carcinoma, Neuroendocrine, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation RecordingOther
| Study group | Role | What they receive |
|---|---|---|
| No Consultation Recording | No intervention | Participant does not receive consultation recording |
| Consultation Recording | Experimental | Participant receives consultation recording Receives: Other: Consultation Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Control Preferences Scale at 1-week post-consultation
Subjective report of actual role played in decision making.
Measured: 1-week post-consultation
Change from Baseline in Control Preferences Scale at 3-months post-consultation
Subjective report of actual role played in decision making.
Measured: 3-months post-consultation
Change from Baseline in Control Preferences Scale at 6-months post-consultation
Subjective report of actual role played in decision making.
Measured: 6-months post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation
Measured: 1-week post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation
Measured: 3-months post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation
Measured: 6-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation
Measured: 1-week post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation
Measured: 3-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation
Measured: 6-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation
Measured: 1-week post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation
Measured: 3-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation
Measured: 6-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation
Measured: 1- week post-consultation
Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation
Measured: 3-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation
Measured: 6-months post-consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tom Hack, University of Manitoba
- Investigators
- Thomas F Hack, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866228
- Sponsor's protocol ID
- H2013:085
- Other IDs
- 126049
- Status last verified
- Feb 2018
- First submitted
- 16 Apr 2013
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hack TF, Ruether JD, Pitz M, Thiessen B, Degner LF, Chateau D. Impact of consultation recordings on patient-reported outcomes in patients with brain tumors: a parallel randomized controlled trial. Support Care Cancer. 2021 Oct;29(10):5681-5690. doi: 10.1007/s00520-021-06038-7. Epub 2021 Feb 17.
PubMed 33595717
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Treatment Consultation Recordings on Cancer Patient Outcomes: A Prospective, Parallel, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01866228
- Acronym / sponsor ID
- H2013:085
- Conditions
- Brain Tumor, Neuroendocrine Cancer
- Keywords
- Consultation Recording, Brain Tumor, Neuroendocrine Cancer, Quality of Life, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 May 2013 (estimated)
- 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.
The time period from diagnosis through to the end of treatment is challenging for patients. Patients need information, assistance with decision making, and emotional and social support to help cope with their diagnosis and treatment. The first meeting with the cancer doctor is especially anxiety-provoking for patients who will learn, for the first time, their treatment options and likelihood of being cured. This anxiety causes many patients to have difficulty remembering the important pieces of information that their cancer doctor tells them during this consultation. The main goal of this study is to demonstrate the benefits of giving cancer patients an audio-recording of their first consultation with their cancer doctor. The investigators will include newly diagnosed patients from cancer centres in Winnipeg and Calgary. The types of cancer that will be included in this study are brain and neuroendocrine. Patients with these types of cancer are more likely to have confused thinking, and therefore may have the most to gain from receiving their consultation recordings. The study will include 244 patients, and those who sign consent forms to participate will be assigned by chance to either receive their treatment consultation recording or not. Patients will receive their recording immediately after their consultation, and will be able to listen to the recording at any time either alone, or with family and friends. To figure out whether the consultation recording provides patients with benefits, the investigators will administer some questionnaires to patients at 1 week after the consultation, and again at 3 and 6 months after the consultation. These questionnaires will assess the following patient outcomes: i) anxiety and depression, ii) perception of being informed about the disease and treatment, iii) satisfaction with cancer care, iv) satisfaction with the doctor, and v) the extent to which patients are satisfied with their degree of involvement in treatment decision making. The investigators hypothesize that patients who receive their consultation recording will experience more benefits than patients who do not receive their consultation recording.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Consultation Recording | No intervention | –Participant does not receive consultation recording |
| Consultation Recording | Experimental | Other: Consultation RecordingParticipant receives consultation recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presenting with a primary diagnosis of non-recurrent or metastatic brain, or neuroendocrine cancer
- 18 years of age or older
- able to read and communicate using the English language
- access to a computer to enable consultation playback
Key exclusion criteria (1 listed)
- deemed by a treating clinician (or primary nurse for the treating clinician) to have any severe psychiatric condition or cognitive dysfunction that precludes provision of free and informed consent to participate
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 |
|---|---|---|
| Consultation Recording | Other | Consultation Recording |
Primary outcome
Change from Baseline in Control Preferences Scale at 1-week post-consultation
Time frame: 1-week post-consultation
Subjective report of actual role played in decision making.
Change from Baseline in Control Preferences Scale at 3-months post-consultation
Time frame: 3-months post-consultation
Subjective report of actual role played in decision making.
Change from Baseline in Control Preferences Scale at 6-months post-consultation
Time frame: 6-months post-consultation
Subjective report of actual role played in decision making.
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation
Time frame: 1-week post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation
Time frame: 3-months post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation
Time frame: 6-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation
Time frame: 1-week post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation
Time frame: 3-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation
Time frame: 6-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation
Time frame: 1-week post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation
Time frame: 3-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation
Time frame: 6-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation
Time frame: 1- week post-consultation
Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation
Time frame: 3-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation
Time frame: 6-months post-consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Derived from this study: PubMed 33595717Hack TF, Ruether JD, Pitz M, Thiessen B, Degner LF, Chateau D. Impact of consultation recordings on patient-reported outcomes in patients with brain tumors: a parallel randomized controlled trial. Support Care Cancer. 2021 Oct;29(10):5681-5690. doi: 10.1007/s00520-021-06038-7. Epub 2021 Feb 17.
- Individual participant dataSharing planned: No
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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.
Thomas F Hack, PhD principal investigator
University of Manitoba
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation Recording in people with Brain Tumor and Neuroendocrine Cancer, run by University of Manitoba 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 1 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: finished, as of the sponsor's last update on 20 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Control Preferences Scale at 1-week post-consultation (time frame: 1-week post-consultation). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01866228, which also lists 1 linked publication.
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 20 Feb 2018.