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Clinical Trial of the Impact of Treatment Consultation Recordings on Cancer Patient Outcomes

Impact of Treatment Consultation Recordings on Cancer Patient Outcomes: A Prospective, Parallel, Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01866228
Enrollment
140
Registered
2013-05-31
Start date
2013-06-30
Completion date
2017-12-31
Last updated
2018-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Neuroendocrine Cancer

Keywords

Consultation Recording, Brain Tumor, Neuroendocrine Cancer, Quality of Life, Patient Satisfaction

Brief 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. 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.

Interventions

OTHERConsultation Recording

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Control Preferences Scale at 1-week post-consultation1-week post-consultationSubjective report of actual role played in decision making.
Change from Baseline in Control Preferences Scale at 3-months post-consultation3-months post-consultationSubjective report of actual role played in decision making.
Change from Baseline in Control Preferences Scale at 6-months post-consultation6-months post-consultationSubjective report of actual role played in decision making.
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation1-week post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation3-months post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation6-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation1-week post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation3-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation6-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation1-week post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation3-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation6-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation1- week post-consultation
Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation3-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation6-months post-consultation

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026