Clinical trial NCT01866228: Clinical Trial of the Impact of Treatment Consultation Recordings on Cancer Patient Outcomes
Official title: Impact of Treatment Consultation Recordings on Cancer Patient Outcomes: A Prospective, Parallel, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Neuroendocrine Cancer
Keywords: Consultation Recording
Brain Tumor
Neuroendocrine Cancer
Quality of Life
Patient Satisfaction
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Control Preferences Scale at 1-week post-consultation
timeFrame: 1-week post-consultation
measure: Change from Baseline in Control Preferences Scale at 3-months post-consultation
timeFrame: 3-months post-consultation
measure: Change from Baseline in Control Preferences Scale at 6-months post-consultation
timeFrame: 6-months post-consultation
measure: Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation
timeFrame: 1-week post-consultation
measure: Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation
timeFrame: 3-months post-consultation
measure: Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation
timeFrame: 6-months post-consultation
measure: Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation
timeFrame: 1-week post-consultation
measure: Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation
timeFrame: 3-months post-consultation
measure: Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation
timeFrame: 6-months post-consultation
measure: Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation
timeFrame: 1-week post-consultation
measure: Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation
timeFrame: 3-months post-consultation
measure: Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation
timeFrame: 6-months post-consultation
measure: Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation
timeFrame: 1- week post-consultation
measure: Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation
timeFrame: 3-months post-consultation
measure: Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation
timeFrame: 6-months post-consultation
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Thomas F Hack, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.