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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866228
• Other study ID #: H2013:085
• Secondary ID: 126049
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: February 19, 2018
• Start date: June 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Neuroendocrine Cancer

Intervention

Other:
• Consultation Recording

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	Cancer Care Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Control Preferences Scale at 1-week post-consultation	Subjective report of actual role played in decision making.	1-week post-consultation
Primary	Change from Baseline in Control Preferences Scale at 3-months post-consultation	Subjective report of actual role played in decision making.	3-months post-consultation
Primary	Change from Baseline in Control Preferences Scale at 6-months post-consultation	Subjective report of actual role played in decision making.	6-months post-consultation
Primary	Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation		1-week post-consultation
Primary	Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation		3-months post-consultation
Primary	Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation		6-months post-consultation
Primary	Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation		1-week post-consultation
Primary	Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation		3-months post-consultation
Primary	Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation		6-months post-consultation
Primary	Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation		1-week post-consultation
Primary	Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation		3-months post-consultation
Primary	Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation		6-months post-consultation
Primary	Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation		1- week post-consultation
Primary	Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation		3-months post-consultation
Primary	Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation		6-months post-consultation