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

Primary Purpose

Brain Tumor, Neuroendocrine Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Consultation Recording
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor focused on measuring Consultation Recording, Brain Tumor, Neuroendocrine Cancer, Quality of Life, Patient Satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Centre
  • British Columbia Cancer Agency
  • Cancer Care Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Consultation Recording

Consultation Recording

Arm Description

Participant does not receive consultation recording

Participant receives consultation recording

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 16, 2013
Last Updated
February 19, 2018
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01866228
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Neuroendocrine Cancer
Keywords
Consultation Recording, Brain Tumor, Neuroendocrine Cancer, Quality of Life, Patient Satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Consultation Recording
Arm Type
No Intervention
Arm Description
Participant does not receive consultation recording
Arm Title
Consultation Recording
Arm Type
Experimental
Arm Description
Participant receives consultation recording
Intervention Type
Other
Intervention Name(s)
Consultation Recording
Primary Outcome Measure Information:
Title
Change from Baseline in Control Preferences Scale at 1-week post-consultation
Description
Subjective report of actual role played in decision making.
Time Frame
1-week post-consultation
Title
Change from Baseline in Control Preferences Scale at 3-months post-consultation
Description
Subjective report of actual role played in decision making.
Time Frame
3-months post-consultation
Title
Change from Baseline in Control Preferences Scale at 6-months post-consultation
Description
Subjective report of actual role played in decision making.
Time Frame
6-months post-consultation
Title
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation
Time Frame
1-week post-consultation
Title
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation
Time Frame
3-months post-consultation
Title
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation
Time Frame
6-months post-consultation
Title
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation
Time Frame
1-week post-consultation
Title
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation
Time Frame
3-months post-consultation
Title
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation
Time Frame
6-months post-consultation
Title
Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation
Time Frame
1-week post-consultation
Title
Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation
Time Frame
3-months post-consultation
Title
Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation
Time Frame
6-months post-consultation
Title
Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation
Time Frame
1- week post-consultation
Title
Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation
Time Frame
3-months post-consultation
Title
Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation
Time Frame
6-months post-consultation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F Hack, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33595717
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.
Results Reference
derived

Learn more about this trial

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

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