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

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 Overview

• Status: Completed
• Conditions: Brain Tumor; Neuroendocrine Cancer
• Intervention / Treatment: Other: Consultation Recording

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
  • British Columbia
    • Vancouver, British Columbia, Canada
      • British Columbia Cancer Agency
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Cancer Care Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Consultation Recording; Participant does not receive consultation recording
Experimental: Consultation Recording; Participant receives consultation recording	Other: Consultation Recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation		1-week post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation		3-months post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation		6-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation		1-week post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation		3-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation		6-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation		1-week post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation		3-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation		6-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation		1- week post-consultation
Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation		3-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation		6-months post-consultation

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Thomas F Hack, PhD, University of Manitoba

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: May 27, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Actual): February 20, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; Brain Tumor; Patient Satisfaction; Neuroendocrine Cancer; Consultation Recording
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neuroendocrine Tumors; Brain Neoplasms; Carcinoma, Neuroendocrine
• Other Study ID Numbers: H2013:085; 126049 (Other Grant/Funding Number: Canadian Institutes of Health Research/126049)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO