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

NCT ID: NCT01866228

Last Updated: 2018-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Tumor Neuroendocrine Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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No Consultation Recording

Participant does not receive consultation recording

Group Type NO_INTERVENTION

No interventions assigned to this group

Consultation Recording

Participant receives consultation recording

Group Type EXPERIMENTAL

Consultation Recording

Intervention Type OTHER

Interventions

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Consultation Recording

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tom Hack

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas F Hack, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 33595717 (View on PubMed)

Other Identifiers

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126049

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H2013:085

Identifier Type: -

Identifier Source: org_study_id

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