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

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ClinicalTrials.gov Identifier: NCT01866228
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Tom Hack, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Neuroendocrine Cancer Other: Consultation Recording Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of Treatment Consultation Recordings on Cancer Patient Outcomes: A Prospective, Parallel, Randomized Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change from Baseline in Control Preferences Scale at 1-week post-consultation [ Time Frame: 1-week post-consultation ]
    Subjective report of actual role played in decision making.

  2. Change from Baseline in Control Preferences Scale at 3-months post-consultation [ Time Frame: 3-months post-consultation ]
    Subjective report of actual role played in decision making.

  3. Change from Baseline in Control Preferences Scale at 6-months post-consultation [ Time Frame: 6-months post-consultation ]
    Subjective report of actual role played in decision making.

  4. Change from Baseline in Patient Satisfaction with Cancer Care Scale at 1-week post-consultation [ Time Frame: 1-week post-consultation ]
  5. Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation [ Time Frame: 3-months post-consultation ]
  6. Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation [ Time Frame: 6-months post-consultation ]
  7. Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation [ Time Frame: 1-week post-consultation ]
  8. Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation [ Time Frame: 3-months post-consultation ]
  9. Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation [ Time Frame: 6-months post-consultation ]
  10. Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation [ Time Frame: 1-week post-consultation ]
  11. Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation [ Time Frame: 3-months post-consultation ]
  12. Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation [ Time Frame: 6-months post-consultation ]
  13. Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation [ Time Frame: 1- week post-consultation ]
  14. Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation [ Time Frame: 3-months post-consultation ]
  15. Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation [ Time Frame: 6-months post-consultation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866228


Locations
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Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Thomas F Hack, PhD University of Manitoba
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Responsible Party: Dr. Tom Hack, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01866228    
Other Study ID Numbers: H2013:085
126049 ( Other Grant/Funding Number: Canadian Institutes of Health Research/126049 )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Tom Hack, University of Manitoba:
Consultation Recording
Brain Tumor
Neuroendocrine Cancer
Quality of Life
Patient Satisfaction
Additional relevant MeSH terms:
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Brain Neoplasms
Carcinoma, Neuroendocrine
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue