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Completed

NCT Number: NCT01866228

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

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.

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Key information

Conditions

Brain Tumor Adenocarcinoma Behavior Brain Diseases Brain Neoplasms Carcinoma Carcinoma, Neuroendocrine Central Nervous System Diseases Central Nervous System Neoplasms Health Behavior Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Cancer Neuroendocrine Tumors Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consultation Recording

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 31, 2013
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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