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

NCT01866228 | Completed

• 2 other identifiers: H2013:085126049
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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.

Conditions

Brain Tumor; Neuroendocrine Cancer

Keywords

Consultation Recording; Brain Tumor; Neuroendocrine Cancer; Quality of Life; Patient Satisfaction

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

No Consultation Recording

NO INTERVENTION

Participant does not receive consultation recording

Consultation Recording

EXPERIMENTAL

Participant receives consultation recording

Other: Consultation Recording

Interventions

Consultation Recording OTHER

Consultation Recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presenting with a primary diagnosis of non-recurrent or metastatic brain, or neuroendocrine cancer
• years of age or older
• able to read and communicate using the English language
• access to a computer to enable consultation playback

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (3)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Related Publications (1)

• 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.

  PMID: 33595717 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Neuroendocrine; Patient Satisfaction

Condition Hierarchy (Ancestors)

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; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Thomas F Hack, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: May 31, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)