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

19 februari 2018 uppdaterad av: Dr. Tom Hack, University of Manitoba

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.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

140

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: No Consultation Recording
Participant does not receive consultation recording
Experimentell: Consultation Recording
Participant receives consultation recording

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline in Control Preferences Scale at 1-week post-consultation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 1-week post-consultation
1-week post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 3-months post-consultation
Tidsram: 3-months post-consultation
3-months post-consultation
Change from Baseline in Patient Satisfaction with Cancer Care Scale at 6-months post-consultation
Tidsram: 6-months post-consultation
6-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 1-week post-consultation
Tidsram: 1-week post-consultation
1-week post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 3-months post-consultation
Tidsram: 3-months post-consultation
3-months post-consultation
Change from Baseline in PrestMan Satisfaction with Doctor Scale at 6-months post-consultation
Tidsram: 6-months post-consultation
6-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 1-week post-consultation
Tidsram: 1-week post-consultation
1-week post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 3-months post-consultation
Tidsram: 3-months post-consultation
3-months post-consultation
Change from Baseline in Hospital Anxiety and Depression Scale at 6-months post-consultation
Tidsram: 6-months post-consultation
6-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 1-week post-consultation
Tidsram: 1- week post-consultation
1- week post-consultation
Change from Baseline in Perception of Being Informed Scale at 3-months post-consultation
Tidsram: 3-months post-consultation
3-months post-consultation
Change from Baseline in Perception of Being Informed Scale at 6-months post-consultation
Tidsram: 6-months post-consultation
6-months post-consultation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Thomas F Hack, PhD, University of Manitoba

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2013

Primärt slutförande (Faktisk)

1 februari 2017

Avslutad studie (Faktisk)

1 december 2017

Studieregistreringsdatum

Först inskickad

16 april 2013

Först inskickad som uppfyllde QC-kriterierna

27 maj 2013

Första postat (Uppskatta)

31 maj 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 februari 2018

Senast verifierad

1 februari 2018

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

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Kliniska prövningar på Hjärntumör

Kliniska prövningar på Consultation Recording

3
Prenumerera