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Interest of a TEteleconsultation of a Psychological Support Nurse on Psychological Distress in Patients With a Primary Malignancy of the Central Nervous System

Study acronym: TECAP
StatusWithdrawn
PhaseNot applicable
Started
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Record History

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  1. Withdrawn before enrolling Sponsor's reason: The principal investigator has left the research center.
    • Enrollment target: estimated 58 to confirmed 0
    • Eligibility criteria expanded, about 13 words
    • Study description expanded, about 12 words
  2. Primary completion date: Mar 31, 2027 to Mar 31, 2028
    • Start date: Mar 31, 2025 to Mar 31, 2026
    • Study completion date: Jun 30, 2027 to Jun 30, 2028
    v5
  3. Start date: Dec 24, 2024 to Mar 31, 2025v4 Show 4 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Primary completion date: Dec 31, 2026 to Mar 31, 2027
    • Study completion date: Jan 31, 2027 to Jun 30, 2027
    • Site details revised
  4. Start date: Sep 24, 2024 to Dec 24, 2024
    • Primary completion date: Oct 31, 2026 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Jan 31, 2027
    v3
  5. Start date: Jun 24, 2024 to Sep 24, 2024
    • Primary completion date: Oct 2026 to Oct 31, 2026
    • Study completion date: Dec 2026 to Dec 31, 2026
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinal trial is to compare the effectiveness of nurse-led teleconsultation with usual care (intervention group) on psychological distress in patients with primary malignant tumors of the central nervous system between diagnosis and first anti-cancer treatment, versus usual care alone (control group). Participants will be randomized into two groups : * group A) intervention: usual care + nurse teleconsultation for psychological support * group B) control: usual care alone Enrolment = Day0 (D0) Participants will : * groups A and B: D0: complete 4 questionnaires (Quality of Life, Screening for Distress, Screening for Anxiety and Depression, Social Support Questionnaire) * Group A : D0+2/4 das : nursing teleconsultation for psychological support * Groups A and B: D0+10days : telephone call to complete the same 4 questionnaires as at inclusion * Group A : D0+15days: semi-directive interview, at home, for voluntary patients.
Trial Details
NCT Number NCT06485310
Lead Sponsor Centre Hospitalier Universitaire de la Réunion
Conditions
(from sponsor)		 Central Nervous System Cancer, Psychological Distress
Related terms Central Nervous System Neoplasms
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov