Depression and Adherence in Head and Neck Cancer

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Eligibility criteria expanded, about 6 words
  2. 4 versions Re-verified since Sep 11, 2024, no change to tracked fieldsv26-v29
  3. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2026v25
  4. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023v24
  5. Primary and study completion dates: Dec 31, 2020 to Dec 31, 2022v23
Show 21 earlier versionsHide 21 earlier versions
  1. Re-verified, no change to tracked fieldsv22
  2. Primary completion date: Dec 2019 to Dec 31, 2020
    • Enrollment target: estimated 350 to confirmed 185
    • Study completion date: Dec 2020 to Dec 31, 2020
    • Start date: Mar 2005 to Mar 15, 2005
    v21
  3. Primary completion date: Mar 2019 to Dec 2019
    • Study completion date: Mar 2019 to Dec 2020
    v20
  4. Re-verified, no change to tracked fieldsv19
  5. Primary completion date: Mar 2018 to Mar 2019
    • Study completion date: Mar 2019
    v18
  6. Primary completion date: Mar 2017 to Mar 2018v17
  7. Primary completion date: Mar 2016 to Mar 2017v16
  8. Primary completion date: Mar 2015 to Mar 2016
    • Study site revised
    v15
  9. Primary completion date: Mar 2014 to Mar 2015v14
  10. Primary completion date: Mar 2013 to Mar 2014v13
  11. Primary completion date: Mar 2012 to Mar 2013v12
  12. Primary completion date: Mar 2011 to Mar 2012v11
  13. Re-verified, no change to tracked fieldsv10
  14. Study site revisedv9
  15. Primary completion date: Mar 2010 to Mar 2011
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  16. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v7
  17. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  18. Re-verified, no change to tracked fieldsv5
  19. Primary endpoint revised
    • Eligibility criteria expanded, about 1 word
    v4
  20. Study description shortened, about 11 words
    • Eligibility criteria shortened, about 1 word
    v3
  21. Primary completion date: Mar 2010v2 Show 4 more changesShow less
    • Interventions: Questionnaire (Behavioral) to Depression Intervention (Behavioral), Questionnaire (Behavioral)
    • Study description expanded, about 58 words
    • Study arms: 0 to 1
    • Eligibility criteria expanded, about 1 word
  1. Study First Submitted
  • 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.
Primary Objectives: * Develop and pilot test an innovative intervention to determine its feasibility and acceptability to patients. Recruitment rate, patient satisfaction, attendance, questionnaire completion rates and the reliability and validity of the questionnaires will be assessed. * Conduct preliminary analyses on the efficacy of the intervention in improving patients' depression. Evaluate whether depression levels in patients receiving the intervention decreases, and whether the decrease is greater among those who complete more sessions. * Test the relationship between patients' depression levels and adherence to swallowing rehabilitation and to dental preventive maintenance regimens.
Trial Details
NCT Number NCT00498875
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Oropharyngeal Cancer, Head and Neck Cancer
Related terms Depression, Head and Neck Neoplasms, Oropharyngeal Neoplasms
Enrollment 185 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov