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Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population

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ClinicalTrials.gov Identifier: NCT04025190
Recruitment Status : Completed
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
The primary purpose of this study is twofold: (1) to assess the feasibility of screening adult hematopoietic stem cell transplantation (HSCT) candidates for psychiatric comorbidity (depression and anxiety), and (2) to assess the feasibility of treating depression and anxiety in adult HSCT candidates through a collaborative care algorithm. The ultimate goal of this project is improving HSCT outcomes for allogeneic HSCT candidates by improving identification and treatment of depression and anxiety disorders.

Condition or disease
Anxiety Depression

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population
Actual Study Start Date : February 22, 2018
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Allogeneic Transplant
All patients seen in the UNC Bone Marrow Transplant clinic who are candidates for allogeneic transplantation attending their pre-admission visit were approached to offer study participation. Study participation included completion of surveys over a time period up to 60 days after their transplant.



Primary Outcome Measures :
  1. Systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale [ Time Frame: Day 0 ]
    Assess the feasibility of systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale in adult patients who are allogeneic HSCT candidates.


Secondary Outcome Measures :
  1. Satisfaction among patients and providers participating in the collaborative care model [ Time Frame: Day 0 ]
    Assess the feasibility of implementing a collaborative care model through assessment of intervention satisfaction scores among participating patients and their health care providers.

  2. Severity of post-transplant outcomes as defined by an investigator-designed post-transplant outcome index in relation to Hospital Anxiety and Depression Scale scores [ Time Frame: Day 0 ]
    Explore an association between an investigator-designed post-transplant outcome index (listed below) in patients undergoing allogeneic transplantation and Hospital Anxiety and Depression Scale scores. Aggregated outcomes abstracted from the medical record included: (a) number of days spent in hospital during transplant admission, (b) number of missed clinic appointments, (c) development of acute GVHD, (d) development of chronic GVHD, (e) admission to ICU within first 100 days of transplant, (f) date of neutrophil engraftment, (g) frequency of viral reactivation requiring antiviral treatment, and (h) death in the first 100 days.

  3. Change in anxiety or depression as measured by the Hospital Anxiety and Depression Scale. [ Time Frame: Day 0 ]
    Explore whether patient's symptoms of depression and/or anxiety change over time within a collaborative care model.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients were English speaking adults (age >18 years) with hematological or non-hematological malignancy with an indication to undergo allogeneic HSCT, who were scheduled to undergo allogeneic transplant within 30 days of enrollment, had a scheduled Pre-Transplant Admission clinic visit at the ambulatory HSCT clinic, and were able to complete self-report measures. Patients were excluded if they were pregnant, unable to complete self-report measures in English, or had pre-existing diagnoses of bipolar affective disorder, schizoaffective disorder or schizophrenia.
Criteria

Inclusion Criteria:

  • hematological or non-hematological malignancy
  • plan to receive an allogeneic stem cell transplant
  • patient at UNC's ambulatory BMT clinic
  • able to complete self-report measures
  • English speaking

Exclusion Criteria:

  • plan to receive an autologous transplant
  • plan to receive allogeneic transplant for a non-malignancy
  • unable to complete self report measures in English
  • pregnant
  • pre-existing diagnoses of bipolar affective disorder, schizoaffective disorder or schizophrenia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025190


Locations
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United States, North Carolina
Eliza Park, MD
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Eliza M Park, MD UNC Chapel Hill

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04025190     History of Changes
Other Study ID Numbers: LCCC 1704
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
anxiety
depression
collaborative care
psycho-oncology
bone marrow transplant

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders