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

NCT04025190 | Completed

• 1 other identifier: LCCC 1704
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Keywords

anxiety; depression; collaborative care; psycho-oncology; bone marrow transplant

Outcome Measures

Primary Outcomes (1)

• Systematic screening for depression and anxiety using the Hospital Anxiety and Depression Scale

  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.

  Day 0

Secondary Outcomes (3)

• Satisfaction among patients and providers participating in the collaborative care model

  Day 0

• Severity of post-transplant outcomes as defined by an investigator-designed post-transplant outcome index in relation to Hospital Anxiety and Depression Scale scores

  Day 0

• Change in anxiety or depression as measured by the Hospital Anxiety and Depression Scale.

  Day 0

Study Arms (1)

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.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Eliza Park, MD

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Eliza M Park, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: July 18, 2019
• Study Start: February 22, 2018
• Primary Completion: May 25, 2018
• Study Completion: August 28, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (1)