| Condition or disease |
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| Anxiety Depression |
Show detailed description
| 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 |
| Group/Cohort |
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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.
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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 |
Inclusion Criteria:
Exclusion Criteria:
| United States, North Carolina | |
| Eliza Park, MD | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Eliza M Park, MD | UNC Chapel Hill |
| Tracking Information | |||||
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| First Submitted Date | May 7, 2019 | ||||
| First Posted Date | July 18, 2019 | ||||
| Last Update Posted Date | July 18, 2019 | ||||
| Actual Study Start Date | February 22, 2018 | ||||
| Actual Primary Completion Date | May 25, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population | ||||
| Official Title | Assessing the Feasibility of Screening and Treating Anxiety and Depression in the Bone Marrow Transplant Population | ||||
| 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. | ||||
| Detailed Description |
Enrollment and depression and anxiety symptom screening: All patients who are candidates for allogeneic transplantation and have a scheduled "Pre-Admission Visit" at UNC will be screened by study team to assess if they are eligible for participation. At their "Pre-Admission Visit" patients will be approached for enrollment in the study. Patients who provide written informed consent will complete the Hospital Anxiety and Depression Scale (HADS) survey at that time. If patients screen positive on the HADS (meaning a score of 8 or greater in the anxiety or the depression sections), they will be offered treatment within a collaborative care model intervention. If patients score less than 8 on the HADS survey (negative for symptoms of anxiety or depression) at the Pre-Admission Visit, they will not be offered treatment on study. Their medical records will still be abstracted periodically to follow post-transplant outcomes. The Collaborative Care Model: The collaborative care model is a team-delivered treatment program and will be provided by a treatment team of HSCT advanced practice providers (APP), HSCT physician, Comprehensive Cancer Support Program (CCSP) clinicians, and a psychiatrist. The collaborative care treatment intervention will be offered if patients score positive (score of 8 or greater) on the HADS. The collaborative care intervention includes medication consideration, therapy evaluation, and referral to psychiatry if needed. Treatment Options in the Collaborative Care Model: There will be three treatment options in the collaborative care model that will be offered to patients who score 8 or greater on the HADS - pharmacologic therapy, non-pharmacologic therapy, or both. If a patient chooses to start pharmacologic therapy after discussion with the APP at the Pre-Admission Visit, this treatment will include one of two antidepressants, which are standard-of-care treatments in medicine. The nonpharmacologic treatment in the Collaborative Care Model will involve a therapy consultation by the CCSP once patient is admitted to the hospital for their HSCT. Patients can also opt to take part in therapy with CCSP as well as taking medications. The study team at the time of enrollment will gather patient demographics and clinical information including gender, age, disease type, donor HLA match, and history of mental health disorders from the medical record. Follow-up HADS Surveys: On Day 0, (day of stem cell infusion) to the hospital for HSCT, patients will undergo another HADS survey, and this will be repeated at Day +14 (+/- 3 days), Day +30 (+/- 3 days), and Day +60 (+/- 3 days). Information will be gathered from the medical records on Day +14, Day +30, and Day +60 regarding symptoms of mucositis, inability to tolerate oral medications, development of hospital-acquired illnesses, ICU admissions, reactivation of viruses (i.e. CMV), readmission to hospital, engraftment status, development of GVHD, and missed clinic appointments. During the course of the study, all cases will be reviewed weekly in meetings with the psychiatrist and HSCT APPs to address mood symptoms, evaluate the need for titration of medications, and evaluate the need for psychotherapy, provided by CCSP therapist or psychiatrist. Satisfaction Surveys: At six months from initial patient enrollment, satisfaction surveys will be distributed to the HSCT APPs and HSCT physicians who have taken part in the study. Each patient at the end of study will also complete a satisfaction survey. |
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| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 6 Months | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | 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.
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
20 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | August 28, 2018 | ||||
| Actual Primary Completion Date | May 25, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04025190 | ||||
| Other Study ID Numbers | LCCC 1704 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | UNC Lineberger Comprehensive Cancer Center | ||||
| Study Sponsor | UNC Lineberger Comprehensive Cancer Center | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | UNC Lineberger Comprehensive Cancer Center | ||||
| Verification Date | July 2019 | ||||