Cancer Within a Pandemic: A Telemental Health Intervention
NCT ID: NCT04659993
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2021-03-10
2021-06-09
Brief Summary
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Detailed Description
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Secondary Objective: To reduce depression and anxiety levels through meaning-making.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Telemental Group
The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms.
Telemental Health Sessions, Support Groups and Questionnaires
Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.
Interventions
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Telemental Health Sessions, Support Groups and Questionnaires
Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.
Eligibility Criteria
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Inclusion Criteria
* Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);
* Aged 18-39
* Must speak English
* Must have computer with audio and visual capabilities.
* Must live within North Carolina
* Must have experienced health-related anxiety and/or distress in last 3 months.
Exclusion Criteria
* Major cognitive impairment, marked concerns with working memory, concentration, or word finding difficulties that significantly impairs daily functioning documented in most recent clinic note or self-reported
* Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years)
* Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or revealed during subject interview
* Moderate to severe alcohol or drug abuse; as evidenced by an ICD-10 codes related to alcohol or illicit substance abuse in the medical record within the past year or revealed during subject interview.
* Severe eating disorders; as evidenced by an ICD-10 code in the medical record such as anorexia nervosa or bulimia within the past year or revealed during patient interview
* Repeated "acute" crises for example: repeated acute crises consisting of marked psychological distress that impairs function and warrants clinician intervention (e.g., occurring once a month or more frequently); this we be evaluated by the clinician screener.
18 Years
39 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Katie Duckworth, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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WFBCCC01520
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00070150
Identifier Type: -
Identifier Source: org_study_id
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