Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients
NCT ID: NCT06015932
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2017-12-20
2029-12-31
Brief Summary
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Detailed Description
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I. To reduce psychological stress.
SECONDARY OBJECTIVES:
I. To increase post-traumatic growth (PTG). II. To increase patient self-efficacy in utilizing therapy skills. III. To estimate patient acceptability and feasibility of conducting CBCSM within the clinical setting.
IV. To estimate differences of conducting CBCSM virtually during the Public Health Emergency (PHE) versus in person pre-PHE.
V. To estimate differences of conducting CBCSM post PHE virtually with limitation to Minnesota patients only.
VI. To explore the difference using the same therapy in patients with advanced, metastatic disease in a individual setting versus patients without the advanced, metastatic disease in a group setting.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
GROUP II: Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (CBCSM)
Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
Cognitive Behavior Therapy
Participate in CBCSM group sessions
Questionnaire Administration
Complete questionnaires
Group II (no CBCSM)
Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
Questionnaire Administration
Complete questionnaires
Interventions
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Cognitive Behavior Therapy
Participate in CBCSM group sessions
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cancer diagnosis with predicted survival \> 1 year
* Cancer treatment within past 1 year or treatment planning in progress
* Age \>= 18-years
* Moderate distress screen, indicated by Impact of Event Scale-Revised (IES-R) score \>= 14 or clinical judgment
* Written informed research consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Shawna L. Ehlers, Ph.D., L.P.
Principal Investigator
Principal Investigators
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Shawna L. Ehlers, Ph.D., L.P.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-00250
Identifier Type: REGISTRY
Identifier Source: secondary_id
17-000947
Identifier Type: OTHER
Identifier Source: secondary_id
17-000947
Identifier Type: -
Identifier Source: org_study_id
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