Psychotherapy (Accelerated Resolution Therapy) for Cancer Related Trauma and Distress
NCT ID: NCT04436835
Last Updated: 2024-12-27
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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COMPLETED
NA
21 participants
INTERVENTIONAL
2019-11-27
2021-08-19
Brief Summary
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Detailed Description
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I. Calculate changes, and estimate mean changes, in primary outcomes of psychological trauma and cancer distress over a six week time period while receiving weekly accelerated resolution therapy (ART).
II. Calculate changes, and estimate mean changes, in secondary outcomes of anxiety and depression over a six week period while receiving weekly ART.
III. Will use a qualitative, descriptive design to explore contextual elements of the cancer experience that are consistently distressing and/or psychologically traumatic to more fully inform a future RCT testing in ART in cancer distress and psychological trauma.
IV. Calculate changes, and estimate mean changes, in secondary outcomes of resilience and symptom distress over a six week period while receiving weekly ART.
OUTLINE:
Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.
After completion of study intervention, patients are followed up at 1 week and again at 1 month.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (ART)
Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.
Psychotherapy
Undergo ART
Questionnaire Administration
Ancillary studies
Interventions
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Psychotherapy
Undergo ART
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergone chemotherapy, radiation therapy, chimeric antigen receptor T cells (CAR-T), or bone marrow transplant for a cancer diagnosis within the previous 3 years or have metastatic cancer
* A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time)
* A minimum score of 3 on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
* Denial of suicidal ideation or intent, with no evidence of psychotic behavior
* Participants must be willing and able to utilize secure web conferencing software, phone calls, or to travel to Mayo Clinic outside of normally scheduled visits to participate in the study
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Cindy Tofthagen
Principal Investigator
Principal Investigators
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Cindy Tofthagen, Ph.D., R.N.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2020-04130
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-006093
Identifier Type: OTHER
Identifier Source: secondary_id
19-006093
Identifier Type: -
Identifier Source: org_study_id