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Psychotherapy (Accelerated Resolution Therapy) for Cancer Related Trauma and Distress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436835
Recruitment Status : Active, not recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
This trial studies whether a form of psychotherapy called accelerated resolution therapy can help with cancer distress and psychological trauma. Accelerated resolution therapy is an evidence-based therapy for the treatment of depressive symptoms, trauma, and stress-related disorders. This study may provide evidence to support integration of accelerated resolution therapy into psychological treatment of cancer patients, which may decrease cancer related trauma and distress.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Behavioral: Psychotherapy Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Accelerated Resolution Therapy for Cancer Related Trauma and Distress: A Pilot Study
Actual Study Start Date : November 27, 2019
Actual Primary Completion Date : June 3, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive care (ART)
Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.
Behavioral: Psychotherapy
Undergo ART
Other Name: talk therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Psychological trauma [ Time Frame: Up to 6 weeks ]
    Symptoms of psychological trauma will be measured with both the Primary Care-Post Traumatic Stress Disorder Screening (PC-PTSD-5) and the Post Traumatic Stress Disorder Checklist (PCL-5). The PCL-5 (PTSD Patient Checklist) is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma). The total symptom severity score ranges from 0 to 80.

  2. Cancer distress [ Time Frame: Up to 6 weeks ]
    Cancer distress will be measured with the Cancer Treatment Distress Scale (CTxD). The CTxD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience.


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: Up to 6 weeks ]
    The General Anxiety Disorder (GAD-7) is a measure of anxiety scored from 0 (not at all)-3 (nearly every day) scale for each item with total scores ranging from 0-21. A score of 10 or more indicates high anxiety, although a cut-score of 7 or higher has been suggested for cancer populations.

  2. Depression [ Time Frame: Up to 6 weeks ]
    The Patient Health Questionnaire (PHQ-8) is an 8 item measure of depression scoring DSM -IV criteria for depression on a 0 (not at all) to 3 (nearly every day) scale for each item with total scores ranging from 0-24 (25). A score of 10 or more indicates depression.

  3. Resilience [ Time Frame: Up to 6 weeks ]
    The Connor-Davidson Resilience Scale (CD-RISC) is a 10 item scale in which participants rate statements on a scale of 0 (not at all true) to 4 (true nearly all the time). Higher scores indicate higher levels of resilience.

  4. Symptom distress [ Time Frame: Up to 6 weeks ]
    The Edmonton Symptom Assessment Scale (ESAS) consists of 11-point numerical rating scales for self-report of ten common symptoms of cancer. A summary score is calculated with higher scores representing greater symptom distress.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to read, write and understand English
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436835


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Cindy Tofthagen Mayo Clinic
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04436835    
Other Study ID Numbers: 19-006093
NCI-2020-04130 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-006093 ( Other Identifier: Mayo Clinic in Florida )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms