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

NCT04436835 | Completed

• 2 other identifiers: 19-006093NCI-2020-04130
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Psychological trauma

  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.

  Up to 6 weeks

• Cancer distress

  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.

  Up to 6 weeks

Secondary Outcomes (4)

• Anxiety

  Up to 6 weeks

• Depression

  Up to 6 weeks

• Resilience

  Up to 6 weeks

• Symptom distress

  Up to 6 weeks

Study Arms (1)

Supportive care (ART)

EXPERIMENTAL

Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.

Behavioral: Psychotherapy; Other: Questionnaire Administration

Interventions

Psychotherapy BEHAVIORAL

Undergo ART

Also known as: talk therapy

Supportive care (ART)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (ART)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Psychotherapy

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Cindy Tofthagen, Ph.D., R.N.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: November 27, 2019
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (1)