Desensitizing Distressing Recollections in Cancer Patients (NET)

The major goal of this study is to determine whether Neuro-Emotional Technique is a viable treatment option for decreasing distress in cancer patients. The potential advantages of NET are: 1) it is designed specifically to address distressing stimuli and unresolved emotional memories; 2) it is a brief, time-limited intervention; and 3) its multi-modal design may appeal to and benefit a broader range of patients than a single mode intervention

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: NET Intervention

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years of age
• Distressing cancer-related recollection that has persisted for at least six months
• Distressing cancer-related recollection that causes physiological reactivity (i.e., increased heart rate and/or increased skin conductance level - SCL), as described in section 4.2.3.
• Received a cancer diagnosis at least 6 months prior to being contacted for participation in this study

Exclusion Criteria:

• Any current Major Mental Disorder, as assessed by Structured Clinical Interview for DSM IV Axis I Disorders (SCID - Clinical Version, First et al, 1997)
• History of Post-traumatic Stress Disorder
• Current active mood primary disorder prior to the cancer diagnosis (as per PI or designate)
• History or current diagnosis of substance or alcohol abuse or dependence (as per PI or designate)
• Use of psychotropic medications within the past month or current use of medications that would interfere with autonomic nervous system measures (benzodiazepines, barbiturates, major tranquilizers).
• Use of some psychotropic medications are allowed such as SSRIs and certain sleep aids, but dosages must be stable from six weeks prior to enrollment and throughout study period
• Any psychological or musculoskeletal problems that would interfere with psychophysiological assessments and treatment
• Currently receiving chemotherapy or radiation
• Are in the terminal stages of illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Subjects will receive NET intervention treatment immediately	Behavioral: NET Intervention; Neuro-emotional Technique
Active Comparator: Control; Subjects will receive NET intervention treatment and serve as a wait-list control	Behavioral: NET Intervention; Neuro-emotional Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post traumatic Cognitions Inventory	change from baseline Post Traumatic Cognitions Inventory score	baseline/ 4 weeks/6 months follow up
State Trait Anxiety Inventory	change from baseline State Trait Anxiety Inventory score	baseline/4 weeks/6 months follow up
Brief Symptom Inventory	change from baseline Brief Symptom Inventory	baseline/4 weeks/6 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomal response to distressing recollections	change from baseline in autonomal response to distressing recollections	baseline/4 weeks follow up
Genomic testing	change from baseline genomic testing before and after intervention	baseline/ 4 weeks follow up

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Daniel A Monti, MD, Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2010
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 28, 2017

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimated): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 09D.182; JT 1487 (Other Identifier: JeffTrial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO