Desensitizing Distressing Recollections in Cancer Patients

NCT02760524 | Completed DMC

• 2 other identifiers: 09D.182JT 1487
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Autonomal response to distressing recollections

  baseline/4 weeks follow up

• Genomic testing

  baseline/ 4 weeks follow up

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects will receive NET intervention treatment immediately

Behavioral: NET Intervention

Control

ACTIVE COMPARATOR

Subjects will receive NET intervention treatment and serve as a wait-list control

Behavioral: NET Intervention

Interventions

NET Intervention BEHAVIORAL

Neuro-emotional Technique

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Neoplasms

Study Officials

• Daniel A Monti, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: May 3, 2016
• Study Start: April 11, 2010
• Primary Completion: August 1, 2015
• Study Completion: September 28, 2017
• Last Updated: May 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)