Desensitizing Distressing Recollections in Cancer Patients

Cancer Clinical Trial

— NET  

Official title:

Desensitizing Distressing Recollections in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760524
• Other study ID #: 09D.182
• Status: Completed
• Phase: N/A
• Start date: April 11, 2010
• Est. completion date: September 28, 2017

Study information

• Verified date: June 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 28, 2017
• Est. primary completion date: August 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• NET Intervention
Neuro-emotional Technique

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post traumatic Cognitions Inventory	change from baseline Post Traumatic Cognitions Inventory score	baseline/ 4 weeks/6 months follow up
Primary	State Trait Anxiety Inventory	change from baseline State Trait Anxiety Inventory score	baseline/4 weeks/6 months follow up
Primary	Brief Symptom Inventory	change from baseline Brief Symptom Inventory	baseline/4 weeks/6 month follow up
Secondary	Autonomal response to distressing recollections	change from baseline in autonomal response to distressing recollections	baseline/4 weeks follow up
Secondary	Genomic testing	change from baseline genomic testing before and after intervention	baseline/ 4 weeks follow up

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University
•   Thomas Jefferson University Hospital