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Effectiveness of Group and Individual Training in EFT for Patients in Remission From Melanoma

Primary Purpose

Melanoma (Skin)

Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Emotional Freedom Techniques (EFT)
Sponsored by
Soul Medicine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Melanoma (Skin)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Melanoma diagnosis over six months prior to the study; confirmed by clinical, dermoscopic examination and pathology results

Exclusion Criteria:

  • In active treatment for melanoma
  • schizophrenia
  • epilepsy
  • other malignant disease

Sites / Locations

  • The School Of Social Work Tel Aviv University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Individual EFT Therapy

Group EFT Therapy

Wait List

Arm Description

Personal EFT instruction and practice group

Group EFT instruction and practice group

Wait list control group

Outcomes

Primary Outcome Measures

Illness perception
Change in score on Revised Illness Perception Questionnaire (IPQ-R)
Perception of recurrence
Change of perceived recurrence risk on a Likert scale

Secondary Outcome Measures

Other physical symptoms
Change in patient's self-report of somatization, pain, and other symptoms on a Likert scale
Depression
Change in depressive symptoms on the Positive and Negative Affect Schedule (PANAS)
Anxiety
Change in anxiety symptoms on the Positive and Negative Affect Schedule (PANAS)
Patient's self-report of quality of life
Change in quality of life scores on the Quality of Life Scale (QOLS)
Wellbeing
Change in score on The Well-being Numerical Rating Scales (WB-NRSs).

Full Information

First Posted
April 3, 2022
Last Updated
April 11, 2023
Sponsor
Soul Medicine Institute
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT05421988
Brief Title
Effectiveness of Group and Individual Training in EFT for Patients in Remission From Melanoma
Official Title
Effectiveness of Group and Individual Training in Emotional Freedom Techniques for Patients in Remission From Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
July 20, 2025 (Anticipated)
Study Completion Date
January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soul Medicine Institute
Collaborators
Tel Aviv University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Serious medical diagnosis frequently induce fear focused on specific anticipations or generalized anxiety, along with uncertainty, insecurity, and disorientation. Other emotions such as anger, depression, hopelessness, shame, or grief may also become involved following a serious diagnosis. The adverse impact of stress on health and immune function is well-established, as well as its link to depression and anxiety. Emotional Freedom Techniques (EFT) has demonstrated efficacy in treating anxiety, depression, and PTSD. This study tests its effectiveness in reducing negative emotional symptoms in general, and fear of recurrence in particular, among individuals previously diagnosed with melanoma and currently in remission.
Detailed Description
Serious medical diagnosis frequently induce fear focused on specific anticipations or generalized anxiety, along with uncertainty, insecurity, and disorientation. Other emotions such as anger, depression, hopelessness, shame, or grief may also become involved following a serious diagnosis. The adverse impact of stress on health and immune function is well-established, as well as its link to depression and anxiety. Emotional Freedom Techniques (EFT) has demonstrated efficacy in treating anxiety, depression, and PTSD. This study tests its effectiveness in reducing negative emotional symptoms in general, and fear of recurrence in particular, among individuals previously diagnosed with melanoma and currently in remission. Specifically, the study aims: To assess the effect of instruction and practice of EFT on illness perception, fear of cancer recurrence, and wellbeing. To assess whether the social support provided by EFT instruction in a group setting makes this efficient mode of implementation non-inferior or even beneficial in comparison to personal instruction. To describe the emotions related to life events reported by patients in connection with the appearance and location of melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants in the two treatment arms, and data analysts, will be blind to group assignment.
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual EFT Therapy
Arm Type
Experimental
Arm Description
Personal EFT instruction and practice group
Arm Title
Group EFT Therapy
Arm Type
Experimental
Arm Description
Group EFT instruction and practice group
Arm Title
Wait List
Arm Type
No Intervention
Arm Description
Wait list control group
Intervention Type
Behavioral
Intervention Name(s)
Emotional Freedom Techniques (EFT)
Intervention Description
EFT is an efficacious method demonstrated in over 100 clinical trials. It combines cognitive and exposure techniques with acupressure, in the form of fingertip percussion on acupuncture meridian points.
Primary Outcome Measure Information:
Title
Illness perception
Description
Change in score on Revised Illness Perception Questionnaire (IPQ-R)
Time Frame
Pre intervention, post 4 week intervention, and 3 month follow-up
Title
Perception of recurrence
Description
Change of perceived recurrence risk on a Likert scale
Time Frame
Pre intervention, post 4 week intervention, and 3 month follow-up
Secondary Outcome Measure Information:
Title
Other physical symptoms
Description
Change in patient's self-report of somatization, pain, and other symptoms on a Likert scale
Time Frame
Pre intervention, post 4 week intervention, and 3 month follow-up
Title
Depression
Description
Change in depressive symptoms on the Positive and Negative Affect Schedule (PANAS)
Time Frame
Pre intervention, post 4 week intervention, and 3 month follow-up
Title
Anxiety
Description
Change in anxiety symptoms on the Positive and Negative Affect Schedule (PANAS)
Time Frame
Pre intervention, post 4 week intervention, and 3 month follow-up
Title
Patient's self-report of quality of life
Description
Change in quality of life scores on the Quality of Life Scale (QOLS)
Time Frame
Pre intervention, post 4 week intervention, and 3 month follow-up
Title
Wellbeing
Description
Change in score on The Well-being Numerical Rating Scales (WB-NRSs).
Time Frame
Pre intervention, post 4 week intervention, and 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Melanoma diagnosis over six months prior to the study; confirmed by clinical, dermoscopic examination and pathology results Exclusion Criteria: In active treatment for melanoma schizophrenia epilepsy other malignant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Benyamini, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Study Director
Facility Information:
Facility Name
The School Of Social Work Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
69978
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
An anonymized data file will be made available to any other qualified investigator who requests it.
IPD Sharing Time Frame
Data will be made available upon publication and for 5 years thereafter.
IPD Sharing Access Criteria
Email request from qualified investigator.

Learn more about this trial

Effectiveness of Group and Individual Training in EFT for Patients in Remission From Melanoma

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