Clinical trial NCT05421988: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Melanoma (Skin)
Lead sponsor: Soul Medicine Institute
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2022-06-16
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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:

1. To assess the effect of instruction and practice of EFT on illness perception, fear of cancer recurrence, and wellbeing.
2. 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.
3. To describe the emotions related to life events reported by patients in connection with the appearance and location of melanoma.

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

Primary outcomes:
measure: Illness perception
timeFrame: Pre intervention, post 4 week intervention, and 3 month follow-up
measure: Perception of recurrence
timeFrame: Pre intervention, post 4 week intervention, and 3 month follow-up
Secondary outcomes:
measure: Other physical symptoms
timeFrame: Pre intervention, post 4 week intervention, and 3 month follow-up
measure: Depression
timeFrame: Pre intervention, post 4 week intervention, and 3 month follow-up
measure: Anxiety
timeFrame: Pre intervention, post 4 week intervention, and 3 month follow-up
measure: Patient's self-report of quality of life
timeFrame: Pre intervention, post 4 week intervention, and 3 month follow-up
measure: Wellbeing
timeFrame: Pre intervention, post 4 week intervention, and 3 month follow-up
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The School Of Social Work Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yael Benyamini, PhD
role: STUDY_DIRECTOR
References: