Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06175208
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-18
First Post:
2023-11-21
Brief Title:
Targeting Fear of Cancer Recurrence in Cancer Survivors Evaluation of Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies
Sponsor:
General Hospital Groeninge
Organization:
General Hospital Groeninge
Study Overview
Official Title:
Targeting Fear of Cancer Recurrence in Cancer Survivors a Multicentre Randomized Controlled Trial to Evaluate Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMOTE
Brief Summary:
In this trial the investigators introduce two internet-based psychological methods to meet the currently unmet medical need to cope with Fear of Cancer Recurrence FCR beyond the acute phase of cancer treatment internet-based emotional freedom techniques iEFT and internet-based mindfulness intervention iMMI The primary aim of this trial is to examine the efficacy of Internet-Based Emotional Freedom Techniques iEFT and Internet-Based Mindfulness Meditation Intervention iMMI to alleviate Fear of Cancer Recurrence FCR in cancer survivors as determined through the Fear of Cancer Recurrence Inventory FCRI in cancer survivors To translate a statistically significant effect on FCR into a clinically significant change the investigators would need to detect a between-group difference in mean FCRI at T1 of 10 points using an independent samples t-test two experimental groups are compared against a single wait-list control When the application of iEFT andor iMMI appears effective to reduce FCR these self-help methods could be implemented in clinical settings The use of these low cost interventions with a low threshold by an internet-based approach will facilitate a potential implementation in clinical practice
Detailed Description:
Despite our adequate medical care and financial support systems the mental wellbeing and quality of life after cancer diagnosis and treatment is often poorly addressed in clinical settings Previous research showed that Fear of Cancer Recurrence FCR is one of the most common psychological burdens faced by 39-97 of cancer survivors In this phase III randomized multicentre trial patients will be allocated to either the iEFT group iMMI group or wait-list control WLC group for a study trajectory of 6 weeks 339 cancer survivors between 6 months and 5 years since diagnosis and who have completed their primary cancer treatment ie surgery radiation andor chemotherapy will be enrolled and randomized 111 to one of the two intervention groups or the WLC group Participants will complete evaluation questionnaires at baseline T0 after 6 weeks T1 and 12 weeks T2 of intervention or waiting list and 24 weeks T3 A biomarker endpoint includes the measurement of chronic biologic stress in hair cortisol concentration Therefore optional hair collection may take place before T0 and after the 6-week intervention T1 Primary objective is to evaluate the feasibility and efficacy of iEFT and iMMI as an intervention strategy to reduce FCR in cancer survivors The investigators hypothesize that an intervention with iEFT or iMMI will be superior compared to the WLC group at T1 Secondary objectives include the following
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None