By InvitationNot Applicable

Targeting Fear of Cancer Recurrence in Cancer Survivors: Evaluation of Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies

Belgium339 participantsStarted 2024-07-03

Plain-language 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 and/or 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients should have reached a minimum age of 18 years at the time of enrolment * Patients should have a histologically confirmed diagnosis of a solid cancer or haematologic malignancy * Patients should have completed surgery, chemotherapy, radiation therapy, immunotherapy, hormone therapy, targeted drug therapy or a combination of these at least 2 months ago and no longer than 5 years ago at the time of enrolment * Patients should have an expected life expectancy of at least 5 years * Patients are disease-free at the time of enrolment, as defined by the absence of somatic disease activity parameters * Patients can be included in a stable phase of their immunotherapy (e.g. adjuvant use of checkpoint inhibitors for melanoma), hormonal therapy (e.g. for breast and prostate cancer), targeted drug therapy (e.g. trastuzumab and pertuzumab for breast cancer; stable dose of PARP inhibitors for ovarian cancer; retuximab for lymphoma), or a combination of these * Patients must suffer from high FCR based on the Cancer Worry Scale (cut-off ≥ 14) * Patients should be able to adequately communicate in Dutch * Patients should present with a sufficient mental and physical functional status (according to investigator's judgment and first baseline assessment) for completing the questionnaires and neuropsychological assessment * Patients under current treatment for a depression or anxiety disorder are allowed to enrol provided their depression or anxiety disorder is stab…

What they're measuring

Fear of Cancer Recurrence

Timeframe: 6 weeks (T1)

Trial details

NCT IDNCT06175208

SponsorGeneral Hospital Groeninge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-01