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

Launched by GENERAL HOSPITAL GROENINGE · Dec 8, 2023

Keywords

ClinConnect Summary

Researchers are testing two online programs to help cancer survivors who worry about cancer coming back. In a three-arm, randomized trial, participants are assigned to one of: internet-based Emotional Freedom Techniques (iEFT), internet-based Mindfulness Meditation (iMMI), or a wait-list control that receives one of the active programs after about 12 weeks. The main goal is to see if iEFT or iMMI can reduce Fear of Cancer Recurrence (FCR) after 6 weeks, measured by the Fear of Cancer Recurrence Inventory (FCRI), which ranges from 0 to 168 (higher scores mean more worry). Participants also complete questionnaires at 0, 6, 12, and 24 weeks to look at other aspects of well-being, quality of life, and overall distress. An optional hair cortisol test may be collected to explore biological stress.

Eligible participants are adults 18 and older who have had a solid tumor or blood cancer, completed their main cancer treatment 2 months to 5 years before enrollment, and are disease-free with a life expectancy of at least 5 years. They must have a high level of FCR (based on a screening scale), be able to communicate in Dutch, and be willing to use online programs. Exclusions include active palliative treatment, significant mental decline, certain other medical or psychiatric conditions, or if they are already practicing EFT or mindfulness regularly. The study plans to enroll about 339 people across multiple Belgian hospitals, and results could show whether these low-cost, online programs could be added to standard survivorship care.

Gender

ALL

Eligibility criteria

• 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 stable
• Exclusion Criteria:
• • Patients who received a treatment with palliative intent
• • Patients showing signs of mental deterioration
• • Patients suffering from organic brain syndrome (concussion without neurological symptoms and negative imaging is allowed)
• • Patients who are alcohol or drug dependent
• • Patients with another serious or chronic medical, neurologic or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in either of the intervention programmes or from the measurement of intervention outcomes; a prior diagnosis of a depressive, anxiety or adjustment disorder is allowed
• • Patients who cannot commit to the intervention schedule; obstacles such as surgery or long-term hospitalisation, change of residence or work, ... can have an emotional and practical impact which makes these patients not eligible for participation.
• • Patients who actively practice EFT or mindfulness(based) meditation