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| Name | Class |
|---|---|
| University Hospital of Cagliari | UNKNOWN |
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Despite its significant impact on individuals and healthcare systems, substantial gaps remain in the clinical and rehabilitative management of depression in oncology patients.
Depression in cancer patients is often under-recognized and untreated, and screening tools and structured healthcare pathways are lacking. Even when depression is identified in oncology patients, evidence of effective treatments is limited. There are no specific guidelines for psychotropic drug use in cancer patients, and antidepressant efficacy is uncertain despite their frequent use.
Emerging strategies like transcranial magnetic stimulation and cognitive rehabilitation show promising findings. However, the cost-effectiveness of therapeutic strategies is understudied.
Repetitive transcranial magnetic stimulation (rTMS) is already used for the treatment and relapse prevention of depression both as monotherapy and as an add-on to antidepressant pharmacotherapy, and it appears effective in improving cognitive performance. However, it has not yet been applied to treat depressive disorders in oncology patients.
Virtual reality-based cognitive behavioral intervention (VR-COG) is designed to improve cognitive functioning, a central feature of depression in oncological conditions. VR-COG enhances learning and skill acquisition with better ecological efficiency than traditional cognitive remediation programs. VR approaches are well-received by oncology patients and show promise in reducing anxiety and depressive symptoms.
The trial aims to evaluate the effectiveness of highly specialized, nonpharmacological interventions on depressive symptoms and quality of life in oncology patients. Specifically, repetitive Transcranial Magnetic Stimulation (rTMS) and Virtual Reality-based Cognitive Remediation (VR-COG) will be analyzed, alongside standard Treatment as Usual (TAU), in comparison to TAU alone. This trial also aims at evaluate cognitive functioning, depression-related conditions and the cost-effectiveness of the interventions under study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality-based Cognitive Remediation (VR-COG) | Experimental | Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as usual (TAU) The "VSail 3D" experimental protocol includes scenarios (virtual environments) dedicated to the sport of sailing. It is based on the software CEREBRUM-VELA (Idego-Promind, srl, Rome, Italy). Frequency: 24 sessions, 2 times a week, for 12 consecutive weeks. The duration of each session is 50 minutes. |
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| Repetitive transcranial magnetic stimulation (rTMS) | Experimental | Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) rTMS group will receive active rTMS using the MagVenture MagPro X100 System (MagVenture A/S, Denmark) equipped with a MagVenture Cool-B65 A/P double-faced coil and a neuronavigation system (Localite GmbH, Sankt Augustin, Germany). Frequency: 24 sessions, 2 times a week, for 12 consecutive weeks. The duration of each session is 60 minutes. |
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| Treatment as Usual (TAU) | Active Comparator | Treatment as Usual (TAU) The path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https://www.aiom.it), includes an initial psychiatric visit and eventual pharmacological therapy with psychiatric follow-up plus psychological counseling. Frequency: 12 weeks. Each counseling session lasts 45-50 minutes, and will be conducted on a monthly basis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU) | Device | The "CEREBRUM-VELA" virtual reality software is made up of exercises designed to train different cognitive functions (i.e.: executive functions, motor ability, language). The different degrees of difficulty are designed to adapt to the user's functional diagnosis. Each session, after an initial part of welcome, psychoeducation and orientation to the instrument, involves alternating virtual reality exercises, positive and corrective feedback and suggestions of practical homework that the individual should try to do during his day. Treatment as usual (TAU) The path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https:// www.aiom.it), includes an initial psychiatric visit aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions). |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression rating scale (HAM-D 17) | The Ham-D is the most widely used clinician-administered depression assessment scale.The original version contains 17 items pertaining to symptoms of depression experienced over the past week. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Dropout rates; Proportion of recruited participants among those considered eligible | Feasibility will be assessed based on tolerability (dropout rates) and acceptability (proportion of recruited participants among those considered eligible). | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Simulator Sickness Questionnaire (SSQ) | Feasibility will be assessed based on side effects through Simulator Sickness Questionnaire (SSQ) self-report questionnaire that evaluates the frequency of unwanted effects due to virtual reality technologies, such as nausea, dizziness, headaches, eye strain, etc. 16 items. | T0 (0 months - baseline); T1 (3 months - post intervention) |
| TMSens_Q | It was developed to report secondary effects following rTMS application. The use of the structured rTMS questionnaire will help to monitor the safety of rTMS. | T0 (0 months - baseline); T1 (3 months - post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol (EQ)-5D | It is self-report questionnaire to assess quality of life and heath status according to five dimensions. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| SF-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | The cost effectiveness will be computed as the ratio of total costs divided by the mean improvements of quality of life across interventions (TAU, TAU+rTMS, TAU+VRCOG). Total costs will include the costs of the healthcare consultations (visits in the TAU condition), psychotropic drugs, equipment and staff. Total costs will be computed as the sum of these costs of each intervention, divided by the number of patients. Quality of life improvements will be computed as the difference between baseline (T0) vs endpoint (T3) quality of life. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martino Belvederi Murri, MD | Contact | 00393335248720 | martino.belvederimurri@unife.it | |
| Barbara Zaccagnino, PsyD | Contact | 00393288657355 | barbara.zaccagnino@edu.unife.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Grassi, MD, PhD | Università degli Studi di Ferrara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Trust, Ferrara | Recruiting | Ferrara | FE | 44124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42022442 | Derived | Sancassiani F, Murri MB, Madeddu C, Atzeni M, Kalcev G, Zaccagnino B, Olivetti AF, Azzolina D, Cruciata M, Nanni MG, Cossu G, Perra A, di Natale L, Primavera D, Tusconi M, Caruso R, Carta MG, Grassi L. Cost-Effectiveness of Transcranial Magnetic Stimulation and Virtual Reality-Based Cognitive Remediation for Depressive Symptoms among Cancer Patients: Protocol for a Three-Arm Randomized Controlled Trial. Clin Pract Epidemiol Ment Health. 2026 Mar 24;22:e17450179376750. doi: 10.2174/0117450179376750250925051532. eCollection 2026. |
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| Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU) | Device | Active rTMS stimulation will be delivered at 90% of the resting Motor Threshold (rMT), adjusted for the depth of the fcMRI-identified target. Personalized targets created for each individual will be located at various cortical depths. For safety reasons, the stimulation intensity will never exceed 120% of the rTMS. Treatment as usual (TAU) The path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https:// www.aiom.it), includes an initial psychiatric visit aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions). |
|
| Treatment as Usual (TAU) | Other | Treatment as usual (TAU) The path, following the guidelines of the Italian Association of Medical Oncology (AIOM-SIPO: https:// www.aiom.it), includes an initial psychiatric visit aimed at assessing the presence of psychopathological conditions that may necessitate pharmacological therapy (antidepressants, hypnotic-sedatives) and subsequent psychiatric follow-up. The treatment also involves psychological counseling (monthly sessions). |
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It is a self-report questionnaire to assess quality of life considering two dimensions, about physical health and mental health.
| T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Demoralization Scale (DS) | It is a 24-item self-administered questionnaire with four subscales: discouragement, loss of meaning/purpose, dysphoria, sense of failure. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Post-Traumatic Embitterment Disorder Self-Rating Scale | It is a rating scale to assess embitterment reactions to negative life events | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Brief Symptom Inventory (BSI) | Il is a questionnaire to evaluate symptoms of psychological distress | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Insomnia Severity Index (ISI) | It is a tool to assess the severity of daytime and nighttime components of insomnia. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Biological Rhythms Interview for Assessment in Neuropsychiatry (BRIAN) | It is a scale consisting of 18 items to assess four areas of circadian rhythm difficulties: sleep, activity, social rhythms, and eating patterns. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Activities of Daily Living (ADL) | It is an instrument to assess disability levels. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Psychosocial Adjustment to Illness (PAIS) | I is a self-report instrument to assess seven dimensions about disability and quality of life. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Toronto Alexithymia Scale 20-item (TAS-20) | It is a self-report questionnaire to assess alexithymia. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Screen for Cognitive Impairment in Psychiatry (SCIP) | It is an instrument to assess cognitive deficit according to five subscales: immediate memory, working memory, phonemic verbal fluency, delayed memory, and psychomotor speed. | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Trail Making Test | Preliminary measures of effectiveness on executive function | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Digit Span | Preliminary measures of effectiveness on memory | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Stroop Test | Preliminary measures of effectiveness on executive function | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Frontal Assessment Battery (FAB) | Preliminary measures of effectiveness on executive function | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Rey's Word Test | Preliminary measures of effectiveness on memory | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) |
| Matrix test | Preliminary measure of effectiveness on selective attention. | T0 (0 months-baseline), T1 (3 months - post intervention), T2 (3 months after T1), T3 (6 months after T1) |
| T0 (0 months - baseline); T3 (6 months after T1-post intervention) |
| University Hospital of Cagliari | Recruiting | Cagliari | 09124 | Italy |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| D060825 | Cognitive Dysfunction |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
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