Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS

NCT06589544 | Recruiting DMC

• 1 other identifier: 199/2023/Disp/AUSLFe PNRR onco
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depressive Symptoms; Quality of Life; Cognitive Impairment

Keywords

Depression; Cognitive functions; Quality of Life; Cancer; Virtual reality; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (17)

• EuroQol (EQ)-5D

  T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

• SF-12

  T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

• Demoralization Scale (DS)

  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

  T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

• Brief Symptom Inventory (BSI)

  T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1)

Other Outcomes (1)

• Cost-effectiveness

  T0 (0 months - baseline); T3 (6 months after T1-post intervention)

Study Arms (3)

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.

Device: Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU)

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.

Device: Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU)

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.

Other: Treatment as Usual (TAU)

Interventions

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).

Virtual Reality-based Cognitive Remediation (VR-COG)

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).

Repetitive transcranial magnetic stimulation (rTMS)

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).

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of oncological disease in the last 5 years
• Diagnosis of Major Depressive Disorder, without psychotic symptoms, according to DSM-5 criteria
• item Hamilton Rating Scale for Depression (HAM-D-17) (score ≥14)
• Age: 18 years or older
• Oncological disease in a non-advanced stage (Karnofsky Performance Status \> 80)

You may not qualify if:

• Current or prior hospitalization in the next 6 months
• Planned surgery in the next 6 months
• Suicidal ideation
• Substance use
• History of significant head trauma, neurological disorders, intellectual deficits
• Recurrent seizures resulting from head trauma or conditions lowering seizure threshold
• Concurrent use of medications that increase the risk of epileptic seizures (e.g., antipsychotics, tricyclics, theophylline)
• Glaucoma, retinal detachment, or other serious vision impairments that may prevent the use of virtual reality technology
• Severe problems with autonomous ambulation

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• University Hospital of Cagliari: collaborator

Study Sites (2)

Health Trust, Ferrara

Ferrara, FE, 44124, Italy

RECRUITING

University Hospital of Cagliari

Cagliari, 09124, Italy

RECRUITING

MeSH Terms

Conditions

Depression; Cognitive Dysfunction; Neoplasms

Interventions

Therapeutics; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy

Study Officials

• Luigi Grassi, MD, PhD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martino Belvederi Murri, MD

CONTACT

00393335248720; martino.belvederimurri@unife.it

Barbara Zaccagnino, PsyD

CONTACT

00393288657355; barbara.zaccagnino@edu.unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: September 19, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-06

Locations

IT (2)