Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS
NCT06589544, Not applicable, Recruiting, University Hospital of Ferrara
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Non-pharmacological Care for Depression in Cancer Patients Using VR and TMS | ClinicalTrials.gov |
| NCT number | NCT06589544 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital of Ferrara | ClinicalTrials.gov |
| Conditions | Depressive Symptoms, Quality of Life, Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Virtual Reality-based Cognitive Remediation (VR-COG) + Treatment as Usual (TAU), Repetitive transcranial magnetic stimulation (rTMS) + Treatment as usual (TAU), Treatment as Usual (TAU) | ClinicalTrials.gov |
| First posted | 2024-09-19 | ClinicalTrials.gov |
| Last updated | 2024-09-19 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hamilton Depression rating scale (HAM-D 17) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | 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. | ClinicalTrials.gov |
| Primary | Dropout rates; 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) | Feasibility will be assessed based on tolerability (dropout rates) and acceptability (proportion of recruited participants among those considered eligible). | ClinicalTrials.gov |
| Primary | Simulator Sickness Questionnaire (SSQ) | T0 (0 months - baseline); T1 (3 months - post intervention) | 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. | ClinicalTrials.gov |
| Primary | TMSens_Q | T0 (0 months - baseline); T1 (3 months - post intervention) | 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. | ClinicalTrials.gov |
| Secondary | EuroQol (EQ)-5D | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | It is self-report questionnaire to assess quality of life and heath status according to five dimensions. | ClinicalTrials.gov |
| Secondary | SF-12 | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | It is a self-report questionnaire to assess quality of life considering two dimensions, about physical health and mental health. | ClinicalTrials.gov |
| Secondary | Demoralization Scale (DS) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | It is a 24-item self-administered questionnaire with four subscales: discouragement, loss of meaning/purpose, dysphoria, sense of failure. | ClinicalTrials.gov |
| Secondary | 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) | It is a rating scale to assess embitterment reactions to negative life events | ClinicalTrials.gov |
| Secondary | Brief Symptom Inventory (BSI) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | Il is a questionnaire to evaluate symptoms of psychological distress | ClinicalTrials.gov |
| Secondary | Insomnia Severity Index (ISI) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | It is a tool to assess the severity of daytime and nighttime components of insomnia. | ClinicalTrials.gov |
| Secondary | Biological Rhythms Interview for Assessment in Neuropsychiatry (BRIAN) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | It is a scale consisting of 18 items to assess four areas of circadian rhythm difficulties: sleep, activity, social rhythms, and eating patterns. | ClinicalTrials.gov |
| Secondary | Activities of Daily Living (ADL) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | It is an instrument to assess disability levels. | ClinicalTrials.gov |
| Secondary | Psychosocial Adjustment to Illness (PAIS) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | I is a self-report instrument to assess seven dimensions about disability and quality of life. | ClinicalTrials.gov |
| Secondary | Toronto Alexithymia Scale 20-item (TAS-20) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | It is a self-report questionnaire to assess alexithymia. | ClinicalTrials.gov |
| Secondary | Screen for Cognitive Impairment in Psychiatry (SCIP) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | It is an instrument to assess cognitive deficit according to five subscales: immediate memory, working memory, phonemic verbal fluency, delayed memory, and psychomotor speed. | ClinicalTrials.gov |
| Secondary | Trail Making Test | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | Preliminary measures of effectiveness on executive function | ClinicalTrials.gov |
| Secondary | Digit Span | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | Preliminary measures of effectiveness on memory | ClinicalTrials.gov |
| Secondary | Stroop Test | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | Preliminary measures of effectiveness on executive function | ClinicalTrials.gov |
| Secondary | Frontal Assessment Battery (FAB) | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | Preliminary measures of effectiveness on executive function | ClinicalTrials.gov |
| Secondary | Rey's Word Test | T0 (0 months - baseline); T1 (3 months - post intervention); T2 (3 months after T1); T3 (6 months after T1) | Preliminary measures of effectiveness on memory | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 42022442 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)