BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory)
NCT04391543, Not applicable, Unknown, Le Mans Universite
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | BIOpsychosocial Approach of the CAncer-RElated FAtigue (BIOCARE FActory) | ClinicalTrials.gov |
| NCT number | NCT04391543 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 86 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Le Mans Universite | ClinicalTrials.gov |
| Conditions | Breast Cancer | ClinicalTrials.gov |
| Interventions | Experimental session | ClinicalTrials.gov |
| First posted | 2020-05-18 | ClinicalTrials.gov |
| Last updated | 2024-04-09 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Sociability status | 18 months | Change from baseline of a Comprehensive interview | ClinicalTrials.gov |
| Primary | Physical characteristics 1 | 18 months | Change from baseline of height (in meters) | ClinicalTrials.gov |
| Primary | Physical characteristics 2 | 18 months | Change from baseline of mass (in kilograms) | ClinicalTrials.gov |
| Primary | Physical characteristics 3 | 18 months | Change from baseline of fat mass (in percentage) | ClinicalTrials.gov |
| Primary | Physical characteristics 4 | 18 months | Change from baseline of leg volum | ClinicalTrials.gov |
| Primary | Postural stability | 18 months | Change from baseline of maximum displacement speed of pressure centre at the postural stability test | ClinicalTrials.gov |
| Primary | Cognitive function 1 | 18 months | Change from baseline of Stroop test score (higher score means worse outcome) | ClinicalTrials.gov |
| Primary | Cognitive function 2 | 18 months | Change from baseline of Montreal Cognitive Assessment score (higher score means better outcome) | ClinicalTrials.gov |
| Primary | Cognitive function 3 | 18 months | Change from baseline of Trail Making test score (higher score means worse outcome) | ClinicalTrials.gov |
| Primary | Fatigability | 18 months | Change from baseline at critical force test measurement | ClinicalTrials.gov |
| Primary | Functional cardio-respiratory capability | 18 months | Change from baseline of the maximum volum of oxygen during Astrand-Rhyming test | ClinicalTrials.gov |
| Primary | Quality of life status | 18 months | Change from baseline of the European Organisation for Research and Treatment of Cancer quality of life C30 questionnaire score (higher score means better outcome) | ClinicalTrials.gov |
| Primary | Fatigue | 18 months | Change from baseline of the European Organisation for Research and Treatment of Cancer Fatigue questionnaire score (higher score means worse outcome) | ClinicalTrials.gov |
| Primary | Anxiety | 18 months | Change from baseline of the Hospital Anxiety and Depression scale score (higher score means worse outcome) | ClinicalTrials.gov |
| Primary | Emotional function | 18 months | Change from baseline of the Brief Cope test score | ClinicalTrials.gov |
| Primary | Level of activity | 18 months | Change from baseline of actimetry mesurement | ClinicalTrials.gov |
| Primary | Inflammatory status (pro-inflammatory cytokines) | 18 months | Change from baseline of blood inflammatory markers determined by ELISA test (pro-inflammatory cytokines : IL-6, TNFα, IL-8, IL-1β) | ClinicalTrials.gov |
| Primary | Inflammatory status (anti inflammatory cytokine) | 18 months | Change from baseline of blood inflammatory markers determined by ELISA test ( anti inflammatory cytokine : IL-1ra) | ClinicalTrials.gov |
| Primary | Sarcopenia 1 | 18 months | Change from baseline of body masse index | ClinicalTrials.gov |
| Primary | Sarcopenia 2 | 18 months | Change from baseline of musculo-skeletal index measurement on the third lumbar vertebra on scanner | 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 4
The papers the trial lists on ClinicalTrials.gov.
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 3
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 |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary 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)