| Protocol ID | NCT02887833 |
| Registration Date | 2016-09-02 |
| Status | completed |
| Sponsor | University of Edinburgh |
| Country | United Kingdom |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2016-10-01 |
| Last Patient Out | 2019-12-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 100 Years |
NCT02887833
An Exploratory Study to Develop and Evaluate a Simple Bedside Tool for Community Use to Identify Who is Most Likely to Benefit From Palliative Radiotherapy for Cancer Induced Bone Pain: Thermal Testing in Bone Pain (TiBoP)
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5384ms / 10568 tok |
OPENAI
gpt-4o Thinking: o3 3767ms / 9152 tok |
GLM
glm-5.1 8021ms / 9298 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility |
N/A
feasibility RCT → feasibility RCT → N/A
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — This is explicitly described as an exploratory study to develop and evaluate a bedside tool with only 27 participants, focused on validation of a biomarker rather than clinical effectiveness.
Thinking: N/A — This is an observational study as explicitly stated, not an RCT.
|
N/A
N/A → N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study is observational and not an RCT.
Thinking: N/A — The study is observational and not a randomized controlled trial.
|
N/A | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study uses thermal rollers (Rolltemp, Somedic, Sweden) which are physical medical devices for thermal sensitivity testing.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial uses physical tools (thermal rollers) for thermal sensory testing, which constitutes a physical device.
|
no | – |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | yes | yes | no | – |
| intervention_palliative |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is an observational study testing a thermal sensitivity diagnostic tool to predict radiotherapy response, not a palliative care intervention itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study investigates a tool to predict response to radiotherapy for bone pain, not palliative care as an intervention.
|
no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is thermal sensory testing using medical devices (thermal rollers) to assess temperature sensitivity, which falls under the device category.
Thinking: no — This is a screening intervention developing a thermal sensitivity test to identify patients likely to benefit from radiotherapy.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention involves the use of thermal sensory testing as a clinical biomarker, which falls under the category of an 'other' intervention, as it does not fit into any of the specified categories such as pharmacologic, chemo/immuno/radio, complementary, device, psychological, etc.
Thinking: no — Thermal sensitivity testing is a screening/assessment tool, which fits the predefined “screening” category.
|
no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome measures sensitivity and specificity of a diagnostic test, which is a feasibility/diagnostic performance metric rather than symptom/QoL/dignity/cost outcomes.
Thinking: yes — Primary outcomes measure sensitivity and specificity of thermal testing, which are feasibility/diagnostic accuracy metrics, not symptom/QoL/dignity/cost outcomes.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The primary outcome includes the sensitivity and specificity of a predictive tool for treatment response, which does not fit into symptom/QoL/dignity/cost categories.
Thinking: yes — Primary outcome is diagnostic accuracy (sensitivity/specificity) of a thermal testing tool, which is not a symptom, QoL, dignity or cost measure.
|
yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |