| Protocol ID | NCT03334071 |
| Registration Date | 2017-11-07 |
| Status | Unknown Status |
| Sponsor | University Hospital Southampton NHS Foundation Trust |
| Country | United Kingdom |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2014-04-04 |
| Last Patient Out | 2019-12-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT03334071
Exercise regiMens Before and duRing Advanced Cancer thErapy: A Pilot Study to Investigate Improvements in Physical Fitness With Exercise Training Programme Before and During Chemotherapy in Advanced Lung Cancer Patients.
| Field |
GLM
glm-5.1 6626ms / 9758 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 10744ms / 11162 tok |
OPENAI
gpt-4o Thinking: o3 4925ms / 9597 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient |
mixed
outpatient → mixed
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: mixed — The exercise intervention is delivered in an in-hospital setting for the first 6 weeks and then transitions to a home-based outpatient setting for the remaining 6 weeks.
|
mixed
mixed → mixed
shaky reasoning✓ Unanimous
Initial: mixed
Requery: mixed — The study explicitly includes both in-hospital supervised exercise training sessions and home-based exercise training components, with patients transitioning from hospital-based to home-based intervention during the study period.
|
mixed
mixed → mixed
shaky reasoning✓ Unanimous
Initial: mixed
Requery: mixed — The study includes supervised in-hospital exercise training transitioning to home-based exercise training, indicating both inpatient and outpatient settings.
|
OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The exercise intervention is primarily delivered in a hospital outpatient setting (supervised in-hospital exercise training during chemotherapy cycles) before transitioning to home-based training, with 'hospital' avoided per guidance since patients are not admitted/inpatient for the intervention.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention involves supervised in-hospital exercise training sessions initially, but transitions to home-based training (weeks 7-12), with the primary delivery being in outpatient/ambulatory care settings rather than requiring hospitalization.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention includes both in-hospital exercise and transition to home-based exercise, making it a mixed setting.
|
OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The active intervention being tested is an exercise training program, while chemotherapy is provided as standard background care for all participants.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The tested intervention is an exercise training program (behavioral intervention), not chemotherapy, immunotherapy, or radiation therapy as the active treatment being studied.
Thinking: no — The tested intervention is exercise training, while chemotherapy (gemcitabine/carboplatin) is given to all patients as standard background treatment.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — Chemotherapy is an active component being tested as part of the intervention with exercise training.
Thinking: no — Chemotherapy is given to all participants as standard care while the trial’s tested intervention is exercise training, not chemo/immuno/radiotherapy.
|
OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| 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 | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | yes | yes | yes | OK |
| outcome_symptom |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study measures quality of life questionnaires (FACT-L, Dukes Activity Status Index, IPAQ, GLTEQ) and physical fitness parameters, but does not include any validated symptom-specific instruments like pain scales, ESAS, or depression/anxiety measures.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial's outcomes focus on physical fitness, exercise adherence, and QoL but do not specify the use of symptom measurement tools like those for pain, fatigue, or anxiety.
|
OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |