| Protocol ID | NCT00920504 |
| Registration Date | 2009-06-15 |
| Status | completed |
| Sponsor | University Hospital, Basel, Switzerland |
| Country | Germany |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2009-06-01 |
| Last Patient Out | 2011-06-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT00920504
Pilot Study to Test the Feasibility and the Efficacy of the German Language Adapted PRO-SELF© Plus Pain Control Program, an Educational Intervention Directed at Patients and Their Family Caregivers to Reduce Cancer Pain and Related Symptoms
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5315ms / 10258 tok |
GLM
glm-5.1 6655ms / 9024 tok |
OPENAI
gpt-4o Thinking: o3 3057ms / 8871 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 | outpatient | outpatient | outpatient | OK |
| setting_place |
home care
home care → home care
shaky reasoning✓ Unanimous
Initial: home care
Requery: home care — The intervention is delivered through home visits by research nurses at weeks 1, 2, 4, 6, 8 and 10, with telephone interviews at weeks 3, 5, 7 and 9, indicating the educational program is delivered in patients' homes.
|
home care
other
shaky reasoning✓ Unanimous
Initial: other
|
home care
other → home care
shaky reasoning✓ Unanimous
Initial: other
Requery: home care — The intervention is delivered in the patient's home as noted by the description of research nurse visits and telephone interviews conducted at the patient's home.
|
OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The PRO-SELF© Plus PCP intervention explicitly combines three distinct interacting strategies: (a) information provision (educational), (b) skill building (behavioral), and (c) nurse coaching (professional support), making it a multicomponent intervention.
|
yes
no
shaky reasoning✓ Unanimous
Initial: no
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention combines educational components with nurse coaching and skill-building, making it a multicomponent intervention involving different types.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is an educational intervention (PRO-SELF© Plus Pain Control Program) to teach pain self-management skills to cancer patients, not a palliative care consultation or service delivery intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is an educational program for pain self-management (PRO-SELF© Plus Pain Control Program), which is a behavioral/supportive therapy rather than a palliative care consultation, service delivery, or care model.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is an educational program for pain management, not a palliative care consultation or service.
|
OK |
| intervention_education | yes | yes | yes | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes measure symptom-related aspects - average and worst pain, and patients' knowledge of cancer pain management - which fall under symptom/QoL categories.
Thinking: yes — The secondary outcome measures patients' knowledge of cancer pain management, which falls under the knowledge/skills category.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The secondary outcome measures patient knowledge of cancer pain management, which falls under the 'knowledge/skills' category not covered by symptom/QoL/dignity/cost.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study includes caregiver outcomes, which are not covered by symptom/QoL/dignity/cost categories.
Thinking: yes — It evaluates patients' knowledge of cancer pain management, a knowledge/skill outcome outside symptom, QoL, dignity, or cost domains.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |