| Protocol ID | NCT01697982 |
| Registration Date | 2012-10-02 |
| Status | completed |
| Sponsor | University of Alberta |
| Country | Canada |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2012-09-01 |
| Last Patient Out | 2014-07-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT01697982
Living With Hope: Pilot Study of Patient-Centered Hope Intervention for Persons Receiving Palliative Care Services
| Field |
GLM
glm-5.1 9460ms / 9569 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 7370ms / 10842 tok |
OPENAI
gpt-4o Thinking: o3 4242ms / 9420 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status |
non-cancer
non-cancer → non-cancer
shaky reasoning✓ Unanimous
Initial: non-cancer
Requery: non-cancer — The eligibility criteria and study design target all palliative home care patients regardless of diagnosis, and do not specifically recruit a cancer patient population.
|
non-cancer
non-cancer → non-cancer
shaky reasoning✓ Unanimous
Initial: non-cancer
Requery: non-cancer — While the study mentions advanced cancer in keywords and involves palliative care patients, the inclusion criteria explicitly targets all palliative home care patients regardless of diagnosis, making this a general palliative care study rather than cancer-specific.
|
non-cancer
Cancer → non-cancer
shaky reasoning✓ Unanimous
Initial: Cancer
Requery: non-cancer — The trial targets general palliative home care patients of all diagnoses, not specifically cancer patients.
|
OK |
| non_cancer_spec |
N/A
N/A
shaky reasoning✓ Unanimous
Initial: N/A
|
N/A
early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: N/A — The study includes patients with all diagnoses receiving palliative care services, which creates a mixed population that is too general to classify into a specific non-cancer category.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study targets a general palliative care population without specifying a non-cancer diagnosis or disease-specific category.
|
OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | home care | home care | home care | 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 | yes | yes | yes | 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
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention being tested is a behavioral psychological program (Living with Hope), which happens to be delivered in a palliative care setting but is not a palliative care service itself.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a behavioral/psychosocial hope program (film viewing and hope activities) delivered to palliative care patients, not palliative care consultation or service delivery itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial involves testing a psychosocial intervention (Living with Hope Program) to increase hope and quality of life, not palliative care consultation or service delivery.
|
OK |
| intervention_education |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is a psychosocial program designed to foster hope through viewing a film and performing therapeutic activities (like writing letters or collections), rather than providing patient education or training.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This is a psychosocial hope intervention involving watching a film and engaging in hope activities (letter writing, collections), which is behavioral/therapeutic rather than primarily educational or training-focused.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary component of the intervention is focused on hope enhancement and improvement of quality of life, not education or training.
|
OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The McGill Quality of Life Questionnaire (MQOL) includes a validated subscale specifically designed to measure existential well-being, which directly aligns with the definition of a dignity-related outcome.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Thinking: yes — The McGill Quality of Life Questionnaire includes existential well-being as one of its five sub-measures.
|
yes
no → no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial focuses on hope and quality of life, without specifically measuring existential or spiritual well-being through specified instruments like the PDI, FACIT-Sp, or Demoralization Scale.
Thinking: yes — The McGill Quality of Life Questionnaire explicitly measures an existential well-being subscale, addressing existential themes relevant to dignity.
|
OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial measures feasibility metrics and caregiver outcomes (care partners' levels of hope) in addition to patient hope, quality of life, and anxiety.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes measure quality of life (McGill Quality of Life Questionnaire) and hope (Herth Hope Index), which fall under the QoL category.
Thinking: yes — The trial evaluates feasibility of study procedures through qualitative interviews, which falls under feasibility metrics.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial includes caregiver outcomes as it collects care partners' levels of hope and their evaluation of the study procedures, which are not covered by symptom/QoL/dignity/cost categories.
Thinking: yes — The study measures care partners’ (caregiver) hope and evaluations, which are caregiver outcomes outside the symptom/quality-of-life/dignity/cost domains.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |