| Protocol ID | NCT01220960 |
| Registration Date | 2010-10-14 |
| Status | completed |
| Sponsor | Dr. Sarkis Meterissian |
| Country | Canada |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2010-08-01 |
| Last Patient Out | 2013-10-01 |
| Publication | n |
| Gender % | FEMALE |
| Mean Age | 18 Years - |
NCT01220960
A Mixed Methods Approach to Evaluating How Art Therapy Can Benefit Women Recently Diagnosed With Breast Cancer
| Field |
GLM
glm-5.1 9941ms / 8680 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5052ms / 9883 tok |
OPENAI
gpt-4o Thinking: o3 4237ms / 8527 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 | other | other | other | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | yes | yes | yes | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological |
yes
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is art therapy, which is a creative/expressive therapy rather than a named structured psychological therapy like CBT, ACT, or psychotherapy.
|
yes
yes → yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — Art therapy is a recognized structured psychological therapeutic approach that uses creative expression to address emotional and psychological needs.
Thinking: yes — Art therapy is a named, structured therapeutic intervention delivered over 8 weeks targeting emotional distress and meaning-making.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial involves art therapy, which is a structured therapeutic approach.
Thinking: yes — Art therapy is a named, structured expressive psychotherapy used as the primary intervention.
|
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 is art therapy, which is a psychological/supportive intervention tested in cancer patients, not a palliative care service itself, even though the study mentions applicability to palliative outpatients.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention being tested is art therapy (a complementary therapy), not palliative care consultation or service delivery - palliative care is mentioned only as a potential setting for implementation.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention being tested is art therapy, not palliative care itself.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — Art therapy is classified as a complementary intervention, which is one of the specified categories that excludes it from being 'other'.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — Art therapy is classified as a complementary therapy, which explicitly fits under the complementary category rather than the residual 'other' category.
Thinking: no — Art therapy is a complementary therapy, as explicitly stated in the brief summary which refers to 'investigating complementary alternative therapies'.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — Art therapy does not fit into any of the specified categories like pharmacologic, device, or others, and is an example of a complementary and expressive form of therapy potentially classified as 'other'.
Thinking: no — Art therapy is a complementary/psychological supportive-care intervention, which is one of the listed categories.
|
OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol |
yes
yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — The study measures outcomes using ESAS, HADS, and FACIT-Sp-12, which are symptom, distress, and spiritual well-being scales rather than validated general Quality of Life instruments like FACT-G or EORTC QLQ-C30.
|
no
no → yes → no
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The study uses FACIT-Sp-12 (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale), which is a validated quality of life instrument from the FACIT family of measures.
Thinking: no — The study uses HADS (anxiety/depression), ESAS (symptoms), GSES (self-efficacy), and FACIT-Sp-12 (spiritual well-being) but none of the validated QoL instruments listed in the guidance.
|
yes
yes → no → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: no — The trial does not mention the use of validated Quality of Life instruments like EORTC QLQ-C30, SF-36, or FACT-G.
Thinking: yes — The study measures quality of life using the FACIT-Sp-12, a validated subscale of the FACIT/FACT QoL instruments.
|
|
| outcome_dignity | yes | yes | yes | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |