| Protocol ID | NCT04345952 |
| Registration Date | 2020-04-15 |
| Status | Withdrawn |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2022-02-01 |
| Last Patient Out | 2023-12-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT04345952
Can a Mindfulness Meditation App Reduce Emotional Distress in Colorectal Cancer Patients Undergoing Adjuvant Chemotherapy
| Field |
GLM
glm-5.1 6809ms / 9834 tok |
CLAUDE
claude-sonnet-4-20250514 7744ms / 11183 tok |
OPENAI
gpt-4o 5679ms / 9670 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
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention is delivered via a smartphone app for patients to use ad libitum in multiple locations, primarily while receiving outpatient chemotherapy at a cancer center as well as at home.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The study is conducted at the Mays Cancer Center outpatient chemotherapy infusion unit where patients receive their scheduled chemotherapy treatments, not as inpatients.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention, a mindfulness meditation app, is delivered via smartphone for use both during chemotherapy sessions at an outpatient clinic and at home, not requiring hospital admission.
|
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 | yes | yes | yes | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The Calm app is specifically described in the study as being developed based on mindfulness and cognitive behavioral therapy (CBT), which qualifies as a named and structured psychological approach.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study involves mindfulness meditation delivered via the Calm app, which is based on tenets of mindfulness and cognitive behavioral therapy and represents a structured therapeutic approach.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial uses the Calm meditation app, which is based on the structured therapeutic approach of Mindfulness-Based Stress Reduction (MBSR).
|
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 | yes | yes | yes | OK |
| intervention_other | no | no | 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 |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary and secondary outcomes, including distress, fatigue, chemotherapy toxicity/tolerability, and quality of life, fall under symptom and quality of life categories.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes (psychological distress, chemotherapy toxicity/tolerability, fatigue, and quality of life) fall within the symptom/QoL categories.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All outcomes focus on symptom management, quality of life, and psychological distress—all covered by symptom/QoL categories.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |