The ECOG-ACRIN SUPPORT Trial: Multilevel Intervention to Improve Diverse Enrollment in Cancer Clinical Trials

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEastern Cooperative Oncology Group

About this trial

The purpose of this study is to conduct a Hybrid Type 1 cluster-randomized, roll-out effectiveness-implementation trial in NCORP community oncology practice sites (N= 500 Black and Latino cancer patients) to evaluate the effectiveness of the EA SUPPORT intervention combining CT navigators and CT research literacy tools in improving Black and Latino patient referral and accrual to NCI-supported CTs (primary outcomes) and participant and provider awareness and knowledge of CTs (secondary outcomes) while assessing implementation factors. Also, with the CUSP2CT data, Evaluation, and Coordinating Center, conduct final site evaluation and disseminate the SUPPORT intervention to NCORP community oncology sites, research bases, and affiliated trial networks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • SUPPORT toolkit

    Other intervention

    The SUPPORT toolkit comprises of the SUPPORT CT website and interaction with a SUPPORT navigator.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Participant Referral

Participant referral to any NCI-supported CT assessed at the end of the 12 months of intervention stage, which will be collected from the referral tracking sheet during the intervention

Time frame
End of 12 months

Secondary outcomes

1

Participant Accrual

Participant accrual assessed at the end of the 12 months of intervention stage, as abstracted from the clinical trials management system and corroborated with abstracted medical records and providers' clinical notes

Time frame
End of 12 months

Other outcomes

1

Provider Referral

Change in provider referral behavior assessed at 12 months after the intervention

Time frame
12 months after the intervention
2

Provider Perceptions of Clinical Trials

Change in provider perceptions of clinical trials assessed at 12 months after the intervention

Time frame
12 months after the intervention
3

Exploratory outcome

Participant referral by provider assessed at 12 months after the intervention and participant referral by clinic site assessed at 12 months after the intervention

Time frame
12 months after the intervention
4

Exploratory outcome

CUSP2CT selected common measures of (a) Participant CT Awareness and Knowledge and (b) Provider CT Awareness and Knowledge

Time frame
12 months after the intervention

Sponsors and contacts

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