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NCT03875885: CONNECT-HNC

CONNECTing Head and Neck Caregivers to Supportive Care Resources

Completed NA Results posted Last updated 27 April 2023
What this trial tests

NA trial testing CONNECT in Head and Neck Cancer in 40 participants. Completed in 31 May 2022.

Timeline
16 September 2020
Primary endpoint
31 May 2022
31 May 2022

Quick facts

Lead sponsorWake Forest University Health Sciences
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment40
Start date16 September 2020
Primary completion31 May 2022
Estimated completion31 May 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Caregivers Who Agree to Participate Primary · 19 months

Number of caregivers who agreed to participate divided by the number of months of recruitment

GroupValue95% CI
Accrual2.1
Number of Eligible Participants Primary · 9 months

Number of eligible participants who agreed to participate

GroupValue95% CI
Participation40
Number of Retention of Participants Primary · 9 months

Number of participants who completed the T2 assessment divided by the number who agreed to participate

GroupValue95% CI
Retention32
Acceptability - (Intervention Arm Only) Primary · 9 months

Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a \~30min (approximately) qualitative interview to further explore acceptability (measures were not at all helpful, a little helpful, somewhat helpful or quite a bit helpful).

Educational video on the CONNECT website (step 1 in guide)
GroupValue95% CI
Acceptability (Intervention Arm Only)1
Acceptability (Intervention Arm Only)3
Acceptability (Intervention Arm Only)5
Acceptability (Intervention Arm Only)3
Online survey to identify the types of resources/services that might be helpful as a caregiver
GroupValue95% CI
Acceptability (Intervention Arm Only)2
Acceptability (Intervention Arm Only)2
Acceptability (Intervention Arm Only)4
Acceptability (Intervention Arm Only)4
List of supportive care resources
GroupValue95% CI
Acceptability (Intervention Arm Only)2
Acceptability (Intervention Arm Only)2
Acceptability (Intervention Arm Only)5
Acceptability (Intervention Arm Only)3
Referral option immediately upon completing the survey to identify resource interest
GroupValue95% CI
Acceptability (Intervention Arm Only)1
Acceptability (Intervention Arm Only)2
Acceptability (Intervention Arm Only)7
Acceptability (Intervention Arm Only)2
2 week follow up phone call to discuss available resources
GroupValue95% CI
Acceptability (Intervention Arm Only)1
Acceptability (Intervention Arm Only)2
Acceptability (Intervention Arm Only)6
Acceptability (Intervention Arm Only)1
Acceptability - (Intervention Arm Only) Primary · 9 months

Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a \~30min (approximately) qualitative interview to further explore acceptability (measures were strongly agree, agree and undecided).

GroupValue95% CI
Acceptability (Intervention Arm Only)2
Acceptability (Intervention Arm Only)7
Acceptability (Intervention Arm Only)5

Sponsor's own description

The purpose of this research is to determine feasibility and acceptability of randomized pilot trial to evaluate a technology-based intervention (CONNECT) to empower and educate caregivers about the benefits of supportive care resources, identify their unmet needs, and connect them with resources.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of CONNECT

Trials testing the same drug.

Other recruiting trials for Head and Neck Cancer

Currently open trials in the same condition.

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03875885.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing