Clinical trial · Interventional
CONNECTing Head and Neck Caregivers to Supportive Care Resources
CONNECTing Caregivers to Supportive Services (CONNECT): A Technology-Based Intervention to Connect Cancer Caregivers With Supportive Care Resources
NCT03875885CI-TRIAL-00066015CONNECT-HNCcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CONNECT | Behavioral | — | UNRESOLVED |
| CONTROL | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- CONNECT Intervention Group - Group A
- description
- A web-based intervention (CONNECT) to empower and connect caregivers of newly diagnosed cancer patients to supportive care resources A randomized pilot study will be conducted to assess feasibility and acceptability and obtain data on caregiver and patient outcomes. CONNECT e-tool, re-education and optional referral (2 weeks post CONNECT e-tool). Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures.
- interventionNames
- Behavioral: CONNECT
- type
- OTHER
- label
- CONNECT Comparison Group - Group B
- description
- Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures.
- interventionNames
- Behavioral: CONTROL
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Eligible caregivers include those who are: * Caregivers must be providing some capacity of informal (unpaid) care for a patient meeting patient eligibility criteria. If a patient unexpectedly becomes deceased during the study period, caregivers will be allowed to continue participation in the assigned study arm and complete study assessments if they wish to. * Greater than or equal to 18 years of age. * Ability to access study materials by internet or complete study activities in person as institutional and government policies allow. Eligible patients include those who: * Have new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV head and neck cancer. * Are receiving cancer treatment or awaiting planned treatment initiation, excluding those receiving neoadjuvant surgery or surgery only. * Patients must be ambulatory and up more than 50% of waking hours, as measured by an ECOG Performance Status rating of level 0, 1, or 2. * Greater than or equal to 18 years of age. * Ability to access study materials by internet or complete study activities in person as institutional and government policies allow. * Patients must be receiving some capacity of informal care from a caregiver meeting the above criteria. If the caregiver unexpectedly becomes deceased during the study period, the patient will be un-enrolled from this study as we are evaluating a caregiver-only delivered intervention. Exclusion Criteria: Caregivers will be excluded if: • Cannot read/communicate in English Patients will be excluded if they: • Cannot read/communicate in English Eligibility to participate in the study is conditional on participation of both the caregiver and patient.
References
Publications (0)
Data not yet available
No reference posted for this study.