CONNECTing Head and Neck Caregivers to Supportive Care Resources

Study Overview
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Brief Summary
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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.

Detailed Description
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The registration is for Objective two and three that refers to the clinical trial. The investigators will determine their ability to recruit caregivers of patients with head and neck cancer being treated at Wake Forest Baptist Comprehensive Cancer Center to a study that uses a technology-based intervention, CONNECT, which may increase head and neck cancer caregivers' knowledge about the benefits of supportive care resources, identify their unmet needs, and connect them with supportive care resources. In this study the investigators also want to look at their ability to recruit a control group of caregivers, that is, caregivers of patients with head and neck cancer being treated at Wake Forest Baptist Comprehensive Cancer Center that will receive a list of supportive care resources. Control groups are used in research to see if the intervention being studied really does have an effect. In addition, the investigators will determine whether or not the intervention has led to improvements in caregivers' use of supportive care resources, quality of care, and overall quality of life.

Official Title
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CONNECTing Caregivers to Supportive Services (CONNECT): A Technology-Based Intervention to Connect Cancer Caregivers With Supportive Care Resources

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: CONNECT
* Behavioral: CONTROL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CONNECT Intervention Group - Group A<br>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. | Behavioral: CONNECT<br>* A novel web-based intervention with input from an advisory panel of cancer caregivers, oncology providers, and psychosocial oncology professionals empowering caregivers with needs to seek services by providing education about the benefits of supportive care resources, systematically identifying their unmet needs, and connecting them with tailored supportive care resources.<br>|
| Other: CONNECT Comparison Group - Group B<br>Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures. | Behavioral: CONTROL<br>* This group will receive a generic resource list. The generic resource list will be printed for participants and emailed to them, if participants have an email address.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Caregivers Who Agree to Participate | Number of caregivers who agreed to participate divided by the number of months of recruitment | 19 months | 
| Number of Eligible Participants | Number of eligible participants who agreed to participate | 9 months | 
| Number of Retention of Participants | Number of participants who completed the T2 assessment divided by the number who agreed to participate | 9 months | 
| Acceptability - (Intervention Arm Only) | 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). | 9 months | 
| Acceptability - (Intervention Arm Only) | 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). | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Cancer Caregivers