CONNECTing Caregivers to Supportive Services (CONNECT): A Technology-Based Intervention to Connect Cancer Caregivers With Supportive Care Resources
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability - (Intervention Arm Only)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
CONNECT Intervention Group - Group A
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.
干预措施: CONNECT (Behavioral)
CONNECT Comparison Group - Group B
Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures.
干预措施: CONTROL (Behavioral)
结局指标
主要结局
Acceptability - (Intervention Arm Only)
时间窗: 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).
Number of Eligible Participants
时间窗: 9 months
Number of eligible participants who agreed to participate
Proportion of Caregivers Who Agree to Participate
时间窗: 19 months
Number of caregivers who agreed to participate divided by the number of months of recruitment
Number of Retention of Participants
时间窗: 9 months
Number of participants who completed the T2 assessment divided by the number who agreed to participate
次要结局
未报告次要终点