Neoplasms

All Conditions

Head and Neck Neoplasms

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.

Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures.

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.

CONNECT

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.

CONTROL

Chandylen Nightingale, PhD, MPH

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.

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.

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

A 12-item instrument measuring physical and mental well-being, though our analyses will focus on physical well-being; widely used in oncology populations. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Unplanned healthcare utilization survey will be calculated using a one item continuous score. The survey will capture patient self-reported unplanned healthcare utilization (number of unplanned visits to the emergency room, urgent care, or healthcare provider) from time points of baseline to end of treatment.

A 20-item instrument with 4 subscales to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Participants will answer questions to indicate how satisfied they are with care family member has received. (Subscales = (S) satisfied, (U) undecided, (D) dissatisfied or (VD) very dissatisfied

An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations

An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of interest, meaning, and purpose.Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety.

A 39-item instrument that measures physical, social, emotional, and functional well-being, as well as additional head and neck-related concerns. Scoring scale is 0 = not at all to 4 = very much). Maximum score of 156. Higher scores indicate a better quality of life.

Adapted version of the 28-item Consumer-Based Cancer Care Value Index- Services and Resources instrument assessing use of services to meet multidimensional supportive needs. Intervention caregivers will also self-report service use by completing an auto-generated REDCap survey to query about utilization of the specific resources that each caregiver expressed interest in accessing.

Caregiver Reaction Assessment - 24-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Each item is rated on a 1 to 4 scale. 1 (not at all) 2 (somewhat) 3 (quite a bit) 4 (completely)

An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety.

An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of interest, meaning, and purpose. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). Scoring scale is 0 = not at all to 4 = very much). Maximum score of 140. Higher scores indicate better quality of life.

A 7-item measure to assess caregiver behaviors for managing self-care. Questions are answered Yes or No and is a summation of the number of risks. Score range of 0-7, the higher the number, the greater the risk.

Survey responses will be coded as "adhered" or "did not adhere" for agency- and caregiver- reported service utilization. The score reporting is a dichotomous outcome of an adhered or not adhered.

21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions). Uses a likert scale from 1 (not at all confident) to 9 (totally confident). Higher scores indicate higher self-efficacy for coping with cancer.

A 16-item survey with an additional "other" category for a caregiver to report additional barriers not noted on the survey. Response options range from never (0) to always (4). Higher scores indicate a greater number of barriers.

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

Number of eligible participants who agreed to participate

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

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).

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).

National Center for Advancing Translational Sciences (NCATS)

Wake Forest University Health Sciences

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.

CONNECT: 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.

CONNECT Intervention Group - Group A

Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures.

CONTROL: 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.

CONNECT Comparison Group - Group B

Total

Age 18-35

Age 36-54

Age 55-72

Age unknown

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Some College Education

Married/ Partnered to Patient

Adult Children to Patient

Partnered. Married

Study Coordinator

Total number of caregivers that agreed to participate divided by the number of months of recruitment.

Accrual

The 40 participants that agreed to participate in the intervention were accrued over a total of 19 months.

Proportion of Caregivers Who Agree to Participate

Number of screened participants found to be eligible versus participants who agreed to participate

Participation

Out of 108 participants found to be eligible to participate in the study intervention only 40 agreed and consented to begin the study intervention.

Number of Eligible Participants

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

Retention

Number of Retention of Participants

Educational video on the CONNECT website (step 1 in guide)

Online survey to identify the types of resources/services that might be helpful as a caregiver

List of supportive care resources

Referral option immediately upon completing the survey to identify resource interest

2 week follow up phone call to discuss available resources

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

Acceptability (Intervention Arm Only)

The acceptability measures were obtained from only 1 arm (intervention arm, since the questions pertain to the acceptability of the intervention), and were asked at the final time point, which means the n is those left in the intervention arm at the last time point.

Acceptability - (Intervention Arm Only)

SF-12 Patient Measures - Physical/Emotional Well-being

Unplanned Healthcare Utilization Survey

FAMCARE Questionnaire (Patient)

PROMIS Emotional Distress-Anxiety-Short Form 8a for Patients

PROMIS Emotional Distress- Depression-Short Form 8a for Patients

Patient - Quality of Life Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N)

Supportive Care Utilization

FAMCARE Questionnaire (Caregiver)

Caregiver Reaction Assessment

PROMIS Emotional Distress-Anxiety-Short Form 8a

PROMIS Emotional Distress- Depression-Short Form 8a

Caregiver Quality of Life Index-Cancer (CqoL-Canc)

Caregiver Risk Scale

Caregiver Adherence to Referral Survey

Caregiving Self-Efficacy Scale

Barriers to Supportive Care Use Survey

Overall Study

At clinics randomized to the CONNECT intervention, oncology nurses will be selected by a nurse advisory panel to receive standardized primary palliative care training. A multi-step deployment strategy will be employed to orient oncologists and implement CONNECT processes. CONNECT nurses will administer CONNECT to enrolled patients and caregivers. An intervention fidelity monitoring and maintenance plan will be implemented to ensure high quality and consistent delivery of the intervention.

At clinics randomized to Usual Care, enrolled patients and caregivers will continue to receive supportive oncology care according to usual practice.

Primary palliative care, care management intervention led by existing oncology nurses. Deployed through a series of nurse-led encounters before or after regularly scheduled oncology visits. Based on best practices in palliative oncology care, the first visit focuses on establishing rapport, addressing symptom needs and choosing a surrogate decision maker. Subsequent visits include additional focus on treatment preferences and future goals.

Visits are guided by patient-reported outcomes. During all encounters, the nurse works with patients/caregivers to complete/update individualized Shared Care Plans. After all visits, the nurse discusses patients' symptoms, preferences and goals with their oncologists via a mandatory check-in session and a follow-up call with the patient and/or caregiver.

Yael Schenker, MD, MAS

The overall goal of this study is to test whether a nurse-led intervention to improve provision of primary palliative care within oncology practices (CONNECT) can decrease morbidity for patients with advanced cancer and their caregivers.

The specific aims are to:

Aim 1. Assess the effects of CONNECT on patient quality of life (primary outcome), symptom burden, and mood at 3-month follow-up.

Aim 2. Assess the effects of CONNECT on caregiver burden and mood at 3-month follow-up.

Aim 3. Assess the effects of CONNECT on healthcare resource use over 1 year of follow-up.

Study investigators will conduct a cluster randomized controlled trial comparing the CONNECT intervention to usual care in 16 oncology clinics. CONNECT (Care Management by Oncology Nurses to address supportive care needs) is a care management intervention using existing oncology nurses to improve provision of primary palliative care within outpatient oncology practices.

The study will enroll 672 patients with advanced cancer and their caregivers. The study will assess the intervention's impact on patient and caregiver quality-of-life and psychological outcomes at three months and on healthcare utilization through one year of follow up. Investigators will follow a rigorous plan to establish and maintain intervention fidelity. Detailed process information will be collected at all sites and the study will evaluate how CONNECT impacts mortality and costs.

Following best practices for complex system-level interventions, the study will use a cluster randomized trial design. The unit of randomization is the oncology practice, defined as a unique location and provider group for outpatient oncology care. The unit of analysis is the individual patient and caregiver.

Designated staff at each clinic will review oncologists' schedules on a weekly basis to identify and track potentially eligible patients with an upcoming appointment. Research staff will review tracking systems weekly to maintain recruitment fidelity. Identified patients will receive a 1-page study information sheet at their next clinic visit, followed by a detailed in-person explanation of the study from a trained staff member. This staff member will obtain informed consent from all participants. To minimize potential selection bias, participants will be told in advance of both groups and not randomized if they decline to be exposed to one of them.

To enhance retention, blinded research assistants will conduct monthly follow-up calls to assess healthcare utilization for participants in both groups. The data collection strategy is designed to minimize participant burden by using parsimonious measures previously pilot-tested with this population.

A Primary Palliative Care Intervention for Patients With Advanced Cancer

A Cluster Randomized Trial of a Primary Palliative Care Intervention (CONNECT) for Patients With Advanced Cancer

The investigators will compare change in the 3-month Human Connection Scale scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.

The investigators will compare change in the 3-month Herth Hope Index scores between enrolled patients and caregivers at intervention clinics and enrolled patients and caregivers at usual care clinics.

The investigators will compare 3-month scores on the Cancer Behavior Inventory-Brief (patients) and the Caregiver Inventory (caregivers) between enrolled patients and caregivers at intervention clinics and enrolled patients and caregivers at usual care clinics.

The investigators will compare change in the 3-month FAMCARE-2 scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics.

The investigators will compare change in the 3 months scores on the Distress Thermometer between enrolled patients at intervention clinics and enrolled patients at usual care clinics.

The investigators will compare change in patient illness understanding, care preferences, and advance care planning between enrolled patients at intervention clinics and enrolled patients at usual care clinics.

The investigators will compare burnout (maslach burnout inventory) between clinicians at intervention clinics and usual care clinics.

The investigators will assess satisfaction with CONNECT and recommendations for improvement among clinicians at intervention clinics annually.

The investigators will compare change in the 3-month FACIT-Pal scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.

The investigators will compare change in the 3-month Edmonton Symptom Assessment Scale (ESAS) scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.

The investigators will compare change in the 3-month Hospital Anxiety and Depression Scale (HADS) scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.

The investigators will compare change in the 3-month Hospital Anxiety and Depression Scale (HADS) scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics.

The investigators will compare change in the 3-month Zarit Burden Interview-Short scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics.

To inform future dissemination efforts and aid in understanding optimal financing models, the investigators will calculate implementation costs of the intervention and determine the effects of CONNECT on healthcare utilization, including hospitalizations, chemotherapy use, and hospice use.

The investigators will calculate survival time from date of enrollment using the Kaplan-Meier method. We will use frailty models to assess for any effect of CONNECT on survival, controlling for the effects of clustering.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CONNECTing Head and Neck Caregivers to Supportive Care Resources	NCT03875885	Head and Neck C...	CONNECT CONTROL	18 Years -	Wake Forest University Health Sciences
CONNECTing Head and Neck Caregivers to Supportive Care Resources	NCT03875885	Head and Neck C...	CONNECT CONTROL	18 Years -	Wake Forest University Health Sciences
A Primary Palliative Care Intervention for Patients With Advanced Cancer	NCT02712229	Advanced Cancer	CONNECT	21 Years -	University of Pittsburgh
A Primary Palliative Care Intervention for Patients With Advanced Cancer	NCT02712229	Advanced Cancer	CONNECT	21 Years -	University of Pittsburgh

Spots Global Cancer Trial Database for connect

Every month we try and update this database with for connect cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for connect

Every month we try and update this database with for connect cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for connect cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.