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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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

Spots Global Cancer Trial Database for head and neck cancer caregivers