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CONNECTing Head and Neck Caregivers to Supportive Care Resources (CONNECT-HNC)

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ClinicalTrials.gov Identifier: NCT03875885
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date April 15, 2019
Estimated Study Start Date  ICMJE May 31, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Proportion of Caregivers Who Agree to Participate [ Time Frame: 9 months ]
    Number of caregivers who agreed to participate divided by the number of months of recruitment
  • Proportion of Eligible Participants [ Time Frame: 9 months ]
    Proportion of eligible participants who agreed to participate
  • Proportion of Retention of Participants [ Time Frame: 9 months ]
    Number of participants who completed the T2 assessment divided by the number who agreed to participate
  • Acceptability [ Time Frame: 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. (Appendices I, J, and K)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03875885 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Supportive Care Utilization [ Time Frame: Over 3 months ]
    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.
  • FAMCARE Questionnaire (Caregiver) [ Time Frame: Over 3 months ]
    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 disatisfied
  • Caregiver Reaction Assessment [ Time Frame: Over 3 months ]
    Caregiver Reaction Assessment - 21-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)
  • PROMIS Emotional Distress-Anxiety-Short Form 8a [ Time Frame: Over 3 months ]
    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.
  • PROMIS Emotional Distress- Depression-Short Form 8a [ Time Frame: Over 3 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2019)
  • SF-12 Patient Measures - Physical Well-being [ Time Frame: Over 3 months ]
    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 [ Time Frame: Over 3 months ]
    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.
  • FAMCARE Questionnaire (Patient) [ Time Frame: Over 3 months ]
    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
  • PROMIS Emotional Distress-Anxiety-Short Form 8a for Patients [ Time Frame: Over 3 months ]
    An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations
  • PROMIS Emotional Distress- Depression-Short Form 8a for Patients [ Time Frame: Over 3 months ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CONNECTing Head and Neck Caregivers to Supportive Care Resources
Official Title  ICMJE CONNECTing Caregivers to Supportive Services (CONNECT): A Technology-Based Intervention to Connect Cancer Caregivers With Supportive Care Resources
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: CONTROL
    This group will receive a generic resource list.
Study Arms  ICMJE
  • CONNECT arm
    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.
    Intervention: Behavioral: CONNECT
  • CONTROL arm
    Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures.
    Intervention: Behavioral: CONTROL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
80
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
40
Estimated Study Completion Date  ICMJE March 30, 2021
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a history (current or past [within prior 18 months]) of providing unpaid care for an adult (>18 years of age) family member or significant other with AJCC stage I-IV HNC (squamous cell carcinoma of the upper aerodigestive tract).
  • Eligible caregivers for Objectives Two and Three include those who are:
  • Providing the majority of the informal (unpaid) care for a patient meeting the below criteria, and
  • Greater than or equal to 18 years of age
  • Eligible patients for Objectives Two and Three include those who:
  • Have new or recurrent AJCC stage I-IV HNC,
  • Are receiving cancer treatment or awaiting planned treatment initiation, and
  • Greater than or equal to 18 years of age

Exclusion Criteria:

  • Participants will be excluded if they are not able to read/understand English, or
  • If they have significant hearing impairment that would hinder participation

Caregivers for Objective Two and Three will be excluded if:

  • They have a current cancer diagnosis, or
  • Cannot read/communicate in English
  • Patients for Objectives Two and Three will be excluded if they:
  • Cannot read/communicate in English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Chandylen Nightingale, PhD, MPH 336-713-5440 cnightin@wakehealth.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03875885
Other Study ID Numbers  ICMJE IRB00056635
5KL2TR001421-04 ( U.S. NIH Grant/Contract )
6459 ( Other Identifier: WF Wiser number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Center for Advancing Translational Science (NCATS)
Investigators  ICMJE
Principal Investigator: Chandylen Nightingale, PhD, MPH Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP