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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CONNECT
CONTROL
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Head and Neck Cancer focused on measuring Head and Neck Cancer Caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CONNECT Intervention Group - Group A

CONNECT Comparison Group - Group B

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of Caregivers Who Agree to Participate
Number of caregivers who agreed to participate divided by the number of months of recruitment
Number of Eligible Participants
Number of eligible participants who agreed to participate
Number of Retention of Participants
Number of participants who completed the T2 assessment divided by the number who agreed to participate
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).
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).

Secondary Outcome Measures

Full Information

First Posted
March 4, 2019
Last Updated
April 4, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03875885
Brief Title
CONNECTing Head and Neck Caregivers to Supportive Care Resources
Acronym
CONNECT-HNC
Official Title
CONNECTing Caregivers to Supportive Services (CONNECT): A Technology-Based Intervention to Connect Cancer Caregivers With Supportive Care Resources
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and Neck Cancer Caregivers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONNECT Intervention Group - Group A
Arm Type
Other
Arm Description
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.
Arm Title
CONNECT Comparison Group - Group B
Arm Type
Other
Arm Description
Baseline, one month post randomization data collection, three months post randomization data collection, quantitative and qualitative measures.
Intervention Type
Behavioral
Intervention Name(s)
CONNECT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CONTROL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Caregivers Who Agree to Participate
Description
Number of caregivers who agreed to participate divided by the number of months of recruitment
Time Frame
19 months
Title
Number of Eligible Participants
Description
Number of eligible participants who agreed to participate
Time Frame
9 months
Title
Number of Retention of Participants
Description
Number of participants who completed the T2 assessment divided by the number who agreed to participate
Time Frame
9 months
Title
Acceptability - (Intervention Arm Only)
Description
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).
Time Frame
9 months
Title
Acceptability - (Intervention Arm Only)
Description
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).
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
SF-12 Patient Measures - Physical/Emotional Well-being
Description
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.
Time Frame
1 year
Title
Unplanned Healthcare Utilization Survey
Description
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.
Time Frame
1 year
Title
FAMCARE Questionnaire (Patient)
Description
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
Time Frame
1 year
Title
PROMIS Emotional Distress-Anxiety-Short Form 8a for Patients
Description
An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations
Time Frame
1 year
Title
PROMIS Emotional Distress- Depression-Short Form 8a for Patients
Description
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.
Time Frame
1 year
Title
Patient - Quality of Life Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N)
Description
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.
Time Frame
1 year
Title
Supportive Care Utilization
Description
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.
Time Frame
1 year
Title
FAMCARE Questionnaire (Caregiver)
Description
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
Time Frame
1 year
Title
Caregiver Reaction Assessment
Description
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)
Time Frame
1 year
Title
PROMIS Emotional Distress-Anxiety-Short Form 8a
Description
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.
Time Frame
1 year
Title
PROMIS Emotional Distress- Depression-Short Form 8a
Description
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.
Time Frame
1 year
Title
Caregiver Quality of Life Index-Cancer (CqoL-Canc)
Description
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.
Time Frame
1 year
Title
Caregiver Risk Scale
Description
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.
Time Frame
1 year
Title
Caregiver Adherence to Referral Survey
Description
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.
Time Frame
1 year
Title
Caregiving Self-Efficacy Scale
Description
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.
Time Frame
1 year
Title
Barriers to Supportive Care Use Survey
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandylen Nightingale, PhD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CONNECTing Head and Neck Caregivers to Supportive Care Resources

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