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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

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

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT03875885

First Posted

March 4, 2019

Last Updated

April 4, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

National Center for Advancing Translational Sciences (NCATS)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Time Frame

9 months

Title

Acceptability - (Intervention Arm Only)

Description

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

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

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

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

Learn more about this trial

CONNECTing Head and Neck Caregivers to Supportive Care Resources

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