CONNECTing Head and Neck Caregivers to Supportive Care Resources

NCT03875885 | Completed Results

• 3 other identifiers: IRB000566355KL2TR001421-04WFBCCC 99519
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer Caregivers

Outcome Measures

Primary Outcomes (5)

• Proportion of Caregivers Who Agree to Participate

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

  19 months

• Number of Eligible Participants

  Number of eligible participants who agreed to participate

  9 months

• Number of Retention of Participants

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

  9 months

• 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).

  9 months

• 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).

  9 months

Other Outcomes (16)

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

  1 year

• Unplanned Healthcare Utilization Survey

  1 year

• FAMCARE Questionnaire (Patient)

  1 year

Study Arms (2)

CONNECT Intervention Group - Group A

OTHER

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.

Behavioral: CONNECT

CONNECT Comparison Group - Group B

OTHER

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

Behavioral: CONTROL

Interventions

CONNECT BEHAVIORAL

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

CONTROL BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

radellin@wakehealth.edu

336-713-0677

Study Officials

• Chandylen Nightingale, PhD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 15, 2019
• Study Start: September 16, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: April 27, 2023
• Results First Posted: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)