CONNECTing Caregivers to Supportive Services (CONNECT): A Technology-Based Intervention to Connect Cancer Caregivers With Supportive Care Resources
Phase: NA
Conditions: Head and Neck Cancer
Sponsor: Wake Forest University Health Sciences

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with 
Supportive Care Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 6459 
Protocol version date 11.05.21 
Page i of 30 
 Principal Investigator: 
Co-Investigator(s): 
Chandylen Nightingale, Ph.D. 
Social Sciences and Health Policy 
Wake Forest University School of Medicine  
Kathryn Greven, MD 
Radiation Oncology 
Wake Forest School of Medicine 
David Miller, MD 
General Internal Medicine 
Wake Forest School of Medicine 
Mercedes Porosnicu, MD
 
Section on Hematology and Oncology
 
Wake Forest School of Medicine 
 
Kathryn Weaver, Ph.D. 
 
Social Sciences and Health Policy 
 
Wake Forest University School of Medicine 
 
Heather Pacholke, MD 
 
Radiation Oncology 
 
Wake Forest School of Medicine 
 
Stacy Wentworth, MD 
 
Radiation Oncology 
 
Wake Forest School of Medicine 
Biostatistician: 
Janet Tooze, Ph.D. 
Department of Biostatistics and Data 
Science Wake Forest University School of 
Medicine 
Beverly Levine 
Department of Social Sciences and Health 
Policy Wake Forest University School of 
Medicine 

Protocol version date 11.05.21 
Page ii of 30 
CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with 
Supportive Care Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 6459 
ClinicalTrials.gov - NCT03875885
 
Informaticists: 
Study Coordinators:  
Protocol Editor: 
Eric Steven Kirkendall, MD, MBI 
Department of Pediatrics 
Wake Forest University School of Medicine 
Paul Yelton, MS  
Healthcare Innovations 
Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
Rebecca Dellinger-Johnston, MS 
Social Sciences and Health Policy 
Wake Forest University School of Medicine  
Sandra Norona 
Clinical Translational Science Institute 
Wake Forest School of Medicine 
Rebecca Dellinger-Johnston, MS 
Wake Forest School of Medicine 
Participating Institution(s): Wake Forest Baptist Medical Center 
Confidential

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
Protocol version date 11.05.21 
Page 3 of 30 
Table of Contents 
1.0 
Schema.................................................................................................................................................. 5 
2.0 
Introduction and Background ................................................................................................................. 6 
3.0 
Objectives .............................................................................................................................................. 9 
3.1 
Primary Objectives ............................................................................................................................. 9 
3.2 
Exploratory Objective(s) ..................................................................................................................... 9 
4.0 
Participant Selection ............................................................................................................................ 10 
4.1 
Inclusion Criteria .................................................................................................................................. 10 
4.2 
Exclusion Criteria ............................................................................................................................. 10 
4.3 
Inclusion of Women and Minorities ................................................................................................... 11 
5.0 
Registration Procedures ....................................................................................................................... 11 
6.0 
Study Outcomes and Study Measures ................................................................................................. 11 
6.1 
Primary Outcome ............................................................................................................................. 11 
6.2 
Secondary Outcomes ....................................................................................................................... 12 
7.0 
Study Plan ........................................................................................................................................... 14 
7.1 
Study Overview ................................................................................................................................ 14 
7.2 
Study-Related Activities ................................................................................................................... 14 
7.3 
Intervention Administration ............................................................................................................... 16 
7.4 
Participant Payment ......................................................................................................................... 22 
7.5 
Informed Consent ............................................................................................................................. 22 
7.6 
Confidentiality and Privacy ............................................................................................................... 22 
7.7 
Data and Safety Monitoring .............................................................................................................. 22 
7.8 
Reporting of Unanticipated Problems, Adverse Events, or Deviations .............................................. 22 
7.9 
Duration of Follow Up ....................................................................................................................... 23 
7.10 
WFUHS IRB AE Reporting Requirements ........................................................................................ 23 
8.0 
Data Management ............................................................................................................................... 23 
9.0 
Statistical Considerations ..................................................................................................................... 23 
9.1 
Analysis of Primary Objectives ......................................................................................................... 24 
9.2 
Analysis of Exploratory Objectives ................................................................................................... 24 
9.3 
Power and Sample Size ................................................................................................................... 25 
9.4 
Estimated Accrual Rate .................................................................................................................... 25 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
Protocol version date 11.05.21 
Page 4 of 30 
9.5 
Estimated Study Length ................................................................................................................... 25 
9.6 
Interim Analysis Plan ........................................................................................................................ 25 
10.0 
Appendices .......................................................................................................................................... 26 
References ...................................................................................................................................................... 27 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
 
1.0 
Schema 
Identification and consent (n = 40-50) 
T0: Baseline data collection (Section 6.2) 
Assessments: 
Caregiver: Sociodemographics, Caregiving characteristics, Race & Ethnicity Verification, Emotional Distress-Anxiety/Depression, 
Self-Care, Supportive Care Service Utilization, Caregiver Burden, Quality of Life, Perceived Care Quality, Caregiving Self Efficacy 
Patient: Clinical information, Sociodemographics, Race & Ethnicity Verification, Perceived Care Quality, Physical/emotional Well-
being, Unplanned Healthcare Utilization, Emotional Distress-Anxiety/Depression, Quality of life 
Caregiver Randomization (n=40) 
Comparison Group (Group B) 
(n=20) 
• Generic resource list 
CONNECT Intervention (Group A) (n=20)  
CONNECT e- tool  
• Educational Video 
• Supportive care needs survey 
• Tailored resource list 
• Optional referral 
Re-education and optional referral  
2 weeks post CONNECT web-based tool 
T1: One month post-randomization data collection (Section 6.2) 
CONNECT Comparison Group (Group B) 
Caregiver: Sociodemographics, Emotional Distress-
Anxiety/Depression, Self-Care, Supportive Care Service 
Utilization, Caregiver Burden, Quality of Life, Perceived Care 
Quality, Caregiving Self Efficacy 
Patient:  Perceived Care Quality, Physical/Emotional Well-
being, Patient Unplanned Healthcare Utilization, Emotional 
Distress-Anxiety/Depression, Quality of Life 
CONNECT Intervention Group (Group A) 
Caregiver: Sociodemographics, Emotional Distress-
Anxiety/Depression, Self-Care, Supportive Care Service 
Utilization, Caregiver Burden, Quality of Life, Perceived Care 
Quality, Caregiving Self Efficacy; semi-structured qualitative 
interview 
Patient:  Perceived Care Quality, Physical/Emotional Well-
being, Patient Unplanned Healthcare Utilization, Emotional 
Distress-Anxiety/Depression, Quality of Life 
T2: Three months post-randomization data collection (Section 6.2) 
CONNECT Comparison Group (Group B) 
Caregiver: Sociodemographics, Emotional Distress-
Anxiety/Depression, Self-Care, Supportive Care Service 
Utilization, Caregiver Burden, Quality of Life, Perceived Care 
Quality, Caregiver Barriers to Care, Caregiving Self Efficacy 
Patient: Perceived Care Quality, Physical/Emotional Well-
being, Patient Unplanned Healthcare Utilization, Emotional 
Distress-Anxiety/Depression, Quality of Life 
CONNECT Intervention Group (Group A) 
Caregiver: Sociodemographics, Emotional Distress-
Anxiety/Depression, Self-Care, Supportive Care Service 
Utilization, Caregiver Burden, Quality of Life, Perceived Care 
Quality, Caregiver Barriers to Care, Caregiving Self Efficacy, 
Adherence to referrals, quantitative survey to assess 
acceptability of intervention  
Patient: Perceived Care Quality, Physical/Emotional Well-
being, Patient Unplanned Healthcare Utilization, Emotional 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 6 of 30 
2.0 
Introduction and Background 
 
The 2.8 million informal (unpaid) caregivers of US cancer patients are vital members of the oncology 
health care team and face tremendous challenges associated with the caregiving experience.1 
Compared to the general population, cancer caregivers have worse mental and physical well-being2 
and are more likely to have high burden compared to other caregiver populations.3 Head and neck 
cancer (HNC) patients receive complicated treatment regimens,4 and experience severe and 
debilitating physical and psychosocial sequela,5–7 necessitating exceptionally high care demands for 
their family members who are integral to their care.8 Cancer caregivers perform complex care tasks 
such as administering medications, managing patients’ symptoms, and coordinating medical care and 
report high unmet needs, including psychosocial, medical, daily activity, and financial needs, which is 
associated with poorer mental health.9 HNC caregivers in particular, have greater unmet supportive 
care needs compared to many other cancer caregiver populations and experience high caregiver 
burden,8 which leads to poor outcomes for patients as well. Caregiver well-being has been associated 
with patient healthcare utilization, perceived quality of care, and distress, suggesting that efforts to 
support caregivers benefit patients as well.10–12 Supportive care resources (e.g., psychological support 
interventions, health behavior programs, cancer education) are available, and our research and others 
has demonstrated cancer caregivers in general, and HNC caregivers specifically, desire these services. 
13–16 Yet, healthcare systems fail to systematically assess cancer caregivers’ needs and connect them 
with needed services. Consequently, there is a critical need to identify systems-level strategies to 
identify and link HNC caregivers to resources to improve both caregiver and patient well-being.  
 
The long-term goal of this program of research is to improve supportive care delivery for cancer 
caregivers, with the ultimate goal of improving both caregiver and patient well-being. We propose to 
refine and evaluate a novel web-based intervention, CONNECTing Caregivers to Supportive Services 
(CONNECT), informed by theory with input from an advisory panel of cancer caregivers, oncology 
providers, and psychosocial oncology professionals. CONNECT empowers 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. This 
intervention is designed to be low cost and to capture resources offered in different oncology 
environments to support future adaptation and dissemination for heterogeneous healthcare settings 
and populations. Initial testing in the proposed study will take place with caregivers of patients with 
HNC due to their high unmet needs and burden. 
 
Significance 
Cancer caregivers provide critical and challenging care for their loved ones and are at risk for their own 
negative psychosocial and physical outcomes. Approximately 2.8 million people provide care for a 
patient with a primary cancer diagnosis in the US.1 Cancer caregivers have worse mental and physical 
well-being when compared to population norms2 and are more likely to have high burden compared to 
non-cancer caregiver populations.3 Head and neck cancer (HNC) patients receive complicated 
treatment regimens,4 and experience severe and debilitating physical and psychosocial sequela,5–7 
necessitating exceptionally high care demands for their family members who are integral to their care.8 
Caregivers engage in difficult and time consuming care tasks including monitoring patient symptoms, 
managing patient behaviors, assisting with treatment and end-of-life care decisions, providing 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 7 of 30 
emotional support, and engaging in household tasks; yet, report low self-efficacy and being unprepared 
for their caregiving role. 17–21 HNC caregivers in particular, have greater unmet supportive care needs 
compared to many other cancer caregiver populations and experience high caregiver burden.8 In 
addition, my work and others suggest HNC caregivers report clinically significant and high rates of 
emotional distress, high levels of caregiver burden, poorer physical and mental health compared to 
population norms, and deteriorations in psychological well-being and overall quality of life over time.13 
22,23 
 
Patient outcomes are interrelated with caregiver’s overall well-being. Extensive research has 
demonstrated that informal caregivers’ overall well-being has implications for patients’ well-being. The 
dementia caregiving literature has shown that higher resilience or improved psychological health in 
caregivers is associated with less frequent institutionalization, delayed nursing home placement, and 
reduced patient mortality.24–28 Another study found that caregiver burden and low quality-of-life 
predicted prolonged hospital stays in dementia patients.29 In cancer dyads specifically, patients who 
have caregivers with higher depressive symptoms are more likely to perceive their quality of care to be 
fair or poor.11 This is significant given that perceived care quality has been associated with mortality in 
cancer patients.30 In addition, caregiver burden has been associated with patient distress in cancer 
dyads.12 Further, lower caregiver self-efficacy is associated with physical and emotional symptoms 
among cancer patients.20 Although less explored in the HNC population, studies suggest associations 
between caregiver and patient psychological functioning and quality of life.31,32 Collectively, these 
findings support the scientific premise that patient outcomes, including healthcare utilization, perceived 
care quality, and psychosocial functioning can be optimized by supporting caregivers’ overall well-
being.  
 
Supportive care services can help mitigate negative outcomes in caregivers, but healthcare systems fail 
to connect caregivers with these services. Our research13 and others14,15,33 demonstrate that HNC 
caregivers are interested in supportive care interventions (see preliminary data). Supportive care 
interventions decrease burden and depression and improve well-being, satisfaction, and knowledge 
and skills in cancer caregivers.34 Despite availability of supportive care resources at cancer centers and 
at the community and national level (see preliminary data), receipt of supportive care services among 
HNC caregivers is low.35–37 Major barriers to connecting cancer caregivers to appropriate services 
include lack of systematic identification, assessment, and referral of caregivers by providers. 3,34  
 
Technology-based interventions offer an ideal solution for connecting cancer caregivers to supportive 
care resources. Current caregiver interventions are costly to deliver and require significant provider or 
support staff engagement, resulting in limited translation to clinical practice.34 Web-based interventions 
overcome both of these barriers (i.e., cost and provider/staff engagement) and support wide-scale 
dissemination. Despite this potential, web-based approaches have been under-utilized in the cancer 
caregiving field and are recognized as a priority for research in this area.3 Additionally, cancer 
caregivers have expressed interest in web-based interventions to reduce burden and address other 
caregiver challenges.38,39  
 
This proposed application is innovative because it: (1) aims to improve HNC patient outcomes by 
intervening with their informal family caregivers, a high burden and understudied population; (2) aims to 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 8 of 30 
improve caregiver psychosocial functioning and perceived care quality by leveraging existing 
evidenced-based supportive care resources that are currently poorly utilized; (3) offers a low-cost 
solution to efficiently connect HNC caregivers with supportive care resources; (4) evaluates an 
intervention informed both by theory and by an advisory panel including HNC providers, psychosocial 
oncology professionals, and caregivers; and (5) includes a flexible e-tool developed to support wide-
scale dissemination that can easily be adapted for heterogeneous healthcare settings with varying 
resources. 
 
Summary. The well-being of HNC caregivers affects patient outcomes, yet caregivers are a vulnerable 
population with high unmet needs. Although supportive care interventions exist and HNC caregivers 
have expressed interest in these types of interventions, caregivers are not systematically being 
connected to these services. Leveraging technology to connect caregivers with existing interventions 
will support translation of current evidence-based interventions into clinical practice. 
 
Approach. Following initial usability testing in a separate study (IRB00060160) to refine a web-based 
intervention (CONNECT) to empower and connect caregivers of cancer patients to supportive care 
resources , a randomized pilot study (Fig.1) will be conducted to assess feasibility and acceptability and 
obtain data on caregiver and patient outcomes. Caregivers and patients (dyads) will be recruited at 
patients’ routine oncology appointments and complete a baseline assessment (T0). Following T0, 
caregivers will be randomized to CONNECT (n=20) or the comparison arm (n=20). Dyads will complete 
follow-up assessments at T1 (1-month post-CONNECT) and T2 (3-months post-CONNECT). Though 
we are recruiting patient-caregiver dyads into the study, the intervention is delivered to caregivers 
only. 
 
Preliminary Data 
HNC caregivers report clinically significant depressive symptoms, poor health behaviors, and desire 
supportive care resources. We assessed psychosocial functioning, health behaviors, and interest in 
supportive care services for HNC caregivers.13 HNC caregivers reported a smoking history (42%), 
depressive symptoms (45%) and anxiety above population norms (33%). Most caregivers were 
interested in supportive care programs focused on cancer education (66.7%), stress reduction (63.6%), 
diet/exercise (71.0%), and educational classes on finances, caregiving, and well-being (57.6%). HNC 
caregivers who were interested in any type of program reported poorer mental health (p=.02) and 
higher anxiety (p=.01). Findings confirm a need for, and interest in, supportive care resources among 
HNC caregivers. 
 
Supportive care resources are available for cancer caregivers. Our team contributed questions to a 
nation-wide assessment of community oncology clinics (through the NCI Community Oncology 
Research Program [NCORP] 2017 Landscape Assessment). Findings revealed that 62% of practice 
groups have supportive care resources available for caregivers. In addition, through preliminary work 
for CONNECT’s e-tool development, we have compiled a comprehensive list of supportive care 
resources for HNC caregivers offered at the Wake Forest Baptist Comprehensive Cancer Center 
(WFBCCC; where this study will take place), the community, and nation-wide. Findings confirm that 
there is robust availability of supportive care resources for cancer caregivers; however, lack of a 
systematic process to connect caregivers inhibits service use.  

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 9 of 30 
 
Our preliminary data provide evidence that: (1) HNC caregivers need and are interested in supportive 
care resources; (2) resources are available, but a systematic process is needed to connect caregivers 
to services; and (3) The PI has experience recruiting HNC caregivers and patients.  
 
Theoretical Underpinnings. This research is informed by 
Longacre’s model of Cancer Caregiver Well-being (Fig 2).22 
The underlying premise is that connecting caregivers to 
supportive care resources will support caregiver well-being, 
leading to improved outcomes for caregivers (e.g., quality of 
life), patients (e.g., improved physical well-being), and the 
healthcare system (e.g., reduced unplanned healthcare 
utilization for patients). 
 
Impact: This study proposes an innovative web-based 
intervention (CONNECT) to improve supportive care delivery for cancer caregivers, CONNECT, 
designed to be low-cost and easily adaptable across heterogeneous healthcare settings to support wide 
dissemination. This work and pilot data will inform a subsequent R01 proposal to conduct a larger multi-
site, nationwide pragmatic trial through the NCI Community Oncology Research Program. CONNECT 
has the potential to improve outcomes for the 2.8 million US patient-caregiver cancer dyads. Further, 
there is potential for CONNECT to be adapted to non-cancer caregiver populations such as the more 
than 15 million Alzheimer’s disease caregivers.40 
 
3.0 
Objectives 
 
3.1 
Primary Objectives 
 
3.1.1 To assess feasibility (accrual, participation, and retention) of CONNECT with HNC 
caregivers (Intervention Group, n=20; Comparison Group, n=20) in a randomized pilot 
study to support a future pragmatic trial.  
 
3.1.2 To assess acceptability of CONNECT with HNC caregivers (Intervention Group, n=20; 
Comparison Group, n=20) in a randomized pilot study to support a future pragmatic trial. 
 
3.2 
Exploratory Objective(s) 
 
3.2.1 To assess adherence to referrals for supportive care resources (caregiver- and 
administrator-reported) among intervention caregivers (n = 20) and barriers to supportive 
care use among intervention and comparison (n=40) caregivers. 
 
3.2.2 To obtain preliminary data on HNC caregiver outcomes (supportive care service use, 
perceived care quality, burden, and distress, quality of life, caregiving self-efficacy, and 
self-care) and HNC patient outcomes (physical well-being, unplanned healthcare 
utilization, perceived care quality, distress, and symptoms)..  

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 10 of 30 
 
3.2.3 To examine changes in the caregiver outcome variables (perceived care quality, burden, 
distress, quality of life, caregiving self-efficacy, and self-care) with changes in in 
supportive care resource use. 
 
3.2.4 To examine if patient physical well-being and patient healthcare utilization are 
associated with change in caregiver burden and distress in intervention arm caregivers. 
 
3.2.5 To characterize the correlation between caregivers and patients with regard to distress 
and perceived care quality. 
 
4.0 
Participant Selection 
4.1 
Inclusion Criteria 
 
4.1.1 Eligible caregivers include those who are: 
4.1.1.1 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.  
4.1.1.2 Greater than or equal to 18 years of age. 
4.1.1.3 Ability to access study materials by internet or complete study activities in 
person as institutional and government policies allow. 
 
4.1.2 Eligible patients include those who: 
4.1.2.1 Have new or recurrent AJCC stage I-IV HNC. 
4.1.2.2 Are receiving cancer treatment or awaiting planned treatment initiation, 
excluding those receiving neoadjuvant surgery or surgery only 
4.1.2.3 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. 
4.1.2.4 Greater than or equal to 18 years of age. 
4.1.2.5 Ability to access study materials by internet or complete study activities in 
person as institutional and government policies allow. 
4.1.2.6 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. 
 
 
4.2 
Exclusion Criteria 
 
4.2.1 Caregivers will be excluded if: 
4.2.1.1 They cannot read/communicate in English 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 11 of 30 
 
4.2.2 Patients will be excluded if they: 
4.2.2.1 Cannot read/communicate in English 
 
Eligibility to participate in the study for is conditional on participation of both the caregiver and patient.  
 
4.3 
Inclusion of Women and Minorities 
Men and women of all races and ethnicity who meet the above-described eligibility criteria are eligible 
for this trial. Based on national head and neck cancer statistics41 and a current patient-caregiver head 
and neck cancer protocol (PI: Nightingale; IRB00038084) at the WFBCCC, we estimate that 
approximately 75% of the patient participants will be male (and 25% female) and approximately 80% of 
the caregiver participants will be female (and 20% male). Further, we estimate that the majority (75%) 
of the participants will be non-Hispanic white, consistent with our current HNC patient-caregiver dyad 
research study conducted at this institution.  
 
5.0 
Registration Procedures 
 
All patients entered on any WFBCCC trial, whether treatment, companion, or cancer control trial, must 
be linked to the study in EPIC within 24 hours of Informed Consent. Patients must be registered prior to 
the initiation of the study intervention.  
 
The following steps will be performed to ensure prompt registration of participants: 
 
1. Complete the Eligibility Checklist (Appendices A and B) 
2. Complete the Patient Protocol Registration Form (Appendix C) and Caregiver Protocol 
Registration Form (Appendix D) as well as the Race Ethnicity Verification Form (Appendix E) 
3. Register the patient and caregiver in WISER, registering the patient by their MRN 
 
6.0 
Study Outcomes and Study Measures 
 
6.1 
Primary Outcome 
 
6.1.1 Feasibility and acceptability outcomes for the randomized pilot trial include:  
 
6.1.1.1 Accrual: Number of caregivers who agreed to participate divided by the number 
of months of recruitment 
 
6.1.1.2 Participation: Proportion of eligible participants who agreed to participate 
 
6.1.1.3 Retention: Number of participants who completed the T2 assessment divided by 
the number who agreed to participate 
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 12 of 30 
6.1.1.3.1 Acceptability: 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 H, I, and J) 
 
6.2 
Exploratory Outcomes 
6.2.1 Preliminary Data of the following measures: 
 
6.2.1.1 Caregiver Measures 
6.2.1.1.1 Supportive Care Service Utilization  
 Survey developed for the purpose of this study to query participants 
about utilization of supportive care services assessed as part of the 
CONNECT Preferences Survey. 
 
6.2.1.1.2 Perceived Care Quality   
FAMCARE42  
20-item instrument with 4 subscales to assess family caregiver 
satisfaction with information giving, availability of care, physical 
patient care, and symptom control.  
 
6.2.1.1.3 Caregiver Burden 
Caregiver Reaction Assessment43  
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 reliability43,44 
 
6.2.1.1.4 Psychological distress- Anxiety  
PROMIS Emotional Distress-Anxiety-Short Form 8a45 
8-item instrument that assesses fear, anxious misery, hyperarousal, 
and somatic symptoms related to arousal; widely used in oncology 
populations. 
 
6.2.1.1.5 Psychological distress- Depression  
PROMIS Emotional Distress- Depression-Short Form 8a45 
8-item instrument that assesses sadness, guilt, self-criticism, 
worthlessness, loneliness, interpersonal alienation, as well as loss of 
interest, meaning, and purpose. 
 
6.2.1.1.6 Quality of Life  
Caregiver Quality of Life Index-Cancer (CqoL-Canc)46  
35-item instrument assessing dimensions of caregiver quality of life 
(burden, disruptiveness, positive adaptation, financial concerns). The 
Cqol-Canc has demonstrated validity and reliability. 
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 13 of 30 
6.2.1.1.7 Self-Care  
Caregiver Risk Scale47 
7-item measure to assess caregiver behaviors for managing self-care. 
 
6.2.1.1.8 Caregiving Self-Efficacy48  
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); 
demonstrated validity and reliability.  
 
6.2.1.1.9 Barriers to Supportive Care Use  
Survey developed for the purpose of this study to assess caregiver 
barriers to accessing supportive care resources. 
 
6.2.1.1.10 Caregiver Adherence to Referral 
Survey developed for purpose of this study to examine referral details. 
This includes date referral received by agency, time point of referral 
(T0/2 week follow up), if participant utilized services, and date those 
services were initially accessed. In addition, 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 
 
 
6.2.1.2 Patient Measures 
6.2.1.2.1 Physical/Emotional Well-being  
SF-1249 
12-item instrument measuring physical and mental well-being; widely 
used in oncology populations. 
 
6.2.1.2.2 Unplanned Healthcare Utilization  
Survey designed for the study to capture patient self-reported 
unplanned healthcare utilization. Total score will reflect number of 
unplanned visits to the emergency room, urgent care, or healthcare 
provider 
 
6.2.1.2.3 Perceived Care Quality  
FAMCARE42  
20-item instrument with 4 subscales to assess family caregiver 
satisfaction with information giving, availability of care, physical 
patient care, and symptom control.  
 
6.2.1.2.4 Psychological distress- Anxiety  
PROMIS Emotional Distress-Anxiety-Short Form 8a45 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 14 of 30 
8-item instrument that assesses fear, anxious misery, hyperarousal, 
and somatic symptoms related to arousal; widely used in oncology 
populations. 
 
6.2.1.2.5 Psychological distress- Depression  
PROMIS Emotional Distress- Depression-Short Form 8a45 
8-item instrument that assesses sadness, guilt, self-criticism, 
worthlessness, loneliness, interpersonal alienation, as well as loss of 
interest, meaning, and purpose. 
 
6.2.1.2.6 Head and Neck Cancer Symptoms  
MDASI-HNC 50 
28 item instrument to assess head and neck cancer specific and 
general symptoms and the impact on daily functioning  
7.0 
Study Plan 
 
7.1 
Study Overview  
 
This study includes piloting a novel technology-based intervention (CONNECT) to connect HNC 
caregivers with needs to supportive care resources (Figure 1) in a randomized trial. Caregivers 
and their care-recipients (i.e., patients) will be identified by screening provider schedules. They 
will be recruited by mailed recruitment packet, myWakeHealth message, telephone, and/or in 
person when presenting for the patient’s routine oncology appointment (as allowed by 
institutional and government policies). Following completion of the consent process, 
patient/caregiver dyads will complete a baseline assessment (T0) (Appendices F and G). After 
the T0 assessment, caregivers will be randomized 1:1 to receive CONNECT (n=20) or the 
comparison arm (n=20). Caregivers and patients will also complete assessments after 
randomization at T1 (1-month post-CONNECT) (Appendices H and I) and T2 (3-months post-
CONNECT) (Appendices J, K, and L). 
 
7.2 
Study-Related Activities 
 
 
 
 
 
T0 
 
T1 
 
T2 
Caregiver sociodemographics  
X 
X* 
X* 
Caregiving characteristics  
X 
X* 
X* 
Patient sociodemographics  
X 
 
 
Patient clinical information data abstraction 
X 
 
 
Collection of feasibility metrics 
X 
X 
X 
Caregiver acceptability 
 
 
X 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
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T0 
 
T1 
 
T2 
Caregiver self-reported adherence to referrals for supportive 
resources 
 
 
X 
Caregiver Supportive Care Service Utilization 
X 
X 
X 
Caregiver PROMIS Emotional Distress- Anxiety Short Form 8a 
(Psychological distress)45 
X 
X 
X 
Caregiver PROMIS Emotional Distress- Depression Short 
Form 8a (Psychological distress)45 
X 
X 
X 
Caregiver Reaction Assessment (Burden)44  
X 
X 
X 
Caregiver Quality of Life Index-Cancer (CqoL-Canc)46  
X 
X 
X 
Caregiver FAMCARE (Perceived care quality)42 
X 
X 
X 
Caregiver Risk Scale (self-care) 47 
X 
X 
X 
Caregiver Barriers to Supportive Care Use 
 
 
X 
Caregiving Self-efficacy48 
X 
X 
X 
Patient FAMCARE42 
X 
X 
X 
Patient SF-12 (Mental and physical well-being)49 
X 
X 
X 
Patient PROMIS Emotional Distress- Anxiety Short Form 8a 
(Psychological distress) 45 
X 
X 
X 
Patient PROMIS Emotional Distress- Depression Short Form 
8a (Psychological distress) 45 
X 
X 
X 
Patient Unplanned healthcare utilization 
X 
X 
X 
MDASI- H&N50 
X 
X 
X 
Study evaluation 
 
 
X 
Service-administrator reported caregiver adherence to 
supportive care referrals 
Administrators for service providers will record 
this information throughout the study period as 
referrals are received and services are utilized. 
 
 
* A limited set of variables from the survey will be included at this time point. 
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 16 of 30 
7.3 
Intervention Administration 
 
7.3.1 Recruitment 
 
In collaboration with the treating oncologist, patients will be identified through clinic schedules. 
Screened patients will be recorded in the Subject Screening Form, an excel document 
(Appendix M) that will be kept on a protected share drive through the Wake Forest Baptist 
network and is only accessible to key staff members. Patients will be recruited for the study via 
a mailed recruitment package (Appendix X) or message sent via myWakeHealth that notifies 
patients that they may be eligible to participate in the study and provides them with an option to 
opt out of additional contact regarding the study. Patients will then be contacted either by phone 
or in person (as institutional and government policies allow). At this time additional information 
will be provided to the patient regarding the study and their eligibility will be confirmed (see 
section 3.1.2.6).  
 
For patients that are not able to communicate verbally, there is an option in the letter for them to 
reply to the message with the name and phone number of a caregiver with whom we can 
discuss the study if they are interested in learning more.  
 
If patient is interested and has an eligible caregiver who is also interested in participating, study 
coordinator will proceed with consenting them (see section 6.5). If the caregiver is not present, 
we will seek permission from the patient to contact the caregiver by phone to discuss study 
participation. 
 
7.3.2 Randomization Plan  
Caregiver participants will be randomized to the CONNECT web-based tool (n=20) or to the 
generic resource list (n=20) after both the patient and caregiver in a dyad return T0 and will be 
considered enrolled in the study. We anticipate that some participants may drop out prior to T0, 
and therefore may recruit up to 50 caregiver-patient dyads to ensure 40 complete T0; this is 
based on a potential drop out rate of up to 20%, although it is expected be lower. Because this 
protocol tests a caregiver-delivered intervention, patients will not be directly randomized, though 
the randomization of a caregiver implies a randomization of a patient. During the enrollment 
process participants will be informed that they could be randomly assigned to 1 of 2 different 
supportive treatments (Group A or Group B) with a general description of what these groups will 
involve, but participants will not be blind to their treatment assignment once they begin the 
study. Patients will also not be blinded regarding their caregiver’s assignment. Allocation to 
treatment arm will be computer-generated and concealed by Dr. Tooze (Biostatistician). Study 
team members will not know group assignment when consenting participants. The Project 
Manager and PI who assign participants to interventions will be made aware of group 
assignment after both the patient and caregiver have provided informed consent and returned 
their baseline questionnaires. 
 
7.3.3 Description and Procedures.  
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 17 of 30 
CONNECT is a web-based intervention designed to empower caregivers with needs who are 
caring for cancer patients to seek supportive care services by providing education about the 
benefits of supportive care resources, systematically identifying their unmet needs, and 
connecting them with tailored supportive care resources, based on each caregivers’ specific 
needs. Caregivers will be recruited in conjunction with the patient’s routine oncology 
appointment. Following recruitment, dyads will complete the T0 assessment and caregivers will 
be randomized to CONNECT or the comparison group. CONNECT includes a multi-component 
e-tool accessible by a study website. CONNECT includes a multi-component web-based tool 
with the following: (1) a brief educational video (Appendix N) that seeks to empower and 
educate caregivers about the importance of self-care and benefits of supportive care resource 
use; (2) an assessment of multidimensional supportive care needs (e.g., psychological, 
behavioral, social, financial, educational, spiritual) (Appendix O); (3) a tailored resource list that 
includes local and national resources corresponding to caregivers’ needs (Appendix P) 
(Table1); and (4) an optional automated referral to a caregiver navigator to facilitate connection 
to resources (for a limited number of resource options). Caregivers and patients will each 
receive a $20 gift card for each assessment (T0, T1, and T2). 
 
 
 
 
After completing the assessment component of CONNECT’s web-based tool, caregivers can 
view their tailored resource list in real time. All caregivers will receive a printed copy of their 
tailored resource list. Additionally they may indicate if they want the tailored resource list sent to 
their email address (Figure 1). For caregivers who select the optional referral option, their 
contact information (name and phone number) will be included in an auto-generated email sent 
to the resource (e.g., Cancer Patient Support Services) that they indicated interest in receiving a 
referral for. Two weeks after the caregiver uses goes through the CONNECT web-based tool, 
the study coordinator will contact caregivers in the CONNECT intervention by phone to provide 
re-education regarding the importance of caregiver self-care and benefits of supportive care 
resource use using a semi-structured script and an additional opportunity to receive a referral to 
facilitate connection to resources (Appendix Q). To extend reach to the minority of caregivers 
who do not accompany the patient to an appointment and allow research to occur during times 
when the study team is unable to conduct study activities in person, we will email the caregiver 
a website link to access CONNECT over the web. Those without home internet access will only 
have the option to participate when in person study visits are possible given the nature of the 
intervention.  
 
 
Table 1. Examples of Supportive Identified Needs and Matched Resources 
Identified Need                                   Matched Resource 
Psychological support 
WFBCCC Cancer Patient Support Program 
Tobacco cessation 
WFBCC Tobacco Cessation Clinic 
Financial counseling 
Winston-Salem Cancer Support Services 
Cancer Education 
American Cancer Society handbook for cancer caregivers 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 18 of 30 
 
Tablets will be available in the clinic (managed by research personnel) for participants to access 
the web-based tool. CONNECT’s web-based tool is hosted on a website and designed to take 
approximately 15 – 20 minutes to complete. The web-based tool was developed and will be 
maintained by a programmer with clinical informatics expertise from the Center for Healthcare 
Innovations. 
 
 
Comparison Arm. Caregivers not randomized to the intervention group will receive minimally 
enhanced usual care. This includes a generic (not tailored) printed list of hospital, community, 
and national supportive care resources (Appendix R). They will not receive the video, complete 
the web-based tool Preference survey, or have an option for an automated referral. The generic 
resource list will be printed for participants and emailed to them, if participants have an email 
address. 
  
Data Collection Procedures. Data collection and instruments are reported in Table 2. At T0, 
patient and caregiver sociodemographics and caregiving characteristics will be collected and 
patient clinical information will be abstracted from the electronic health record (EHR) (Appendix 
S). Feasibility data will be collected throughout the study period (T0-T2).  Caregivers and 
patients will complete self-report quantitative assessments at T0-T2 through REDCap We will 
email or text a link to complete the REDCap surveys at the appropriate times. To minimize 
missing data, we will call any participant who fails to complete a survey within 48 hours of the 
link being sent. In the case that a patient dies, caregivers may choose whether or not continue 
in the study and complete follow up questionnaires.  
 
Data Management. All screened and approached participants will be recorded in an Excel 
document Appendix MThe responses of anonymous refusal surveys (Appendices V and W) will 
be recorded in a separate REDCAP Refusal project. All completed surveys for consented 
patients and caregivers will be recorded in an third REDCap project.   
 
Figure 1. Study and Intervention Schema 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 19 of 30 
Qualitative Data Collection: At 2-weeks post-intervention - T1, caregiver qualitative interviews 
will be completed in person (or by telephone, if participant prefers) to assess acceptability of the 
intervention (est. 30min) using semi-structured guides with open-ended questions (Appendix T).  
During interviews, CONNECT elements will be reviewed and open-ended questions will be used 
to elicit feedback on functionality, strengths, and weaknesses of the web-based tool. All 
interviews will be audio-recorded and transcribed verbatim.  
 
Adherence to referrals for supportive care services will also be tracked by each participating 
resource in a study spreadsheet (Appendix U). We will collect name, date referral was received, 
if service was accessed, and date service accessed. This spreadsheet will be collected by email 
quarterly throughout the study period.  
 
Refusal Data Collection 
If participants refuse to participate in the study, we will ask them to fill out a brief questionnaire 
with the following information: age, race, ethnicity, gender, marital status, education level, 
employment status, why the chose not to participate, and rating their distress in the past week 
(Appendices V and W) 
 
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 20 of 30 
Table 2. Assessment Plan  
Assessment 
Time 
Description 
Caregiver sociodemographics & caregiving 
characteristics * 
T0, T1, 
T2 
Age, gender, race/ethnicity, education, employment status and impact, income and financial impact, insurance status, marital status, 
living with patient (yes/no), relationship to patient, respite assistance (yes/no) 
Patient sociodemographics  * 
T0, T1, 
T2 
Age, gender, race/ethnicity, education, employment status, and insurance status  
Patient clinical information 
T0 
Time since diagnosis, AJCC Stage, and treatment history for current cancer diagnosis 
 
Accrual  
T0, T1, 
T2 
Number of caregivers who agreed to participate divided by the number of months of recruitment  
Participation 
T0, T1, 
T2 
Proportion of eligible participants who agreed to participate  
Retention  
T0, T1, 
T2 
Number of participants who completed the T2 assessment divided by the number who agreed to participate  
Caregiver acceptability 
T1 
Survey developed for study to assess how much caregivers liked different aspects of CONNECT; and a ~30min (approximately) 
qualitative interview to further explore acceptability.  
 
Caregiver Measures 
Supportive Care Service Utilization 
T0, T1, 
T2 
Survey developed for the purpose of this study to query participants about utilization of supportive care services assessed as part of 
the CONNECT Preferences Survey. Participants will also self-report service use by selecting (yes/no) from a list of resource options 
consistent with the e-tool resource list. 
FAMCARE42 (Perceived care quality) 
T0, T1, 
T2 
20-item instrument with 4 subscales to assess patient and family satisfaction with information giving, availability of care, physical 
patient care, and symptom control.  
Caregiver Reaction Assessment (Burden)43  
T0, T1, 
T2 
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 reliability43,44 
PROMIS Emotional Distress-Anxiety-Short 
Form49 
T0, T1, 
T2 
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 49 
T0, T1, 
T2 
8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of 
interest, meaning, and purpose 
Caregiving Self-efficacy48 
T0, T1, 
T2 
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); demonstrated validity and reliability.  
Caregiver Risk Scale47 
T0, T1, 
T2 
7-item measure to assess caregiver behaviors for managing self-care 
Caregiver Quality of Life46 
T0, T1, 
T2 
35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). 
The Cqol-Canc has demonstrated validity and reliability 
Caregiver Barriers to Supportive Care 
T2 
Survey developed for the purpose of this study to assess caregiver barriers to accessing supportive care 
Patient Measures 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 21 of 30 
SF-1249 (physical well-being) 
T0, T1, 
T2 
12-item instrument measuring physical and mental well-being, though our analyses will focus on physical well-being; widely used in 
oncology populations. 
Unplanned healthcare utilization 
T0, T1, 
T2 
Survey designed for the study to capture patient self-reported unplanned healthcare utilization. Total score will reflect number of 
unplanned visits to the emergency room, urgent care, or healthcare provider. 
FAMCARE42 (Perceived care quality) 
T0, T1, 
T2 
see description above 
PROMIS Emotional Distress-Anxiety-Short 
Form49 
T0, T1, 
T2 
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 49 
T0, T1, 
T2 
8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of 
interest, meaning, and purpose 
MDASIH&N50 
T0, T1, 
T2 
28 item instrument to assess head and neck cancer specific and general symptoms and the impact on daily functioning 
 
*A limited set of these variables will be included at T1 and T2. 
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 22 of 30 
7.4 
Participant Payment 
 
Caregivers and patients will each receive a $20 gift card for each assessment (T0, T1, and T2). 
 
7.5 
Informed Consent 
This study poses no more than minimal risk and has a waiver of signed consent. During 
recruitment, dyads will have the study explained to them and have the opportunity to ask 
questions.  Interested dyads will be presented with a form (hard copy or by REDCap) detailing 
study procedures including written documentation of study procedures and outlining what 
participation entails.  In addition to providing written documentation of study procedures and 
outlining what participation entails, a statement at the end of the form will indicate that by 
continuing, the participant agrees to participate in the study. A copy of this information will be 
sent to participants at the email address they provided for their records. A notice on the 
REDCap form when the participant continues will read “Thank you. You will received a link to 
your first survey shortly”.    
 
No study procedures will occur until the consent has occurred.  
 
7.6 
Confidentiality and Privacy  
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner.  To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the data 
collection form.  Any collected patient identifying information corresponding to the unique study 
identifier will be maintained on a linkage file, store separately from the data.  The linkage file 
will be kept secure, with access limited to designated study personnel.  Following data 
collection, subject identifying information will be destroyed six years after closure of the study, 
consistent with data validation and study design, producing an anonymous analytical data set.  
Data access will be limited to study staff.  Data and records will be kept locked and secured, 
with any computer data password protected.  No reference to any individual participant will 
appear in reports, presentations, or publications that may arise from the study. 
 
7.7 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants.  The principal investigator will be assisted by other members of the study 
staff. 
7.8 
Reporting of Unanticipated Problems, Adverse Events, or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government agency if appropriate. 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 23 of 30 
7.9 
Duration of Follow Up 
Caregiver and patients participate in this study for approximately 3 months. After completing a 
baseline (T0) assessment and receiving the intervention, they will have 1-month and 3-month 
follow-up assessments. Participation in the study ends after completing the 3-month follow-up 
assessment. 
 
7.10 
WFUHS IRB AE Reporting Requirements 
 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to the 
IRB and sponsor or appropriate government agency if appropriate. 
 
In the rare event that a participant becomes distressed as a result of participating in this study or rather 
becomes more reflective and wants to talk about these issues in more depth, we will provide referrals to 
members of the psychosocial support team and/or other clinical staff as appropriate. 
 
8.0 
Data Management 
 
Table 3: Data Management 
Protocol registration form 
WISER/OnCore 
Caregiver measures 
REDCap 
Patient measures 
REDCap 
 
9.0 
Statistical Considerations 
 
Statistical Considerations. For the primary objective, the quantitative analyses will provide estimates of 
accrual, participation, and retention rates. For the secondary objectives, quantitative analyses will provide 
estimates of the mean and variance of CONNECT for acceptability and outcome variables to refine the 
protocol for a larger study. Though CONNECT is a caregiver-only intervention, analyses will also examine 
patient outcomes and relationships between caregiver and patient outcomes. 
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 24 of 30 
 
9.1 
Analysis of Primary Objectives 
 
9.1.1 For Objective 2.1.1, participation rate will be the percent of eligible participants who 
agree to participate. Accrual rate will be the number of caregivers who agreed to 
participate divided by the number of months of recruitment. Retention rate will be the 
number of participants who completed measures divided by the number who consented. 
We will construct 95% confidence intervals around these rates. 
 
9.1.2 For Objective 2.1.2, acceptability will be summarized quantitatively and qualitatively (with 
assistance from WFSOM Qualitative and Patient-Reported Outcomes [Q-PRO] shared 
resource). Descriptive statistics (mean, standard deviation) will be used to summarize 
participants’ acceptability rating. A codebook for analyzing qualitative interviews will be 
developed using a thematic analysis procedure, facilitating coding into discrete 
categories, and frequent themes pertinent to caregivers’ likes/dislikes for CONNECT 
including the e-tool, message to provide re-education, and optional referral (process and 
navigator interaction) will be summarized. Qualitative acceptability data will be analyzed 
following a thematic analysis approach, facilitating coding into discrete categories. 
 
9.2 
Analysis of Exploratory Objectives 
 
9.2.1 For Objective 2.2.1, frequencies will be used to summarize the number and type of 
referrals selected by intervention caregivers. Referral adherence will be defined as 
completion of referral (i.e. services utilized) within the caregiver’s duration of study 
participation. Frequencies will also be used to summarize the number of intervention 
caregivers who adhered to referrals selected, among those who selected an automatic 
referral. This percentage will be calculated for caregiver-reported adherence as well as 
service administrator-reported adherence and concordance among caregiver- and - 
service administrator reported adherence will be calculated using McNemar’s test. 
Number of barriers to supportive care use will be summarized using descriptive statistics 
(mean and standard deviation) and compared between intervention and control 
caregivers using an independent samples t-test.  
 
9.2.2 For Objective 2.2.2, we will calculate descriptive statistics by arm and the difference 
between arms for the variables of interest at T0, T1 and T2, and change in variables 
from T0-T2 to provide estimates of variance for a larger study. We will examine 
differences by arm but are not powered for hypothesis testing at a 0.05 alpha-level 
between the two arms.  
 
9.2.3 For Objective 2.2.3, we will examine change in supportive care resource use with 
change in the caregiver outcome variables (perceived care quality, burden, and distress, 
quality of life, caregiving self-efficacy, and self-care) using a regression approach to 
examine whether changes in supportive care resource use are associated with change 
in the outcomes. 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 25 of 30 
 
9.2.4 For Objective 2.2.4,we will model changes in patient physical well-being and the patient 
healthcare utilization score at T1 and T2 as a function of change in caregiver 
psychosocial functioning from baseline using mixed effects models for the outcomes of 
interest with the baseline value of the outcome, change in caregiver burden and distress, 
arm, and time as the predictors.  
 
9.2.5 A mixed model with a random family effect will also be used to characterize dyadic 
relationships between patients and caregivers for distress and perceived care quality for 
Objective 2.2.5.  
 
9.3 
Power and Sample Size 
The sample size is based on feasibility, and we draw on our current patient-caregiver head and 
neck cancer protocol (PI: Nightingale; IRB00038084) at the WFBCCC, prior recruitment with 
HNC caregivers, 13,51,52 and clinic estimates. Our primary feasibility measures are participation, 
accrual, and retention rates. Assuming a negative binomial distribution and true rate of 50%, the 
probability that we would approach >96 dyads to recruit 40 is <0.05. If we approach ≥96 dyads 
to enroll 40, it is unlikely the true probability is 50% or greater, and we will conclude the study 
may not be feasible. We anticipate accruing 40 dyads within 9 months (4-5/month). A sample 
size of 40 achieves 92% power to detect a difference between a mean accrual rate of 4 
participants/month and an alternative mean of 3 or fewer participants/month with a significance 
level of 0.025 using a two-sided one-sample Poisson test. Out of the 40 participants, if the true 
rate of retention is 70%, we expect 23 or more will be retained (i.e., probability of n≤22 
successes is <0.05); we have 85% power to test that the hypothesis that the rate is 70% 
compared to 50%. 
 
9.4 
Estimated Accrual Rate 
We anticipate accruing 40 dyads within 9 months (4-5/month) (see section 8.4 above) 
 
9.5 
Estimated Study Length 
We anticipate recruitment will take approximately 9 months, with data collection complete in 12 
months.  
 
9.6 
Interim Analysis Plan 
N/A 
 
 
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 26 of 30 
10.0 Appendices 
 
Appendix A 
Eligibility Checklist (Patient) 
Appendix B 
Eligibility Checklist (Caregiver) 
Appendix C 
Protocol Registration Form (Patient) 
Appendix D 
Protocol Registration Form (Caregiver) 
Appendix E 
Race and Ethnicity Verification Form 
Appendix F 
Patient Survey (T0) 
Appendix G 
Caregiver Survey (T0) 
Appendix H 
Patient Survey (T1) 
Appendix I 
Caregiver Survey (T1 Interv and Comparison)  
Appendix J 
Patient Survey (T2) 
Appendix K 
Caregiver Survey (T2 Comparison) 
Appendix L 
Caregiver Survey (T2 Intervention) 
Appendix M 
Excel Subject Screening Form  
Appendix N 
Video Script 
Appendix O 
Preference Survey 
Appendix P 
HNC Tailored Resource List 
Appendix Q 
2 Week Follow Up Reminder 
Appendix R 
HNC Generic Resource List 
Appendix S 
Patient Clinical Information 
Appendix T 
CONNECT Semi Structure Interview Guide 
Appendix U 
Caregiver Utilization 
Appendix V 
Patient Refusal Questionnaire 
Appendix W 
Caregiver Refusal Questionnaire  
Appendix X 
Participant Recruitment Packet 
 
 
 
 
 

CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
Resources 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
Protocol version date 11.30.20 
 
 
 
 
 
Page 27 of 30 
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CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
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Wake Forest Baptist Comprehensive Cancer Center 
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CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
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Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # 99519 
 
 
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CONNECTing Caregivers to Supportive Services (CONNECT):  
A Technology-Based Intervention to Connect Cancer Caregivers with Supportive Care 
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WFBCCC # 99519 
 
 
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