A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence of Efficacy of the Families Addressing Cancer Together (FACT) Intervention
Phase: NA
Conditions: Neoplasms, Cancer, Parenting, Communication, Parents, Parent-Child Relations
Sponsor: UNC Lineberger Comprehensive Cancer Center

 
 
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Study Protocol and Statistical Analysis Plan 
LCCC2030:  A Pilot Study Evaluating the Feasibility, Acceptability, and Preliminary Evidence 
of Efficacy of the Families Addressing Cancer Together (FACT) Tool 
 
Clinical trial registration:  NCT04342871 on 03/29/2020 
 
Ethical approval: Institutional Review Board at the University of North Carolina at Chapel Hill 
(20-0513) 
 
Funding Source: National Institutes of Health, K07 CA218167-03 awarded to Dr. Park. 
 
Protocol review date: September 9, 2021 
Document Submission Date:  April 13, 2022 
 
Principal Investigator 
Eliza Park, MD, MS 
 
Co-Investigators(s) 
Donald Rosenstein, MD 
Justin M. Yopp, PhD 
Laura C Hanson, MD, MPH 
Carmina G. Valle, PhD, MPH 
Mi-Kyung Song, PhD, RN 
 
Study Coordinator(s) 
Savannah M Bowers, BS 
Ahrang Jung, PhD, RN 
 
Biostatistician  
Allison M Deal, MS 
 
Sponsor:  Lineberger Comprehensive Cancer Center 
 
 
 

 
 
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Study Synopsis 
This is a single-arm pilot study using a pretest-posttest design to evaluate the feasibility and 
acceptability of a novel psychosocial intervention, Families Addressing Cancer Together 
(FACT). In this single-center study, we will recruit up to 60 patients with a new or recurrent 
diagnosis of cancer who also have minor children to participate in a newly developed 
psychosocial intervention for parents with cancer. The purpose of the intervention is to decrease 
parental distress by facilitating parental communication about cancer with their children. The 
primary hypothesis being tested is that an intervention that assists parents with their 
communication needs with their children can be feasible, acceptable, and reduce parental 
psychological distress. Findings from this study will inform a future grant application to further 
test this intervention in a randomized controlled trial. 
 
Background 
Parents with cancer are encouraged to be “honest and open” with their minor children about their 
illness. Parental communication about illness is linked to better emotional adjustment for both 
themselves and their children,1-3 yet most cancer centers lack the resources to address these 
patients’ needs. Lay publications to support parental illness communication exist, but patients 
prefer tailored resources specific to their concerns and disease.4,5 The few evidence-based 
interventions to facilitate parental cancer communication demonstrate high acceptability, yet are 
limited by the need for extensive infrastructure or highly specialized providers, thus limiting 
dissemination. What remains unknown is how to deliver timely, customized parental 
communication guidance across cancer treatment settings. Without this support, parents with 
cancer and their children experience avoidable psychosocial distress. In order to better support 
parental communication needs in cancer, psychosocial interventions that can be implemented 
across clinical practice settings are needed.   
 
To address this gap, we have developed a novel psychosocial intervention, Families Addressing 
Cancer Together (FACT). FACT is a theory-guided, tailored psycho-educational communication 
resource for parents with cancer. FACT was developed through an extensive review of the 
scientific literature and publicly-available resources, consultation with mental health, social 
work, oncology, and palliative care clinicians, patient and caregiver stakeholder interviews, and 
data from the PI’s prior observational studies with parents living with advanced cancer.  
Purpose and Rationale 
This pilot study will provide the necessary data to inform the development and testing of a 
communication intervention to support parents in their communication with children about 
cancer. The research questions to be answered by this study are whether the intervention being 
tested can be feasible and acceptable, and provide preliminary estimates of improvement in 
parental psychological distress. 
Primary Objective 
The primary objective of this study is to evaluate the acceptability of a pilot psychosocial 
intervention for parents with cancer. Acceptability will be defined through satisfaction ratings.  
Secondary Objective  
A secondary objective of this study is to evaluate the feasibility of the study and study 

 
 
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procedures in preparation for a future RCT of the intervention. We will report on participant 
screening, recruitment, and retention. 
Exploratory Objectives 
An exploratory objective of this study is to explore the impact of the intervention on target 
outcomes of anxiety symptom severity (Hospital Anxiety and Depression Scale, HADS) 
depression symptom severity (HADS), social/family well-being (Social/Family Well-Being 
subscale of the Functional Assessment of Cancer Therapy-General, FACT-G), quality of life 
(FACT-G), family functioning (McMaster Family Assessment Device General Functioning 
Scale) and communication self-efficacy in parents with cancer. Data from this study will be used 
for preliminary estimates to power a future R01 testing the intervention. 
 
An exploratory objective of this study is to explore the impact of the intervention to promote 
parents’ communication about cancer with their children as measured by an investigator-
designed survey of parental cancer communication concerns and behaviors. 
 
Study Population 
Inclusion Criteria 
Confirmation of eligibility criteria is required for all potential study subjects prior to study 
enrollment.  Subjects will be eligible for study participation as defined by the inclusion and 
exclusion criteria as follows: 
1. Informed consent reviewed and signed; 
2. Age equal to or above 18 years; 
3. Ability to understand and comply with study procedures; 
4. Able to complete all study measures and visits in English; 
5. Be a parent, primary caregiver, or guardian of at least one child between the ages of 3-18 
years old with whom the subject has regular contact. The child must have cognitive 
ability to understand verbal communication; 
6. Have a new or recurrent/progression diagnosis of invasive solid tumor within the past six 
months, or have a solid tumor cancer diagnosis with disease that is either stage IV or 
equivalent. Staging determined to be “equivalent” to cancer with distant metastases 
reflects disease in which long-term survival is poor, and will be defined as: 
a. Stage III lung (extensive stage or NSCLC) cancer; 
b. Ovarian cancer with platinum resistant/persistent/refractory disease; 
c. Stage III cervical cancer with recurrence; 
d. Head/neck cancer considered stage IV in the absence of distant metastases; 
e. Stage III endometrial cancer with recurrence after chemotherapy; 
f. Stage III pancreatic cancer; 
g. Glioblastoma multiforme (GBM); 
h. Anaplastic oligodendroglioma with grade 3 or above. 
7. Have a cancer diagnosis that is likely to require systemic anti-neoplastic therapy, non-
office based surgical intervention, radiation therapy, or palliative care/hospice within the 
next three months. 

 
 
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Exclusion Criteria 
Eligible subjects must not have any of the following to be enrolled in the study: 
1. Unable to complete self-report instruments due to illiteracy, neurologic illness, inability 
to speak or read English, or other causes. 
2. Unwilling to be audio recorded during the feedback interview portion. 
Study Details 
Screening 
Potential study subjects will be identified through conversations with clinicians and review of 
oncology service rosters. The principal investigator (PI), study coordinator, or the research 
assistant (RA) will confirm study eligibility with patients’ oncology provider prior to 
approaching potential subjects.   
 
Recruitment and informed consent 
All subjects will provide informed consent for the study and HIPAA authorization. When 
approaching an eligible patient, the study team member will describe the nature of the study 
questions and their purposes and written informed consent will be sought. When the treating 
oncology team believes it may be more acceptable to an individual patient, a member of the 
oncology team may first introduce the study. The provider will briefly describe the study, 
provide an approved brochure or “quick-sheet” to the patient, and assess willingness to be 
contacted by the study team. 
In addition to in-person recruitment, recruitment will occur by email and telephone. These 
methods of recruitment will be used to recruit potential subjects when in-person recruitment is 
not feasible (and during COVID-19 restrictions for in-person research contacts). This method 
will also be used to recruit potential subjects who express interest in the study but who do not 
provide written informed consent at the time of initial in-person recruitment. As with in-person 
recruitment, telephone and email recruitment will only occur after receiving healthcare provider 
permission to approach the patient and verbal statements from the patient that the study team can 
call them to further discuss the study. 
In addition to the above methods, patients may self-identify for potential enrollment in the study. 
The study will be listed in Research for Me @UNC. Flyers and brochures will be available in 
waiting rooms or other common areas in NCCH. Self-identifying patients may complete a pre-
screen link via Qualtrics to ascertain whether the patient meets eligibility criteria. Ineligible 
patients will be provided with information about existing resources and services. 
We will make all attempts to obtain written informed consent from all individuals. Under 
circumstances in which individuals cannot provide written consent due to convenience, burden, 
or UNC COVID-19 guidelines, verbal telephone consent will be sought. In these circumstances, 
the study team will email a copy of the consent form to the individual and provide a hard copy if 
possible. When collecting verbal consent, study staff will employ similar procedures for written 
informed consent 
Participation in this study is voluntary. Patients who choose not to participate in this study will 
not be subject to prejudice in the delivery of health care by their physicians and clinical staff nor 
by the research institution.  
 

 
 
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Baseline study assessment (T0) 
After receiving consent, the study team member will obtain baseline assessment information 
from the subject. Subjects will complete the study forms online via a secure REDCap link or via 
pen and paper if they wish to complete them immediately after providing informed consent.  
The baseline study assessment consists of a demographic form and several patient-reported 
outcome measures. Baseline assessments must be completed before the intervention study visit.  
 
Study visit (T1) 
For the study visit, the subject will first complete a web-based questionnaire that guides the 
selection of tailored materials and resources. Subjects will only be able to access the 
questionnaire after they have received a unique de-identified study ID which they will use when 
completing the questionnaire. If the subject does not have internet access or does not wish to 
complete the study visit electronically then they will be scheduled for an in-person study visit in 
a private room of the NCCH. They will complete the web-based questionnaire via a password-
protected iPad provided by the study team.  
 
Items on the study visit assessment measure will be forced-response, as missing items would 
result in being unable to generate participants' customized content. Subjects will be told during 
the informed consent process that those specific items will be forced-response, will have the 
opportunity to preview the items before consenting if desired, will be informed that all other 
study questions may still be skipped if preferred, and will be informed as to the rationale for 
making these items forced-response. 
 
Post-intervention assessments (T2)  
After reviewing their customized communication materials, subjects will be contacted 2-weeks 
(with an additional 2-week window) to complete the first post-intervention assessments. Subjects 
will be asked to complete study measures as well as a semi-structured interview. Subjects will 
complete the study measures via a secure REDCap link or via pen and paper if they do not have 
internet access.  
 
The post-intervention semi-structured interview consists of a face-to-face or telephone interview 
addressing barriers and facilitators to intervention use, communication content areas not 
addressed in the current communication tool, feedback on their experiences communicating with 
their children, suggestions for improvement, review of the future prototype of the intervention, 
and any psychosocial follow-up needs. The interview is expected to last approximately 30 
minutes and will be conducted by a trained member of the study team. Subjects are not required 
to answer questions they find emotionally distressing. All interviews will be audiotaped and then 
transcribed to facilitate analysis. To allow flexibility for participants, we will allow the semi-
structured interview to occur between 2-12 weeks post-intervention.  
 
Post-intervention assessments (T3)  
12-weeks (with an additional 2-week window before/after), subjects will be asked to complete 
the same survey measures that they completed at T0 and T2. Subjects will complete the study 
measures via a secure REDCap link or via pen and paper if they do not have internet access. 
 
Chart abstraction 

 
 
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The PI and RA will also abstract basic data from the medical record such as cancer type and 
treatment at the time of study enrollment. 
 
Subject self-report study measures 
Subjects will complete several outcome measures. Subjects may complete some or all of the 
surveys and they can skip any questions they find distressing.  
 
Demographic form 
The investigator-designed demographic form is a brief self-administered questionnaire. 
 
Eastern Cooperative Oncology Group Performance Status Scale (ECOG) 
The ECOG evaluates the severity of symptoms and amount of assistance the participant 
requires to complete “normal activities” using a 5-point scale. The ECOG is used to assess 
how the disease affects the daily living abilities of the patient and determine appropriate 
treatment and prognosis.6 It has been modified for patient self-report. Subjects are also 
asked two questions assessing their appraisals of illness severity.  
 
Parental Cancer Communication Questionnaire 
Subjects will be asked several investigator-designed questions assessing their parental 
communication concerns, their beliefs about anticipated consequences of discussions with 
their children about cancer, and their communication behaviors with their children about 
cancer. Parents who have engaged in any communication with their children about cancer 
will also be asked questions about their child(ren)’s response to these discussions.  
 
Hospital Anxiety and Depression Scale (HADS) 
The HADS is a 14-item self-administered rating scale to assess depression and anxiety 
symptoms in patients with physical illness. The HADS has two 7-item sub-scales addressing 
depression and anxiety. It is graded on a 4-point scale with scores ranging from 0 to 42 (or 
0-21 for each subscale) with higher scores representing greater degrees of mood symptoms. 
The HADS is a well-validated instrument frequently used in oncology populations.7,8  
 
Functional Assessment of Cancer Therapy – General (FACT-G) 
The FACT-G is a 27-item self-administered assessment of general quality-of-life measures 
in cancer patients.  It has been extensively validated in the literature and permits 
measurement of a number of symptoms including nausea, pain, and insomnia. It is graded 
on a five-point scale and has four sub-scales addressing emotional, social/family, physical 
and functional well-being.  The general adult population norm is a mean total score of 80.1 
(standard deviation = 18.1) with a total score range from 0-108.9  
 
Communication Self-Efficacy scale 
The nine-item Communication self-efficacy scale is adapted from Murphy et. al.’s maternal 
HIV disclosure self-efficacy scale.10  Subjects rate nine statements assessing their level of 
confidence in their ability to tell their child about their diagnosis using a visual analogue 
scale. This scale has been extensively used in the parental HIV communication literature. In 
prior studies the Cronbach’s alpha for the scale was 0.90. 
 

 
 
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FACT Satisfaction scale 
The intervention satisfaction assessment includes four investigator-designed core question 
items assessing the relevance and acceptability of the study intervention with an additional 6 
items assessing specific intervention components. Subjects rate each item on a 4-point 
ordinal scale. The questions have been adapted from other assessments of psychosocial 
intervention satisfaction/acceptability in the literature.  
 
McMaster Family Assessment Device – General Functioning Scale (GFS) 
The GFS is a 12-item self-administered scale that measures the overall health of the family 
unit. It is measured on a 4-point scale and the sum of values is divided by 12 to give a total 
score ranging from 1-4. Higher scores indicate unhealthier levels of family functioning. The 
GFS is widely used in research and clinical practice to identify families experiencing 
problems.  
 
Post-intervention study interview 
Subjects will participate in a semi-structured interview with a member of the study team to 
obtain feedback on the intervention.  
 
Medical record abstraction 
The PI or RA will abstract demographic and medical history data from the subject’s chart 
including illness history and treatment and medical co-morbidities.  
Expected Risks 
Approaching patients about enrollment in the clinic poses a risk to privacy. We expect this risk 
to be low. In the UNC ambulatory oncology clinics, RAs routinely approach patients for 
enrollment in clinical studies, and members of our team have completed prior studies with 
careful attention to patient privacy and high acceptability on the part of subjects. Approaching 
patients via telephone also poses a risk to privacy although we expect this risk to be low.  
 
Loss of confidentiality could occur if the study database was breached. This risk will be 
minimized as a result of numerous steps to protect confidentiality. The alternative of not keeping 
identifiable information is not possible, because we will need to access the medical record. 
 
Eligible subjects may be at higher risk for brief additional emotional discomfort or distress due 
to this study. Questions about communication concerns may be temporarily uncomfortable or 
distressing for some subjects. We expect the risks of discomfort or distress to be low relative to 
the overall distress that the patients experience due to their serious illness.  
 
Adequacy of Protection Against Risks 
The PI, study coordinator, or RA will receive permission from the patient’s oncology provider 
before approaching any eligible patients. As such, patients whom the oncology team believes are 
at high risk of emotional distress from study participation will not be approached. All subjects 
will provide informed consent for the study and HIPAA authorization. When approaching an 
eligible patient, the study member will describe the nature of the study questions and their 
purposes and written informed consent will be sought. For telephone recruitment, written consent 
via secure Qualtrics link or verbal consent will be sought. Participants providing Qualtrics or 
verbal consent will provide HIPAA consent electronically through secure Qualtrics link.  

 
 
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Participation in this study is voluntary. Patients who choose not to participate in this study will 
not be subject to prejudice in the delivery of health care by their physicians and clinical staff nor 
by the research institution. All subjects will be specifically reminded that they may withdraw at 
any time without impacting their treatment or relationship with their clinical team and that they 
may choose not to answer any study question they would rather not answer. 
 
All members of the study team will undergo and maintain training in the responsible conduct of 
research. To protect against loss of privacy, all study-related interactions will be conducted in 
private rooms at UNC hospital or clinics or via telephone after ascertaining with the subjects that 
the location is private. To protect against the risk of a loss of confidentiality, study files will be 
password-protected and housed on a secure server within the UNC School of Medicine. Consent 
and HIPAA forms will be kept in a locked cabinet in the locked office of the PI and will be 
destroyed upon study completion. For analysis, identifiable information will be removed from 
the analytic dataset and interviews, and subjects will be assigned a unique study identifier. To 
protect against the risk of emotional distress to subjects from study questions, the study team will 
review all study components and materials prior to starting the study. Should study staff observe 
emotional reactions necessitating clinical intervention, the study subjects will be offered 
immediate support services in the form of psycho-oncology assessment by a member of the UNC 
Comprehensive Cancer Support Program psycho-oncology service. The PI will report to the IRB 
any adverse events that occur during the study and will notify the subject’s primary oncologist. 
Removal of Patients from Protocol  
Subjects will be removed from the study when any of the exclusion criteria apply or the subject 
elects to withdraw from the study. If this occurs, the PI will be notified and the reason for study 
removal and the date the subject was removed will be documented in the Case Report Form.   
Sample Size and Accrual 
We will recruit up to 60 patients over 12 months for the proposed study. A 95% exact binomial 
confidence interval will be calculated for the acceptability rate. For qualitative interview data, 
sample size estimation is based on projections of the number of subjects needed to reach 
saturation of the concept. The sample size for the proposed study is adequate for qualitative 
analysis and consistent with psychosocial intervention development.11,12 
Data Analysis Plans 
Evaluate acceptability of the intervention 
To evaluate acceptability of the intervention, we will administer a satisfaction assessment to each 
participant after each follow-up study visit (T2 and T3) and conduct post-intervention interviews 
at T2.  In the post-intervention interviews, we will use content analysis, a widely accepted 
qualitative analysis approach in health research, to identify major themes from interviews.13 The 
study team will review interview transcripts, coding and categorizing the data by expanding and 
collapsing categories until thematic saturation is reached.14 We will use best practices for 
qualitative research such as member checking, and creation of an audit trail.15 We will use this 
feedback to refine the intervention prior to launching the randomized controlled trial. We will 
use qualitative analysis software to aid with analyses. Descriptive statistics from the quantitative 
rating scale and qualitative interview data will be collected concurrently, analyzed separately, 

 
 
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and the two sets of findings converged.16  
 
Evaluate feasibility of the intervention 
To evaluate feasibility of intervention, we will report the percentage of patients who are 
approached about the study who: (1) enroll in the intervention (percent approached), (2) 
complete the intervention at each time point. We will use descriptive statistics to assess the 
demographic characteristics of patients who enter, remain in, and drop out of the study. We will 
evaluate feasibility of study procedures including: (1) Number of patients screened, (2) Number 
of contacts, (3) Duration of study visits, and (4) Proportion of completed study measures at each 
visit. Although adverse events are unlikely, we will examine the procedures for adverse event 
reporting and the study teams’ response to such events. We will use qualitative analyses of post-
intervention semi-structured interview data to explore barriers and facilitators to participation, 
including reasons for enrollment, non-participation, ineligibility, or withdrawal and use this 
information to refine study procedures in preparation for a larger-scale study.  
 
Explore impact of intervention on target outcomes 
We will report on changes in patient-reported outcomes of interest and will use paired t-tests to 
evaluate whether mean scores pre- (T0) and post-intervention (T2) are significantly different 
from 0. This pilot study is not designed nor powered to detect differences as the primary 
objectives are to evaluate the acceptability and feasibility of the intervention. We will use 
descriptive statistics to report on the percentage of patients who engage in any communication 
behaviors about cancer with their children, the depth of their discussion, and their assessments of 
how their children responded to these conversations.  
Data Management/Audit 
As an investigator-initiated study, this trial will be audited by the Lineberger Cancer Center audit 
committee every six or twelve months, depending on the participation of affiliate sites. 
References 
 
1. 
Grenklo TB, Kreicbergs UC, Valdimarsdottir UA, et al: Communication and trust 
in the care provided to a dying parent: a nationwide study of cancer-bereaved youths. J Clin 
Oncol 31:2886-94, 2013 
 
2. 
Kennedy VL, Lloyd-Williams M: Information and communication when a parent 
has advanced cancer. J Affect Disord 114:149-55, 2009 
 
3. 
Forrest G, Plumb C, Ziebland S, et al: Breast cancer in the family--children's 
perceptions of their mother's cancer and its initial treatment: qualitative study. BMJ 332:998-
1003, 2006 
 
4. 
Lustria MLA, Noar SM, Cortese J, et al: A meta-analysis of web-delivered 
tailored health behavior change interventions. Journal of health communication 18:1039-1069, 
2013 
 
5. 
Turner J, Clavarino A, Yates P, et al: Development of a resource for parents with 
advanced cancer: what do parents want? Palliat Support Care 5:135-45, 2007 
 
6. 
Oken MM, Creech RH, Tormey DC, et al: Toxicity and response criteria of the 
Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-55, 1982 
 
7. 
Bjelland I, Dahl AA, Haug TT, et al: The validity of the Hospital Anxiety and 
Depression Scale. An updated literature review. J Psychosom Res 52:69-77, 2002 

 
 
10 
 
8. 
Ziegler L, Hill K, Neilly L, et al: Identifying psychological distress at key stages 
of the cancer illness trajectory: a systematic review of validated self-report measures. J Pain 
Symptom Manage 41:619-36, 2011 
 
9. 
Cella DF, Tulsky DS, Gray G, et al: The Functional Assessment of Cancer 
Therapy scale: development and validation of the general measure. J Clin Oncol 11:570-9, 1993 
 
10. 
Murphy DA, Armistead L, Marelich WD, et al: Pilot trial of a disclosure 
intervention for HIV+ mothers: the TRACK program. J Consult Clin Psychol 79:203-14, 2011 
 
11. 
Patrick DL, Burke LB, Gwaltney CJ, et al: Content validity--establishing and 
reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for 
medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--
assessing respondent understanding. Value Health 14:978-88, 2011 
 
12. 
Patrick DL, Burke LB, Gwaltney CJ, et al: Content validity--establishing and 
reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for 
medical product evaluation: ISPOR PRO good research practices task force report: part 1--
eliciting concepts for a new PRO instrument. Value Health 14:967-77, 2011 
 
13. 
Boeije H: A purposeful approach to the constant comparative method in the 
analysis of qualitative interviews. Quality & Quantity 36:391-409, 2002 
 
14. 
Hewitt-Taylor J: Use of constant comparative analysis in qualitative research. 
Nurs Stand 15:39-42, 2001 
 
15. 
Sage handbook of mixed methods in social & behavioral research. Los Angeles, 
SAGE Publications, 2010  
 
16. 
Creswell JW, Clark VLP: Designing and conducting mixed methods research. 
2007