Living WELL: A Web-Based Program to Improve Quality of Life in Rural and Urban Ovarian Cancer Survivors
Phase: NA
Conditions: Ovarian Cancer
Sponsor: Susan Lutgendorf

 
 
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University of Iowa  
Holden Comprehensive Cancer Center 
 
Observational or Low-Risk Interventional Protocol 
 
 
Title: Living Well: A Web-Based Program to Improve Quality of Life in Rural and 
Urban Ovarian Cancer Survivors 
 
 
 
Principal Investigator: 
Susan K Lutgendorf, Ph.D. 
G60 Psychological and Brain Sciences 
Building  
Telephone: 319-335-2432 
Fax: 319-335-0191 
susan-lugendorf@uiowa.edu 
Sub-Investigators:  
 
Michael Goodheart, MD 
Department of Obstetrics and Gynecology 
Division of Gynecologic Oncology 
31506 PFP 
(319)-356-2015   
 
Barbara Norquist, MD 
Department of Obstetrics and Gynecology 
Division of Gynecologic Oncology 
University of Washington Cancer 
Consortium 
 
Frank Penedo, Ph.D. 
Department of Psychology and Sylvester 
Cancer Center, University of Miami  
 
Matthew Schlumbrecht, MD, MPH, 
FACOG 
Division of Gynecologic Oncology 
University of Miami 
 
 
 
Biostatistician: 
Bridget Zimmerman, Ph.D. 
Department of Biostatistics 

 
 
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Primary Research Coordinator: 
 
Sharaf Zia, M.A. 
IRB Number: 
201911073  
Version Date: 
8.7.23 
Version: 
3.15 
 
 
 
SUMMARY OF CHANGES 
Section 
 
 
 
Change 
30 September 2020  
 
Version 2.0 to 3.0 
Cover Page 
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throughout to Fred Hutch/University of Washington Cancer 
Consortium 
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throughout  
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PHQ-9 replaced with CES-D for depression screening. 
Substance abuse criteria limited to last two years, active 
suicidality removed from exclusion 
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Patient contact process updated 
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CES-D 
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Randomization, trainings, and process language updated 
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updated. Webcams added in addition to tablets. 
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PHQ-9 replaced with CES-D for depression screening 
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3rd September 2021 
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Study Activities 
 
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Risks Updated 
 
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10th Oct 2022 
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Study Activities 
 
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Study Activities 
 
9 October 2024 
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Statistical Evaluation updated 
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TABLE 1. SCHEMA  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PATHS TO RECRUITMENT 
Path 1 Clinical Sites 
Fred Hutch/University of Washington 
Cancer Consortium 
University of Miami 
University of Iowa 
Screen and consent survivors 
Path 2 Referring Gynecologic 
Oncologists, Social Media, and Clearity 
Foundation 
Alaska, Montana, Wisconsin, Wash U. 
Refer survivors to Coordinating and Data 
Core at Iowa or to Fred Hutch/University 
of Washington Cancer Consortium 
(Alaska/Montana) 
 
Coordinating and Data Core at U of Iowa 
Screen and Consent survivors from Path 2 
Other than Alaska/Montana 
Obtain release for information from 
Randomization   
Subjects cluster randomized by 
statistician 
Pre-group individual training session in 
use of Zoom and baseline assessments  
Mindful Living Group 
Week 0 orientation 
Weeks 1- 10    1.5 - 2 hour sessions 
Booster sessions 4.5 and 9 months post-
randomization 
Healthy Living 
Week 0 orientation 
Weeks 1- 10    1.5 - 2 hour sessions 
Booster sessions 4.5 and 9 months post-
randomization 
Assessments 
Weeks 12, 26, 52 
Data Analysis and 
Manuscript Preparation 
Pre-group individual training session in 
use of ML or HL websites  
 

 
 
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Table 2. ORGANIZATIONAL TABLE 

 
 
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REVISION HISTORY 
 
Version 3.1 Version Date 2.25.21 
 
 
TABLE OF CONTENTS 
 
 
PROTOCOL SUMMARY ..................................................................................................  
 
1. ABSTRACT………………………………………………………………………………….7 
 
2. BACKGROUND/RATIONALE ................................................................................... 7 
 
3. STUDY GOALS/OBJECTIVES ................................................................................. 8 
 
4. STUDY POPULATION .............................................................................................. 9 
   4.1 Inclusion Criteria ................................................................................................. 9 
   4.2 Exclusion Criteria .............................................................................................. 10 
 
5.   STUDY DESIGN AND METHODS .......................................................................... 10 
 
6.   STUDY PROCEDURES…………………………………………………………………. 12 
 
7. STATISTICAL EVALUATION/CONSIDERATIONS  ............................................... 18 
 
8. DATA COLLECTION AND RECORD KEEPING .................................................... 21 
 
9. REFERENCES ........................................................................................................ 23 
 
10.  APPENDIX ............................................................................................................. 27 
10.1 Data and Safety Monitoring Plan.……………………………….………………....27 
10.2  General Consent Summary for Clinical Trials……………………………………63 
10.3  Informed Consent Document………………………………………………………65 
10.4 IRB Application...…………………………………………………………………….99 
 
 
 
 
 
 
 
 
 
 
 

 
 
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LIST OF ABBREVIATIONS 
CBSM 
Cognitive Behavioral Stress Management 
HRQOL 
Health related quality of life 
MBSR 
Mindfulness-Based Stress Reduction 
ACT 
Acceptance and Commitment Therapy 
HL 
Healthy Lifestyles 
RCT 
Randomized Controlled Trial 
STOC 
Steps Through Ovarian Cancer 
UI 
University of Iowa Holden Comprehensive Cancer Center 
UW 
Fred Hutch/University of Washington Cancer Consortium 
UM 
University of Miami Sylvester Comprehensive Cancer Center 
RA 
Research Assistant 
PHI 
Protected Health Information 
FACT-O 
Functional Assessment of Cancer Therapy-Ovarian 
CES-D 
Center for Epidemiological Studies-Depression Scale 
POMS-SF 
Profile of Mood States Short Form 
TMD 
Total mood disturbance 
FACIT-F 
FACIT Fatigue Inventory 
OC 
Ovarian Cancer 
SPS 
Social Provisions Scale  
MOCS 
Measurement of Current Status  
FMI 
Freiburg Mindfulness Inventory  
AAQ-2 
Acceptance and Action Questionnaire  
BEAQ 
Brief Experiential Avoidance Questionnaire  
PSQI 
Pittsburgh Sleep Quality Index  
RUCC 
US Department of Agriculture’s Rural Urban Continuum Codes  
PHQ-9 
Patient Health Questionnaire-9  
WRAT 
Wide Range Achievement Test  
ML 
Mindful Living 
CBT 
Cognitive Behavioral Therapy 
PHQ 
Personal Habits Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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1. Abstract 
Over the last two decades, it is well documented that the chronic and often debilitating experience 
of ovarian cancer survivorship may include poor health-related quality of life (HRQOL), elevated 
anxiety and depression, poor sleep, fatigue, multiple symptoms/side effects, existential concerns, 
and a generally poor prognosis. Because of compromises to many aspects of HRQOL combined 
with low rates of survival for the majority of these patients, development of innovative approaches 
for improving HRQOL and potentially improving clinical outcomes is of paramount importance. 
This need is particularly true in rural settings where women may have less access to clinic-based 
support systems. Despite the multiple challenges experienced by ovarian cancer survivors, 
research targeting the potential efficacy of psychosocial interventions in enhancing HRQOL has 
been extremely limited. Over the last several years a 11-week group-based and web-delivered 
psychosocial intervention now entitled Mindful Living, targeting key concerns of ovarian cancer 
survivors has been developed and piloted with input from survivors. The overarching goal of the 
current project is to examine the efficacy of the Mindful Living intervention verses a Health 
Promotion active control intervention called “Healthy Living” in a cluster-randomized Phase II 
clinical trial. It is hypothesized that the Mindful Living intervention will be efficacious in improving 
HRQOL and decreasing perceived stress and depressive mood. This application is highly 
innovative because it combines elements of evidence-based psychosocial interventions in a novel 
way to target the needs of ovarian cancer survivors using a state-of-the-art web-based platform 
that has the potential for wide dissemination. This work is highly translational as it is a direct 
application of findings from mechanistic stress-related research to testing an intervention to 
reduce stress in ovarian cancer survivors. The significance of the application is that this 
intervention has the potential to overcome prior barriers to the implementation of such 
psychosocial interventions and improve HRQOL, thus providing public health benefits to an 
understudied and compromised cancer population with a high likelihood of recurrence. 
 
2. Background / Rationale 
Although ovarian cancer ranks second in incidence among gynecologic cancers, more women 
die from ovarian cancer than from all other gynecologic cancers combined. Over the last two 
decades, it is well documented that the chronic and often debilitating experience of ovarian cancer 
survivorship which may include poor quality of life (HRQOL), elevated anxiety and depression, 
poor sleep, fatigue, multiple physical symptoms/side effects, existential concerns, and a generally 
poor prognosis.1–9 Additionally, factors such as social isolation, stress, and/or depression are 
associated with key biological processes promoting tumor progression as well as poorer 
survival.10–15 These data have been supported by parallel findings in animal and in in vitro 
models.11,16–22 Because of compromises to many aspects of HRQOL, combined with low survival 
rates for most patients, development of innovative approaches for improving HRQOL and 
potentially impacting disease progression is of paramount importance. This need is particularly 
true in rural settings where women may have less access to clinic-based support systems.  
 
Despite the multiple challenges experienced by ovarian cancer survivors, research targeting the 
potential efficacy of psychosocial interventions in enhancing HRQOL has been extremely limited. 
Barriers to development and implementation of group-based interventions for ovarian cancer 
survivors have included: a) a limited population of ovarian cancer survivors at any one site; b) 
extensive distances between home and gynecologic oncology specialized care; and c) debility 
that would prohibit travel to participate. The proposed intervention is ideally suited to overcome 
these barriers. Over the last several years a 11-week group-based and web-delivered 
psychosocial intervention entitled “Mindful Living” targeting key concerns of ovarian cancer 
survivors has been developed and piloted with input from survivors. The program draws from core 
elements of Cognitive Behavioral Stress Management (CBSM), Mindfulness-Based Stress 

 
 
11 
 
Reduction (MBSR), and Acceptance and Commitment Therapy (ACT). The intervention has been 
shown to be feasible and acceptable, and preliminary data indicate increases in HRQOL and 
decreases in perceived stress and depression among ovarian cancer survivors in one-armed field 
trials.23 A Health Promotion comparator intervention (Healthy Living) has also been tested. The 
overarching goal of the current project is to examine the efficacy of the Mindful Living intervention 
verses a Health Promotion active control intervention in a cluster-randomized Phase II clinical 
trial. This application is highly innovative because it combines elements of evidence-based 
psychosocial interventions in a novel way to target the needs of ovarian cancer survivors, using 
a state-of-the-art web and video conferencing platform that allows wide dissemination, including 
to rural survivors. This work is highly translational as it is a direct application of mechanistic stress-
related research findings to a scalable intervention designed to reduce distress and improve 
HRQOL in a broad audience of ovarian cancer survivors. The significance of the application is 
that this intervention has the potential to overcome prior barriers to the implementation of such 
psychosocial interventions and improve HRQOL thus providing public health benefits to an 
understudied and compromised cancer population with a high likelihood of recurrence. 
 
3. Study Goals/Objectives  
The main objective of the current study is to determine the efficacy of a group-based and web-
delivered psychosocial intervention for ovarian cancer survivors  (Mindful Living [ML]) compared 
to a Health Promotion attention-matched condition (Healthy Lifestyles  [HL]) in increasing HRQOL 
and decreasing perceived stress, depressive mood, anxiety, and fatigue across a 12-month 
period. 
 
Subjects will also be able to participate in an optional Immune Marker Sub-Study. This sub-study 
is being done to gather preliminary data on effects of the Mindful Living intervention on 
inflammatory biology in a subset of study participants using home collection of dried blood spots 
(DBS). The sub-study will examine expression of the conserved transcriptional response to 
adversity (CTRA), a 53-gene composite associated with chronic stress, as well as involvement of 
lymphocyte subsets. 
 
Specific Aim 1. To determine the efficacy of a group-based and web-delivered psychosocial 
intervention for ovarian cancer survivors compared to a Health Promotion attention-matched 
condition in increasing HRQOL and decreasing perceived stress, depressive mood, anxiety, and 
fatigue across a 12-month period. 
• Hypothesis 1: Subjects in the Mindful Living intervention will show greater increases in 
HRQOL and greater decreases in perceived stress and depressive mood (primary 
outcomes), anxiety, and fatigue (secondary outcomes) compared to HL subjects.  
• Rationale: This aim tests the effects seen in one-armed preliminary trials in a randomized 
controlled trial (RCT) with a well-powered cohort and long-term follow-up.  
 
Specific Aim 2. To determine whether the skills provided in Mindful Living (i.e., cognitive 
reframing, relaxation, mindfulness- and acceptance-based skills) mediate the effects of 
Mindful Living on these outcome measures. 
• Hypothesis 2a:  Subjects in the Mindful Living intervention will show a greater acquisition of 
relaxation, mindfulness, acceptance, and cognitive coping skills compared to those in the HL 
group.  
• Hypothesis 2b: Subjects with greater increases in mastery in relaxation, cognitive coping, 
mindfulness, and acceptance skills will show greater increases in HRQOL and greater 
decreases in perceived stress, depressive mood, anxiety, and fatigue. 

 
 
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• Rationale: Our preliminary data and research by other groups(Antoni, Kazi et al. 2006) has 
shown that greater acquisition of intervention-based skills mediates the effects of the 
interventions. 
 
Exploratory Aim 3. To determine whether the effect of the intervention varies across several 
factors such as rural vs. urban residence, recurrence status, age, disease stage, or time since 
diagnosis. 
 
Exploratory Aim 4. To characterize effects of the Living WELL intervention in ovarian cancer 
survivors on inflammatory biology in peripheral blood cells as assessed with dried blood spot 
technology. 
• Hypothesis 4a:  Peripheral leukocytes from ovarian cancer survivors in the Mindful Living 
intervention will show less polarization towards a pro-inflammatory CTRA profile from pre-
intervention to post-intervention compared to those in the Health Promotion condition. 
• Hypothesis 4b: Peripheral leukocytes from ovarian cancer survivors in the Mindful Living 
intervention will show less CD14 (monocyte) mRNA prevalence from pre-to post intervention 
compared to those in the Health Promotion condition. 
• Hypothesis 4c: Greater decreases in depression and perceived stress and increases in 
HRQOL from pre-to post intervention in both groups will be associated with decreased 
polarization towards a pro-inflammatory CTRA profile. 
• Rationale: Prior evidence has shown significant interaction between inflammatory profiles 
and healthcare outcomes in survivors of ovarian cancer.   
 
 
4. Study Population 
Subjects will be 256 women with epithelial ovarian, fallopian tube, peritoneal cancer, or cancer of 
Mullerian origin between the end of initial treatment and 5 years after completion of initial therapy 
with no more than one recurrence and not currently on chemotherapy for active disease. The 
study will include three clinical sites. Survivors will be recruited from Gynecologic Oncology 
Services at 3 clinical sites: the University of Iowa Holden Comprehensive Cancer Center (UI), the 
University of Miami Sylvester Comprehensive Cancer Center (UM), and the Fred Hutch/University 
of Washington Cancer Consortium (UW). In addition to these clinical sites, to increase our rural 
representation, we will also receive referrals from gynecologic oncology colleagues at Alaska 
Women’s Cancer Care (Anchorage, AK), Billings Clinic in Montana, and HSHS St. Vincent 
Hospital in Green Bay, Wisconsin, all of whom serve at least 50% rural patients, and from 
Washington University (St. Louis) where approximately 33% of ovarian cancer patients are rural. 
We will also recruit from postings on social media by survivor advocate and survivor Susan 
Leighton and from Steps Through Ovarian Cancer: Support for Life with Ovarian Cancer (STOC), 
a new non-profit created by the Clearity and Susan Poorman Blackie Foundations. Based on our 
previous retention rates, and that of similar studies,24–26 we anticipate up to a 25% attrition rate 
over the course of the intervention and follow-up. Thus to randomize 16 cohorts of 8 survivors to 
each condition, approximately 256 survivors will need to be recruited to yield a final sample of 
192. 
 
Inclusion/Exclusion Criteria  
Survivors aged 18 and older with a cytological or histological diagnosis of any stage of epithelial 
ovarian cancer, peritoneal cancer, fallopian tube cancer, or cancer of Mullerian origin consistent 
with ovarian/fallopian tube/peritoneal origin and who have not had more than one recurrence, will 
be eligible following completion of active chemotherapy and up to 5 years after completing primary 

 
 
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chemotherapy. We will not recruit survivors who are younger given the extremely low prevalence 
of ovarian cancers among females under 18. 
 
4.1 Inclusion Criteria  
1. Survivors 18 years or older with a cytological or histological diagnosis of any stage of 
epithelial ovarian cancer, peritoneal cancer, fallopian tube cancer, or cancer of Mullerian 
origin consistent with ovarian/fallopian tube/peritoneal origin (not consistent with 
endometrial cancer). Individuals diagnosed with synchronous ovarian and endometrial 
cancer primaries may be included if the initial endometrial cancer was stage I.22 
2. Survivors who have completed primary treatment (surgery and chemotherapy or 
chemotherapy alone for a new diagnosis ovarian/peritoneal/fallopian tube cancer within the 
last 5 years). Date of completion of primary treatment is defined as within approximately 60 
days after the last chemotherapy infusion. Maintenance therapy infusions do not count in 
determining date of completion of primary therapy. Women who were not recommended to 
receive adjuvant chemotherapy (for example, in the case of certain stage IA/IB cancers) are 
eligible after surgery alone. Women receiving consolidation or maintenance therapy 
following primary chemotherapy or following treatment for first recurrence are eligible. 
3. Survivors must not have had more than one recurrence. Those who have had one 
recurrence will be eligible if they have completed active therapy for their recurrence.27  
4. Although most women meeting the above criteria will be in remission, complete clinical 
remission (normal tumor markers and normal CT scan) is not a requirement for eligibility. 
Even women with low-level disease after completion of cytotoxic chemotherapy who do not 
meet the strict definition of remission may have stable disease and may not require 
additional cytotoxic chemotherapy for a prolonged period of time, particularly if they are on 
maintenance therapy. If subjects recur during the group they will be allowed to continue to 
participate, as able, even while taking chemotherapy.  
5. Survivors must be fluent in spoken English (6th grade level), which is necessary to participate 
in the intervention.  
6. Survivors must be willing to be randomized and followed for 12 months 
7. Ability to understand and the willingness to sign a written informed consent document 
8. Survivors receiving active treatment for another cancer may be eligible when their 
treatment is completed. 
 
 
4.2 Temporary Exclusion Criteria  
1. Survivors involved in Steps through OC must wait until they have completed that program 
to participate. 
2. Survivors currently involved in a study involving another behavioral intervention or an 
exercise intervention must wait until the prior study is over to participate. (In cases 1 and 
2, the temporary exclusion will end once survivors have completed their Steps through 
OC or behavioral intervention or exercise intervention. Study team will note down the date 
when Steps through OC or the behavioral intervention will end. At this point, the study 
team will recontact survivors and consent them to the study if they wish to participate.) 
3. Survivors who score greater than or equal to 24 on the CESD can be rescreened when 
their depressive symptoms resolve. (In case 3, temporary exclusion will end when a 
survivor feels that their depressive symptoms have resolved, at which point they will retake 
the online screening on their own. If survivor's score on the CES-D of the online screening 
is less than 24 on rescreening, the study team will approach them to be consented if they 
wish to participate.) 
 

 
 
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4.3 Exclusion Criteria  
1. Non-epithelial ovarian cancer, ovarian tumors of low malignant potential (“borderline”), 
cancers originating from other organs. Survivor who have a history of a prior cancer besides 
their ovarian cancer will be considered eligible as long as they are not in active therapy for 
said other prior cancer. 
2. History of prior inpatient psychiatric treatment for severe mental illness (e.g. psychosis) or 
current psychosis, history of bipolar disorder or schizophrenia in the last 2 years or current 
bipolar disorder or schizophrenia, current major depression (CESD ≥ 24), dementia, history 
of substance use disorder in the last 2 years or current substance dependence, or organic 
mental disorder (e.g., dementia). 
3. Survivors who are younger than 18 or older than 90 years of age  
4. Unable to meet study requirements. 
5. Currently receiving primary chemotherapy. 
6. History of depression is not excluded as long as the survivor is not currently depressed (see 
#7). 
7. Survivors who are currently depressed as indicated by a CES-D Score ≥ 24. (As indicated 
in 4.2.3 above, they can be rescreened once the depressive symptoms resolve.)  
 
 
 
4.3 Inclusion of Minorities 
 
Members of all races and ethnic groups are eligible for this trial. 
 
5. Study Design and Methods 
 
5.1. Primary Outcomes (Endpoints) 
Health Related Quality of Life: The Functional Assessment of Cancer Therapy-Ovarian (FACT-
O) includes 4 subscales related to dimensions of HRQOL, including physical, functional, social, 
and emotional well-being and a 12-item ovarian cancer-specific subscale related to ovarian 
cancer and treatment-specific HRQOL issues.28,29 
 
Current Stress: The Perceived Stress Scale30 contains 14-items assessing feeling in control vs. 
overwhelmed with current stressors over the last month. Internal reliability and construct validity 
are high31 and scores have previously been associated with illness markers.12,32,33 
 
Depressive Symptoms: The Center for Epidemiological Studies-Depression Scale (CES-D) is 20-
item measure rating frequency of depressive symptoms over the past week. Scores of 24 or 
higher are associated with severe clinical depression.34,35 The CES-D and its subscales have 
been strongly related to physiological variables in previous ovarian cancer research.12 
 
5.2. Secondary Outcomes  
Distress/Fatigue/Anxiety: The Profile of Mood States Short Form (POMS-SF)36 is a validated 
scale listing 37 mood adjectives over the last month. Six factors have been identified: anxiety, 
dysphoria, anger, vigor, fatigue, and confusion. A total mood disturbance (distress) score (TMD) 
is calculated by summing the 5 negative mood factors minus vigor. The POMS has good reliability 
and validity, and has been widely used to assess distress in cancer populations.37 
 

 
 
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The FACIT Fatigue Scale is a short, 13-item survey tool that measures an individual's level 
of fatigue during their usual daily activities over the past week. The level of fatigue is measured 
on a four-point Likert scale (4 = not at all fatigued to 0 = very much fatigued)38. 
 
The Cancer Worry Scale assesses fear of cancer recurrence in patients and survivors of a variety 
of different cancers. The 6-item version of the Cancer Worry scale has been shown to have good 
construct validity, convergent and divergent validity, and high internal consistency.39 As fear of 
recurrence is very salient in OC survivors, we are assessing this to achieve greater specificity in 
understanding anxiety.  
 
Social Support: The Social Provisions Scale (SPS) is a 24-item self-report scale measuring 
perception of social support in current relationships. The scale has demonstrated adequate 
reliability and validity.40 The total scale and attachment subscale have been highly correlated to 
physiological measures in previous work with OC patients.13,14,41 
 
5.3. Potential Mediating Variables 
Coping: The Brief COPE42 is a 28-item survey assessing ways of coping with an individual’s life 
stress. It includes both adaptive and maladaptive coping and has been widely used in cancer 
research. 
 
Skills Acquisition: The Measurement of Current Status (MOCS) assesses skill acquisition from an 
intervention, including ability to relax, recognize stress-inducing situations, restructure 
maladaptive thoughts, and choose appropriate coping responses. Subjects indicate their degree 
of confidence for each skill on a 5-point scale. Effects on this scale have been shown to mediate 
effects of a stress management intervention.43  
 
Mindfulness: Freiburg Mindfulness Inventory (FMI)44 is a 14-item instrument measuring aspects 
of mindfulness including the acceptance of experience and a non-judgmental stance.  
 
Experiential Avoidance: Acceptance and Action Questionnaire (AAQ-2) is a 10-item scale 
measuring a person’s experiential avoidance along with acceptance and action45,46 that is used 
quite widely in outcome studies of ACT interventions. Because of concerns that this instrument is 
too influenced by neuroticism,47 we will also use the Brief Experiential Avoidance Questionnaire 
(BEAQ) a 15-item scale focusing on acceptance and avoidance.48 
 
5.4. Demographic and Clinical Characteristics and Control Variables 
Demographic and lifestyle characteristics including age, race, ethnicity, relationship status, 
rural/urban residence, education, income, sleep, mental health history, and physical activity will 
be assessed as possible confounds. The 4-item Godin Leisure Time Physical Activity survey49 
the Women’s Health Initiative Personal Habits Questionnaire50 will be used to assess physical 
activity, and the Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality.51 We 
will monitor (self-report) for use of psychotherapy, psychotropic medications (e.g. 
antidepressants, anti-anxiety medications), and service utilization (e.g., support groups) at each 
assessment point and control for these if necessary. Rural residence will be categorized by the 
US Department of Agriculture’s Rural Urban Continuum Codes (RUCC) which distinguish 
counties by degree of urbanization and adjacency to metropolitan areas.52 Codes 4-9 have often 
been used to indicate rurality (non-metro),53 whereas 7-9 have been used to indicate more 
isolated rural locations.  
 

 
 
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Data regarding stage, grade, pathology, recurrence, treatment, and medications will be abstracted 
from medical records. Subjects who come through non-clinic referrals will be asked to provide 
contact information for their physician and sign a release of information form as part of the consent 
process to verify self-reported clinical information. We will request the pathology report, most 
recent clinic notes, and patient insurance status.  
6. Study Procedures 
 
6.1. Recruitment 
There are two paths to recruitment and screening. Path 1 is at the clinical sites (UI, Fred 
Hutch/University of Washington Cancer Consortium, UM), where potential study subjects will be 
identified by the collaborating gynecologic oncologist or a member of the health care team. 
Potentially eligible study subjects with upcoming appointments will be identified by the 
collaborating gynecologic oncologist or a member of the health care team or a review of medical 
records by the site Research Coordinator (RC). Potential subjects will be approached by the 
gynecologic oncologist, member of the health care team, or RC with study information and screen 
and consent the subject if they are interested either with a hard copy of the consent or with a 
REDCap consent on tablet, and the subject will also indicate availability for scheduled sessions 
and availability of technology resources. The research team will then follow up with a phone call 
to arrange for technical training. If the person is approached in person but wants more time to 
think about it, the research team can give study information to the patient and arrange to call or 
email the patient at another time to ascertain if the patient is interested in participation.  
 
Alternately, potentially eligible individuals with upcoming clinic visits may be mailed or emailed a 
study brochure and an accompanying letter describing the study before their clinic visit, giving the 
potential subjects a phone number to call to opt out if they are not interested in the study. If they do 
not opt out, a member of the study team will call or email them to determine potential interest in 
the study. If they are not reached after 5 attempts, they may be approached in 
the clinic to discuss the study and to potentially consent and enroll. 
 
B. Phone Recruitment from Clinical Sites. 
 
In situations in which it is not feasible for the study team to consent the patient in the clinic, 
potentially eligible subjects will be approached by the gynecologic oncologist, member of the 
health care team, or a member of the study team with study information and asked for permission 
for the study team to contact them by phone or email. If verbal permission is provided, the patient 
name, email address, and phone number will be provided to the study team who will complete 
the screening and consent by phone or email. Because people are often reluctant to answer 
calls with phone numbers they do not recognize, the study team will be able to try up to 8 times 
to reach the potential subject, and will be able to leave up to 3 messages for a number to call 
back if the survivor is interested in the study, or 4 reminder emails. The patient may also be 
provided with the phone number or email address of the RC. 
 
1B) As a supplement to in clinic recruitment, the study team will get a list of the ovarian cancer 
patients who have been treated in the last 5 years at the institution. These individuals will be 
mailed or emailed a study brochure and an accompanying letter describing the study and giving 
the potential subjects a phone number to call to opt out if they are not interested in the study. If 
they do not opt out, a member of the study team will call them to determine potential interest in 
the study. Because people are often reluctant to answer calls with phone numbers they do not 
recognize, the study team will be able to try up to 8 times to reach the potential subject, and will 

 
 
17 
 
be able to leave up to 3 messages for a number to call back if the survivor is interested in the 
study.  
 
Additionally, the team at UMiami will work with the Florida Cancer Data System (FCDS) to obtain 
a list of potential participants meeting our study criteria. Identified participants from the FCDS will 
be mailed a packet including a patient contact letter and a patient response form and a letter from 
the Department of Health. If after 3 weeks from sending the initial packet there is no patient 
response, a second mailing will be sent with the addition of the telephone opt-out card. The 
telephone opt-out card explains to the patient if no response is received, the study investigator 
and/or a member of the study team will attempt to contact them via a telephone call, text, or email 
to introduce the study. If there is no response to the second mailing and the telephone opt-out 
card after 3 weeks, a telephone call will be attempted by the study staff. We will continue to use 
the established pre-screening and consent protocol for those participants who express an interest 
in our study (see below). For FCDS subjects the Miami team will use a Question and Answer 
Script (provided by the FCDS) that explains “how our study received their name”. Information 
obtained from the FCDS registry will be treated with the utmost security, all data will be stored in 
our UM secure servers and only study personnel will have access to this information. 
 
In Path 2, ovarian cancer survivors will hear about the study from referring gynecologic 
oncologists (Alaska, Montana, GreenBay, WashU), from social media, Steps Through Ovarian 
Cancer, from other study subjects or contacts, and gynecologic oncologist colleagues of the 
research team. Survivors seen by referring gynecologic oncologists (Alaska, Montana, GreenBay, 
WashU), or gynecologic oncologist colleagues of the research team will be given or emailed an 
informational brochure about the study. They will also be able to see posters of Living WELL at 
the gynecologic oncologists’ offices. These brochures and posters contain contact information 
that the potential subject can use to contact the study team. They will be asked to contact the 
study coordinator at the Fred Hutch/University of Washington Cancer Consortium (if they are from 
Alaska, Montana or Green Bay), at Miami (if they are from Florida) or alternately the Coordinating 
and Data Core at UI (these and other locations) by phone or email if they are interested in 
participating, or alternately will give permission for a study team member to call them or email 
them to provide more information about the study. In addition to a phone number and email 
address for more information, the brochure and social media advertisements will contain a link to 
a REDCap prescreening questionnaire for potentially interested subjects to determine if they 
qualify. If they qualify for the study on the pre-screening questionnaire, the potential subject can 
enter their name and contact information and a member of the study team will contact the subject 
to confirm the screening, describe the study and answer questions about the study, and complete 
the informed consent if the individual is interested. The informed consent may be completed by 
REDCap or with an emailed or mailed copy using procedures described above.  
 
Alternatively, at the end of the prescreening questionnaire, they will also be given a phone number 
and email address if they would like to contact the study team instead. If potential subjects email 
or call Fred Hutch/University of Washington Cancer Consortium (Alaska/Montana) or the 
Coordinating and Data Core at UI (other sites) for more information about the study or give 
permission for the UI to call them to provide more information, these potential subjects will be 
screened by phone by Coordinating and Data Core staff or Fred Hutch/University of Washington 
Cancer Consortium staff and consented following successful screening. Screening by phone 
utilizes self-report data and enrollment will be based upon self-report data. Patients who do not 
come from clinical sites will provide contact information for their gynecologic oncologist or 
oncologist as part of the consent process. Following the consent their physician(s) will be 
contacted to verify the self-report medical information. Information requested from the physician 

 
 
18 
 
will include most recent clinic notes, initial clinic and surgery note, and information about cancer 
diagnosis (stage, grade, tumor histology, extent of cytoreduction, completion of chemotherapy, 
current medication, CA125, significant past medical history). We anticipate that situations in which 
self-report data does not match physician data will be rare; however, in such situations, subjects 
continue in the group and sensitivity analyses will be performed. All study information including 
PHI will be collected in a secure REDCap interface housed at the UI. 
 
6.2 Screening  
Potential subjects will be screened for exclusion criteria. Screening for depression will use the 
CES-D34,35. The Center for Epidemiological Studies-Depression Scale (CES-D) is 20-item 
measure rating frequency of depressive symptoms over the past week. Scores of 24 or higher 
are associated with severe clinical depression and will be excluded.34,35 The CES-D and its 
subscales have been strongly related to physiological variables in previous ovarian cancer 
research.12 So that they can receive adequate attention, survivors with scores equal to or above 
24 will not be included in groups. Instead, they will be mailed a list of resources that they can use 
to address their health concerns. If the study team has concerns about a subject’s ability to 
understand English for participation in the intervention, the Wide Range Achievement Test 
(WRAT)56 will be administered. Mental health history and current status and substance use will 
be abstracted from survivor medical records and will be included in screening questions. This 
screening will occur at the clinical sites for local survivors, will occur at Fred Hutch/University of 
Washington Cancer Consortium for survivors recruited from Alaska and Montana, and by Redcap 
screening interface or by phone at the Coordinating Core for survivors from elsewhere.  It should 
be noted that because of time it may require to fill the various cohorts, time between screening 
and randomization may vary. It is possible that potential subjects may have recurred or gone on 
active chemotherapy before the start of the trial. This will be assessed in the initial assessment 
which is done within 1-2 weeks of the study. In the case of such a change, these individuals will 
still be allowed to participate in the intervention.  
 
6.2 Randomization 
Assignment to either ML or HL will be done by cluster-randomization stratified by time slot as 
follows. When subjects enroll, they will provide their availability for each of 3 time slots during 
which a group will be offered. Subjects will be assigned to a time slot for a web group cohort 
according to their availability, in the order of enrollment, with each cohort comprised of 5-8 
subjects. Before randomization subjects will be re-contacted to confirm that they are still available.  
Once a time-slot cohort of 5-8 is filled, the cohort will be randomized to either ML or HL, drawn 
from the corresponding stratum. The cluster-randomization for each strata will employ permuted 
blocks of block size 2 or 4. To avoid a cluster having a majority of participants with recurrence an 
exception will be made for subjects with recurrence, such that if there are already 3 subjects with 
recurrence in the same web-group cohort, the subject will be assigned to the next cohort at that 
time slot. To minimize waiting time, when the first person recruited has been waiting 3 months of 
longer, the cohort may begin with at least 5 subjects. Randomization lists will be generated by the 
statistician prior to the enrollment of subjects and allocation will remain concealed until a group of 
5-8 needs to be assigned. The randomization sequence will be stored in a password protected 
file via a password protection software interface. The Research Coordinator will be the only 
person with access to this file. When a group is complete and ready to start, to facilitate planning, 
the group will be randomized by the research coordinator accessing the file. Upon entering an ID 
code for that particular group an assignment will be shown for that group. Facilitators will be 
informed approximately 1-2 weeks in advance so that they can plan for the group. It should be 
noted that facilitators’ knowledge of group assignment the week before the group starts will not 
bias subject recruitment because the slots will have already been filled for that group. Subjects 

 
 
19 
 
will learn their randomization via a letter sent through mail/email. Randomization should render 
equal representation of racial/ethnic, SES, and geographic backgrounds, and recurrence status 
but we will control for any baseline differences. 
 
6.3 Study Activities 
The following procedures refer to both arms of the intervention trial. Subjects will be given the 
option of using their own tablets, laptops, or desktops for the group conferencing, or a study-
provided tablet (and headset if necessary) or webcam which will be mailed out to them if they 
need it. Tablets with wireless connectivity will be available for subjects who do not have internet 
connections available. Subjects will return the tablets or webcams when their study participation 
is completed. Groups will begin when a cohort of 8 subjects has been randomized. Groups may 
begin with 5-7 individuals if any participants have been waiting for longer than 2 months for their 
group to start. 2-3 cohorts of each arm of the study will be conducted simultaneously to 
accommodate different time preferences of subjects. Subjects will receive periodic reminders from 
the time of their consent to the beginning of their group about the total number of people enrolled 
in their respective group, and when they can approximately expect group activities to begin. In 
the unlikely circumstance that following randomization but before participation in Week 0 a 
participant has circumstances arise that prevent their participating in the group, the participant 
may be rescheduled to participate in a future group of the same randomized arm.  However, if 
that rescheduling occurs more than a month following their initial completion of baseline surveys, 
they will be requested to complete their baseline surveys again before their new group starts. 
 
Before beginning either arm of the intervention, subjects will receive a guide with a link to surveys, 
instructions for use of the website and videoconferencing, and will have individual training phone 
calls/zooms for using the website and web-interface conferencing with the study team at UI. The 
first training will take place before randomization, and the second post-randomization. When a 
cohort time slot has been filled, subjects will complete an initial assessment using a secure 
REDCap interface housed at UI and subsequently subjects will be randomized. Subjects will 
receive notification of their randomization via a letter sent through mail or email.  They will then 
participate in a web-based introductory group informational session with members of their group 
(Mindful Living or Healthy Lifestyles). This gives subjects additional practice using web 
conferencing in a group setting and introduces the expectations and ground rules for the group. 
Subsequently, each subject will attend 10 group sessions lasting 1.5 to 2 hours via secure web-
video conferencing. Number of log-ins, extent of meditation practice and daily reflections, and 
session attendance are assessed on the study website or through brief questions sent daily and 
securely through REDcap.  
 
Subjects will participate for 12 months following randomization. There will be a booster session 
at approximately 4.5 and at 9-10 months post-randomization. After the 11 week session, research 
coordinators may contact participants over phone, by email, or by text to remind them of their 
booster sessions and surveys. There will be an assessment at following completion of the group 
(at approximately 3-months post-randomization), at 6-months and 12-months post-randomization. 
Participants will receive $20 for completing the assessment at 6-months and another $20 for 
completing the assessment at 12 months. There will be approximately a 30 day window on either 
side of these dates to account for potential scheduling issues. 
 
If participants wish to contact other participants at the end of their participation in their respective 
group, they can do so by using the private chat function of Zoom. They can also contact the study 
after their groups have finished to share their contact information with other participants. 
Establishing contact with other participants at the end of a group’s sessions is not a requirement 

 
 
20 
 
for this study. During their participation, participants will also receive a letter thanking them for 
their support and a gift tote-bag (Attached: Living Well 10 Week Thank You Letter). After the 11-
week session, participants may also, if they wish, submit 5-10 minute testimonial videos or 
testimonial texts about their experience of the program which can be uploaded to the study 
website at (livingwellstudy.org) with the participant's permission, or shared on social media 
(Twitter, Facebook, Reddit, TikTok) with their permission. At successful completion of 12-month 
surveys, depending on which group participants are randomized to, they will either receive a USB 
containing recordings or a document containing summary of the information covered in the group 
they were not randomized to. 
 
 
Recordings of missed sessions will be made available to people who miss a session. If 
participants miss a session and choose to view a recording of the missed session, they are not to 
share the contents of the recording with anyone so that the confidentiality of the other participants 
can be preserved. However, even if participants arrange a time and watch the recording for a 
missed session, that session will still count as missed, and they may not be able to continue if 
they miss more than 2 sessions. In the event that a participants misses a session, the group 
leader will have the option of calling the participant later in the week to check in and see if the 
participant has been able to keep up with study items.  
 
 
Blood Spot Sub-study: 
Blood spots will be collected before randomization of the intervention and again within 2 weeks 
following the end of the 11-week intervention. If subjects consent to this sub-study, they will be 
provided with two small kits that will contain a lancet to do the finger-prick, an alcohol swab for 
sterilizing their skin, cotton gauze for cleanup, a band aid, the blood spot collection card, and a 
pre-paid return envelope for sending the materials back.  After subjects who have consented for 
the substudy receive their bloodspot kits, they can be contacted over the phone and walked 
through the process if necessary.  They will be provided with reference materials on how to use 
items in the bloodspot kit. Subjects will then return the completed Blood Spot Card in the pre-paid 
envelope.  They will also be contacted at the end of the group intervention and walked through 
the process a second time should this be considered necessary for their post group finger prick. 
 
 
 
 
 
 
 
 
 
 
TABLE 3. FLOW CHART OF STUDY TIME-POINTS 
 

 
 
21 
 
Procedures 
Screening 
Enrollment 
Pre-Randomization 
Randomizationd 
Pre-Group Activities 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8 
Week 9 
Week 10 
Week 11 
Week 12 
Week 19-20 
Week 26 
Week 39-40 
Week 52 
Screening 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical historya 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessmentsb 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
X 
Randomizationc 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Technical training 
 
 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group introduction 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study intervention 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Booster sessions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
Adverse event review 
& evaluation 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
a: Disease and treatment status 
 
b: FACT-O, PSS, AAQ-II, BEAQ, FACIT-F, MOCS, CESD, POMS-SF, FMI, CWS, Brief COPE, SPS, PSQI, Godin, PHQ, 
demographics, COVID survey  
c: See section 6.0 for randomization process 
d. technical training  and pre-group assessments may occur before or after randomization 
 
6.4 Interventions 
 
Mindful Living Condition. This is a behavioral web-conferenced group intervention teaching 
stress reduction, cognitive behavioral therapy (CBT), mindfulness strategies, acceptance and 
commitment strategies, communication, and other skills during an introductory session and 10 
1.5-2 hour sessions facilitated by a clinical psychologist and a graduate student or postdoc. 
 
 
Table 4. Weekly Mindful Living Session Topics and Relaxation/Meditation Exercises 
Wk 
Session Topic 
Exercises 
Linkage to sample OC issues/ 
concerns 
1 
Stress 
response 
and 
stress 
management. 
Developing an awareness of personal stressors. 
Finding meaning and sources of personal strength 
Progressive muscle 
relaxation (PMR) &  
breathing 
High levels of stress, and uncertainty 
Disease/treatment related concerns (e.g., 
progression, symptom burden) 
2 
Cognitive 
Appraisal: 
Relationships 
between 
thoughts, emotions, and physical responses.  
Passive PMR with 
guided imagery 
Fear of recurrence/death, bodily changes, 
dreading 
the 
worst 
with 
any 
new 
symptoms 
3 
Cognitive 
Restructuring: 
Demonstration 
& 
discussion on alternative responses to negative 
self-talk. 
Autogenic relaxation 
Fear of recurrence, self-image; adjusting 
expectations; dealing with symptoms 
4 
ACT: Identification of avoidance and control 
strategies; finding effective alternatives through 
personal values, acceptance, and gratitude; using 
defusion to reduce emotional reactivity; overcoming 
avoidance 
Introduction to 
Mindfulness, Guided 
mindful body scan  
Fear of recurrence, living in the face of 
uncertainty in the future, abilities, work, 
meaning, creating a new normal, avoiding 
pain and anxiety  
5 
Coping strategies: problem-focused or emotion-
focused coping strategies. Acceptance-based 
strategies 
for 
painful 
emotions; 
decreasing 
avoidance. 
Mindfulness meditation 
Coping with symptoms, coping with loss of 
abilities, work challenges, challenges of 
asking for help, self-nurturance 
6 
Social support: Benefits & types of support. 
Strategies for enhancing support and meaningful 
relationships. 
Mindfulness meditation 
Changes in relationships, loss of intimacy, 
avoiding conversations about symptoms, 
death, 

 
 
22 
 
 
Health Promotion (HL) Condition (Healthy Lifestyles). This is a web-conferenced group 
intervention designed to provide relevant lifestyle information for ovarian cancer survivors. The 
HL arm will provide sessions on ovarian cancer survivorship and quality of life, exercise, nutrition, 
sleep, stress, cognition, body image, integrative medicine, and development of a lifestyle 
survivorship plan. There will be a group introductory session and 10 1.5-2 hour sessions facilitated 
by a health educator and a graduate student or postdoc. 
 
           Table 5. Weekly Health Promotion Session Topics 
 
 
 
Stopping points 
Criteria for suspending or terminating the study would be if during the study there is a perceived 
danger for subjects due to participation. This is not anticipated.  However, if during interim analysis 
we find that more than 25% of subjects in the Mindful Living arm move from  a non-depressed 
state (CESD < 24) to a depressed state (CESD ≥24) we would evaluate whether the trial should 
be stopped.. 
 
6.5. Risks 
Based on our previous work, this study as described is of minimal risk. Minimal risk is defined as 
the probability and magnitude of harm or discomfort anticipated in the research not greater than 
that ordinarily encountered in daily life or during routine physical or psychological exam.  
 
During the psychosocial questionnaire administration, there are minimal potential emotional risks 
to subjects due to the somewhat personal nature of the questions asked regarding mood and 
quality of life. Answering the questions may make subjects upset or uncomfortable; subjects will 
be informed that they can choose not to answer questions they do not wish to answer.  
 
During the group conferencing sessions, sensitive topics may be discussed; subjects are free to 
participate as much or as little as they feel comfortable.  
 
There is a potential loss of confidentiality from the web conferencing format; all subjects will be 
instructed in confidentiality practices at the beginning of the groups (see below).   
7 
Effective communication: Becoming aware of 
needs and communicating them effectively.    
Mindfulness meditation 
Expressing needs adaptively & asking for 
help; 
doctor-patient 
and 
intimate 
relationships 
8 
Anger management: Identifying patterns of anger 
expression and dealing with anger.  
Loving kindness 
meditation 
Interpersonal conflict, frustration with 
health care, assertiveness 
9 
ACT: Meaning and values: Discussion of personal 
values, spirituality, meaning in life with respect to 
cancer. Strategies to deepen meaning and 
enhance committed action.  
Guided relaxation and 
visualization 
Creating a meaningful life in the face of 
uncertainty, acceptance of a new normal 
10 
Wrap up: Review & assessing personal growth. 
Developing a maintenance plan with strategies for 
living more fully.  
Guided relaxation and 
visualization  
Generalizing skills to daily life, redefining 
roles, empowerment 
Week 
Session Topic 
Linkage to sample OC concerns 
1 
Common Survivorship Issues 
Understanding OC, importance of HRQOL 
2 
New Directions in Ovarian Cancer Treatment 
Understanding new treatment options 
3 
Exercise and Cancer Survivorship 
Benefits/ challenges of remaining active 
4 
Nutrition and Cancer Survivorship 
Appetite changes, adequate nutrition in cancer care 
5 
Sleep 
Healthy sleep maintenance; improving sleep 
6 
Stress and Health 
Importance of stress and stress reduction 
7 
Cognition, Aging, and Chemo-Brain 
Cognitive symptoms & memory challenges 
8 
Body Image and Sexuality 
intimacy and relationships; role changes 
9 
Integrative Medicine  
Finding reliable information on integrative care 
10 
Wrap-up: Developing a Survivorship plan 
Advance planning; survivorship care  

 
 
23 
 
 
Risks of Immune Response Sub-Study 
Slight discomfort or stinging sensation when using the lancet. 
Small risk of infection and/or bruising. 
 
What Is Done To Minimize The Risks 
Because interactions will be in a group setting, in the first session subjects will be instructed about 
the importance of confidentiality. They will be required to access the web-based intervention in a 
private location where others could not overhear the group conversation. Additionally, subjects 
can choose to disclose as much or as little personal information as they feel comfortable with in 
the group. Confidentiality of subject information will be strictly preserved, and subject names will 
not be revealed in publications or reports.  
 
Subjects will be informed that they may withdraw from the study at any time, with no penalty, 
should this occur; conversely, we will attempt to resolve any problems causing these responses, 
should survivors wish to continue participating.   If a participant experiences an adverse or 
unanticipated event during the study, research staff in contact with that participant will notify the 
lead investigator at each participating site or at UI if the participant is not being followed at one of 
the participating clinical sites. Subjects will be asked to report any new health problems that arise 
in connection with the study to the study coordinator at their site or to the Coordinating and Data 
Core at the UI if they are not from a participating clinical site. He/she will refer the survivor to their 
physician for serious health problems. Should a survivor disclose high levels of emotional distress 
(e.g. levels of depression consistent with a diagnosis of depression [CESD > 24] ) during the study 
period, designated study personnel will contact the participant to offer appropriate resources as 
determined by the lead investigators. Documentation of appropriate resources offered to the 
survivor and of the survivor's acceptance or rejection of the resources will be made by the 
Coordinating and Data Core.  
 
Study data will be collected and managed using REDCap (Research Electronic Data Capture) 
electronic data capture tools supported by the Biomedical Informatics group in the UI Institute for 
Clinical and Translational Science. REDCap (www.project-redcap.org) is a secure, web-based 
application with controlled access designed to support data capture for research studies, 
providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data 
manipulation and export procedures; 3) automated export procedures for seamless downloads to 
common statistical packages; and 4) procedures for importing data from external sources. For 
multi-center studies REDCap uses Data Access Groups (DAGs) to ensure that personnel at each 
institution are blinded to the data from other institutions Each study team member will be granted 
access to REDCap through a secure login by the study PI, study manager or their proxy. REDCap 
supports Two-factor authentication using DUO. 
 
Risks of Immune Marker Sub-Study: 
For Risks of Immune Response Sub-Study: The process and products in the kit are used routinely 
in a wide range of healthcare applications, including measurement of blood glucose (blood sugar) 
in diabetes. The equipment is sterile and following the instructions provided in the kit (like cleaning 
the area) will minimize infection risk. 
 
 
6.6. Benefits 
There may or may not be benefits to subjects in the study, however, risks are minimal. Subjects 
have the possibility of learning useful information about stress management, meditation, and 

 
 
24 
 
health promotion that may provide benefit to them. The results of the study may support efficacy 
of an intervention that may improve health related quality of life and decrease distress among 
ovarian cancer survivors. Moreover, this study will allow ovarian cancer survivors to connect with 
each other independent of rural/urban residence without the need for travel. Thus, we believe that 
the risks are reasonable in relation to the anticipated benefits. 
 
6.7. Potential benefits to society in terms of knowledge to be gained 
This study addresses an unmet need in ovarian cancer survivors- that is a group psychosocial 
intervention to address distress and/or to provide information about healthy lifestyle practices 
that are relevant to ovarian cancer. Our ultimate goal is to substantially improve outcomes in an 
understudied group of cancer survivors (ovarian cancer) with a high level of mortality by 
developing actionable strategies to address modifiable psychosocial factors to improve health 
related quality of life. Thus, this work is of great clinical and public health significance. 
 
7. Statistical Evaluation/Considerations 
Descriptive statistics will be computed for all demographic and baseline variables for each of the 
treatment arms and distributions of continuous variables will be evaluated for normality. If data 
are non-normal, appropriate transformation will be applied or non-parametric methods may be 
used. Demographic and baseline variables will be compared between treatment groups using t-
test for continuous variables, Wilcoxon-rank sum test for ordinal, and non-normally distributed 
continuous variables, and Pearson Chi-square test for categorical variables. Variables found to 
differ significantly between the groups will be used as covariates in the comparison of outcome 
measures between the treatment groups. A number of variables known to influence our primary 
outcomes (e.g., income, education, marital status, and race/ethnicity) will be considered as 
possible covariates. These putative control measures will be analyzed as covariates if they are 
correlated with our outcomes (at p<.10). The internal consistency (coefficient alpha) and test-
retest correlations over the course of data collection will be evaluated for multi-item inventories. 
While every effort will be made to follow-up with subjects, it is expected that approximately 25% 
of the subjects may be lost across the study period. Intent to Treat (ITT) analysis will be performed 
using all available data for all randomized subjects. Reasons for subject drop-out will be recorded 
and compared between treatment groups. Subject characteristics and outcome measures 
collected prior to drop-out will be compared to those that complete the study follow-up. In the 
presence of missing data, under the assumption of missing at random (MAR), linear mixed model 
analysis, which can handle incompletely observed subjects and uses a likelihood estimation 
method, will provide correct likelihoods and lead to valid estimates. However, since the data under 
analysis cannot distinguish if data is MAR or if it is missing not at random (MNAR), sensitivity 
analysis will also be performed using pattern mixture models. Multiple imputation will be used for 
sensitivity analysis by imputing from a non-random pattern mixture model. Per protocol analyses 
will be performed including participants that attended at least 6 sessions of their respective 
intervention condition and completed the immediate post-intervention surveys or any subsequent 
follow-up surveys.  
 
Aim 1 tests whether the Mindful Living vs. HL intervention increases HRQOL, and decreases in 
perceived stress (primary), and decreases anxiety, depressive mood, and fatigue (secondary) 
during a 11-week intervention, and whether changes are sustained over a 12-month follow-up. 
Based on preliminary data, there will be a detectable differences in mean immediate (post-
treatment) change from baseline and in mean sustained change (6 and 12 month) from baseline, 
for the primary and secondary outcome measures between the ML and the HL arms with an 
anticipated final sample size of 192 subjects. The detectable group mean difference was 
calculated for a two-tailed test at the 0.05 significance level with 0.80 power for a final sample 

 
 
25 
 
size of 96 subjects per treatment arm for a cluster-randomized design with corresponding 
intracluster correlation coefficient (ICC) estimated from our pilot data. The 96 subjects are from 
16 web-groups (cohorts) per arm with an average of 6 subjects per cohort. This assumes 25% 
dropout, so that a total of 256 subjects will be enrolled, comprised of 32 cohorts, with 8 subjects 
per cohort, that will be randomized to one of the two treatment arms. Based on the calculations 
below we anticipate that our sample size and the variability in our data will enable us to detect 
smaller intervention effects than those observed in our pilot for our primary variables and for 
several of our secondary variables for Aims 1 and 2. The effect sizes we anticipate being able to 
detect are consistent with the medium effect sizes generally observed in other studies of 
psychosocial interventions in cancer survivors.  
 
Table 6. Power Considerations 
  
SD 
  
Detectable difference 
(effect size=diff/pooled SD) 
Between Group Difference 
in Immediate Change 
(from pilot) 
Outcome Variables 
Aim 1    
Between 
Subject 
Residual 
ICC 
Immediate 
(Post-tx) 
Sustained (6 
and 12 mo.) 
Observed 
Mean 
(effect size) 
95% CI 
FACT-Total 
13.6 
9.3 
0.010 
5.5 (0.19) 
6.1 (0.46) 
9.1  (0.69) 
(-3.7, 22.0) 
PSS 
7.1 
4.2 
0.010 
2.5 (0.29) 
2.8 (0.47) 
-6.7  (-1.13) 
(-12.6, -
0.9) 
CESD 
7.6 
5.3 
0.150 
4.1 (0.34) 
4.5 (0.60)  
-5.8  (-0.77) 
(-13.0, 1.5) 
POMS-anxiety 
4.1 
2.9 
0.078 
2.0 (0.49) 
2.2 (0.54) 
-2.0  (-0.49) 
(-6.0, 1.9) 
POMS-fatigue 
4.6 
2.9 
0.204 
2.4 (0.59) 
2.7 (0.66) 
-2.0  (-0.49) 
(-5.9, 1.9) 
AIM 2 
 
 
 
 
 
 
 
MOCS relaxation 
1.4 
1.2 
0.125 
0.9 (0.53) 
1.0 (0.59) 
3.0  (1.77) 
(1.0, 5.0) 
MOCS coping 
4.1 
1.8 
0.010 
1.1 (0.43) 
1.2 (0.47) 
3.8  (1.49) 
(0.7, 6.9) 
FMI 
7.4 
3.5 
0.010 
2.1 (0.42) 
2.3 (0.46) 
3.5  (0.71) 
(-1.7, 8.8) 
AAQ 
2.8 
2.5 
0.284 
2.3 (0.65) 
2.5 (0.71) 
-2.7  (-0.76) 
(-6.3, 1.0) 
 
7.1. Statistical analyses for Aim 1  
Aim 1 will be tested using linear mixed model (LMM) analyses for repeated measures with 
treatment group (ML vs. HL), time,  and treatment*time interaction as fixed effects. Random 
effects include web group cohort (within treatment) and subjects (within cohort, within treatment). 
In fitting the LMM, appropriate covariance structures for the longitudinal measures within subject 
will be considered, such as compound symmetry, or heterogeneous compound symmetry, and 
then selected based on Akaike Information Criteria (AIC) and Schwarz’s Bayesian Information 
Criteria (BIC). Specifically, to test for immediate change (post-intervention), the linear mixed 
model analysis will include the baseline and immediate post-intervention timepoints. The 
difference in immediate change post-treatment between the different conditions will be tested by 
the interaction effect. For the mixed model analysis of long-term change, data from all 4 timepoints 
will be used in fitting the model, with the difference in long-term change at 6 and 12 months 
assessed using tests of mean contrast. Bonferroni adjustment will be applied to the p-value to 
test for long-term change at 6 and 12 months. For each of the two analyses, if confounding 
variables are found to differ between the treatment groups such that covariate adjustment is 
necessary, a secondary comparison of the primary outcome variable between treatment groups 
will be made by expanding the LMM to include covariates. These variables may include age, 
education, income, race/ethnicity, geographic location, recurrence, maintenance chemotherapy, 
recurrence during the study period, and disease stage. Statistical significance for efficacy of ML 
vs. HL will be based on a two-tailed test at the 0.05 significance level with treatment effect 

 
 
26 
 
summarized as mean difference with 95% confidence interval. Similar analyses will be performed 
for the secondary outcome measures.  
 
7.2. Statistical analyses for Aim 2  
The statistical analyses for Aim 2 will examine potential mediators of any observed intervention 
effects on outcome measures, with examination of skills that support post-intervention and 
sustained skills. For Hypothesis 2A effects of the intervention on relaxation, coping, mindfulness 
and acceptance outcomes, the analytic plan will be similar to those in Aim 1, with similar targeted 
effect sizes and similar power projections.  For Hypothesis 2b, testing mediation of intervention 
effects, mediation analysis will explore the causal pathway between intervention (ML and HL) and 
changes in primary outcomes (HRQOL, depressed mood, and perceived stress) and secondary 
outcomes (anxiety and fatigue) from baseline to post-intervention (immediate) and from baseline 
to 12 months (sustained) with change in reported relaxation, mindfulness, acceptance, and 
cognitive coping skills as mediators. With the independent variable X (intervention) randomized 
to web-group cohorts, and the mediator variables M (change in mastery in relaxation, 
mindfulness, avoidance, and cognitive coping skills), and the dependent variable Y (change in 
HRQOL, depressive mood, stress, and secondary variables) measured at the subject level within 
cohorts, we have a two-level hierarchy with a 2-1-1 design. For this multilevel design, multilevel 
structural equation modeling (MSEM) will be used to estimate and test the direct and indirect 
effects to assess multilevel mediation57 using SEM or GSEM in Stata or MPLUS. 
 
Power for Hypothesis 2B is based on the pilot data where large effects of group assignment (ML 
vs. HL) were observed on changes in potential mediators (relaxation, coping skills, mindfulness, 
and acceptance; range of d = .70-1.7). In the proposed model multilevel mediation framework this 
effect will include some variance attributable to the cohort to which the subject is randomized 
within the treatment arm, as well as the effect of the treatment itself, the latter of which is the effect 
of interest.  We therefore conservatively estimate the true treatment effect for the mediators to be 
d = .60, representing the first arm of the mediation pathway. The second arm of the mediation 
pathway reflects the association between change in the mediators (relaxation, coping, 
mindfulness, and acceptance) and change in the outcomes of interest (HRQOL, stress, etc.) In 
our pilot work shown above, the absolute correlation values between these change variables 
ranged from .41-.76, corresponding to a d range of .89-2.3,58 and we conservatively adopt this 
lower estimate (.89) for purposes of estimating power.  Here we use the Monte Carlo approach 
for evaluating indirect (mediation) effects with 5000 replications and two Monte Carlo draws per 
repetition and an attrition-adjusted sample size of 192 (96 per group).59 This produces power in 
excess of .99 for calculating significant mediated effects with a 95% confidence interval. In the 
event that the true effect sizes are substantially smaller (i.e., d=0.4 rather than .6 for the first path, 
and d = .6 rather than .89 for the second path) we will still have .80 power to detect significant 
mediated (indirect) effects. 
 
7.3. Statistical Analyses for Aim 3 
Aim 3, an exploratory aim, provides the opportunity to determine whether the effect of the 
intervention varies as a function of moderators such as rural residence, age, and specific clinical 
characteristics. For example, it is possible that subjects in rural areas might benefit more from the 
intervention because they have less access to connections with other survivors and health care 
information. Survivors who are closer to diagnosis or those who have not recurred may have more 
interest in acquiring information and skills that will assist them in negotiating their survivorship. 
Alternatively, survivors who are farther from diagnosis may have had more experience negotiating 
survivorship issues and may be more open to receiving new skills. Survivors who have recurred 
may be more highly motivated to develop new skills and acquire new information. As this Aim is 

 
 
27 
 
exploratory there are no directional hypotheses. The purpose of this Aim is to provide data for 
future research with this program to determine whether there are specific individual characteristics 
that make them more or less likely to benefit from the intervention. As an exploratory aim, Aim 3 
is not powered for definitive results but to examine possible trends. To test Hypothesis 3, the LMM 
analyses described for Aim 1 will be expanded to include one of the factors of interest (rural vs. 
urban residence, recurrence (0,1), disease severity (early vs. advanced-stage), or time since 
diagnosis), age (< 65; >65). The model will include the factor as a main effect, and interaction 
effects with treatment and time (i.e. factor*treatment, factor*time, and factor*treatment*time). If 
any interaction effect is found to be statistically significant, specific tests of mean contrast will be 
performed to assess for intervention effect by the factor subgroups, with appropriate Bonferroni 
adjustment applied to the p-values to account for the number of tests.   
  
7.4. Missing Data 
While every effort will be made to follow-up with subjects, it is expected that approximately 25% 
of the subjects may be lost at follow-up. Reasons for subject drop-out will be recorded and 
compared between treatment groups. Participant characteristics and outcome measures 
collected prior to drop-out will be compared between those that drop out and those that complete 
the study. In the presence of missing data, under the assumption of missing at random (MAR), 
linear mixed model analysis which can handle incompletely observed subjects and uses a 
likelihood estimation method will provide correct likelihoods and lead to valid estimates. However, 
since the data under analysis cannot distinguish if data is MAR or it is missing not at random 
(MNAR), sensitivity analysis will also be performed following approaches recommended by 
Molenberghs and Kenward.60 Methods for sensitivity analysis such as marginal delta adjustment, 
conditional delta adjustment, reference-based controlled imputation, and pattern mixture models 
will be considered. Nonnormality will be assessed, and if needed, variables will be transformed to 
approximate normality before imputation and retransformed back to original scale values. To 
avoid imputation bias, all variables in the substantive analyses and, if feasible, all variables 
predictive of the missing values (i.e. immediate post and 6 month response of the outcome 
measure, if available) or variables influencing the cause of missing data will be included. These 
multiple imputation analyses will be conducted using SAS PROC MI and SAS PROC 
MIANALYZE.  
 
8. Data Collection and Record Keeping  
The study will be administered by the lead institution, University of Iowa (UI). It will be monitored 
by a single Institutional Review Board at UI, which will set up reliance agreements with the Fred 
Hutch/University of Washington Cancer Consortium and UM IRBs. Each of the sites will be 
responsible for the screening, recruitment, enrollment, and support of assessment completion of 
subjects recruited at their respective institutions. The Coordinating and Data Core at UI will 
develop standardized operating procedures for regulatory and protocol compliance for all 3 clinical 
sites (UM, Fred Hutch/University of Washington Cancer Consortium, and UI) and for all study 
activities and data collection. 
 
 
8.1 Collection and Storage of Data 
REDCap data management software will be used to organize all data including documentation of 
informed consent, self-report measures, and clinical data. REDCap is supported at UI by NIH 
CTSA awards. All study information including PHI will be collected in a secure RedCap interface 
housed at the UI. Self-report measures will be collected after study enrollment. Subjects will be 
provided with a computer link and instructions for completion of surveys from home during the 

 
 
28 
 
week prior to the beginning of the group.  Clinical data will be extracted from the medical record 
by study team members. Intervention website usage will be extracted from the administrator page 
by study team members.  
 
There may be situations in which subjects would prefer to complete surveys using hard copies. 
In this situation, hard copy data will be hand entered into RedCap by study team members. When 
entering subject data, research assistants are only aware of the individual’s subject number for 
the study. All materials are labeled with subject ID and not labeled with any other identifying 
information (medical record number or name). RedCap data identified only by subject ID may be 
downloaded into SPSS files kept on password protected servers in the Department of 
Psychological and Brain Sciences. These password protected files are only available to team 
members who have set up access through Information Technology Systems (Trent Petersen). 
Electronic data is stored only on these servers. The exception is that data which is being 
statistically analyzed by the PI or project statisticians is on password protected computers.  
 
8.2. Screening Log 
Information collected will include an individual's address, phone number and e-mail address, 
subject number and reason for not enrolling e.g., exclusion, lack of interest, currently excluded 
but may be eligible in the future. Women who are screened that do not enroll may subsequently 
be able to participate. For example, this would apply to individuals currently finishing 
chemotherapy who will be eligible when they complete it or to survivors whose availability does 
not fit the timing of the current group but will fit the timing of the next group being offered. The 
screening log will be kept so that these individuals can be called back when they either become 
eligible or a group is being offered that would work for them. 
 
8.3. How Long Are Records Kept 
For survivors who are eligible and approached but decline participation, their identifiers will be 
kept until the end of enrollment and then destroyed to make sure we do not contact them again. 
Similarly, for survivors who are ineligible, their identifiers will be kept until the end of enrollment 
to avoid their being evaluated again. They will be destroyed at 3 years post-chemotherapy or the 
end of the study whichever comes first. Information of subjects that are temporarily ineligible but 
may become eligible following the end of treatment or involvement in another study will be kept 
until the end of enrollment. Study records will be kept for 10 years after the close of the study to 
allow for complete data analysis of primary endpoints as well as moderators, mediators, and other 
information. Enrolled subjects who have indicated that we may contact them for future research 
studies will have their contact information kept for 10 years following the study. 
 
 
 
For any study in which Iowa is the lead site, the Holden Comprehensive Cancer Center’s (HCCC) 
Data Safety Monitoring Committee(DSMC) will be the DSMB of record. If the participating sites 
will be performing any onsite monitoring or auditing activities during the course of the study, any 
resulting reports should be sent to HCCC’s DSMC. It will have oversight of overall data and safety 
monitoring for all sites. The level of DSMC monitoring and oversight is dependent on the risk level 
assigned to the protocol at the time of initial PRMC/DSMC review. Basic requirements entail 
subject registration in OnCore, documentation of adverse events and protocol deviations, and 
annual review by the DSMC. Regardless of risk level, all studies are required to have data 
collection forms developed in OnCore (eCRFs) to facilitate data and safety review by the DSMC. 
The Holden Comprehensive Cancer Center has a protocol development coordinator who is 
available to assist investigators with their protocol documents. This person serves as a point of 
contact between PIs, regulatory, and clinical staff to ensure the document includes all the 
necessary components prior to committee review. There also is an eCRF developer who works 

 
 
29 
 
with investigators and staff to ensure data collection forms meet all the necessary requirements. 
The complete Data and Safety Monitoring Plan is attached. 
 
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10. Appendix  
 
  10.1 
DATA AND SAFETY MONITORING PLAN  
 
 
 
Type of Clinical Trial: 
        Investigator-initiated (UI/HCCC)  
 Investigator-initiated, participating site 
 Pilot study 
 Phase I 
 Phase I/II 
        Phase II  
 Phase III 
 Compassionate-use/Expanded Access  
 Interventional Treatment 
        Interventional Non-Treatment 
 Non-Interventional 
 
 
Study risk-level:  
       Level 1—low risk of morbidity or death, * <1% of death or any adverse event  
          Level 2—risk of death* <1% or any adverse event 1% – 5%    
        Level 3—risk of death* 1% – 5% or grade 4 – 5 SAE 1% – 5%  
        Level 4—risk of death* >5% or grade 4 – 5 SAE >5%  
        Drugs being used on a “compassionate” basis  
 
* Risk of death” refers specifically to 100-day treatment-related mortality 
___________________________ 
Reporting and Monitoring Requirements:  
All institutional investigator initiated trials (IITs), regardless of assigned risk level are subject to 
routine DSMC monitoring activities which may include but are not limited to review of signed 
consent documents, eligibility and adverse event reporting.  
 
All institutional IITs have the following reporting requirements as part of their DSMP: 
• 
Register all subjects in HCCC’s Clinical Trial Management System, OnCore 
• 
Document Adverse Events  
• 
Document protocol deviations  
• 
Provide an annual progress report to the DSMC via OnCore data export 
 
Selected monitoring strategy based on risk-level: 
 
Risk Level 2 
Interventional trials with a risk of death* (<1% or any adverse event 1% – 5%), e.g. behavioral 
interventions, nutritional therapies, low risk procedures (e.g., endoscopy, glucose-tolerance tests, 
induced sputum, skin or muscle biopsy, nasal wash, lumbar puncture, bone marrow biopsy, 

 
 
34 
 
imaging requiring sedation), as well as therapeutic trials involving agents with known safety 
profiles already licensed for the indication and age group.  Most disease-prevention trials will be 
considered at least a Risk Level 2.  
 
Study Safety Review 
The PI or designated study personnel will review all study data for completeness. 
 
Additional Reporting Requirements 
- Serious adverse events will be entered directly into an OnCore SAE report by the research 
team.  OnCore will send an automatic notification to the DSMC Chair/acting Chair and staff 
for review.  
 
Routine Adverse Event Reporting 
 
For non-serious Adverse Events, documentation must begin from the first day of study 
intervention and continue through the 30 day follow-up period after the study intervention is 
discontinued.  
 
Collected information should be recorded in the electronic/Case Report Forms (eCRF/CRF) for 
that subject. A description of the event, its severity or toxicity grade (according to NCI’s Common 
Toxicity Criteria (CTCAE 5.0)), onset and resolved dates (if applicable), and the relationship to 
the study drug should be included. Documentation should occur in real time. The principal 
investigator has final responsibility for determining the attribution of the event as it is related to 
the study drug. 
 
 
 
Serious Adverse Event Reporting 
 
For any experience or condition that meets the definition of a serious adverse event (SAE), 
recording of the event must begin after signing of the informed consent and continue through the 
30 day follow-up period after treatment is discontinued.  
Investigators must report to the DSMC any serious adverse events (SAE), whether or not they 
are considered related to the investigational agent(s)/intervention (21 CFR 312.64). SAEs must 
be reported via an OnCore SAE Report within 24 hours of learning of the event.  
An adverse event is considered serious if it results in ANY of the following outcomes:   
 
1. Death 
2. A life-threatening adverse event  
3. An adverse event that results in inpatient hospitalization OR prolongation of existing 
hospitalization for ≥ 24 hours  
4. A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions  
5. A congenital anomaly/birth defect.  
6. Important Medical Events (IME) that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 

 
 
35 
 
prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and 
ICH E6). 
 
Data Monitoring and Management  
 
Subject Registration 
All studies that undergo PRMC review and/or utilize HCCC Clinical Research Services (CRS) 
resources are required to register subjects in OnCore. Each subject registration includes the 
following: 
• 
The subject’s IRB approved (version date) consent form and the date of their consent.  
• 
Date of eligibility and eligibility status (eligible, not eligible) 
• 
On study date and subject’s disease site (and histology if applicable) 
• 
On treatment date (if applicable)  
 
All subject registration information is expected to be entered into OnCore within 2 (two) business 
days after the subject’s study visit.  
Subject Data 
For HCCC investigator initiated trials, research staff are responsible for entering subject study 
data (data collection) into OnCore electronic case report forms (eCRFs). These eCRFs must be 
approved by the PI and statistician prior to study activation to ensure sufficient and necessary 
data acquisition. All information entered into eCRFs will be traceable to the source documents 
which are generally maintained in the subject’s file.  
 
eCRF data entry needs to be timely and should be entered into OnCore as soon as possible but 
no later than 14 (fourteen) business days after the subject’s visit, including adverse events, 
tumor measurements, administration of study medication, concomitant medications, labs, and 
vitals. Physical exam assessments must be entered no later than 14 (fourteen) business days 
following completion of the physician’s clinic note in the medical record.  
 
Timely data entry facilitates remote monitoring of data, allows the data to progress appropriately 
through the data cleaning process, and helps prevent a backlog of data queries. 
 
Forms Monitoring 
OnCore eCRF data are monitored on a routine basis (dependent on accrual) to ensure all data 
are entered completely, accurately, and within time requirements outlined above. The assigned 
DSMC monitor will coordinate and complete the data monitoring review. When the time comes to 
monitor a study (based on patient accrual and assigned risk level of trial) the monitor arranges for 
a selection of cases to be reviewed from among the subjects registered in OnCore.  As part of 
the forms monitoring process, the assigned monitor will issue queries via OnCore (linked to the 
eCRF) to resolve missing, incomplete, and/or incorrect information. A member of the research 
team is expected to respond to these monitoring queries within 14 (fourteen)  business days.  
 

 
 
36 
 
The monitoring process can often identify misunderstandings or deficiencies in the written, 
research protocol requirements earlier in the study process and thereby improve data quality and 
reduce rework.  
 
 
Final Reports 
A summary of each subject’s data record is continually available to the PI, research staff, and 
DSMC from OnCore’s Biostat Console. The availability of this information is a valuable tool for 
the preparation of final reports and manuscripts as well as ongoing deficiency reports. 
 
 
Antoni, M. H., et al. (2006). "How stress management improves quality of life after treatment for breast 
cancer." J Consult Clin Psychol 74: 1143-1152.