REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
Phase: NA
Conditions: Ovarian Cancer, Fatigue, Coping Behavior, Coping Skills
Sponsor: Dana-Farber Cancer Institute

REVITALIZE: A Telehealth Intervention for Women with Advanced Ovarian Cancer and PARP 
Inhibitor-Related Fatigue 
Page 1 of 35
PROTOCOL TITLE: REVITALIZE: A Telehealth Intervention for Women with Advanced 
Ovarian Cancer and PARP Inhibitor-Related Fatigue
Funding Organization:
National Comprehensive Cancer Network (NCCN) 
Research Funding:                AstraZeneca 
Sponsor Investigator:           Alexi A. Wright, MD, MPH 
Director, Gynecologic Oncology Outcomes Research
Medical Oncology 
Dana-Farber Cancer Institute 
     Alexi_Wright@dfci.harvard.edu
Principal Investigators (PI):  Alexi A. Wright, MD, MPH 
Director, Gynecologic Oncology Outcomes Research
Medical Oncology 
Dana-Farber Cancer Institute 
     Alexi_Wright@dfci.harvard.edu
Hanneke Poort, PhD 
Department of Psychosocial Oncology and Palliative Care
Dana-Farber Cancer Institute
Hanneke_Poort@dfci.harvard.edu  
     Joanna Arch, PhD 
     Department of Psychology and Neuroscience 
                                                University of Colorado Boulder 
                                                Joanna.Arch@Colorado.edu 
VERSION NUMBER: 7.0
DATE:
June 3, 2022
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Table of Contents
1.0
Protocol Schema ...............................................................................................................3
2.0
Objectives..........................................................................................................................4
3.0
Background and Rationale ................................................................................................4
4.0
Inclusion and Exclusion Criteria ........................................................................................7
5.0
Study-Wide Number of Subjects .......................................................................................8
6.0
Study Wide Recruitment Methods.....................................................................................8
7.0
Multi-Site Research .........................................................................................................11
8.0
Study Timelines...............................................................................................................13
9.0
Study Endpoints ..............................................................................................................13
10.0
Procedures Involved.....................................................................................................14
11.0
Data Management and Confidentiality .........................................................................26
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects.................................29
13.0
Withdrawal and Replacement of Subjects ...................................................................29
14.0
Risks to Subjects..........................................................................................................29
15.0
Potential Benefits to Subjects.......................................................................................30
16.0
Resources Available.....................................................................................................30
17.0
Provisions to Protect the Privacy Interests of Subjects................................................31
18.0
Compensation for Research-Related Injury .................................................................31
19.0
Economic Burden to Subjects ......................................................................................31
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1.0
Protocol Schema 
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2.0
Objectives 
Our long-term goal is to develop an effective and scalable intervention to reduce fatigue 
and symptom-related suffering in women with advanced ovarian cancer on PARP inhibitors 
(PARPi). In this study, we propose a two-arm, multicenter pilot randomized controlled trial to 
compare the feasibility, acceptability, and preliminary efficacy of REVITALIZE, a 6-week 
Acceptance and Commitment Therapy (ACT) telehealth intervention vs. enhanced usual care 
(EUC) in up to 50 fatigued patients with ovarian cancer on maintenance PARPi. Designed to 
increase psychological flexibility and values-based behavior, we hypothesize that REVITALIZE 
will improve psychological flexibility and fatigue-related interference and reduce fatigue, 
psychological distress, and fear of cancer recurrence, while improving overall quality of life 
(QOL). Collaborating across three academic cancer centers, our Specific Aims are to: 
Aim 1: To assess the feasibility and acceptability of REVITALIZE in women with 
advanced ovarian cancer who experience PARPi-related fatigue. After pre-piloting the 
REVITALIZE intervention in a sample of up to 5 patients at the Dana-Farber Cancer Institute to 
test and refine the newly developed intervention, we will randomize up to 50 fatigued patients 
with ovarian cancer on maintenance PARPi to a 6-week ACT intervention vs. enhanced usual 
care (educational materials). Feasibility will be defined as ≥50% approach-to-enrollment rate 
of eligible participants and ≥70% completion of 3-month outcome assessments. Acceptability 
will be defined ≤20% withdrawing from the study overall, and ≤20% of participants on the 
intervention arm reporting high study burden.
Aim 2: To explore the effects of REVITALIZE on fatigue, emotional distress, fear of 
cancer recurrence, quality of life, and adherence in up to 50 women with advanced 
ovarian cancer on PARPi. We expect that REVITALIZE will improve psychological flexibility 
and
fatigue-related interference reducing fatigue (primary outcome), psychological distress, and 
fear of cancer recurrence, while improving overall QOL (secondary outcomes), compared to 
enhanced usual care.
3.0
Background and Rationale 
3.1
Background 
Oral PARPi have dramatically changed the treatment landscape for women with 
advanced ovarian cancer, but are poorly tolerated in a subset of patients. PARPi have been 
shown to improve progression-free survival in women with and without BRCA mutations 
(BRCAm and BRCAwt)[1], and are FDA approved for maintenance after first-line treatment of 
women with ovarian cancer, platinum-sensitive recurrent ovarian cancer,[2, 3] and treatment of 
recurrent ovarian cancer after three lines of treatment.[4] While PARPi have fewer side effects 
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than chemotherapy, many women cannot tolerate PARPi due to fatigue or nausea.[1] In 
clinical trials of PARPi, 18% of patients experienced moderate fatigue, and nearly 10% had 
severe to disabling fatigue.[5] Yet, the prevalence of PARPi-related fatigue is likely higher than 
documented because clinical trials rely upon clinician-reported symptoms, single-item 
measures to assess fatigue, or exclude grade 1 levels of fatigue in QOL analyses.[6, 7] 
Despite the many benefits that PARPi offer, many patients cannot tolerate treatment due to 
fatigue, which may impact adherence, treatment discontinuation, and ultimately progression-
free survival.
Cancer-related fatigue is one of the most common and distressing symptoms reported by 
patients with ovarian cancer[8]. Fatigue compromises QOL, resulting in substantial physical, 
psychosocial, and economic losses for both patients and caregivers.[9] The National Cancer 
Institute has designated cancer-related fatigue a high-priority research area,[10] and national 
guidelines recommend routine screening for cancer-related fatigue and treatment with 
psychological or exercise interventions.[11] In prior work, we have demonstrated that more 
than 40% of women with ovarian and endometrial cancer in remission have clinically-
significant fatigue one year after diagnosis.[12] In another study, we demonstrated that 25% of 
patients on oral chemotherapy have moderate-severe fatigue,[13] and these patients 
experience more anxiety and depressive symptoms, compared with patients without fatigue, as 
well as decreased physical functioning. To our knowledge, however, researchers have not 
specifically examined the prevalence of cancer-related fatigue in women with ovarian cancer 
on PARPi outside of clinical trials, or tested interventions to reduce fatigue in this population.
Our qualitative research in women with advanced ovarian cancer demonstrates that 
PARPi-related fatigue is associated with significant symptom-related suffering and functional 
interference. Recently, we conducted 21 in-depth interviews with fatigued patients with 
advanced ovarian cancer on PARPi (18-315, PI: Wright). While patients described their 
symptoms as milder than intravenous chemotherapy, they noted that fatigue insidiously limited 
their daily activities, interfering with their desire to participate in social events, physical activity, 
and work. One patient retired because she could not balance the PARPi- associated fatigue 
with her employment. Others reported the need for dose-reductions, treatment holidays, or 
changes in PARPi because of fatigue. Although most patients wanted to continue on PARPi, 
many reported difficulty coping, which evoked psychological distress and fears of cancer 
recurrence. All participants endorsed the importance of developing an ovarian cancer-specific 
intervention and indicated a preference for telehealth over clinic-based delivery. Interventions 
that reduce PARPi-related fatigue may increase treatment tolerability, enabling more patients 
to remain on treatment.
CBT vs. ACT for treating cancer-related fatigue 
Cognitive behavioral therapy (CBT) is a highly effective, yet under-utilized, treatment for 
cancer- and treatment-related fatigue. The American Society of Clinical Oncology recommends 
CBT to address fatigue in cancer survivors.[11] Research has shown that CBT is effective in 
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reducing fatigue in patients with advanced cancer receiving palliative chemotherapy.[14-16] In 
a multi-center study, Poort (MPI) demonstrated that CBT significantly reduced fatigue and 
improved QOL, compared with usual care, with effects sustained for 3-months post-
intervention.[17] However, only 5% of the participants had ovarian cancer; thus, it is unclear 
whether CBT is efficacious in this population. Moreover, 76/210 (36%) of eligible patients 
declined study participation because the required clinic visits were too burdensome. 
Acceptance and Commitment Therapy (ACT) is another promising approach for treating 
fatigue, specifically in patients with ovarian cancer. ACT promotes actively facing and 
accepting distress and choosing life directions that reflect one’s values, enabling patients to 
address multiple concomitant problems simultaneously (e.g. fatigue, depression, anxiety, and 
pain).[18] While CBT typically focuses on addressing one problem (e.g. fatigue), ACT targets 
the functional underpinnings that are common to multiple psychological and behavioral 
problems. ACT helps individuals to clarify who and what are most important to them (their 
values) to increase their ability to align their daily behavior with their values even in the 
presence of distressing thoughts, feelings, and physical sensations (e.g., fatigue, pain).[19] 
Instead of struggling to avoid fatigue (and the distressing thoughts and feelings that it evokes), 
ACT focuses on helping patients to cultivate acceptance and reduce the dominance of the 
distressing thoughts and beliefs on behavior, an empowering stance that prevents fatigue from 
becoming a barrier to moving towards the people and activities that are most important to 
them, such as spending time with loved ones (e.g., values-aligned behavior).[19] 
Acceptance-based interventions such as ACT provide a strongly matched approach to 
patients with advanced cancer, who even under ideal care, will experience some degree of 
symptoms or side effects. In support, the one published randomized trial of ACT versus CBT 
for patients with late-stage ovarian cancer found that ACT led to superior outcomes, including 
for quality of life, anxiety, depression, distress, and acceptance, by large and significant 
effects.[20] This study was small, did not target fatigue, and required 12 face-to-face individual 
intervention sessions, which remains unscalable, but it nevertheless demonstrates the promise 
of ACT for the targeted population. Given the range of difficulties and high symptom burdens 
associated with advanced ovarian cancer,[12, 21, 22] novel approaches that leverage shared 
intervention principles to address multiple behavioral issues in a single intervention—including 
fatigue, distress, and fear of cancer recurrence—are urgently needed.
Few ACT-based intervention studies have investigated the changes in fatigue. Dr. Arch (co-
PI) conducted a group-based ACT intervention for anxious cancer survivors and found 
significant improvements in cancer-specific distress and fatigue, as well as fear of cancer 
recurrence in a single-arm pilot trial.[23] She next conducted a randomized controlled trial of 
this ACT intervention versus enhanced usual care (EUC) for anxious cancer survivors. The 
final analyses, which are in preparation for publication, demonstrate that ACT led to superior 
reductions on all three of these outcomes (fatigue, cancer-specific distress, and fear of cancer 
recurrence) relative to EUC, through 6-month follow-up (the longest time point studied).[24] 
Further, compared to EUC, the ACT intervention led to fewer missed medical appointments. A 
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third study by Dr. Arch adapted ACT into a briefer format that alternated group and online 
sessions, and specifically targeted anxiety, depression, and advanced care planning 
engagement among anxious and depressed patients with stage IV cancer (mixed solid tumor 
types).[25] Though fatigue was not a targeted outcome, this briefer ACT intervention for 
patients with metastatic cancers showed promising pilot findings, including feasibility and 
acceptability, and significantly reduced anxiety, depression, and fear of dying, along with 
significantly increased rates of advanced care planning. This study also demonstrates Dr. 
Arch’s ability to adapt ACT into scalable formats that meet the needs of patients with 
metastatic cancers. This study will build upon our earlier work to test a novel ACT intervention 
for women with advanced ovarian cancer who experience moderate-severe PARPi-related 
fatigue.
3.2
Rationale
REVITALIZE meets a critical unmet need for women with advanced ovarian cancer 
who experience fatigue on PARPi. The proposed ACT intervention represents an 
innovative and systematic attempt to address PARPi-related fatigue. Additionally, this 
study harnesses telehealth as a scalable strategy to improve symptom management 
and QOL. The intervention will use a HIPAA-compliant telehealth platform for 
intervention delivery (Zoom for Healthcare), enabling us to draw patients from broader 
geographic areas, including rural areas. Results from this research will inform the 
design and conduct of a multicenter RCT to test the effectiveness of REVITALIZE 
among patients with advanced ovarian cancer on PARPi. If successful, REVITALIZE will 
provide a scalable, patient-centered approach to improve symptom management and 
QOL for patients with advanced ovarian cancer on PARPI. 
4.0
Inclusion and Exclusion Criteria 
4.1
Inclusion criteria 

Women ≥18 years of age who have been diagnosed with epithelial 
ovarian, fallopian tube, or primary peritoneal carcinoma. 

Receiving PARPI inhibitors for ≥ 2 months. 

Able to read/speak English. 

Have an Eastern Oncology Group (ECOG) performance of 0-2.

Report moderate-severe fatigue in the past week (average score ≥4 on a 
Fatigue Symptom Inventory scale of 0-10) 
4.2
Exclusion Criteria 
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
Patients with an untreated clinical condition or comorbid illness (e.g. 
anemia, hypothyroidism) that could explain their fatigue. 

Patients with chronic severe fatigue that pre-dates their use of PARPi. 
The following special populations will be excluded from this research: 

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
5.0
Study-Wide Number of Subjects
Before initiating the RCT, we will pre-pilot the REVITALIZE intervention in up to 5 patients 
at the Dana-Farber Cancer Institute (DFCI). This run-in phase serves to test and refine the 
newly developed 6-week ACT intervention in a smaller sample size prior to initiating the RCT 
portion of the study. After we’ve tested and refined the ACT intervention, we will enroll and 
randomize up to 50 fatigued patients with advanced ovarian cancer on maintenance PARPi at 
Dana-Farber Cancer Institute and the Abramson Cancer Center at the University of 
Pennsylvania, to ensure 40 evaluable participants. Participants will be randomized to receive 
either a 6-week ACT intervention or enhanced usual care (educational materials). 20-25 
patients will be enrolled to each study arm. 
6.0
Study-Wide Recruitment Methods 
6.1
Screening and Recruitment 
This is a two-arm, multi-center pilot randomized trial to compare the feasibility, 
acceptability, and preliminary efficacy of REVITALIZE, a 6-week ACT intervention vs. 
enhanced usual care in up to 50 fatigued patients with advanced ovarian cancer. We will enroll 
patients from the DFCI Gynecologic Oncology Program and the Abramson Cancer Center at 
University of Pennsylvania. Study staff, oncology providers and other members of the oncology 
team will identify patients who may be eligible for this study. Prior to obtaining informed 
consent, study staff will review electronic medical records of patients listed on the oncology 
providers’ clinic schedules to identify patients with advanced ovarian cancer who are on 
PARPi. These patients’ medical records will only be reviewed to confirm this protected health 
information (PHI), and it will only be shared in the context of patients’ eligibility for the study. 
When an eligible patient is identified, study staff will contact the patients’ oncology provider 
to confirm they meet the eligibility criteria and to request permission to approach the patient at 
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either an upcoming clinic visit or remotely via telehealth procedures (over the phone or via 
Zoom). Participants who are recruited remotely will be provided with a recruitment letter 
outlining additional details about the study, such as the procedures and time commitment 
involved (Appendix A). If the oncology provider deems the patient ineligible or too distressed to 
participate in a research study at this time, the patient will not be approached for inclusion. If 
the patient is approved to approach for enrollment, the study staff will coordinate with the 
oncology provider to meet with the patient to discuss the study at the time of their next clinic 
visit or at a time that is convenient for the patient. During this visit (in-person or remote), 
patients will be screened for the presence of moderate-severe fatigue in the past week 
(average score ≥4 on a Fatigue Symptom Inventory scale of 0-10). We will only actively screen 
eligible patients once. If a patient is deemed ineligible due to a lack of fatigue, but the patient 
or oncologist indicates that they have more fatigue later during PARPi and want to participate, 
we will re-approach the patient. Additionally, if the study team approaches a patient and they 
want to participate, but mention that now is not a good time, we will confirm with this patient if it 
is okay for the study team to re-approach them at another time. If they agree to be re-
approached, we will note this in a secure password-protected screening and enrollment log, 
and re-approach the patient at another date.
PHI will not be shared with anyone outside of the study team and patients’ oncology 
providers. A partial HIPAA waiver requesting permission to review the PHI of these select 
patients prior to consent during screening and recruitment has been submitted to justify this 
process.
6.2
Informed Consent 
If a patient agrees to learn more about the study, a member from the study team will 
describe the study, review the consent form with the patient, answer any questions they may 
have, and provide their contact information. Appendix B will be used by the study staff member 
for a verbal consent script (Appendix B1 for Dana-Faber or Appendix B3 for University of 
Pennsylvania). The staff member will encourage patients to take their time in deciding whether 
they want to participate in the study or not. 
If a patient is interested in participating, the staff member will obtain their informed verbal  
consent, which will include explaining why this research is being conducted, information about 
study procedures, the risks and benefits of participation, and how long the patient will be 
involved in this research study. The staff member will reiterate that the data collected are not a 
part of the patient’s standard of care treatment and will underscore the importance placed 
upon maintaining patient confidentiality and a patient’s rights while they are involved in the 
study. This includes the right to withdraw participation at any time for any reason during the 
study because participation is completely voluntary. All participants will be given a copy of the 
verbal consent form (Appendix B2 for Dana-Faber participants or Appendix B4 for University of 
Pennsylvania participants). 
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Patients will also be consented for medical record review so that we can examine their 
treatments, side effects, hospitalizations, and outcomes over time. The verbal informed 
consent form will contain a section dedicated to explaining what constitutes PHI and how this 
information will be protected as confidential per HIPAA guidelines. The verbal consent form will 
also provide contact information for both the Principal Investigator (PI) as well as the Office for 
Protection of Research Subjects. 
Remote consenting will be permitted if a patient is unable to be approached in-person at an 
upcoming clinic visit. With permission from the patient’s oncology provider, study staff will send 
the potential patient a recruitment letter via mail or email to provide them with more information 
about the study, and to allow them to opt out of being contacted (Appendix A). Study staff will 
then follow up by phone with all potential patients who do not opt out of further contact and 
send verbal consent forms for patients to review if they are interested in participating in the 
study. Consent forms will be sent either by mail, email, or electronically through a secure and 
personalized link in REDCap, depending on participant preference. The verbal consent forms 
will be IRB approved. During the consent discussion, study staff will emphasize that the study 
is voluntary, patients may withdraw from the study at any time, and that withdrawal of consent 
will not affect their medical treatment in any way. Consent discussions can be completed via 
phone or Zoom.
All informed consent processes will adhere to the policies set forth by the Institutional 
Review Board. Patient verbal consent will be documented and tracked in a secure password-
protected screening and enrollment log and in the patient registration form in REDCap. Only 
study staff will have access to the enrollment log and REDCap database.
If a patient is unsure if they would like to participate in the study, they will be offered the 
consent form to review and the contact information of study staff. If the patient does not 
contact the staff after a 3-4 days and further contact is appropriate, the staff member will 
contact the patient to follow up. If a patient is not interested, the staff member will thank them 
for considering, and reassure the patient that the process will have no impact on their care. No 
further interactions will occur with patients who either decline or prove to be ineligible for the 
study. If the patient decides to participate, a staff member will engage in the informed consent 
process with the patient.
6.3
Subject Registration and Randomization 
After informed verbal consent is obtained, participants will be assigned a unique study ID 
and registered to the study in REDCap. Participants will be retrospectively registered in 
OnCore, the Clinical Trials Management System (CTMS) for Dana-Farber in a de-centralized 
fashion. Registration may occur up to 30 days after verbal consent is obtained per REGIST-
101.
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To complete registration for participants at UPenn, the following documents should be 
completed by site staff and emailed to the Dana-Farber study team at: 
wrightlab@dfci.harvard.edu. 

Informed Consent Documentation 

Completed External Site Subject Registration Form 

Completed Fatigue Symptom Inventory (FSI) Indicating moderate-severe fatigue 
(average score ≥4 on the FSI scale of 0-10)
Note: Study coordinators or research assistants at external sites (defined as outside of the 
DF/HCC) may complete the checklist. At minimum, subject initials must be included. The 
remaining fields are not required for minimal risk trials. The local study coordinator/research 
assistant may sign the checklist as Screening Staff. An Enrollment Monitor signature is not 
required and may be marked as not applicable.
To complete the registration process, the Dana-Farber study team will:

Follow the DF/HCC Standard Operating Procedure for Human Subject Research Titled 
Subject Protocol Registration (SOP #: REGIST-101) and register the participant on the 
protocol

Call or email the site staff at the participating site to provide the participant study 
number and to confirm registration.
NOTE: Registration can only be conducted during the business hours of 8:00 AM 
and 5:00 PM Eastern Standard Time Monday through Friday.
The Dana-Farber study team will register and randomize applicable patients, instead of 
ODQ, because randomization will occur after the patient has signed informed consent (to 
minimize multiple visits/contacts for this minimal risk protocol). Enrolled participants will be 
randomized to one of two arms: 1) enhanced usual care, 2) REVITALIZE, a 6-week ACT-
based intervention using a 1:1 ratio with a computer-generated random allocation sequence 
between conditions and stratification by site, with the sequence concealed until the data are 
finalized. 
7.0
Multi-Site Research
This is a multi-site study. The lead and coordinating center for this protocol is Dana-Farber 
Cancer Institute. The Funding Organization for this study is the National Comprehensive 
Cancer Network (NCCN) and the Research Funding Provider is AstraZeneca. The regulatory 
sponsor is Dr. Alexi A. Wright, MD, MPH. The proposed research will take place at Dana-
Farber Cancer Institute (Overall PI Alexi Wright, MD, MPH) and the Abramson Cancer Center 
(Site PI Anna Smith, MD, MPH, MSc). MPI Dr. Joanna Arch, at University of Colorado, will 
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serve as the licensed psychologist supervising the study interventionists. The study 
interventionists will be clinical psychology doctoral students who have earned a master’s 
degree in clinical psychology (hereafter referred to as “clinical psychology trainees”). The Data 
Safety Monitoring Plan for this project is located in Appendix C. 
7.1
Regulatory Sponsor and Coordinating Center 
The regulatory sponsor, Dr. Alexi Wright, MD, MPH, will accept responsibility for all 
aspects of conducting this multi-center protocol, which includes but is not limited to: 

Oversee the coordination, development, submission, and approval of the protocol as 
well as subsequent amendments. 

Ensure that investigators, study team members, and other research staff are 
qualified and appropriately resourced to conduct the protocol. 

Make sure that all sites are using the correct version of the protocol and that each 
participating site has adequate protocol training (and/or a Site Initiation Visit prior to 
enrolling participants) and throughout the trial’s conduct as needed. 

Monitor progress and overall conduct of the study at all Participating Institutions. 

Ensure compliance with all requirements as set forth in the Code of Federal 
Regulations, HIPAA requirements, the approved protocol, and site-specific 
requirements. 
The general responsibilities of the Coordinating Center may include but are not limited to: 

Review registration materials for eligibility and register participants from Participating 
Institutions in the DF/HCC clinical trial management system (CTMS).

Distribute protocol and informed consent document updates to Participating 
Institutions as needed.

Oversee the data collection process from Participating Institutions.

Maintain Regulatory documents of all Participating Institutions which includes 
but is not limited to the following: local IRB approvals/notifications from all 
Participating Institutions, confirmation of Federalwide Assurances (FWAs) for 
all sites, all SAE submissions, Screening Logs for all sites, IRB approved 
consents for all sites

Conduct regular communications with all Participating Institutions (conference 
calls, emails, etc.) and maintain documentation all relevant communications.
If the outside sites have any questions or concerns throughout the study, the study team 
and Overall PI will be available to assist. 
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8.0
Study Timelines
Each individual subject will remain in the study for the duration of the intervention and 
follow-up assessments, which is approximately 3 months once the intervention begins. 
Participants in the run-in phase will remain in the study for the duration of the intervention, 
approximately 6 weeks. We expect to be able to recruit our target sample size of up to 55 (run-
in phase + pilot RCT) patients over the period of 18 months. The study team anticipates 
completing data analysis within 6 months of study completion. 
9.0
Study Endpoints
9.1
Primary Endpoints 
1) To assess the feasibility and acceptability of REVITALIZE, a pilot RCT 
designed to help women with advanced ovarian cancer manage PARPi-
related fatigue and estimate outcome parameters for a full-scale RCT. 
a. Feasibility will be defined as ≥50% approach-to-enrollment rate of 
eligible participants and ≥70% completion of 3-month outcome 
assessments. 
b. Acceptability will be defined ≤20% withdrawing from the study 
overall, and ≤20% of participants on the intervention arm reporting 
high study burden.
 
2) To compare changes in fatigue (FSI) from baseline to 8- and 12-weeks. 
9.2
Secondary Endpoints 
1) To compare changes in emotional distress (GAD-7 and PHQ-8), fear of 
cancer recurrence (FCRI), and quality of life (FACT-O) at baseline, 8- 
and 12-weeks. 
9.3
Exploratory Endpoints
1) To explore patient adherence to PARP inhibitors (Voils Measure).
2) Explore whether process outcomes (i.e., catastrophizing, fatigue self-efficacy, 
psychological flexibility, experiential avoidance, values) change from baseline 
to 4-, 8-, and 12-weeks.
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3) Explore the trajectory of change in process and outcome measures from 
baseline to 4-, 8-, and 12 weeks to determine at what point in treatment 
changes start occurring.
10.0
Procedures Involved
10.1 Design/Study Type  
First, we will test and refine the REVITALIZE intervention in a sample of up to 5 patients 
with ovarian cancer who report fatigue associated with PARPi in a single-arm pre-pilot run-in 
phase of a 6-week ACT intervention (REVITALIZE). We will then enroll up to 50 patients (to 
ensure 40 evaluable patients) with advanced ovarian cancer who report fatigue associated 
with PARPi treatment to a pilot RCT to assess the feasibility, acceptability, and preliminary 
efficacy of REVITALIZE vs. enhanced usual care (EUC). See Sections 10.31 and 10.34 for 
more information about each study arm.
We will recruit cohorts of patients at each site and randomize half of the sample to 
REVITALIZE and half to EUC. Participants randomized to REVITALIZE will receive 6 weekly 
sessions lasting approximately 60-75 minutes over a 6-8 week period, delivered face-to-face 
using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If 
participants have difficulty connecting to the platform, telephone sessions are permitted. 
Participants randomized to EUC will receive educational materials developed by the National 
Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment. 
Based upon participant and interventionist feedback from the pre-pilot, we will allow 
participants up to 8 weeks from the start of the intervention for completion of the 6-week 
intervention and 60-75 minutes per session. During the pre-pilot 2/4 participants needed to 
reschedule 1 session, which made it challenging to deliver the intervention in 6 weeks. 
Similarly, 2/4 participants required more than 60 minutes per session, as each session ends 
with an experiential exercise and participants had varying responses to this (several 
experienced insights during this moment and wanted to debrief with the interventionist 
afterwards). To minimize study burden, if a session is running >60 minutes the interventionist 
will offer the participant a choice of whether to continue or table the remaining content to the 
next week, emphasizing that there is no expectation from the interventionist to continue. 
Additionally, we have added one “booster session,” which will take place 4 weeks after 
intervention completion. This session is designed to reinforce and enhance the skills acquired 
during intervention. No new skills will be included, but we will help participants troubleshoot 
areas needed to be worked on as participants integrate the skills that they learned during the 
intervention into their lives without interventionist support. Finally, it will also help hold study 
participants accountable for maintaining behavior change after intervention completion, helping 
to reinforce habit formation. 
During the pre-pilot, we also recognized that we did not assess process measures (i.e. 
patient catastrophizing, fatigue self-efficacy, psychological flexibility, experiential avoidance, 
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values) until after intervention completion. In the revised protocol we will add another 
assessment at 4 weeks post-intervention start to enable us to explore whether these process 
measures change during the intervention. Additionally, to assess participant’s satisfaction with 
each session we will ask the interventionists to perform a brief assessment of the “Session 
Rating Scale” after each session.  
After all patients have completed the intervention, we will conduct a preliminary analysis to 
assess our aims of feasibility and acceptability. Feasibility will be defined as ≥50% approach-
to-enrollment rate among eligible participants and ≥70% completion of 3-month outcome 
assessments. Acceptability will be defined ≤20% withdrawing from the study overall, and ≤20% 
of participants on the intervention arm reporting high study burden.
We will also examine the effects of REVITALIZE on fatigue (primary outcome); 
psychological distress, fear of cancer recurrence, and overall QOL (secondary outcomes); and 
adherence and process outcomes, including additional measures of acceptability at study-
completion (exploratory outcomes). 
Our final analyses will provide preliminary estimates of the feasibility, acceptability, scale 
scores, missing data, and participant feedback.  
10.2 Selection of Instruments 
The following validated measures will be used in the study surveys at baseline (Participant 
Baseline Interview, Appendix D), 4-, 8- and 12-weeks post-intervention start (Participant Post-
Baseline Interview Appendix E) to assess primary outcomes (fatigue), secondary outcomes 
(emotional distress, fear of cancer recurrence, quality of life), exploratory outcomes 
(adherence), and process outcomes (catastrophizing, fatigue self-efficacy, psychological 
flexibility, experiential avoidance, values, and therapeutic process). 
All participants will be compensated for their time and effort by receiving a $20 gift card for 
completing each survey plus a $5 bonus for completing their survey within 48 hours of our 
sending or administering it—up to $25/survey, $100 for all four. 
10.21a Fatigue Symptom Inventory (FSI) 
The Fatigue Symptom Inventory is a tool designed to assess the severity, frequency and 
daily pattern of fatigue, as well as its perceived interference with daily functioning.[26, 27] It is 
a 14-item, 11-point rating scale developed to assess subjective fatigue. Severity is measured 
on 11-point scales that assess most, least, and average fatigue in the past week as well as 
current fatigue. Higher scores indicate greater levels of fatigue. Frequency is measured as the 
number of days in the past week (0-7) that patients felt fatigued as well as the extent of each 
day on average they felt fatigued. Perceived interference is measured on separate 11-point 
scales from 0 (no interference) to 10 (extreme interference) that assess the degree to which 
fatigue in the past week was judged to interfere with general levels of activity, ability to bathe 
and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, 
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and mood. The interference items can be summed to obtain a total perceived interference 
score. 
10.21b General Anxiety Disorder Questionnaire (GAD-7)
    The Generalized Anxiety Disorder 7-Item (GAD-7) is a reliable and validated self-
report measure to assess anxiety symptoms. Respondents rate how often they have 
been bothered by 7 anxiety symptoms over the past two weeks using the following 
scale: 0 = Not at all; 1 = Several Days; 2 = Over half the days; and 3 = Nearly every 
day. Respondents also answer a question to assess the duration of their anxiety 
symptoms. Responses are tallied, and the total score indicates the presence and 
severity of GAD.[28] The measure has been validated in the general population[29] and 
is the recommended evaluative measure for anxiety in adult patients with cancer in the 
2014 American Society of Clinical Oncology (ASCO) Guideline Adaptation.[30]
10.21c Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 is a validated self-report measure that assesses eight 
depressive symptoms (excluding self-harm) using the Diagnostic and Statistical Manual of 
Mental Disorders (DSM) diagnostic criteria for major depressive disorder.[31] It is used to 
screen, diagnose, and monitor depressive symptoms[32] and has demonstrated validity in 
cancer patients.[33, 34] Respondents report if each symptom has bothered them “not at all”, 
“several days,” “more than half the days,” or “nearly every day” during the previous two weeks 
to measure their mental and emotional health.[35] 
10.21d Fear of Cancer Recurrence Inventory (FCRI) 
To measure fear of cancer recurrence (FCR) we will use the 42-item Fear of Cancer 
Recurrence Inventory (FCRI). This survey has been validated across diverse cancer 
populations, has strong psychometric qualities, and is the most comprehensive multi-
dimensional scale of FCR available.[36, 37] Items are scored on a Likert scale ranging from 0 
(“not at all” or “never”) to 4 (“a great deal or “all the time”). Higher scores indicate higher FCR. 
The FCRI is both internally consistent (Cronbach’s α=0.75 to 0.91 across subscales) and 
stable over a two-week interval (ρ = 0.58 to 0.83 across subscales). It also has convergent 
validity with other standardized measures of FCR (ρ = 0.66 to 0.77) and discriminant validity 
with QOL amongst a large sample (n = 600) of Canadian cancer patients with varying tumor 
types.[36] 
10.21e Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) 
Participants’ quality of life (QOL) will be assessed with the Functional Assessment of 
Cancer Therapy-Ovarian Cancer, which has demonstrated internal consistency, reliability, and 
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validity.[38] This measure is composed of the Functional Assessment of Cancer Therapy-
General scale, with an ovarian cancer-specific subscale (OCS) included. The measure is 
divided into five primary QOL domains: physical well-being (7-items), social/family well-being 
(7-items), emotional well-being (6-items), functional well-being (7-items), and additional 
concerns (OCS subscale, 12-items).[38] Participants will rate each symptom over the past 7 
days as: 0) Not at all; 1) A little bit; 2) Somewhat, 3) Quite a bit, and 4) Very much. Subscales 
can be analyzed separately or aggregated to produce a total score. 
10.21f Medication Adherence Measure (Voils Measure)
We will use a validated self-report measure to assess dual conceptualizations of 
patient medication nonadherence—the extent of patient nonadherence and reasons for 
nonadherence.[39] Comparison measures include medication self-efficacy, beliefs 
about medications, impression management, conscientiousness, habit strength, and an 
existing nonadherence measure. The extent of nonadherence is measured with three 
positively correlated items, and reasons for nonadherence are assessed using several 
independent items.[39] Unlike extent of nonadherence, reason items are treated 
individually and descriptively, while extent items are averaged into an overall score. The 
three extent items can be used to help identify nonadherent patients and reason items 
can be used to identify and tailor intervention targets. 
10.21g Fatigue Catastrophizing Survey (FCS)
      We will assess participant catastrophizing using the Fatigue Catastrophizing Survey 
(FCS). Catastrophizing is a psychological process that can negatively contribute to the 
intensity of symptoms patients may be experiencing and increase a patient’s level of 
distress, thus impacting their quality of life.[40] Modified from the Catastrophizing Scale 
of the Cognitive Coping Strategies Inventory (CCSI), this survey measures 10 fatigue-
related items that reflect patients’ tendencies to engage in overly negative thoughts (i.e. 
“I worry all the time” or “I feel I can’t go on”). Patients rate each question on a 5-point 
scale (1=never true to 5=all of the time) to indicate how often each item is true for them 
when they’ve experienced fatigue. In prior research, more catastrophizing (as indicated 
by higher scores on the FCS) were associated with more severe fatigue in women with 
breast cancer.[41]
10.21h Fatigue Self-Efficacy
     Self-efficacy concerning fatigue (i.e. the belief in one’s capabilities to execute 
behaviors) will be measured with the 7-item Self-Efficacy Scale (SES28).[42] Items are 
scored on a 4-point Likert scale, and total scores range from 4 to 28. Higher scores 
indicate a greater sense of control over fatigue. 
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10.21i  Acceptance and Action Cancer Questionnaire (AAQ-cancer) 
     We will measure changes in psychological flexibility (ACT processes) using a 15-
item measure adapted from the widely validated AAQ-II and diabetes-adapted AAQ 
towards cancer specific items.[23] Numerous adaptations of the AAQ towards specific 
clinical targets have been shown to produce valid measures that mediate ACT 
outcomes for the specific population.[23] 
10.21j Brief Multidimensional Experiential Avoidance Questionnaire (BEAQ)  
      The Multidimensional Experiential Avoidance Questionnaire is a 62-item measure 
developed to assess six domains of experiential avoidance (EA).[43] These domains are 
behavioral avoidance, distress aversion, procrastination, distraction and suppression, 
repression and denial, and distress endurance. For this study, we will use the abbreviated 
version of this measure, the Brief Multidimensional Experiential Avoidance Questionnaire 
(BEAQ) which only includes 15-items and covers all dimensions of experiential avoidance. 
This measure is internally consistent and has been broadly associated with 
psychopathology and quality of life.[44]  
10.21k Valuing Questionnaire (VQ) 
A primary objective of ACT is to facilitate valued living. We will use the 10-item 
Valuing Questionnaire (VQ) to assess personal values enactment during the past two 
weeks.[45] Respondents rate on a 6 point scale (0 “not at all true” to 6 “completely true”) 
how often each item was true for them during the past two weeks and evaluate using a 
two-factor scale; the Progress scale and Obstruction scale.[45] High VQ Progress 
scores are associated with positive affect, satisfaction with life, purpose in life and 
mastery and self-acceptance, while high VQ Obstruction scores are associated with 
depressive symptoms and negative affect. 
10.21l Session Rating Scale 
After each REVITALIZE study session, interventionists will use the Session 
Rating Scale (SRS) to assess participant’s satisfaction with each session. The SRS is a 
brief 4-item measure developed by Miller, Duncan & Johnson (2002) that enables 
participants to rate each REVITALIZE study session based upon their therapeutic 
alliance with the interventionist, approach or method, goals and topics, and an overall 
rating. The SRS will be administered orally at the end of each session and a total score 
will be calculated based on responses. Total scores will be recorded in a graph for each 
session and scores < 35 will prompt a discussion with the patient about how to better 
meet their needs during the REVITALIZE intervention sessions. (See Appendix I).  
10.21m Demographic Information 
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Basic demographic information will be collected for all participants including: age, marital 
status, race/ethnicity, education, household structure, income, and employment. The questions 
will only take a few minutes to complete. In addition, clinical information will be collected from 
patient’s medical records including: stage, treatments (number of and specific treatments 
used), time since diagnosis of advanced ovarian cancer, ECOG performance status, genetic 
testing results, and the starting dose and date of PARPi treatment. We will also obtain the 
dates of prior dose delays and/or reductions and reasons for each.
10.21n Patient Interviews 
We will also conduct qualitative interviews with patients in the intervention arm to further 
understand the challenges and facilitators of each intervention component. We will interview 
up to 20 patients, or until thematic saturation is met, sampling both from those who completed 
the study, and those who dropped out. With a focus on acceptability, relevance, and barriers to 
implementation, these semi-structured interviews will provide data on both intervention and 
context-level factors, enabling us to further refine the intervention and design a larger RCT. An 
interview guide is provided in Appendix F; in accordance with qualitative interviewing 
procedures, additional themes and topics that arise over the course of the study may be 
explored further in qualitative interviews, in addition to the list of questions in the interview 
guide. 
Interviews will be recorded to ensure that the interviewer adequately captures all feedback 
from patients. The consent forms for the study include information that the debriefing interview 
will be recorded, and we will also verbally request permission from patients to record the 
interview before starting the interview. We will not administer a qualitative interview to any 
person who does not consent to being recorded during the debriefing interview. All recordings 
of study sessions will be stored in secure, restricted-access locations. Recordings will be tied 
to a study ID number, and the only documents linking the patient’s study ID to identifiable 
information are in a restricted-access file stored securely on restricted-access folders. 
Recordings of interviews will be transcribed for analysis using a DFCI-approved, HIPAA-
compliant transcription vendor or locally at Dana-Farber. All patient identifiable information will 
be removed when the recordings are transcribed. Recordings of debriefing interviews will be 
destroyed when analyses are complete. 
10.21o Pandemic Stress Index 
To understand the impact of the novel coronavirus (or COVID-19) pandemic on 
study participants, we will administer the Pandemic Stress Index. Developed by 
researchers at the University of Miami, the Pandemic Stress Index is a 3-item measure 
used to assess behavior changes and stress that individuals may have experienced or 
are experiencing during the COVID-19 pandemic. The first item “What are you doing/did 
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you do during COVID-19 (coronavirus)?” assesses behavior changes in response to 
COVID-19. This includes changes that may have taken place in response to public 
health messaging (e.g., physical distancing, isolation, quarantine), changes in the 
workplace (e.g., working remotely, job loss), and changes to protect one’s own or 
others’ health (e.g. caretaking). The second item asks individuals to rate the overall 
degree to which COVID-19 has impacted their daily life, “How much is/did COVID-19 
(coronavirus) impact your day-to-day life?” rated on a 5-point scale. Finally, participants 
are asked to report the psychosocial impact of COVID-19, “Which of the following are 
you experiencing (or did you experience) during COVID-19 (coronavirus)?” with a 
checklist of items pertaining to emotional distress, substance use, sexual behavior, 
financial stress, stigma, and support.[46, 47]
10.21p Acceptability of Intervention Measure (AIM)
A primary objective of our study is to evaluate acceptability, which will be defined 
as ≤20% withdrawing from the study overall, and ≤20% of participants on the 
intervention arm reporting high study burden. To more fully understand patients’ 
experiences on the REVITALIZE arm, we will also use the 3-item Acceptability of 
Intervention Measure (AIM) to assess acceptability.[48] Items are measured on a 5-
point Likert scale. Total scores range from 4 to 20. Higher scores indicate greater 
acceptability of the intervention.
10.3 Description of Interventions 
This is a 12-week pilot randomized control trial. Prior to the start of the RCT, 
we will enroll up to 5 patients at Dana-Farber in a single-arm intervention testing 
phase of REVITALIZE. Upon completion of the run-in phase, we will enroll 
participants onto the RCT portion of the study. Eligible participants will be 
randomized to one of two study arms: 
1)
Acceptance and Commitment Therapy Arm (REVITALIZE) 
2)
Enhanced Usual Care (Educational Materials) 
See the protocol schema (Section 1.0) for more details. 
10.31 Intervention Arm (REVITALIZE) 
The REVITALIZE intervention was developed by the study investigators based on 
evidence-based protocols for Cognitive Behavior Therapy (CBT) in advanced cancer and 
Acceptance and Commitment Therapy (ACT) based protocols used in patients with cancer. 
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The REVITALIZE intervention is a skills-based psycho-educational intervention that will target 
all processes of the ACT model of behavior change, including present moment, self-as-
context, cognitive defusion, acceptance, values, and committed action. The intervention will 
also emphasize developing mindfulness skills and engaging in actions aligned with personal 
values. Participants randomized to the intervention arm will receive six 60–75-minute weekly 
sessions over a 6-8 week period delivered face-to-face using iPads or personal 
computers/tablets and a HIPAA-compliant platform (Zoom for Healthcare) or telephone (per 
patient preference). 
We will provide psychoeducation about PARPi-related fatigue, including information on 
precipitating and perpetuating factors. During the six intervention sessions, we will work to 
identify the negative impacts associated with the struggle to control unwanted thoughts, 
feelings, and physical symptoms or side effects linked with advanced ovarian cancer and 
PARPi treatment. Patients will learn about the importance of balancing acceptance and 
behavior change strategies. We will use values-clarification exercises to formulate goals in 
behavioral terms, such as resuming activities or leisure interests. In addition, mindfulness and 
acceptance strategies will be used to foster psychological flexibility when faced with cancer-
related barriers. Finally, cognitive defusion techniques will be taught to reduce the behavioral 
impact of negative thoughts and feelings associated with advanced cancer and PARPi-related 
fatigue. Patients will gradually work toward realizing their treatment goals that they formulated 
earlier. Although each participant will learn the same skills, session content and home practice 
will be tailored to individual patients’ cancer-and fatigue-related experiences and other 
challenges. Patients will be provided with study workbooks (Appendix K) and will review many 
of these concepts with the interventionists during sessions, aided by diagrams (Appendix J). If 
the patient requests, we will allow for sharing of the audio recordings from the sessions to aid 
in review of core concepts. However, sharing of the audio recording from each session is not 
required.
Table 1 below provides a more detailed session-by-session overview:
Based on patient and therapist feedback from the run-in phase (4 patients, 4 therapists) 
and from the empirical literature showing that flexible application of intervention manuals is 
more effective than rigid application, we have built in greater flexibility into each session, 
allowing, for example, therapists to select one of any three specified metaphors for illustrating 
cognitive defusion, rather than having to use all three with all patients, or allowing them to 
spend more versus less time debriefing on patient’s behavioral goals, depending on a given 
patient’s goals and her difficulty in reaching them. 
Session 1 --- 
Introduction and 
Psychoeducation 
In this first session, we will focus on building rapport and taking a brief 
(cancer-related) history. We will provide basic psychoeducation on cancer-
related fatigue and link this to triggers for fatigue (i.e. reinforcing the 
knowledge that PARP inhibitors are considered ongoing cancer treatment) 
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as well as psychosocial factors that may add to this fatigue.  We will elicit 
participants’ fears and worries about their cancer and cancer treatment 
which may contribute to their fatigue. Participants who identify sleep 
disturbance as a barrier will be asked to complete a sleep diary as part of 
their home practice. 
Session 2 --- Choice 
Point, Values, and 
Goals
After a brief acceptance-based meditation, the therapist will debrief and 
evaluate the previous session, as well as any barriers or thoughts that they 
observed in between sessions. We will introduce the Acceptance and 
Commitment Therapy (ACT) model to patients using the “Choice Point 
2.0”. In this educational exercise patients will learn about Towards and 
Away Moves, who and what are most important (values), and what gets in 
the way of accomplishing values-based behavior (barriers). Participants 
will be asked to complete a Choice Point on cancer-related fatigue and 
think about things that get in the way of working towards ones’ values. This 
session will also focus on formulating values-based behavioral goals to 
explore what patients would be doing if they were no longer moderate-
severely fatigued. Participants will be asked to set a Fatigue Action Goal, a 
small and doable behavioral activation goal (in the domains of sleep, 
activity or social support) for the next week that will be a part of each 
week’s session.
Session 3 --- 
Challenging Feelings 
and What We Can and 
Can’t Control
After a brief acceptance-based meditation, the therapist will debrief and 
evaluate the previous session, as well as any barriers or thoughts that they 
observed in between sessions. What are barriers to going towards values-
based behavior, and what thoughts keep “hooking” patients? We will then 
select a metaphor/exercise or two (from a list, with an ability to tailor to a 
given patient) to help patients experience the “Illusion of Emotional and 
Cognitive Control”. We will link these exercises to thoughts and emotions 
participants have in relation to cancer and fatigue and present alternative 
strategies. We will focus on recognizing that the struggle against difficult 
thoughts and feelings around the fatigue and the cancer itself, not the 
thoughts or feelings themselves, is the problem. We will use the “Struggle 
Switch”, “Finger Trap”, or related metaphors to illustrate that we cannot 
control how we feel but we can control the extent to which we struggle. 
Depending on time, we will end the session with or assign for home 
practice a meditation exercise about noticing and accepting thoughts and 
feelings. Participants will be asked to notice internal barriers (responses to 
thoughts, feelings, sensations) that get in the way of values-based 
behavior in their everyday lives between sessions. 
Session 4 --- Detach 
from Thoughts and 
Beliefs that Hook Us
After a brief acceptance-based meditation, the therapist will debrief and 
evaluate the previous session, as well as any barriers or thoughts that they 
observed in between sessions. The main topic for this session is Defusion. 
We will focus on what’s hooking them, what’s getting in the way, how is 
your mind talking you out of this, what’s stopping them from acting on 
these values or achieving goals. Importantly, the therapist will normalize 
and validate difficult thoughts/beliefs related to fatigue and cancer, which 
facilitates both acceptance and defusion. The goal is for participants to 
become more willing to have their thoughts without being unduly 
influenced by them, and reduce the energy they put into getting rid of 
them. The therapist will briefly summarize the main content of fusion, 
identify the relationship between fusion and behavior (away moves), and 
offer the possibility of learning a new approach as an alternative to fusion. 
We will use a metaphor (such as “The Hands as Thoughts and Feelings 
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Metaphor” or Changing Radio Stations”) to help the patient experience 
fusion and defusion. The basic idea of this and other defusion skills is that 
they create more distance between the participant and their thoughts and 
help them recognize that they aren’t necessarily a part of who they are. We 
will explain that there are several helpful defusion skills that illustrate how 
to accept your thoughts while not identifying them or taking them too 
seriously. We will present participants with a handout of 10 common 
defusion techniques, briefly discuss them, and will ask participants to pick 
one or two that resonate with them and ask them to practice these in 
between sessions. Depending on the timing, the session will end with the 
Leaves on a Stream eyes-closed exercise or the next session will begin 
with this exercise.
Session 5 --- Flexibly 
Attaining Values and 
Goals
After a brief acceptance-based meditation, the therapist will debrief and 
evaluate the previous session, as well as any barriers or thoughts that they 
observed in between sessions. This session will include a more in-depth 
discussion and exploration of participants’ values and goals. Values are 
chosen life directions; what you want to stand for; desired personal 
qualities. Values are like an “inner compass”: they give us guidance, help 
us find a direction, stay on track, and help us find our way again when we 
go off track. We will help the patients distinguish values from goals and as 
needed help them connect with and clarify their values so they can use 
them to guide ongoing behavior. We will then move into committed action, 
translating values into ongoing, evolving, effective, dynamic patterns of 
overt and covert behavior (towards moves). We will focus on three skills: 
problem solving, goal setting, and action planning. We will use the 
“Challenge Formula” to help participants see they have choices, despite 
the difficult situation they are in. We all have limited time on this planet and 
cancer peels away the pretense that we are going to live forever, it peels 
away the curtain that keeps us away from our own vulnerability. It is very 
painful and associated with losses AND it’s also an opportunity to re-
evaluate who and what are most important to patients and to direct their 
energy towards that. We will then segue to committed action, on living by 
our values and acting effectively to achieve values-congruent goals. For 
some participants, helping them get in touch with their values and asking 
about values-congruent goals will be enough to get them moving, and they 
may have done this work already. For others, there may be some barriers 
and we’ll look at what these are and how to overcome them. We will also 
assess the goals in terms of whether they are: a live person’s goals, it is a 
realistic goal, what the payoffs are, and what plan B is. Particularly around 
fatigue, what if they have limited energy, what if they get really sick? 
Participants will be invited to engage in formal SMART goal setting and 
action planning in between this session and the last one. 
Session 6 --- Integration, 
Review, and Future 
Planning
After a brief acceptance-based meditation, the therapist will debrief and 
evaluate the previous session, as well as any barriers or thoughts that they 
observed in between sessions. During this final session, we will review the 
skills that participants learned and identify a plan moving forward to 
promote daily vitality and coping with fatigue through the skills that spoke 
most strongly for the individual participant. We will create a plan even if 
fatigue worsens and will review and draw upon the home practice that they 
engaged in between session 5 and 6. 
Booster Session --- 
Reinforcing and 
This booster session will be provided 4 weeks after Session 6. This 
session is designed to reinforce and enhance the skills acquired during the 
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Enhancing Acquired 
Skills
intervention, while holding participants accountable for maintaining the 
behavior changes initiated during the intervention. No new skills will be 
included, but we will help troubleshoot areas needed to be worked on.
10.32 Zoom for Healthcare
Zoom for Healthcare is a HIPAA compliant telehealth platform that creates real-time and 
easy to use video communication solutions for the health care industry and enables secure, 
virtual healthcare delivery. The platform allows physicians, patients, and specialists to connect 
remotely across hospitals, clinics, homes and geographically isolated areas to raise levels of 
patient care and improve the delivery of treatment.
Additionally, this technology is easily integrated into site workflows to allow 
interventionists and patients to connect at specific dates and times, allowing enhanced control 
around who has access to appointments and when they take place.
If technical problems occur with the telehealth technology during a patient’s scheduled 
virtual visit—or the patient expresses a preference for a telephone-based approach--then the 
trained REVITALIZE interventionist may switch to calling the patient and conduct the session 
via telephone. The REVITALIZE interventionist should notify the research team to address the 
technical issue prior to the patient’s next ACT session. The study team may also contact 
patients via email, phone, or in-person to assist with technology set-up and troubleshooting.
10.33 Interventionist Training and Supervision 
Interventionists will be master’s level clinical psychology trainees. Prior to intervention 
delivery, interventionists will participate in a 3-day training provided by two topical experts in 
the areas of cancer-related fatigue and ACT (Drs. Poort and Arch, respectively), as well as 
ovarian cancer (provided by Dr. Wright). The training will provide the background and rationale 
for each of the intervention sessions and will involve active, evidence-based training methods, 
including role-playing with expert and peer feedback to practice intervention components. In 
addition, weekly supervision will be provided by Dr. Arch throughout the study. Drs. Arch and 
Poort will also provide additional ongoing weekly remote supervision to the interventionists with 
help from Dr. Wright.  We will monitor study and intervention fidelity by using content checklists 
and the DFCI study team will analyze a random sample of recorded sessions (~10%) for 
content and quality. The DFCI study team will also have bi-weekly check-ins with the study 
teams at UC Boulder and UPenn to provide additional study oversight. 
10.34 Control Arm (Enhanced Usual Care) 
The Enhanced Usual Care arm will receive quality educational materials developed by 
the NCCN (Appendix G) about fatigue and exercise during cancer treatment. 
10.4 Data Collection 
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Table 2 specifies the instrument and intervention data collection timeline. 
Table 2. Study Measures and Data Collection  
STUDY TIMEPOINT
Baseline 
Visit
4 weeks post-
intervention 
start
8 weeks 
post-
intervention 
start
12 weeks post-
intervention 
start
Participant Baseline Interview

Participant Post-Baseline 
Interview



Provision of NCCN Education 
Materials (EUC Arm Only) 

Debriefing Interview 
(REVITALIZE Arm Only) 

INSTRUMENT
Chart Abstraction Data 
Data obtained via interviews, surveys, and chart abstractions will be stored on the 
Partners REDCap server. 
10.5 Description of Study Process
10.51 Instrument Administration 
Participant Baseline Survey: 

Participants will complete the interview on the same day informed 
consent is obtained; if this is not possible, then the survey may be 
completed at a subsequent visit or remotely (i.e. over the phone, via 
mail or email). 

All data from the interview will be stored in REDCap; if paper copies 
are used, they will be stored in restricted access locations. 

Estimated time to completion: 40-45 minutes 
Participant Post-Baseline Survey: 

Participants will complete a post-baseline survey at about 4-, 8-, and 
12-weeks post-intervention start. Surveys should be completed as 
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close to the projected assessment date, ideally within +/- 14 days. The 
flexible administration window accounts for variations in participants’ 
schedules. The study team will account for delays in scheduling time 
with an interventionist (REVITALIZE arm) and mail delivery (EUC arm) 
when considering participants “intervention start date”. 

Participants may complete the survey remotely or in-person. 
Chart Abstractions: 

Study staff will review patients’ medical records to complete the chart 
abstractions form at the time of the participants’ baseline and post-
baseline visits. 
10.6 Special Concerns 
10.61 Surveys
Participants will be contacted in advance to complete their upcoming study 
survey. After three unreturned voicemails and three unreturned emails, they will not be 
contacted again for additional surveys. 
10.62 Discontinuation of PARPi 
If a participant discontinues PARPi treatment due to disease progression or drug 
tolerability, they will be given the option to either continue on the study intervention or to 
withdraw. Participants who are no longer taking PARPi will be considered non-evaluable 
and will be replaced with a new study participant. See section 13 for further guidance on 
replacements.
11.0
Data Management and Confidentiality
11.1 Statistical Analysis 
Primary Endpoints 
1) To assess the feasibility and acceptability of REVITALIZE in women with 
advanced ovarian cancer who experience PARPi-related fatigue. 
2) To compare changes in fatigue (FSI) from baseline to 8-weeks and 12-weeks. 
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Secondary Endpoints 
1) To compare changes in emotional distress (GAD-7 and PHQ-8), fear of cancer 
recurrence (FCRI), and quality of life (FACT-O) at baseline, 8-weeks, and 12-
weeks.
Exploratory Endpoints 
1) Assess patient-reported adherence to PARP inhibitors (Voils Measure).
2) Explore whether process outcomes (i.e. catastrophizing, fatigue self-
efficacy, psychological flexibility, experiential avoidance, values) change 
from baseline to 4-, 8-, and 12-weeks.
3) Explore the trajectory of change in process and outcome measures from 
baseline to 4-, 8-, and 12-weeks to determine at what point in treatment 
changes start occurring. 
11.2 Sample Size and Statistical Power or Precisions 
We have selected a pilot trial sample of up to 50 participants to allow us to: a) ensure 40 
evaluable participants; b) recruit cohorts of the size needed for a future fully powered trial, to 
assess feasibility of recruitment and randomization; c) to pilot-test the intervention with multiple 
patients per site, allowing us to examine feasibility and acceptability within each site to 
establish a foundation for a future multi-site trial; d) obtain estimates of means and variance for 
each condition (the use of n=20 per condition allows for some stability in effect size estimates); 
d) assess usual/non-study care in both conditions, to examine the potential for use to be higher 
in EUC than the REVITALIZE arm. We will not include data from the 5 participants enrolled 
onto the run-in phase since this group of patients will not undergo randomization. 
11.3 Data Analysis Plan 
11.3a Feasibility/Acceptability
Feasibility will be defined as ≥50% approach-to-enrollment rate of eligible 
participants and ≥70% completion of 3-month outcome assessments. Acceptability will 
be defined ≤20% withdrawing from the study overall, and ≤20% of participants on the 
intervention arm reporting high study burden. Descriptive statistics will be used to 
summarize participants’ demographic and clinical characteristics and to evaluate 
whether the trial has met its stated feasibility and acceptability endpoints for the portion 
consented, acceptability, and assessments completed. We will use basic inferential 
statistics (χ2 for categorical, t-tests or ANOVAs for dimensional DVs) to assess for the 
presence of systematic difference in feasibility between conditions. This will include a) 
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drop out patterns and characteristics between study arms; b) baseline characteristics 
between those lost to follow-up vs. retained. 
11.3b Primary/Secondary Outcomes
Guided by NIH and statisticians’ recommendations for the conduct of pilot trials 
and clustered trials, we did not power this small pilot trial to determine efficacy but to 
assess the feasibility of a fully-powered future RCT. Thus, we will evaluate means, 
standard deviations, and data clustering at each time point by condition. We will 
evaluate the clustering by cohort and recruitment site with intraclass correlation 
statistics. Additionally, we will examine the degree of usual/non-study supportive care 
use using descriptive statistics and will test association with condition. To examine 
trajectories of change over time by condition, we will use mixed effects repeated 
measures analyses that account for nested data. We will examine cohort and site as 
sources of variability and consider them as fixed or random effects as appropriate. 
11.3c Qualitative Analysis
Qualitative interviews provide a critical lens to understand participants’ 
experiences and perceptions. Thus, the analytic approach will be oriented toward 
framework analysis, a multi-stage coding process that includes both a priori defined and 
emergent codes. Through comprehensive indexing, charting, and mapping we will 
examine and compare within and across interviews to characterize the nature of the 
participant experiences with REVITALIZE and develop strategies for improving 
relevance and acceptability.
11.4 Data Management and Confidentiality  
The study will be run by Dana-Farber Cancer Institute as the coordinating center. We will use 
the Partners REDCap infrastructure to capture information about study participants. All 
participant survey data will be specifically entered and maintained securely on the REDCap 
database. Only study staff members who have completed required institutional and study-
specific training will have access to study data. All original copies of data will be kept in 
restricted-access locations, locked in file cabinets in study staff offices. Computerized 
databases will be password protected. Data will be collected, coded, and managed by study 
staff only. Data and software will be backed up on a nightly basis as per institutional norm. 
All recordings of study interviews and intervention sessions will be stored in secure locations in 
restricted-access, locked filing cabinets and in password-protected folders on the Dana-Farber 
servers. Recordings will be tied only to a study ID number, and the only document linking the 
patient’s study ID to identifiable information will be in a restricted-access, password-protected 
files.
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The study protocol will strictly adhere to all HIPAA and Dana-Farber and participating site 
regulations. Confidentiality of subjects will be maintained. No data will be linked to a particular 
name or personal identifiers. Only de-identified datasets will be provided for analysis.
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects
No adverse events are expected in this minimal risk study; however, some participants may 
be distressed when answering questions about their fatigue and other symptoms. Study staff 
will monitor for adverse events during ACT intervention sessions or when they are interviewing 
participant, and either the participant or the interventionist can decide to end the interview, if 
needed. Should participants become exceedingly upset, disoriented or fatigued or need to 
attend to matters of personal care during the interviews or study visits, study staff will ask the 
subject if they would like to take a break or reschedule the survey for another time. 
13.0
Withdrawal and Replacement of Non-Evaluable Subjects
Subjects are notified during the informed consent process that they may contact the study 
team in writing to request withdrawal of their complete data from use. If a participant decides to 
withdraw from the study, research staff will assure them that this will have no impact on their 
clinical care or relationship with their clinical oncology team.
If a participant has disease progression while on study, the participant may choose to 
continue the intervention, but will be deemed non-evaluable given disease progression can be 
accompanied by significant fatigue.
If a participant discontinues PARPi treatment due to disease progression or another 
medical reason (e.g. renal failure, severe cytopenias, cardiac arrhythmia), the participant may 
choose to continue the intervention, but will be deemed non-evaluable.
Regardless of evaluable status, we will give all participants on both arms the opportunity to 
continue the study surveys.
Non-evaluable participants will be replaced. 
14.0
Risks to Subjects
We anticipate that this study will entail minimal risk to subjects. Discussing lived experiences 
with advanced cancer with a therapist or answering surveys about the emotional impact of 
cancer can be upsetting to some. Subjects will be informed of this minimal risk during the 
consenting process. 
Should participants become exceedingly upset, disoriented or fatigued or need to attend to 
matters of personal care during the surveys, study staff will ask the subject if they would like to 
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take a break or reschedule the survey for another time. In the event that participants 
experience distress while completing surveys, we will follow standard procedures used in our 
behavioral health intervention studies for counseling and referral. The PI will be notified 
immediately, and participants will be provided with the pager number for the study PI in the 
consent form.
15.0
Potential Benefits to Subjects
There is no direct benefit to subjects taking part in the research. Subjects may benefit from 
awareness of fatigue as an important symptom that can be associated with PARPi and the 
potential for ACT to reduce this symptom, as well as a potential benefit of knowing that they 
have contributed to the generation of research that may help future patients. 
16.0
Resources Available
16.1 Qualifications of Study Staff 
Alexi A. Wright, MD, MPH (along with her collaborators Hanneke Poort, PhD and Joanna 
Arch, PhD) is well poised to execute the proposed research focusing on fatigued advanced 
ovarian cancer patients on PARP inhibitors because of her training, expertise, and experiences 
as a clinician-researcher focused in this area of study. As a member of the Gynecologic 
Oncology Program at the Brigham and Women’s Hospital and Dana-Farber, she has access to 
patients on PARPi for advanced ovarian cancer and expertise in managing PARPi- associated 
symptoms. Within the group there are 10 medical oncologists, 6 gynecologic oncology 
surgeons, 2 radiation oncologists, 5 nurse practitioners, 1 physician assistant, 7 program 
nurses, 4 study nurses, and 12 research coordinators. Each year, the group cares for 
approximately 3,600 patients with gynecologic cancers, totaling 11,000 or more patient visits. It 
is a programmatic priority to involve all patients in therapeutic or outcomes trials. Dr. Wright will 
have all of the resources available to her at DFCI for the duration of this award, including 
statistical, research, and nursing support in addition to grants support and the support of the 
collaborating institutions participating in this work (DFCI, UPenn, and University of Colorado).  
Hanneke Poort, PhD is a psychologist specializing in psychosocial oncology and palliative 
care. She successfully conducted several studies on cancer-related fatigue, including a similar 
adaptation study of CBT for patients on tyrosine kinase inhibitors for chronic myeloid leukemia, 
and a randomized controlled trial on the efficacy of CBT for fatigue in advanced cancer. In 
addition, she is involved in an active protocol (17-680, PI: Joffe) that studies the incidence, 
course, and predictors of fatigue developing on palbociclib in patients with advanced HR+ 
HER2- breast cancer. Dr. Poort is a member of the Department of Psychosocial Oncology and 
Palliative Care at Dana-Farber. The department provides world-class clinical care, while also 
conducting innovative, leading-edge research to help better understand the experience of 
living with cancer and identify novel approaches to improve quality of life. 
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Joanna Arch, PhD is a clinical psychologist at the University of Colorado. Over the past 8 
years, Dr. Arch has led/leads four grant-funded studies of ACT interventions for cancer 
survivors with local cancer care centers. Dr. Arch, an early stage investigator, has strong 
institutional support from the University of Colorado and her department. First, Dr. Arch has a 
tenure-track appointment that reserves 40% of the academic year and 100% of the summer 
months for research. Second, Dr. Arch was given generous startup and retention funds of 
which sufficient funds remain to cover unexpected expenses on the proposed project. Third, as 
described above, Dr. Arch has ample designated space in which to conduct research, 
including ample space for the proposed project. Fourth, Dr. Arch’s department and the 
university voted unanimously to grant her tenure and to promote her to Associate Professor, 
reflecting strong positive feedback and support. Drs. Arch and Wright have been working 
together since 2017 and have a paper under review together on anxiety among cancer 
survivors.
17.0
Provisions to Protect the Privacy Interests of Subjects
Only study staff that have completed all required institutional and CITI training and are familiar 
with the protocol will contact patients for an informed consent. Subjects will be given the 
opportunity to ask questions during the informed consent process, as well as during study 
participation. The informed consent includes information about the minimal risk of being 
uncomfortable with certain interview questions regarding patients’ lived experiences with 
advanced cancer. Only study staff that completed training can access Epic. Study staff may 
conduct a limited review of a patient’s medical record in order to schedule the interview and 
extract demographic and clinical data for research purposes.
18.0
Compensation for Research-Related Injury
This study involves minimal risk to subjects. Therefore, no compensation is available to 
subjects in the event of research-related injury. This is explained clearly in the informed 
consent.
19.0
Economic Burden to Subjects
There are no costs associated with study participation. Participants will be compensated for 
their time and effort by receiving a $20 gift card for completing each survey plus a $5 bonus for 
completing it within 48 hours of our sending or administering it—up to $25/survey or $100 for 
all four. 
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Appendices 
Appendix A: Recruitment Letter 
Appendix B: Telephone Script and Verbal Consent Template 
Appendix C: Data Safety Monitoring Plan 
Appendix D: Registration Form and Baseline Interview 
Appendix E: Post-Baseline Interview 
Appendix F: Participant Interview Guide 
Appendix G: NCCN Educational Materials 
Appendix H: External Site Registration Form 
Appendix I: Session Rating Scale
Appendix J: Interventionist Slide Decks
Appendix K: Participant Workbook
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References 
1.
Gonzalez-Martin, A., et al., Niraparib in Patients with Newly Diagnosed Advanced 
Ovarian Cancer. N Engl J Med, 2019. 381(25): p. 2391-2402.
2.
U.S. Food & Drug Administration. FDA approved olaparib (LYNPARZA, AstraZeneca 
Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or 
suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) 
advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in 
complete or partial response to first-line platinum-based. 2018; Available from: 
https://www.fda.gov/drugs/fda-approved-olaparib-lynparza-astrazeneca-
pharmaceuticals-lp-maintenance-treatment-adult-patients.
3.
U.S. Food & Drug Administration. Niraparib (ZEJULA). 2017; Available from: 
https://www.fda.gov/drugs/resources-information-approved-drugs/niraparib-zejula.
4.
U.S. Food & Drug Administration. FDA approves olaparib tablets for maintenance 
treatment in ovarian cancer. 2017; Available from: https://www.fda.gov/drugs/resources-
information-approved-drugs/fda-approves-olaparib-tablets-maintenance-treatment-
ovarian-cancer.
5.
Ledermann, J., et al., Olaparib maintenance therapy in platinum-sensitive relapsed 
ovarian cancer. N Engl J Med, 2012. 366(15): p. 1382-92.
6.
Oza, A.M., et al., Quality of life in patients with recurrent ovarian cancer treated with 
niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, 
randomised controlled trial. Lancet Oncol, 2018. 19(8): p. 1117-1125.
7.
Ledermann, J.A., et al., Quality of life during olaparib maintenance therapy in platinum-
sensitive relapsed serous ovarian cancer. Br J Cancer, 2016. 115(11): p. 1313-1320.
8.
von Gruenigen, V.E., et al., Quality of life, symptoms and care needs in patients with 
persistent or recurrent platinum-resistant ovarian cancer: An NRG 
Oncology/Gynecologic Oncology Group study. Gynecol Oncol, 2018. 150(1): p. 119-
126.
9.
Hofman, M., et al., Cancer-related fatigue: the scale of the problem. Oncologist, 2007. 
12 Suppl 1: p. 4-10.
10.
Barsevick, A.M., et al., Recommendations for high-priority research on cancer-related 
fatigue in children and adults. J Natl Cancer Inst, 2013. 105(19): p. 1432-40.
11.
Bower, J.E., et al., Screening, assessment, and management of fatigue in adult 
survivors of cancer: an American Society of Clinical oncology clinical practice guideline 
adaptation. J Clin Oncol, 2014. 32(17): p. 1840-50.
12.
Poort, H., et al., Predictors and trajectories of fatigue in ovarian and uterine cancer. 
Journal of Clinical Oncology, 2019. 37(15_suppl): p. 11603-11603.
13.
Poort, H., et al., Fatigue in patients on oral targeted or chemotherapy for cancer and 
associations with anxiety, depression, and quality of life. Palliat Support Care, 2019: p. 
1-7.
14.
Gielissen, M.F., et al., Effects of cognitive behavior therapy in severely fatigued 
disease-free cancer patients compared with patients waiting for cognitive behavior 
therapy: a randomized controlled trial. J Clin Oncol, 2006. 24(30): p. 4882-7.
15.
Goedendorp, M.M., et al., Is increasing physical activity necessary to diminish fatigue 
during cancer treatment? Comparing cognitive behavior therapy and a brief nursing 
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intervention with usual care in a multicenter randomized controlled trial. Oncologist, 
2010. 15(10): p. 1122-32.
16.
Abrahams, H.J.G., et al., The efficacy of Internet-based cognitive behavioral therapy for 
severely fatigued survivors of breast cancer compared with care as usual: A 
randomized controlled trial. Cancer, 2017. 123(19): p. 3825-3834.
17.
Poort, H., et al., TIRED: A randomised controlled trial evaluating efficacy of cognitive 
behavior therapy and graded exercise therapy in severely fatigue patients with 
advanced cancer. Journal of Clinical Oncology, 2018. 36(34_suppl): p. 183-183.
18.
Hayes SC, S.K., Wilson KG., , Acceptance and Commitment Therapy: An Experiential 
Approach to Behavior Change. 1999, New York, NY: Guilford Press.
19.
Hayes, S.C., et al., Acceptance and commitment therapy: model, processes and 
outcomes. Behav Res Ther, 2006. 44(1): p. 1-25.
20.
Rost, A.D., et al., Improving psychological adjustment among late-stage ovarian cancer 
patients: Examining the role of avoidance in treatment. Cognitive and Behavioral 
Practice, 2012. 19(4): p. 508-517.
21.
Webber, K., et al., OVQUEST - Life after the diagnosis and treatment of ovarian cancer 
- An international survey of symptoms and concerns in ovarian cancer survivors. 
Gynecol Oncol, 2019. 155(1): p. 126-134.
22.
Matulonis, U.A., et al., Long-term adjustment of early-stage ovarian cancer survivors. Int 
J Gynecol Cancer, 2008. 18(6): p. 1183-93.
23.
Arch, J.J. and J.L. Mitchell, An Acceptance and Commitment Therapy (ACT) group 
intervention for cancer survivors experiencing anxiety at re-entry. Psychooncology, 
2016. 25(5): p. 610-5.
24.
Arch, J.J., et al., A randomized controlled trial of a group acceptance-based intervention 
for cancer survivors experiencing anxiety at re-entry ('Valued Living'): study protocol. 
BMC Cancer, 2019. 19(1): p. 89.
25.
Arch, J.J., et al., Acceptability, Feasibility, and Efficacy Potential of a Multimodal 
Acceptance and Commitment Therapy Intervention to Address Psychosocial and 
Advance Care Planning Needs among Anxious and Depressed Adults with Metastatic 
Cancer. J Palliat Med, 2020.
26.
Hann, D.M., M.M. Denniston, and F. Baker, Measurement of fatigue in cancer patients: 
further validation of the Fatigue Symptom Inventory. Qual Life Res, 2000. 9(7): p. 847-
54.
27.
Hann, D.M., et al., Measurement of fatigue in cancer patients: development and 
validation of the Fatigue Symptom Inventory. Qual Life Res, 1998. 7(4): p. 301-10.
28.
Spitzer, R.L., et al., A brief measure for assessing generalized anxiety disorder: the 
GAD-7. Arch Intern Med, 2006. 166(10): p. 1092-7.
29.
Lowe, B., et al., Validation and standardization of the Generalized Anxiety Disorder 
Screener (GAD-7) in the general population. Med Care, 2008. 46(3): p. 266-74.
30.
Andersen, B.L., et al., Screening, assessment, and care of anxiety and depressive 
symptoms in adults with cancer: an American Society of Clinical Oncology guideline 
adaptation. J Clin Oncol, 2014. 32(15): p. 1605-19.
31.
Kroenke, K., R.L. Spitzer, and J.B. Williams, The PHQ-9: validity of a brief depression 
severity measure. J Gen Intern Med, 2001. 16(9): p. 606-13.
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32.
Lowe, B., et al., Measuring depression outcome with a brief self-report instrument: 
sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord, 2004. 
81(1): p. 61-6.
33.
Thekkumpurath, P., et al., Screening for major depression in cancer outpatients: the 
diagnostic accuracy of the 9-item patient health questionnaire. Cancer, 2011. 117(1): p. 
218-27.
34.
Johns, S.A., et al., Longitudinal comparison of three depression measures in adult 
cancer patients. J Pain Symptom Manage, 2013. 45(1): p. 71-82.
35.
Spitzer, R.L., K. Kroenke, and J.B. Williams, Validation and utility of a self-report version 
of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental 
Disorders. Patient Health Questionnaire. Jama, 1999. 282(18): p. 1737-44.
36.
Simard, S. and J. Savard, Fear of Cancer Recurrence Inventory: development and initial 
validation of a multidimensional measure of fear of cancer recurrence. Support Care 
Cancer, 2009. 17(3): p. 241-51.
37.
Lebel, S., et al., Empirical validation of the English version of the Fear of Cancer 
Recurrence Inventory. Qual Life Res, 2016. 25(2): p. 311-321.
38.
Basen-Engquist, K., et al., Reliability and validity of the functional assessment of cancer 
therapy-ovarian. J Clin Oncol, 2001. 19(6): p. 1809-17.
39.
Voils, C.I., et al., Initial validation of a self-report measure of the extent of and reasons 
for medication nonadherence. Med Care, 2012. 50(12): p. 1013-9.
40.
Lukkahatai, N. and L.N. Saligan, Association of catastrophizing and fatigue: a 
systematic review. J Psychosom Res, 2013. 74(2): p. 100-9.
41.
Jacobsen, P.B., M.A. Andrykowski, and C.L. Thors, Relationship of catastrophizing to 
fatigue among women receiving treatment for breast cancer. J Consult Clin Psychol, 
2004. 72(2): p. 355-61.
42.
de Vree, B.P.W., Van der Werf, S. P., Prins, J. B., Bazelmans, H. M., Vercoulen, J. H. 
M. M., Servaes, P., & de Vries, M., , Meetinstrumenten bij chronische vermoeidheid. 
[Measurement of chronic fatigue]. Gedragstherapie, 2002. 35: p. 157–164.
43.
Gamez, W., et al., Development of a measure of experiential avoidance: the 
Multidimensional Experiential Avoidance Questionnaire. Psychol Assess, 2011. 23(3): 
p. 692-713.
44.
Gamez, W., et al., The brief experiential avoidance questionnaire: development and 
initial validation. Psychol Assess, 2014. 26(1): p. 35-45.
45.
Matthew Smout, M.D., Nicholas Burns, Alison Christie,, Development of the Valuing 
Questionnaire (VQ). Journal of Contextual Behavioral Science,, 2014. Volume 3, (Issue 
3,): p. 164-172,.
46.
Harkness, A., V. Behar-Zusman, and S.A. Safren, Understanding the Impact of COVID-
19 on Latino Sexual Minority Men in a US HIV Hot Spot. AIDS Behav, 2020.
47.
Research, U.o.M.C.o.E.f.H.D. Pandemic Stress Index (PSI). 2020  [cited 2020 May 8]; 
Available from: https://elcentro.sonhs.miami.edu/research/measures-library/psi/psi-
english/index.html.
48.
Weiner, B.J., et al., Psychometric assessment of three newly developed implementation 
outcome measures. Implement Sci, 2017. 12(1): p. 108.
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