Building Resiliency Among Caregivers of Curvivors and Metavivors: A Pilot Randomized Trial
Phase: NA
Conditions: Stress, Cancer Diagnosis, Distress, Emotional
Sponsor: Massachusetts General Hospital

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
Page 1 of 33 
 
 
PROTOCOL TITLE: 
Building Resiliency Among Caregivers of Curvivors and Metavivors: A 
Pilot Randomized Trial  
 
*Sponsor-Investigator: 
 
Name: Elyse R. Park, PHD MPH 
 
Institution: Massachusetts General Hospital 
 
e-mail address: epark@partners.org 
 
 
*Principal Investigators (PI): 
 
Name: Elyse R. Park, PHD MPH 
 
Institution: Massachusetts General Hospital 
 
Address: 100 Cambridge Street, 15th floor, Boston MA, 
 
02114 
 
Telephone: 617-724-6836 
 
Fax: 617-724-4738 
 
e-mail address: epark@partners.org 
 
 
 
PROTOCOL NUMBER: 22-357 
 
VERSION NUMBER: 
Version 3.14 
DATE: 
1/29/2025

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
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Table of Contents 
1.0 
Objectives ................................................................................................................ 3 
2.0 
Background .............................................................................................................. 3 
3.0 
Inclusion and Exclusion Criteria .............................................................................. 6 
4.0 
Study-Wide Number of Subjects ............................................................................. 7 
5.0 
Study-Wide Recruitment Methods .......................................................................... 7 
6.0 
Multi-Site Research ................................................................................................. 8 
7.0 
Study Timelines ....................................................................................................... 8 
8.0 
Study Endpoints ....................................................................................................... 9 
9.0 
Procedures Involved............................................................................................... 10 
10.0 Data and Specimen Banking .................................................................................. 17 
11.0 Data Management* and Confidentiality ................................................................ 17 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 21 
13.0 Withdrawal of Subjects .......................................................................................... 21 
14.0 Risks to Subjects .................................................................................................... 21 
15.0 Potential Benefits to Subjects ................................................................................ 22 
16.0 Vulnerable Populations .......................................................................................... 22 
17.0 Community-Based Participatory Research ............................................................ 22 
18.0 Sharing of Results with Subjects* ......................................................................... 22 
19.0 Setting .................................................................................................................... 22 
20.0 Resources Available............................................................................................... 23 
21.0 Prior Approvals ...................................................................................................... 23 
22.0 Recruitment Methods ............................................................................................. 23 
23.0 Local Number of Subjects ..................................................................................... 23 
24.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 23 
25.0 Compensation for Research-Related Injury ........................................................... 24 
26.0 Economic Burden to Subjects ................................................................................ 24 
27.0 Consent Process ..................................................................................................... 24 
28.0 Process to Document Consent in Writing .............................................................. 24 
29.0 Drugs or Devices.................................................................................................... 24 
 

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
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1.0 
Objectives 
This is a randomized controlled trial assessing an evidence-based mind-body group 
resiliency treatment, the Stress Management and Resiliency Training-Relaxation Response 
Program (SMART-3RP) to intervene on 58 caregivers and cancer survivor dyads with the 
following aims: 
 
Aim 1. To determine the feasibility and acceptability of the SMART-3RP for cancer 
caregivers and survivors. Feasibility will be assessed by the percent of survivor/ 
caregivers who are eligible and enroll, complete the follow-up survey, and intervention 
session attendance. Acceptability will be assessed by intervention satisfaction (e.g., 
structure, delivery and content) reported via the follow-up survey and exit interview. 
Hypothesis 1a: We hypothesize: > 45% enrollment of eligible participants, >70% 
completion of 3-month follow-up survey, and >70% complete 6/9 intervention sessions 
(intake + 8 sessions). Hypothesis 2a: We hypothesize >75% satisfaction (4/5) with the 
study intervention. Aim 1b. We will also examine the feasibility and acceptability of 
collecting hair samples to examine intervention-related changes in cortisol, a stress 
biomarker. 
 
Aim 2. To determine the preliminary efficacy of the SMART-3RP for improving 
resiliency in caregivers and survivors. Hypothesis: Caregivers and survivors randomized 
to SMART-3RP will demonstrate greater improvements in resiliency compared to those 
randomized to enhanced usual care (online support groups). Secondary outcomes include 
(a) caregiver and survivor stress management and growth enhancement processes and (b) 
biobehavioral assessment of chronic stress (hair cortisol). 
 
Aim 3: To explore effects of SMART-3RP on caregivers’ and survivors’ health care 
utilization (e.g., hospitalizations, ED visits, surveillance, preventive services, and 
mental healthcare services). 
 
2.0 
Background 
2.1 Overview 
Caregivers of cancer survivors experience chronic, ongoing stress which affects their 
emotional and physical health. Caregivers of cancer survivors experience chronic 
ongoing stress that spans the survivorship continuum. When unmanaged, this chronic stress 
leads to substantial emotional distress as caregivers  help patients navigate the physical 
and psychological toll of the patient’s illness.1 Caregivers for cancer survivors report 
unaddressed needs (e.g., psychosocial, medical, financial),2 in particular multiple unmet 
psychological needs (e.g., anxiety, distress)3, 4 extending years following a patient’s 
diagnosis.5 Furthermore, caregivers of cancer survivors report low levels of resilience, 
which  contribute to difficulties managing stress; this leads to high caregiver burden and 
low quality of life.6  These chronic caregiving roles may lead to worsening physical health,7, 
8 placing them at risk for morbidity.9 While the majority of caregivers of  cancer 
survivors report a willingness to accept psychological support, treatments to address the 

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
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needs of this population are lacking.3 We propose a novel, virtual group intervention to 
intervene upon caregiver resiliency and emotional distress.  
 
A growing number of cancer “curvivors” and “metavivors” has resulted in a growing 
population of caregivers who face ongoing stressors- irrespective of cancer diagnosis. 
With advances in early detection and cancer treatments, there is a growing population of 
cancer survivors who have completed curative therapy (i.e., curvivors). Similarly, targeted 
therapies and immunotherapy have revolutionized cancer care leading to a growing 
population of cancer survivors who live for many years with metastatic disease (i.e., 
metavivors). While metavivors is a term initially coined in describing survivors living with 
metastatic breast cancer, the advances in oncological therapies have created a rapidly 
growing population of metavivors across cancer diagnoses. Caregivers of curvivors and 
metavivors face similar ongoing challenges, such as fear of cancer recurrence/ progression, 
addressing treatment toxicities and late effects, emotional and financial distress.10, 11 The 
immense unmet needs of caregivers of curvivors and metavivors have been described 
across the continuum of survivorship, irrespective of cancer type. We propose fill the 
critical need to support these caregivers. 
 
Caregivers’ and survivors’ stress regulation and distress are often related.  
There is increasing recognition regarding the importance of reciprocal dynamics between 
patient and caregiver distress, underscoring the importance of addressing  needs among 
caregivers and patients to improve health outcomes.12 Patient distress is associated with 
poor caregiver health and vice versa.13, 14 Similarly, stress  regulation 
among 
cancer 
survivors and their caregivers is interdependent,15  and  benefit finding (i.e., deriving a 
positive growth from cancer) experiences are also interdependent.16 It is critical to attend, 
simultaneously, to the needs of caregivers and cancer survivors. We propose to intervene 
simultaneously, yet separately, on caregivers and survivors. 
 
Chronic stress may affect caregivers’ health through physiological mechanisms. 
Chronic stress can lead to the metabolic wear and tear described as  allostatic 
load.17 
Chronic stress is associated with increased adrenergic activation and an increase in cortisol 
levels over time, which may be reduced through skills that elicit the Relaxation Response 
(RR) state. RR is a physiological state of decreased arousal of the sympathetic nervous 
system.18-20 RR strategies are aimed  at reducing muscle tension, breathing rate, heart rate, 
and blood pressure. Eliciting  RR lessens the adverse physiological effects of stress.19-21  
Cortisol assessments  provide a biobehavioral measure of chronic stress. We will examine 
the biobehavioral effects of an RR-based intervention. 
 
Emotional distress may affect caregivers’ health due to deleterious healthcare 
utilization. Caregivers often have the responsibility of overseeing survivors’ follow-up 
care and appropriate use of health care services, such as cancer screening, preventive 
services22 and surveillance for late effects. Unmanaged emotional  distress could result in 
underutilization of appropriate healthcare services or overutilization of ED or urgent care 
visits and hospitalizations. Caregivers are at  risk for underutilizing appropriate healthcare 

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
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services,23 including mental  healthcare.24 We will assess the impact of our intervention 
on healthcare utilization.  
 
Resiliency skills leveraging growth enhancement can ameliorate the deleterious 
health effects of chronic stress. Resilience is often characterized as a response to 
adversity; specifically, it refers to a set of protective factors and resources within an 
individual and their environment that facilitate one’s ability to “bounce back.”25-33 
Resilience is demonstrated when one is able to maintain adaptive functioning when faced 
with ongoing chronic stress,30, 34-37 as experienced  by caregivers of curvivors and 
metavivors. Post-traumatic growth (i.e., positive changes that occur after a trauma) can 
occur among caregivers.38-41 Growth  enhancement skills (i.e., skills focused on post-
traumatic growth, a positive  change that occurs after a trauma) can increase resiliency 
and ameliorate the deleterious health effects of chronic stress.  
 
Interventions are needed that simultaneously address the needs of caregivers  and 
cancer survivors. Caregiver intervention studies have primarily focused on the impact of 
caregiving during active treatment or at the end of life in patients with advanced illness.42-
50 Few have addressed the chronic, unrelenting demands facing caregivers of cancer 
curvivors and metavivors during the survivorship phase of illness. Interventions conducted 
to support cancer survivors and caregivers have cognitive-behavioral therapy (CBT) skills 
51  have yielded small  effect sizes. Pilot studies explored the effects of mindfulness and 
positive psychology approaches for caregivers;48, 52-54 but differ from the proposed study 
in terms of the targeted population, delivery time, delivery modality, and outcomes. 
Resiliency interventions are critically needed that are delivered virtually,  incorporate 
mind-body, CBT and positive psychology skills, and simultaneously address the needs of 
caregivers of curvivors and metavivors. 
 
Resiliency intervention conceptual framework. Our team has developed a resiliency 
intervention, the Stress Management and Resiliency Training: Relaxation Response 
Resiliency Program (SMART-3RP)55 which has shown promising efficacy for improving 
resilience and reducing stress among individuals with a myriad of physical and 
psychological symptoms.56  This framework (Figure 1) is informed by the diathesis-stress 
model,57 which posits  that resilience is 
the 
outcome 
of 
an 
individual’s 
experiences 
and 
environment, 
in 
combination with one’s coping ability. 
The 
SMART-3RP 
emphasizes 
the 
elicitation of the Relaxation Response 
(RR) as an internal physiological state 
that facilitates the effective use of coping 
skills to combat the deleterious effects of 
chronic stress. (1) Mind-body techniques 
promote elicitation of the RR through 
mind-body practices, such as meditation, 

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
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mindfulness, guided imagery, and contemplation. (2) CBT skills teach individuals to 
reappraise their thoughts, beliefs, and expectations about stressors to promote adaptive 
coping and to better manage stressors. This work is guided by Lazarus and Folkman’s 
transactional model of stress and coping,58  which suggests that the experience of stress 
depends on the  interplay between the situation and a person’s appraisal of it. (3) Positive 
psychology strategies focus on increasing positive affect, self-compassion, and 
connectedness to oneself and to others. This component is guided by a positive 
psychology59 lens and post-traumatic growth perspective that stressful events can lead to 
greater personal growth.60, 61 The resiliency processes that result are achieving RR state, 
stress management, and growth enhancement, which collectively build resiliency. 
 
3.0 
Inclusion and Exclusion Criteria 
3.1. Screening Procedures  
The study team will utilize an EHR-based screening algorithm to identify potentially 
eligible survivors, which we have utilized in MGH-based clinical and research programs. 
A dashboard of potentially eligible survivors will be generated from the EHR program. 
The research assistant (RA) will then review the survivors’ EHR to ensure they meet the 
study eligibility criteria.  
 
3.2. Eligibility Criteria. 
Patient Eligibility Criteria 
Patient Inclusion Criteria 
1. English speaking adult patients with cancer (18 years or older)  
2. Treated at MGH, who are either within approximately: 
• 3 months to 5 years after completing potentially curative therapy for cancer 
diagnosis including surgery, radiation, and/or chemotherapy or other novel 
therapies (e.g., immunotherapy, biological therapy). Patients can be on long-
term maintenance hormonal or biological therapy at the time of enrollment. 
• 3 months after diagnosis of metastatic disease with an expected prognosis of >1 
year as confirmed by the treating oncology clinician 
3. Able to identify a caregiver (i.e., spouse/partner or patient-identified family member or 
friend) who is willing to participate in the study 
Patient Exclusion Criteria: 
1. Prognosis less than one year as determined by the treating oncology clinician 
2. Active psychiatric or cognitive comorbidity that prohibits the capacity to provide 
informed consent as determined by the treating oncology clinician 
3. Patients without a caregiver who is willing to participate 
4. Patients enrolled in another supportive care trial 
Caregiver Eligibility Criteria 
Caregiver Inclusion Criteria: 

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
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1. English speaking adult caregiver (age 18 years or older) 
2. Identified by the patient as the spouse/partner or family member/friend62  
3.3. Special populations 
We will not enroll the following special populations: adults unable to consent, 
individuals who are not yet adults, pregnant women, and prisoners. 
 
4.0 
Study-Wide Number of Subjects 
This study will enroll 58 patient-caregiver dyads (n=116 total) from the MGH Cancer 
Center. 
 
5.0 
Study-Wide Recruitment Methods 
Participants will be recruited through an EHR-based screening tool that uses a tailored 
algorithm to identify cancer survivors who have completed cancer treatment and 
metavivors who are on active therapy. The EHR-based algorithm has been previously used 
at MGH for clinical and research programs. The RA will review survivors identified 
through the EHR-based algorithm to ensure they meet study eligibility criteria. 
Additionally, participants will be recruited from referring oncology clinicians, local 
support groups, survivorship events, flyers posted in MGH Cancer Center clinics, and 
social media using IRB-approved flyers. Study staff will also submit a recruitment 
advertisement to the MGB Rally Recruitment Portal. Through this portal, interested and 
potentially eligible patients will be able to send their contact information to the study staff. 
 
Once a potentially eligible patient-caregiver dyad is identified, the RA will then 
communicate with the oncology clinician (i.e., attending physician, or the advance practice 
provider) via email, through the electronic health record, or verbally to notify them that the 
patient is eligible for the study and inquire about any concerns regarding their participation. 
For metavivors, the RA will also ask the oncology clinician to confirm their eligibility for 
study participation using the surprise question “Would you be surprised if this patient died 
within 12 months” (Y/N)63 and confirm an expected prognosis >12 months as well as 
confirm cognitive and psychiatric fitness to participate. 
 
If the oncology clinicians have objections to their patients’ or caregivers’ participation in 
the study, we will document the reason and not approach those individuals. If the oncology 
clinicians have no objections, the RA will approach the potentially eligible patient-
caregiver dyad and inform them that their oncology clinician have agreed for them to be 
contacted for the study and review the details the nature of all study procedures. The RA 
will also ask to send the patient a recruitment letter via Patient Gateway or email that 
provides an overview of the study and a link to an outreach informational video. The RA 
can approach the patient-caregiver dyad in-person during their oncology visit or over the 
telephone/video or mail and obtain verbal consent. Reasons for refusal and ineligibility will 
be documented. Eligible and interested survivors will be asked to identify a caregiver. If 

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
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eligible, the RA will review the study procedures with potential dyads and obtain verbal 
consent from each person.  
 
We are requesting a Waiver of Written Documentation of Consent  
This Waiver is being requested to assist with patient and caregiver recruitment. Our study 
meets the waiver requirements given our study is considered minimal risk and all study 
procedures could be conveyed orally. This waiver will reduce the risk to patients and 
caregivers who may not be coming regularly to the cancer center for their care and is 
necessary for our research procedures to continue.  
 
We are requesting a HIPAA Waiver of Authorization to Review Preparatory to 
Research from the IRB. We are requesting this Waiver to identify potential patient 
participants from a minimal chart review. In accordance with the DF/HCC policy, this 
Waiver: (1) is being sought solely to review Protected Health Information as necessary to 
prepare a research protocol, (2) will not include removing Protected Health Information 
from the Covered Entity by the researcher, and (3) is necessary for the research purposes. 
 
The RA will then administer the baseline questionnaire (detailed on section 9.1) in-person, 
online via REDCap, text, or by phone. If a patient-caregiver dyad signs the consent form 
but does not complete the baseline questionnaire within approximately 40 business days, 
they will neither be registered on the study nor count towards the accrual numbers. 
Participants who withdraw from the study or die during the study period will not be 
replaced and they will count towards the accrual numbers. 
 
We will register eligible participants in the Clinical Trials Management System (CTMS) 
Oncore as required by DF/HCC SOP REGIST-101. Registration must occur prior to the 
initiation of protocol-specific procedures or assessments. For registration of patients, study 
staff will complete the DF/HCC protocol-specific eligibility checklist using the eligibility 
assessment documented in the participant’s medical record and/or research chart. Study 
staff will confirm that the participant meets all inclusion criteria as described in this 
protocol and the criteria on the eligibility checklist.  
 
Participants will be randomized to the SMART-3RP intervention or enhanced usual care 
using a computer-generated 1:1 randomization schema, stratified by survivor status 
(curvivor/metavivor).  Patients who have completed the baseline survey will be assigned 
to treatment arm according to the randomization schema list. 
 
6.0 
Multi-Site Research 
 Not applicable since this is a single center study. 
 
7.0 
Study Timelines 
Patient-caregiver dyads will remain on the study for approximately 6 months. Participants 
will be consented prior to randomization. Enrollment of all study subjects will occur over 

PROTOCOL TITLE: Building Resiliency Among Caregivers of Curvivors and 
Metavivors: A Pilot Randomized Trial  
 
 
Page 9 of 33 
 
approximately 12-15 months. It will take approximately two years to complete the 
primary analyses.  
 
8.0 
Study Endpoints 
8.1. Primary study endpoint. 
• To examine the feasibility of SMART-3RP for cancer caregivers and survivors 
(feasibility a priori defined in section 11.1) 
• 
To examine the acceptability of SMART-3RP for cancer caregivers and survivors 
 
8.2. Secondary endpoints. 
• To determine the preliminary efficacy of SMART-3RP to improve resilience in 
cancer caregivers and survivors 
• To determine the preliminary efficacy of SMART-3RP on improving stress 
management in cancer caregivers and survivors 
• To determine the preliminary efficacy of  SMART-3RP in promoting growth 
enhancement 
• To determine the preliminary efficacy of  SMART-3RP in reducing chronic stress 
(hair cortisol) 
 
8.3. Exploratory endpoints. 
• To compare hospitalizations between survivors receiving SMART-3RP versus 
enhanced usual care 
• To compare urgent care and emergency department (ED) visits between survivors 
receiving SMART-3RP versus enhanced usual care 
• To compare primary care visits between survivors receiving SMART-3RP versus 
enhanced usual care 
• To explore use of mental health services (e.g., social work, psychiatry, psychology, 
and other mental health professionals, and support groups, occurring within and 
outside of MGH) and psychiatric medication between survivors receiving SMART-
3RP versus enhanced usual care 
• To compare hospitalizations between caregivers receiving SMART-3RP versus 
enhanced usual care 
• To compare urgent care and ED visits between caregivers receiving SMART-3RP 
versus enhanced usual care 
• To compare primary care visits between caregivers receiving SMART-3RP versus 
enhanced usual care 
• To explore use of mental health services (social work, psychiatry, psychology, and 
other mental health professionals, and support groups, occurring within and outside 
of MGH), psychiatric medication between caregivers receiving SMART-3RP 
versus enhanced usual care 

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9.0 
Procedures Involved 
9.1. Study Design 
This is a single site pilot randomized clinical trial of SMART-3RP versus enhanced usual 
care to simultaneously intervene with 58 caregiver and cancer survivor dyads (n=116) 
(Figure 1). Survivors and caregivers will be randomized together, stratified by survivor 
status (curvivor/metavivor), using a random plan generator  with 1:1 randomization. 
 
9.2. Study Intervention and Comparator 
This pilot randomized controlled trial assesses the feasibility, acceptability, and efficacy of 
SMART-3RP for improving resiliency among caregivers and cancer survivors compared 
to enhanced usual care.  
 
Intervention. The SMART-3RP has been created at the 8th grade reading level. 64  The 
intervention components include: 1. Eliciting the relaxation response (RR) involves 
sustained mental focus with an attitude of open receptive awareness. 2. CBT to improve 
stress management involves increasing awareness and identification of the components of 
one’s stress response (negative thoughts, emotions, physical reactions, behaviors, and 
relational) and learning skills at each session to alter these components (e.g., cognitive 
restructuring). 3. Positive psychology strategies to achieve growth enhancement focus on 
utilizing techniques and skills to promote positive growth. Skills focus on increasing social 
support, positive affect, and compassion. Study interventionists trained in the SMART-
3RP (e.g., participated in the Benson-Henry Institute for Mind Body Medicine SMART-
3RP training program https://bensonhenryinstitute.org/training-apply-for-certification/ 
and/or co-facilitated a clinical SMART-3RP group within the MGH Cancer Center) will 
deliver the SMART-3RP via virtual HIPAA-compliant videoconferencing technology, 
Zoom, that is accessible via smartphone, laptop, tablet, desktop. The intervention consists 
of a group intake session and eight 1.5 hour sessions. The  sessions will be conducted 
separately, with survivors and caregivers (n= approximately 8 per group). A recording link 
with the session’s RR-elicitation method will be sent via REDCap after each session. The 
session content is detailed on Table 2. Participants may be sent reminders (e.g., emails 
and/or text messages, phone calls) to remind of them of the group time prior to each session. 
The RA may assist participants with teleconferencing software set up and may complete 
test calls to ensure proficiency with the software prior to the group initiation. The RA will 
be available to assist with any questions. Participants will also be sent a link via REDCap 
for an option to document their practice of skills provided in the intervention. 
 
Table 2. Resiliency Program Content 
Intake Session  
Introducing Resiliency and the 
Relaxation Response 
• 
Resiliency and the Relaxation Response 
• 
Core components of the program 
• 
Setting SMART and resiliency goals 
• 
Monitoring Stress and Coping 
Session 1 
Stress Management and Resiliency 
Training 
• 
Stress & Relaxation Response and Allostatic Load 
• 
Energy Battery: stress and resiliency inducing factors 
• 
Appreciation 

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Metavivors: A Pilot Randomized Trial  
 
 
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• 
RR-elicitation method: single pointed focus mediation 
and breath awareness 
Session 2 
The Relaxation Response 
• 
Stress Warning Signs 
• 
Recuperative Sleep 
• 
Mini RR 
• 
RR-elicitation method: body scan or autogenic 
training 
Session 3 
Stress Awareness and Buffering 
• 
Identifying emotions and positive physical sensations 
• 
Social Support 
• 
RR-elicitation method: Mindful Awareness 
Session 4 
Mending the Mind and Body 
• 
Thoughtful Distortions 
• 
Negative Automatic Thoughts 
• 
RR-elicitation method: chair yoga 
Session 5 
Creating an Adaptive Perspective 
• 
Creating adaptive perspectives 
• 
Problem-Solving vs Acceptance 
• 
Healthy Eating 
• 
RR-elicitation method: insight imagery 
Session 6 
Promoting Positivity 
• 
Strategies for enhancing positivity 
• 
Relaxation Signals 
• 
Promoting physical activity 
• 
RR-elicitation method: lovingkindness meditation 
Session 7 
Healing States of Mind 
• 
Empathy and self-compassion 
• 
Creativity 
• 
RR-elicitation method: compassion meditation 
Session 8 
Humor & Staying Resilient 
• 
Staying Resilient 
• 
Humor 
• 
RR-elicitation method: idealized self 
 
Enhanced Usual Care. Survivors and caregivers randomized to enhanced usual  care 
will be referred to an online support group at cancare.org. The MGH Cancer Center 
resource center refers patients to these groups. These groups are held separately for cancer 
survivors and caregivers. Participants use a password-protected message board format to 
participate in groups that are facilitated by oncology social workers who provide support 
for loneliness and emotional  distress; teach coping, enhancing feelings of  hope 
and 
empowerment, and promote use of social support. Participants´ attendance data will be 
provided by Cancare.org. Patient data will be transferred using a HIPAA-compliant 
Dropbox account for secure file transfer.  
 
 
9.3. Fidelity of Study Design, Methods, and Intervention 
We will monitor treatment fidelity following recommendations of  the Treatment Fidelity 
Workgroup of the NIH Behavior Change Consortium.65 An evidence-based intervention 
manual will be used. Systematic screening and enrollment  strategies 
will 
minimize 
participation bias. Participation rates will be tracked and characteristics between 
participants and non-participants examined. To ensure that the delivery of SMART-3RP is 
consistent, all intervention sessions will be audio-recorded. The study interventionists will 
complete post-session REDCap surveys indicating  attendance 
and 
session 
topics 

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Metavivors: A Pilot Randomized Trial  
 
 
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covered. Drs. Park and Perez will oversee all intervention delivery and treatment fidelity 
aspects of the project, as well as the exit interview qualitative data collection and analyses 
to ensure intervention  fidelity.  
 
9.4. Study Measures 
Participants Self-Report Measures. Caregivers and survivors will complete self-report 
measures at baseline, 3 and 6 months after enrollment (Table 3). Participant-reported 
measures are selected based on our prior studies and the theoretical framework of our 
SMART-3RP, documenting resiliency, coping, and psychological distress. Participants 
will receive a $20 gift card for each survey completed. 
 
Patient and Caregiver Measures 
Baseline only: 
• Demographics and Health Measures: age, sex, gender identity, ethnicity, race, 
marital status, language, religiosity, education, employment status and health 
insurance coverage. For caregivers only: caregiver type and whether or not living 
with patient).  
• Self-Administered Comorbidities Questionnaire (SACQ-16): 14-item assessment of 
common medical problems and severity (survivors only) 
• PROMIS Cognitive Function (PROMIS-CF): 8-item scale assessing cognitive 
functioning (survivors only) 
Baseline and 3-month follow-up: 
• The Current Experiences Scale (CES):67 23-item measure of resilience 
• Measure of Current Status (MOCS-A):68 13-item scale examining coping skills 
• 
Distress Scale: 3 0-10 analog scale items examining distress, stress, and coping  ability 
• Generalized Anxiety Disorder Scale (GAD-2):69 2-iem scale examining symptoms of 
anxiety 
• Patient Health Questionnaire (PHQ-2):69 2-item scale examining symptoms of 
depression 
• Penn State Worry Questionnaire (PSWQ-3):70 3-item subscale of the tendency 
towards worry 
• Cognitive and Affective Mindfulness Scale-Revised (CAMS-R-12):71 12-item scale 
of mindfulness 
• Self-Compassion Scale-Short Form (SCS-SF-12):72 12-item short form scale for self-
compassion  

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• Patient Reported Outcome Measure Information System for Social Support 
(PROMIS-Social Support-8):73 8-item subscale to examine emotional and 
informational support 
• Positive and Negative Affect Schedule (PANAS-A-10):74 10-item scale assessment 
of positive affect 
• World Health Organization Wellbeing Index (WHO-5):84 5-item scale examining 
current mental-wellbeing 
• Measure of Relationship  Quality: 5-item scale examining perceived quality of 
caregiving relationship 
• Measure of Communication: 7-item scale examining perceived quality of 
communication in caregiving relationship (survivors only) 
• Cancer Screening Questions: 6-item scale for females and 4-item scale for males 
examining cancer screening history 
• Likert scale: 3 or 5-response scale to examine intervention satisfaction, needs met, 
program quality structure (delivery methodology, length and number of sessions), and 
helpfulness (intervention group only) 
• Group Cohesiveness Scale (GCS-7):75 7-item scale examining level of perceived 
connectedness (intervention group only) 
• Participants self-reported use of health care: see Section 9.5. for more detail 
 
Table 3. Survivor and Caregiver Outcomes  
 
 
Outcome 
Name of outcome 
Measure 
Survivor/Caregiv
er 
Timepoints 
Primary 
Feasibility 
Percentage of enrollment, follow-
up survey completion, and 
intervention session attendance 
Both 
Baseline, 3 
months, 6 
months  
Primary 
Acceptability 
Likert scale items of satisfaction, 
needs met, program quality, 
structure and helpfulness  
GCS 
Participant-reported RR practice  
Both 
3 months 
Secondary 
 
Resilience 
CES 
Both 
Baseline, 3 
months 
Secondary 
Stress 
management: 
coping 
MOCS-A  
Both 
Baseline, 3 
months 
Secondary 
Stress 
management: 
Distress Scale 
cortisol levels from hair samples 
Both 
Baseline, 3 
months 
 
84  

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distress, stress and 
coping ability  
Secondary 
Stress 
management: 
emotional distress 
GAD-2, PHQ-2 
Both 
Baseline, 3 
months 
Secondary 
Stress 
management: 
worry/stress 
cognitions 
PSWQ-3 
Both 
Baseline, 3 
months 
Secondary 
Stress 
management: 
mindfulness 
CAMS-R-12 
Both 
Baseline, 3 
months 
Secondary 
Growth 
enhancement: self-
compassion 
SCS-SF-12 
Both 
Baseline, 3 
months 
Secondary 
Growth 
enhancement: 
social support 
PROMIS-Social Support-8 
Both 
Baseline, 3 
months 
Secondary 
Growth 
enhancement: 
positive affect 
PANAS-A-10 
Both 
Baseline, 3 
months 
Exploratory 
Growth 
enhancement: 
well-being 
WHO-5 
Both 
Baseline, 3 
months  
Exploratory 
Growth 
enhancement: 
relationship quality 
Measure of Relationship Quality 
Both 
Baseline, 3 
months 
Exploratory 
Growth 
enhancement: 
communication 
quality 
Measure of Communication 
Survivors  
Baseline, 3 
months 
Exploratory 
Healthcare 
utilization: 
participant-
reported 
Cancer Screening Questions  
Both 
Baseline, 6 
months 
Exploratory 
 
Healthcare 
utilization: EHR 
data extraction 
(survivors only) 
Overutilization: number of 
hospitalizations, number of ED 
visits 
Underutilization: adherence to 
NCCN cancer restaging 
recommendations (e.g., 
surveillance scans), age-
appropriate cancer screening, 
primary care visits, vaccines, and 
mental health services (e.g., 
outpatient psychological or 
psychiatric visits)  
Survivors 
6 months 
Exploratory  
Healthcare 
utilization: 
participant-
reported (survivors 
and caregivers) 
Overutilization: number of 
hospitalizations, number of 
urgent care and ED visits 
Underutilization: age-appropriate 
cancer screening, primary care 
Both 
6 months 

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visits, vaccines, and mental health 
services and psychiatric 
medications 
Covariates 
Medical 
problems/severity 
SACQ-16 
Survivors  
Baseline 
Covariates  
Cognitive 
functioning 
PROMIS-CF 
Survivors 
Baseline 
 
Hair cortisol sampling. At enrollment and 6-month follow-up, participants will be asked 
to provide a hair sample. Hair cortisol collection at the 6-month follow-up will reflect 
cortisol concentration in the 3-month period following the end of the intervention. 
Participants will not be required to provide a sample; participants with insufficient hair 
length will be excluded from sample collection. Participants who are taking hormonal or 
steroidal medications will also be excluded from sample collection. Cortisol assessments 
provide a biobehavioral measure of stress level. Hair cortisol provides a more robust 
assessment of cortisol concentration levels across longer periods68, 77  and may be less 
burdensome and easier to collect than saliva sampling.78 Participants will receive a $25 gift 
card for each hair cortisol sample collected. A hair cortisol collection instruction sheet will 
be mailed/emailed to participants. 
 
9.5. Data collection 
We will develop data collection tools, dictionaries, collection instructions and the REDCap 
database to ensure that we collect data systematically from all study participants. We will 
ask participants to provide their email address to allow us to send study assessments via 
REDCap and will inquire their preferences for encrypted or unencrypted delivery. 
Preference for unencrypted delivery will be documented prior to email delivery. 
Participants can also choose to complete the questionnaire verbally over the telephone. The 
participant-reported assessments take approximately 10-15 minutes to complete and 
qualitative interviews approximately 30 minutes to complete. We will also track the 
method of assessment completion. 
 
Data obtained from Electronic Health Records (EHR). In addition to collecting data on 
healthcare utilization from the EHR, the study staff will also extract clinical and treatment 
data at 6 months including survivor status (curvivor vs. metavivor), ECOG performance 
status, cancer type, cancer diagnosis date, treatment(s) completion, treatments received, 
cancer stage, time since diagnosis, second primary  tumors/recurrence and death, and 
clinical comorbidities 
 
 
Data reported by participants. Participants will complete self-reported measures at 
baseline, 3 and 6 months (Table 3) in-person, online via REDCap, or by phone or mail. 
Exit interviews: Following completion of their 3-month follow-up measures, 
approximately 10 intervention curvivor-caregivers and 10 metavivor-caregivers will be 
randomly selected to participate in in-depth interviews. We estimate the 10 are needed for 
each strata (survivor status/caregiver status) to reach thematic saturation (no new data are 

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obtained).77 Using a semi-structured  interview guide, study staff will conduct virtual 
interviews. Participants will be asked open-ended questions about a) study outreach (video, 
modality), b) intervention content (topics most and least helpful), c) group format, d) 
virtual 
delivery 
(simultaneous 
intervention, 
group), 
and 
e) 
participation 
barriers/challenges. Participants will receive a $25 gift card for completion of the exit 
interview. 
 
Data on feasibility, acceptability and preliminary efficacy. Feasibility (Aim 1)  will be 
assessed by 1) the percent of eligible participants (survivors, caregivers) approached that 
enroll, 2) the percent of participants who complete the follow-up survey, and 3) the number 
of sessions attended (interventionists after session surveys and cancare.org). Additionally, 
we will analyze the exit interviews to assess the study outreach strategies, intervention 
content (topics most and least helpful), c) group format, d) virtual delivery (simultaneous 
intervention, group), and e) participation barriers/challenges.  Acceptability (Aim 1) will 
be examined on overall intervention satisfaction, program quality, structure, needs met and 
helpfulness as well as level of perceived connectedness and between session RR practice. 
We will also examine the results of the survey and exit interviews to assess the intervention 
content, group and format delivery.  Efficacy (Aim 2, Table 3) will be evaluated based on 
the comparative effectiveness of SMART-3RP and enhanced usual care on patient-reported 
measures documenting resiliency, coping, and psychological distress (see Figure 1). All 
participant-reported measures have strong psychometric properties with high internal and 
external validity and responsiveness to change, are well validated and commonly used in 
this population in our trials as well as in other studies.55, 79-82  
Data on healthcare utilization (Aim 3, Table 3). At around 6 months, data on health care 
utilization will be collected from the EHR (survivors) and the self-report forms (survivors 
and caregivers) that have been previously used in prior studies.83  Survivor´s data collected 
from EHR will include number of primary care visits, ED visits, and hospitalizations, as 
well as the use of mental health services including outpatients psychological or psychiatric 
visits. Survivors and caregivers will self-report healthcare utilization in measures 
previously used83 that capture number of urgent visits, visits to the ED, use and frequency 
of mental health services (including social work, psychiatry, psychology, and other mental 
health professionals, and support groups) over the past months at and outside of MGH. 
We will also ask psychiatric medications used (e.g., anxiolytics, antidepressants, sedatives, 
and stimulants).  
Hair cortisol collection. Participants will be asked to provide hair samples at enrollment 
and 6-month follow-up to measure potential changes in cortisol (“stress hormone”) 
except those on hormonal or steroidal medications. This method has been used 
successfully in stress studies and is currently being utilized in other 3RP studies led by 
study co-investigator, Dr. Perez (DF/HCC #17-063 and DF/HCC #18-248 PI: Perez). 
Hair grows roughly 1cm/month, thus ensuring sufficient growth for collection. The RA 
will mail/email detailed sampling instructions (See instructions sheet) and stamped, 
addressed envelopes to facilitate returns. Participants will be instructed to provide one 
hair sample at baseline and one sample at the 6-month follow-up. Hair cortisol collection 

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at 6-month follow-up will reflect cortisol concentration in the 3-month period following 
the end of the intervention. Participants will be instructed to cut a small sample of hair 
(approximately 150 strands, about the diameter of a small paperclip) from the back of 
their head, as close to the scalp as possible. They will be asked to tie the strands near the 
scalp end, place the sample in aluminum foil, and mail to MGH. See section 10.0 for 
storage of hair samples collected.   
 
10.0 Data and Specimen Banking 
 
Hair samples will be collected, labeled with study ID, stored at room temperature, and 
sent to Dr. Kestutis Bendinska´s laboratory at State University of New York at Oswego. 
Prior to shipping, samples will remain wrapped in aluminum foil, labeled with a study 
ID, and stored at room temperature in a padded envelope. 
 
11.0 Data Management and Confidentiality 
11.1. Sample Size and Power 
Sample size was based on the primary feasibility aim. Efficacy analyses will have 80% 
power at a significance level of 0.05 to detect an effect size of 0.57 for the  mean 
difference at 3-months based on a mixed models test for slope difference in a three-level 
hierarchical design with 2 measurements per subject, 2 subjects per dyad (1 survivor, 1 
caregiver), and 24 dyads per intervention group and assuming the correlation between 
baseline and 3-month values is 0.5. We have decided on a larger sample size than 24 dyads 
per intervention group to ensure adequate number of participants in the last SMART-3RP 
groups. We chose the sample size and decision rules so that the probability of declaring 
feasibility would be approximately 5% under unacceptable rates and at least 80% under 
anticipated rates—see table below. If true enrollment, retention, completion, and 
acceptability rates were ≤39%, ≤60%, ≤58%, and ≤62%, respectively, which we would 
consider too low to continue with an efficacy trial, then the probability of declaring 
feasibility would be ≤5%. If the true rates align with our anticipated rates, the probability 
of declaring feasibility would be ≥80%.  
 
Feasibility 
Measure 
Anticipated 
Rate  
Acceptable 
Rate 
Unacceptable 
Rate 
Decision Rule 
for Feasibility 
Prob. of 
Declaring 
Feasibility 
Under 
Anticipated 
Rate 
Prob. of 
Declaring 
Feasibility 
Under 
Unacceptable 
Rate 
Enrollment 
of eligibles 
50% 
45% 
39% 
≥96 enrolled of 
213 eligible 
93% 
4% 

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Retention 
75% 
70% 
60% 
≥67 of 96 
enrolled 
complete 3-
month follow-
up survey 
90% 
3% 
Intervention 
attendance 
75% 
70% 
58% 
≥34 of 48 
intervention 
participants 
attend ≥6 of 9 
sessions 
80% 
5% 
Intervention 
acceptability 
80% 
75% 
62% 
≥36 of 48 
intervention 
participants 
report overall 
intervention  
satisfaction 
(4/5 on Likert 
scales) 
85% 
4% 
 
11.2. Data Analysis 
Aim 1: We will evaluate feasibility using rates of eligibles enrolled, retention,  and 
intervention 
session 
attendance.55, 
80-82 
Descriptive 
analyses 
(frequencies, 
means/medians, confidence intervals) will be used to evaluate hypotheses regarding 
enrollment (≥45% of eligible), retention (≥70% follow-up survey completion) and 
intervention attendance (≥70% attending at least 6 of 9 sessions). Acceptability of the 
intervention will be examined by patient-reported overall intervention satisfaction (>75%) 
and group cohesiveness ratings. Fisher’s exact and Wilcoxon rank sum tests will be used 
to explore whether feasibility and acceptability outcomes are affected by 
sociodemographic (e.g. age, sex), clinical (e.g. metavivor vs curvivor), medical, and 
baseline efficacy outcome characteristics. We will collect similar metrics for hair cortisol 
collection. In particular, we will track the reasons why any hair samples were not collected, 
as this informs the feasibility and acceptability of hair cortisol collection and analysis for 
this population. Exit Interview Data analysis. The exit interview data will be transcribed 
and analyzed using NVivo qualitative software. Content analysis will be conducted by the 
study members who will iteratively create themes, categories, and codes. Coding matrices 
will be used to compare caregivers of curvivors and metavivors. To ensure coding 
reliability, coding discrepancies will be resolved through discussion and comparison of raw 
data. To ensure coding reliability, coding discrepancies will be resolved through discussion 
and comparison of raw data. Coding will continue until a high level of reliability (Kappa= 
>0.80) is established. To ensure validity, Dr. Haman (consultant) will provide the expert 
review of the final analyses.   
 
Aim 2: Linear regression models will be used to evaluate the preliminary efficacy on 
change in resiliency and other secondary outcomes (stress management and growth 

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enhancement processes; biobehavioral assessment of chronic stress). We will first 
assess for intra-cluster correlation in our groups and if the intra-cluster correlation is very 
small (< 0.1), we will employ linear regression models, adjusting for baseline criterion 
score, to examine the preliminary effects of the intervention on study outcomes at 3 
months. Analyses will be conducted across all study participants, as well as by caregiver 
and survivor cohorts, separately. If intra-cluster correlation is >0.1, , sensitivity analyses 
will be conducted using mixed linear models to account for the intraclass correlation within 
intervention group cohorts and caregiver-survivor dyads. Cohen’s d effect size will be 
calculated by dividing the group differences in outcomes at 3 months by the pooled 
standard deviation. These models will include random effects to account for the correlation 
between measurements from the same individual and the same survivor-caregiver dyad. 
The interaction between timepoint and intervention will be used to evaluate whether the 
change in outcome differs between the two groups. We will assess our assumption that the 
intervention effect is similar for caregivers and survivors using models with a three-way 
interaction (time by intervention by participant type) and conduct subgroup analyses within 
caregivers and survivors if there is evidence of a differential effect. Moderation of the 
intervention effects will be examined using linear regression models within 
caregiver/survivor subgroups. Interaction terms (time by intervention by potential 
moderator) will be assessed to determine whether intervention efficacy is associated with 
sociodemographic (e.g. age, sex), clinical (e.g. metavivor vs curvivor), medical 
characteristics, and baseline efficacy outcome.  
Aim 3: Health care utilization analyses: We will explore the effect of the intervention on 
participants’ (survivors and caregivers) utilization of healthcare, with outcomes including 
hospitalizations, ED visits, urgent care visits, primary care visits, mental health visits, and 
use of psychiatric medications. These exploratory analyses will be carried out separately 
for caregivers and survivors due to fundamental differences in the healthcare needs of 
caregivers and survivors. Intervention effects on dichotomous healthcare utilization 
outcomes will be explored using Fisher’s exact test  
Covariate and Moderator variables will include sociodemographic, clinical and medical 
characteristics described on Section 9.5. (data reported by participants and  data obtained 
from the EHR). Additionally,  survivors´ reported physical symptoms will be extracted 
from the PROMIS-CF and survivor reported comorbidities will be captured on the Self-
Administered Comorbidities Questionnaire.76 
Missing DataAnalyses will be based on the intention-to-treat principle with participants 
analyzed according to their randomly assigned group regardless of how many intervention 
sessions they attend. Efficacy analyses will initially focus on study completers to estimate 
the effect of SMART-3RP on study participants who completed the protocol assessments. 
We will also conduct sensitivity analyses to  explore how various assumptions about 
missing data and differences between completer and non-completers affect the estimated 
outcomes. If data appear to be missing at random, we will employ multiple imputation 
methods, maximum  likelihood estimate approach with EM algorithm, and mixed effect 
modeling that  can adequately account for data missing at random. However, if we find that 

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Page 20 of 33 
 
participants do not complete the study because of disease worsening suggesting that data 
are not missing at random, we will employ joint modeling approaches to handle incomplete 
data and perform sensitivity analyses to assess the impact of missing data.  
 
 
Randomization. Survivor-caregivers will be randomized together, stratified by survivor 
status (curvivor/metavivor), using a random plan generator with 1:1 randomization. 
 
11.3. Data Storage 
All participant information and study source documents will remain confidential  and be 
scanned and stored on secure institutional computers and in REDCap. The  REDCap 
survey is a tool for building and managing online surveys. Our research team has extensive 
experience using REDCap and will create and design the surveys in a web browser, with 
institutional information technology support. Data abstracted from the EHR (see Section 
9.5) will be maintained in REDCap. The REDCap Survey system offers secure, HIPAA 
compliant, web-based applications that provide an intuitive interface for participants to 
enter data, with real-time validation rules at the time of entry. Exit interviews will be 
recorded. All digital recordings will be immediately uploaded to a MGB secure study 
folder, which is password protected and only accessible to study staff. The files will be 
immediately deleted from the audio recorder. Audio recordings will be destroyed  after 
we complete all transcriptions. Only the Principal Investigators and the RA will have 
access to identifiable patient information, which will be stored only in a password protected 
file on the secure MGH network.   
 
Hair cortisol will be collected and stored as outlined in sections 9.5 and 10. In brief, 
samples will remain wrapped in aluminum foil, labeled with a study ID and stored at 
room temperature in a padded envelope within a locked, filing cabinet in our team lab. 
 
Drs. Park and El-Jawahri will oversee all aspects of data collection and will develop study 
specific data management protocol and standard operating  procedures for the creation 
and testing of all study forms, data collection, quality control, and data extraction. They 
will provide ongoing oversight of data management throughout the study and will be 
responsible for generating reports and datasets for quality control and data analysis.  
 
We will comply with all requirements for data safety and monitored specified by the IRB 
and NIH. As per Public Law 110-85, this is an applicable trial and will be registered and 
results reported with ClinicalTrials.gov. Ms. Horick will be responsible for handling 
ClinicalTrials.gov requirements for this project under Drs.  Park 
and 
El-Jawahri 
oversight. She will work closely with the Partners Human Research Affairs QI Program to 
register the trial prior to enrolling the first subject. Once a record is established, she will 
confirm accuracy of record content,  resolve problems, and maintain records including 
content update and modification.  
 
11.4. Data Quality 

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Drs. Park and El-Jawahri will train the study RA in  administration and data management 
of participant self-report questionnaires. Data extraction from participants’ EHR will be 
supervised by Dr. El-Jawahri who is a board-certified oncologist possessing the necessary 
expertise to oversee collection of patient clinical characteristics and oncology treatment 
information. For hair cortisol, samples will be dissolved in phosphate-buffered saline, 
randomly distributed on different plates to avoid a batch effect and analyzed in 
quadruplicate  using Saltimetrics cortisol ELISA. If readings for a sample differ by more 
than 10%, of the measurements will be repeated; also, 5% of samples will be randomly 
reanalyzed to ensure reproducibility. Study fidelity will be ensured as described on Section 
9.3. Fidelity of Study Design, Methods, and Intervention. 
 
11.5. Data Security 
Participant data will be collected using REDCap and exit interviews saved on MGB secure 
study folder. Data collected from participants will be kept confidential and accessible only 
to trained study staff. Participants will be assigned a study identification number and all 
collected data will be stored securely with this identification number in files which do not 
include patient names or any other identifiable information. A link between names and 
identification numbers will be stored separately in a password protected file. All electronic 
data will be stored in  password protected computer files. Any data files exported from the 
database will  be de-identified, with only a case number identifying each participant, and 
no other identifying information.  
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
This research involves no more than minimal risk to subjects.  
 
13.0 Withdrawal of Subjects 
We do not anticipate that any research participants will be withdrawn from the study 
without their consent. If a participant requests withdrawal from the study, we will ask them 
if they are comfortable sharing the reason for withdrawal to ensure that there are no adverse 
events to report to the IRB. We will ask the study participant if they are still willing to 
permit the study team to continue to monitor their health record, but withdraw from all 
other study procedures.  
 
14.0 Risks to Subjects 
The risks involved in the study are minimal and will be clearly delineated on the consent 
form. It is unlikely that participants will be at any risk for physical harm as a result of study 
participation. We experienced no adverse events in our prior clinical work and studies with 
survivors. Confidentiality will be detailed on the consent form and discussed in detail so 
that participants are fully informed of their right to request information and to withdraw 
from the study at any time without impacting their care. We will also discuss the 
importance of maintaining confidentiality at the beginning of each intervention group so 
as to keep information shared confined to the group. Participants will also be made aware 
of the limits of confidentiality, including that confidentiality would be broken if 
participants reported thoughts of harming themselves or others, in order to obtain 

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Page 22 of 33 
 
appropriate care for the participant. Participants may choose not to participate in the study 
or any of the study procedures without penalty. Those who do agree to participate may 
withdraw their participation at any time without penalty. 
 
Potential risks to participants are minimal across various study procedures. Questionnaire 
batteries. Participants may experience some discomfort answering questions on surveys; 
however, they may choose not to answer questions that are distressing. Group 
videoconferencing. 
Participants 
may 
have 
concerns 
about 
the 
security 
of 
videoconferencing and will be informed that the system is HIPPA compliant and 
sanctioned by MassGeneral Brigham HealthCare to protect privacy. SMART-3RP and 
support groups. Participants might find some of the exercises (e.g., meditation training in 
the SMART-3RP, discussing concerns with fellow group participants) to be difficult or 
uncomfortable at first. These difficulties are typically minimal and temporary and are often 
a natural and valuable part of the treatment process. Hair samples. Participants might find 
it distressing to cut their hair for the hair sample, though this procedure has been tested in 
prior protocols and has been typically well-tolerated. Provision of a hair sample is not a 
requirement for study participation. 
 
15.0 Potential Benefits to Subjects 
It is possible that some patients and caregivers may benefit from the intervention or 
enhanced usual care. Some may value the possibility that their contribution to the study 
may benefit other cancer survivors and their caregivers. It is also possible that some may 
not derive these benefits. However, the risk from participation in the study is small (and 
will be minimized by the procedures outlined above), and the overall risk to benefit ratio 
is favorable. 
 
16.0 Vulnerable Populations 
Not applicable  
 
17.0 Community-Based Participatory Research: Not applicable  
 
18.0 Sharing of Results with Subjects 
Given the nature of the population included in the study, it is not appropriate to proactively 
contact participants at the conclusion of this study. We anticipate that a proportion of our 
participants will die during or within months of completing the study. We do not wish to 
cause unnecessary distress to participants’ family members by attempting to contact 
participants who have died. Therefore, we provide the research team contact information 
to each participant and encourage them to contact us if they would like to receive updates 
and information on the research findings. 
 
19.0 Setting 
The study will include participants with cancer treated at the Massachusetts General 
Hospital. Participants will be approached for participation in-person, phone or email, or via 

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Page 23 of 33 
 
patient gateway. The intervention will be delivered via a virtual-HIPPA-compliant 
videoconferencing technology, Zoom, that is accessible via smartphone, laptop, tablet, or 
desktop. Randomly selected participants will take part on an exit interview that will be 
conducted virtually or in person. Hair cortisol collection will be sent to Dr. Kestutis 
Bendinska´s laboratory.  
 
20.0 Resources Available 
20.1. Team Qualifications and Oversight 
The overall MPI of the project (Drs. Park and El-Jawahri) are responsible for full oversight 
of the project at MGH. They will meet with the CRC on weekly basis (and more often as 
urgent issues arise) to ensure the study process is being followed accurately and to address 
potential challenges or issues that occur. The MGH research team will also review the 
CONSORT diagram, recruitment and enrollment procedures, and any potential problems 
or issues related to the study operations on weekly basis. Drs. Park and El-Jawahri have 
extensive experience conducting supportive care intervention clinical trials. 
20.2. Other Resources  
Drs. Park and El-Jawahri are members of the MGH Cancer Outcomes Research and 
Education Program (CORE). CORE has extensive experience conducting randomized 
clinical trials of supportive care interventions in oncology and has the necessary expertise 
to ensure the success of the proposed project. Drs. Park and El-Jawahri are also members 
of the MGH Health Promotion and Resiliency Intervention Research Program, which 
houses expertise and research staff focused on mind-body interventions. 
 
 
21.0 Prior Approvals 
The DF/HCC will serve as the IRB of record for this trial.   
 
22.0 Recruitment Methods 
Please see section 5.0 for recruitment methods.  
 
23.0 Local Number of Subjects 
We will include 58 caregiver and cancer survivor dyads (n=116) that will be randomized 
1:1 to SMART-3RP and enhanced usual care. 
 
24.0 Provisions to Protect the Privacy Interests of Subjects 
The main risk to participants in this study is loss of privacy or confidentiality. Data 
collected from participants will be kept confidential and accessible only to trained study 
staff. To protect against this risk, the participants will be assigned a study identification 
number and all collected data will be stored securely with this identification number in files 
which do not include patient names or any other identifiable information. A link between 
names and identification numbers will be stored separately in a password protected file. 
All electronic data will be stored in password protected computer files. Any data files 

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Page 24 of 33 
 
exported from the database will be de-identified, with only a case number identifying each 
participant, and no other identifying information.  
 
 
25.0 Compensation for Research-Related Injury 
We do not anticipate any research-related injury due to involvement in this supportive care 
trial. 
 
26.0 Economic Burden to Subjects 
We do not anticipate any financial burden on study participants. Participants will not be 
financially responsible for the intervention. 
 
27.0 Consent Process 
The RA will review the study procedures, required data collection, and consent process 
with the participants either in-person during their oncology follow-up or over the telephone 
or video. The verbal consent form will include all of the study procedures, information 
about potential risks and benefits of participation, and information regarding who 
participants can contact for further questions (PIs and study staff). It also will state that 
participation is voluntary, that participants can refuse to answer any question, that they can 
withdraw from the study at any time, and that study participation is in no way related to 
their medical care. The verbal consent form will identify alternatives to participation. 
Willing participants will be asked to provide verbal consent and to complete the baseline 
questionnaires. Participants will also be provided a copy of the verbal consent document 
in-person, electronically, or by mail. As stated previously, we are requesting a Waiver of 
Written Documentation of Consent given that this is a minimal risk study and that all of 
the study procedures could be easily conveyed orally. This waiver will reduce the risk to 
patients and caregivers who may not be coming regularly to the cancer center for their care 
and is necessary for our research procedures to continue.  
 
28.0 Process to Document Consent in Writing 
As stated previously, the RA will conduct informed consent procedures with potential 
participants and obtain verbal consent. We will follow all the requirements of SOP: 
Informed Consent Process (CON-100) in obtaining informed consent for study participants 
and participants will be consented via verbal consent. 
 
29.0 Drugs or Devices 
Not applicable 
 
30.0 References 
1. 
Kent EE, Rowland JH, Northouse L, Litzelman K, Chou WY, Shelburne N, Timura 
C, O'Mara A, Huss K. Caring for caregivers and patients: Research and clinical priorities 
for informal cancer caregiving. Cancer. 2016;122(13):1987-95. doi: 10.1002/cncr.29939. 
PubMed PMID: 26991807; PMCID: PMC5597246. 

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Page 25 of 33 
 
2. 
Soothill K, Morris SM, Harman JC, Francis B, Thomas C, McIllmurray MB. 
Informal carers of cancer patients: what are their unmet psychosocial needs? Health Soc 
Care Community. 2001;9(6):464-75. doi: 10.1046/j.0966-0410.2001.00326.x. PubMed 
PMID: 11846826. 
3. 
Sklenarova H, Krumpelmann A, Haun MW, Friederich HC, Huber J, Thomas M, 
Winkler EC, Herzog W, Hartmann M. When do we need to care about the caregiver? 
Supportive care needs, anxiety, and depression among informal caregivers of patients with 
cancer and cancer survivors. Cancer. 2015;121(9):1513-9. doi: 10.1002/cncr.29223. 
PubMed PMID: 25677095. 
4. 
Oberoi DV, White V, Jefford M, Giles GG, Bolton D, Davis I, Winship I, Prince 
HM, Millar J, Harrison S, Kay A, Hill D. Caregivers' information needs and their 
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