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Protocol
Quality of Life in Patients and Their Spouses and Cohabitating
Partners in the Year Following a Cancer Biopsy (the Couples
Cope Study): Protocol for a Prospective Observational Study
Patricia I Moreno1, PhD; Sarah M Worch2, PhD; Jessica L Thomas3, MA; Rebecca L Nguyen4, BS; Heidy N Medina1,
MPH, PhD; Frank J Penedo5, PhD; Judith T Moskowitz3, PhD; Betina Yanez3, PhD; Sheetal M Kircher6, MD; Shilajit
D Kundu7, MD; Sarah C Flury8, MD; Elaine O Cheung9, PhD
1Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, United States
2Department of Psychology, Lynn University, Boca Raton, FL, United States
3Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States
4Department of Psychology, University of Maryland, Baltimore County, Baltimore, MD, United States
5Departments of Medicine & Psychology, University of Miami, Miami, FL, United States
6Division of Hematology and Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, United States
7Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States
8Department of Urology, Vanderbilt University School of Medicine, Nashville, TN, United States
9Hinge, Inc, New York, NY, United States
Corresponding Author:
Patricia I Moreno, PhD
Department of Public Health Sciences
University of Miami Miller School of Medicine
1120 NW 14th St
Miami, FL, 33136
United States
Phone: 1 3052439844
Email: patricia.moreno@miami.edu
Abstract
Background: Receiving a diagnosis of cancer is a profound and often very stressful experience. Few studies have prospectively
recruited patients prior to receiving a new diagnosis of cancer and included spouses or partners.
Objective: The aim of the Couples Cope Study is to understand the impact of undergoing a diagnostic biopsy and receiving a
new cancer diagnosis on quality of life (QoL) in both patients and their spouses or partners, as well as on the quality of their
relationship. This protocol paper describes the study design and assesses the feasibility of recruitment and retention.
Methods: Study staff reviewed the schedules of collaborating physicians using specific encounter codes to identify patients
scheduled for breast or prostate biopsies. Potential participants were prescreened via the electronic health record and sent a
recruitment letter at least 2 to 3 weeks prior to their biopsy procedure. Patients subsequently underwent a phone screening to
determine eligibility. Patients who enrolled provided study staff with contact information for their spouses or partners. All consent
forms were completed online. Surveys were completed online prior to receiving the biopsy results (baseline), and at 1, 3, 6, and
9 months after the biopsy. Study staff engaged in ongoing, personalized contact with participants and sent assessment completion
reminders via phone and email.
Results: A total of 2294 patients undergoing a breast or prostate biopsy were identified and 69% (n=1582) were eligible for
phone screening following electronic health record prescreening. Of the 431 patients who underwent phone screening, 75%
(n=321) were eligible to participate. Of the eligible patients, 72% (n=231) enrolled and 82% (n=190) of enrolled patients had an
accompanying partner or spouse who also enrolled. A total of 77% (34/44) of patients who received a cancer diagnosis and 72%
(26/36) of their spouses or partners were retained through 9 months, while 80% (53/66) of patients who received a benign diagnosis
and 68% (42/62) of their partners were retained.
Conclusions: Prospective recruitment of patients undergoing diagnostic biopsy and their partners is feasible and requires both
strategic collaboration with providers and concerted prescreening and recruitment efforts by study staff. Importantly, this study
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was able to conduct all study activities online without disrupting clinical workflow and without requiring patients and their spouses
or partners to come into the laboratory. Consideration should be given to the ratio of biopsies to cancer diagnoses, which can
vary significantly by cancer type. Prospective studies are needed and can inform our ability to provide effective support earlier
to couples facing a possible cancer diagnosis. Future studies should examine other tumor types that have received less attention
in QoL studies, include behavioral and neurobiological assessments beyond self-report measures, and follow couples beyond 9
months in order to examine long-term effects on QoL.
International Registered Report Identifier (IRRID): DERR1-10.2196/52361
(JMIR Res Protoc 2024;13:e52361) doi: 10.2196/52361
KEYWORDS
quality of life; cancer; biopsy; couples; dyads; caregiver; patients; patient; cancer biopsy; spouse; spouses; partner; partners;
diagnostic; diagnostic procedure; feasibility of recruitment; recruitment; prostate biopsy; breast biopsy; screening; electronic
health record; survey; surveys
Introduction
Overview
Receiving a diagnosis of cancer is a profound and often very
stressful experience. A new diagnosis of cancer introduces
uncertainty and distress as individuals navigate treatment
decisions, experience disruptions to social or occupational roles
and routines, and undergo arduous treatments such as surgery,
radiation, and chemotherapy [1,2]. Individuals who are newly
diagnosed with cancer commonly experience decrements in
quality of life (QoL) and are at elevated risk for psychological
and physical symptoms, including anxiety, depressed mood,
fatigue, and pain [1,3,4]. A cancer diagnosis and its subsequent
treatment significantly impact not only patients but also their
spouses and romantic partners. Spouses or partners are by far
the most common informal cancer caregivers, helping patients
manage disease symptoms, treatment side effects, and emotional
distress [5]. However, caregiving in the cancer context is
associated with well-documented risks to psychological and
physical health [5-13].
Despite the fact that the impact of cancer extends well beyond
the patient, and that patient and caregiver well-being are closely
linked and reciprocally influence each other [14-20], few studies
incorporate the assessments of spouses or partners or examine
how both patients and their spouses or partners report cancer
has affected the quality of their relationship. Furthermore,
although there is widespread interest in prospective research on
QoL following a cancer diagnosis, there is a paucity of
non-epidemiological studies that have prospectively recruited
patients prior to receiving a new diagnosis of cancer [21-26].
A 1998 study by Northouse et al [27] recruited couples prior to
a woman’s diagnostic breast biopsy and examined psychosocial
adjustment to either a malignant or benign diagnosis at 60-day
and 1-year follow-ups. Results demonstrated that couples who
received a breast cancer diagnosis reported worse psychosocial
adjustment and a greater decrease in marital functioning than
couples who received a benign diagnosis. Furthermore,
psychosocial adjustment was highly interrelated between women
with breast cancer and their spouses. To our knowledge, since
this landmark study 25 years ago, no study has prospectively
examined trajectories of QoL among both patients and their
spouses or partners from prior to a diagnostic biopsy through
the year following a malignant or benign diagnosis.
Couples Cope Study
The goal of the Couples Cope Study is to understand the impact
of undergoing a diagnostic biopsy and receiving a new cancer
diagnosis on QoL in both patients and their spouses or partners,
as well as on the quality of their relationship. Using a
prospective observational study design and quantitative
approaches that model actor-partner effects, we will examine
predictors and trajectories of QoL, individual well-being, and
relationship quality and functioning among couples who undergo
a cancer biopsy. Patients and their spouses or partners will be
recruited prior to a breast or prostate biopsy and complete
follow-up assessments for 9 months after the biopsy.
Comprehensive assessments will include multiple domains of
QoL, such as psychosocial adjustment, social well-being, sexual
functioning, symptom burden, and physical functioning. Couples
will be stratified into 2 groups based on biopsy result (ie,
malignant vs benign). The aim of this study is to describe the
Couples Cope Study protocol and examine the feasibility of
recruitment and retention of patients undergoing diagnostic
biopsy and their spouses or partners.
Methods
Overview of Study Design
This is a prospective, nontherapeutic observational study of
patients undergoing a diagnostic biopsy for prostate or breast
cancer and their spouses or partners. Participants completed a
baseline assessment prior to receiving the biopsy result and
follow-up assessments at 1, 6, and 9 months after the biopsy,
as well as daily diary assessments over a 1-week period at 3
months after the biopsy (Figure 1). Data were collected between
April 2018 and November 2020. Study procedures were not
altered in response to the COVID-19 pandemic as the study
design included only remote contact with participants.
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Figure 1. Participant flow diagram for patients and cohabitating partners or spouses; baseline and 1-, 3-, 6-, and 9-month follow-ups.
Ethical Considerations
All study procedures were reviewed and approved by the
institutional review board at the Northwestern University
Feinberg School of Medicine (STU00206691). All participants
provided informed consent prior to participation via an
electronic consent form. Survey data are stored in encrypted
form on Northwestern University Feinberg School of Medicine
computers on its corresponding secure, password-protected
server. Prior to analysis, data were deidentified and stripped of
all relevant personal health information. Participants were
compensated US $10 for the baseline assessment, US $20 for
each follow-up assessment (3 in total), and US $5 for each daily
diary assessment (7 in total), for a possible total of US $105 per
participant. The payment was dispensed in the form of a prepaid
Visa debit card.
Inclusion and Exclusion Criteria
Patients and their spouses or partners were eligible if they were
aged 18 years or older, married or cohabitating, able to speak
and read in English, had access to the internet via at least 1
web-enabled device (eg, computer, tablet, or smartphone), and
undergoing a diagnostic biopsy for prostate or breast cancer
(patients only). Patients were ineligible if they had a previous
cancer diagnosis (except nonmelanoma skin cancer like basal
cell carcinoma), evidence of distant metastasis (stage IV cancer),
inpatient psychiatric treatment in the past 6 months, and were
unable to consent.
Recruitment and Enrollment
Authorized study staff reviewed the schedules of collaborating
Northwestern Medicine physicians in the Department of Urology
and Lynn Sage Comprehensive Breast Center using specific
encounter codes to identify patients scheduled for breast or
prostate biopsies. The encounter codes used for prescreening
via physicians’ electronic schedules were (1) “biopsy” for
patients with prostate cancer and (2) either “US guided breast
biopsy core” or “mamo stereo core ndl bx.” Potential
participants were prescreened via the electronic health record
(EHR) and sent a recruitment letter that introduced the study
along with the study flyer at least 2 to 3 weeks prior to their
biopsy procedure. Approximately 1 week after receipt of the
recruitment letter, study staff called patients to provide
additional information about the study and screened patients to
assess their eligibility over the phone. Patients who were eligible
and enrolled, provided study staff with their own contact
information and that of their spouse or partner. If a patient and
his, her, or their spouse or partner were determined to be eligible
following phone screening, study staff sent each potential
participant an email with a link to the online consent form and
the baseline assessment. Study staff reviewed the consent form,
including all study procedures, with potential participants on
the phone in order to ensure understanding and respond to any
questions or concerns. Completion of the online consent form
allowed participants to proceed to the baseline assessment.
Assessments
Baseline and follow-up study assessments, including variable
domains and measures, time points, and sources of data, are
described in Multimedia Appendix 1 [28-48]. All surveys were
completed online. If patients received a malignant biopsy result
(ie, cancer diagnosis), patients and their spouses or partners
completed follow-up assessments at 1, 6, and 9 months after
the biopsy, as well as daily diary assessments over a 1-week
period at 3 months after the biopsy. If patients received a benign
biopsy result (ie, no cancer diagnosis) and were among the first
80 couples to enroll in the study, patients and their spouses or
partners completed follow-up and daily diary assessments across
the same time frame. After the first 80 couples, patients who
received a benign biopsy result and their spouses or partners
completed only the baseline assessment.
The baseline assessment captured medical and
sociodemographic characteristics (eg, age, sex, gender identity,
marital status, parental status, race, ethnicity, relationship length,
education, and income). EHRs were also reviewed by study
staff in order to capture diagnostic biopsy results and, if
applicable, cancer stage and cancer treatments (eg, surgical
resection, radiation, chemotherapy, and hormone therapy). Both
baseline and follow-up assessments included measures of
individual well-being (ie, gratitude, empathy, meaning and
purpose, attachment style, relatedness, and social support),
relationship quality (ie, relationship quality and social
constraints), and QoL (ie, depressive symptoms, positive and
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negative affect, life satisfaction, stressful life events, financial
toxicity, and sexual functioning). Follow-up questionnaires also
included peer reports of specific measures of individual
well-being (ie, participants reported their perception of their
spouses’ or partners’ gratitude, empathy, and meaning and
purpose). Cancer-specific measures of health-related QoL and
symptom burden, intrusive thoughts and avoidance, and
supportive care needs were included in follow-up questionnaires
only for patients who received a cancer diagnosis. The baseline
and follow-up questionnaire batteries were expected to take
approximately 30 and 50 minutes to complete, respectively.
Daily diaries assessed dyadic processes (ie, disclosure, social
support [general, emotional, informational, instrumental, and
cancer-specific], empathy, and cognitive processing and
meaning-making) using items adapted from previous studies
[49-51]. Daily diary assessments, including variable measures
and response options, are described in Table 1. Daily diaries
were expected to take 5 minutes or less to complete.
Table 1. Daily diary assessments at 3-month follow-up for patients and cohabitating partners or spouses.
RespondentsResponse optionsVariable and measure
Disclosure
All participantsYes or no“Did you discuss stressful or negative events with your romantic
partner today?”
Patients with cancerYes or no(If yes) “Was it about your cancer diagnosis/treatment?”
Spouses or partners of patients
with cancer
Yes or no(If yes) “Was it about your experience caregiving or your partner’s
cancer diagnosis?”
Social support
All participants0=none, 1=a little, 2=some, 3=quite a
bit, and 4=a lot
“How much support did your partner provide today?”
All participants0=none, 1=a little, 2=some, 3=quite a
bit, and 4=a lot
“How much comfort/reassurance did your partner provide?” (emo-
tional support)
All participants0=none, 1=a little, 2=some, 3=quite a
bit, and 4=a lot
“How much advice/information did your partner provide?” (infor-
mational support)
All participants0=none, 1=a little, 2=some, 3=quite a
bit, and 4=a lot
“How much help/assistance did your partner provide?” (instrumental
support)
Patients with cancer and their
spouses or partners
0=none, 1=a little, 2=some, 3=quite a
bit, and 4=a lot
“How much did your partner help you cope with your cancer expe-
rience or other stressful events today?” (cancer-specific support)
Empathy
All participants0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“How empathic or caring was your partner toward you today?”
Cognitive processing and meaning making
Patients with cancer0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did you actively reflect on your cancer experience
or stressors today?”
Patients with cancer0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did you try to understand or make sense of your
cancer experience or stressors today?”
Patients with cancer0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did your cancer experience or stressors make you
think about what is important and the meaning in your life today?”
Spouses or partners of patients
with cancer
0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did you actively reflect on your cancer experience
or stressors today?”
Spouses or partners of patients
with cancer
0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did you try to understand or make sense of your
cancer experience or stressors today?”
Spouses or partners of patients
with cancer
0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did your cancer experience or stressors make you
think about what is important and the meaning in your life today?”
Benign biopsy patients and their
spouses or partners
0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did you actively reflect on your stressors today?”
Benign biopsy patients and their
spouses or partners
0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did you try to understand or make sense of your
stressors today?”
Benign biopsy patients and their
spouses or partners
0=not at all, 1=a little bit, 2=moderately,
3=quite a bit, and 4=extremely
“To what extent did your stressors make you think about what is
important and the meaning in your life today?”
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Retention Strategies
Strategies to optimize engagement and retention included
reminder calls, text messages, and emails prior to upcoming
assessments (tailored according to participants’ preferences)
and providing participants with study contact phone numbers
and emails to facilitate communication and accessibility.
Flexible questionnaire administration online also eliminated the
need for participants to travel to in-person assessments. In
addition, our study team sent holiday cards that were personally
signed by the principal investigators and lead study coordinator.
Results
As seen in the Consolidated Standards of Reporting Trials
(CONSORT) diagram (Figure 2), 2294 patients undergoing a
breast or prostate biopsy were identified and prescreened in the
EHR. Of those prescreened in the EHR, 69% (n=1582) were
eligible for subsequent phone screening and 31% (n=712) were
ineligible. Common reasons for patient ineligibility in EHR
prescreening included a previous diagnosis of prostate (n=162),
breast (n=223), or other (n=149) cancer or not being partnered
(n=121). Of the 1582 patients eligible for phone screening, 27%
(n=431) underwent phone screening, 13% (n=198) declined
phone screening, and 60% (n=953) were unable to be reached.
Common reasons for declining phone screening included not
being interested in research (n=77), not having time (n=31),
and feeling too stressed (n=10). Of the 431 patients who
underwent phone screening, 75% (n=321) were eligible to
participate and 25% (n=110) were ineligible. Common reasons
for patient ineligibility in phone screening included a previous
diagnosis of prostate (n=15), breast (n=15), or other (n=18)
cancer or not being partnered (n=46). Of the 321 eligible
patients, 72% (n=231) enrolled and 82% (n=190) of the enrolled
patients had an accompanying spouse or partner who also
enrolled.
Figure 2. CONSORT diagram for Couples Cope Study protocol. A prospective, nontherapeutic observational study of patients undergoing a diagnostic
biopsy for prostate or breast cancer and their spouses or partners. bx: biopsy; ca.: cancer; CONSORT: Consolidated Standards of Reporting Trials; dx:
diagnosis; EHR: electronic health record; hx: history; prev.: previous.
On average, patients who enrolled were 50.4 years old (SD 12.5;
min: 20, max: 80) and their spouses or partners were 50.8 years
old (SD 11.8; min: 21, max: 85). Patients were primarily
non-Hispanic White (81%) with some representation of Asian
(9%), Black (7%), multiracial (2%), and Native American (<1%)
patients. Additionally, 7% of patients were Hispanic. Similarly,
spouses or partners were primarily non-Hispanic White (78%)
with some representation of Black (8%), Asian (7%), multiracial
(4%), and Native American (<1%) spouses or partners.
Additionally, 6% of spouses or partners were Hispanic.
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Approximately 2% of patients and 4% of spouses or partners
identified as sexual or gender minorities. More patients
underwent breast biopsies (73%) than prostate biopsies (27%).
However, 46% of those undergoing a prostate biopsy received
a cancer diagnosis, while only 12% of those undergoing a breast
biopsy received a cancer diagnosis. A total of 77% (34/44) of
patients who received a cancer diagnosis and 72% (26/36) of
their spouses or partners were retained throughout the 9-month
follow-up assessment, and 80% (53/66) of patients who received
a benign diagnosis and 68% (42/62) of their spouses or partners
were retained through the 9-month follow-up assessment.
Discussion
Principal Findings
The goal of the Couples Cope Study is to understand the impact
of undergoing a diagnostic biopsy and receiving a new cancer
diagnosis on QoL in both patients and their spouses or partners,
as well as on the quality of their relationship. Our preliminary
data demonstrate that prospective recruitment of patients
undergoing diagnostic biopsy and their spouses or partners is
feasible and requires both strategic collaboration with medical
providers and concerted prescreening and recruitment efforts
by study staff. The majority of patients who underwent phone
screening were eligible to participate (72%) and most patients
who were eligible to participate actually enrolled (75%).
Furthermore, most patients who enrolled had an accompanying
spouse or partner who also enrolled (82%). Retention through
the study duration was also generally good and was higher
among patients with either a malignant or benign biopsy result
(77%-80%) and spouses or partners of patients with cancer
(72%) than spouses or partners of patients with a benign biopsy
(68%).
Importantly, the design of the Couples Cope Study allowed us
to conduct all study activities remotely (either via phone or
online) without disrupting clinical workflow and without
requiring patients and their spouses or partners to come into the
laboratory. Previous studies that have prospectively recruited
patients prior to receiving a new diagnosis of cancer have
primarily relied on in-clinic recruitment by physicians or
medical or research staff [22-26]. These approaches are
resource-intensive and can disrupt clinical workflows during
sensitive medical appointments. In fact, patients with cancer
are more likely to enroll in a research study when they are
contacted at home [52]. Given that these factors of convenience
influence enrollment, online recruitment and participation in
prospective studies may be desirable alternatives to in-person
approaches with people faced with a possible cancer diagnosis.
The most resource-intensive aspect of recruitment for this study
was the EHR prescreening and outreach for phone screening.
Even though most patients were eligible for phone screening
after the EHR prescreening (69%) and only a minority of
patients actively declined phone screening (13%), stress and
the short time frame between scheduling a diagnostic biopsy
and the completion of the procedure most likely contributed to
our inability to reach a large portion of patients who were
eligible for phone screening prior to their biopsy (60%).
Furthermore, consideration should be given to the ratio of
biopsies to cancer diagnoses, which can vary significantly by
cancer type. In our sample, almost half of the patients
undergoing a prostate biopsy received a cancer diagnosis, while
approximately 1 in 8 patients undergoing a breast biopsy
received a cancer diagnosis.
Strengths
The strengths of this study include comprehensive psychosocial
assessments that incorporate measures of both distress and
symptom burden, as well as protective factors like positive
affect and social support. An additional strength is the use of
multimodal measurement, including daily diary sampling to
examine dyadic processes as predictors or mechanisms of QoL
and peer-reported measures of individual well-being to examine
observability and convergent validity. Our assessment of
relationship quality in both patients and their spouses or partners
will allow us to capture each member’s perspective and examine
correspondence in evaluations of relationship quality.
Correspondence (or lack thereof) may provide a unique indicator
of relationship dynamics, which may also predict QoL. A
prospective design that includes a baseline assessment prior to
biopsy allows us to predict QoL based on individual and
relational protective and risk factors present prior to a cancer
diagnosis and reduce the recall bias inherent in retrospective
measures. Furthermore, we include a comparison group of
patients who undergo a cancer biopsy but receive a benign result
(ie, no cancer diagnosis) and their spouses or partners. Although
it is likely that patients with cancer and their spouses or partners
will demonstrate greater decrements in QoL than couples in our
benign biopsy comparison group, patients who receive a benign
biopsy result and their spouses or partners may also experience
some impact as a result of the mortality salience related to a
“cancer scare.”
Limitations
Limitations include primary reliance on clinic-based recruitment
in 1 academic medical center in a metropolitan city, which
constrains generalizability including racial or ethnic
representation. Furthermore, we focused exclusively on patients
undergoing breast or prostate biopsies, which are 2 of the most
common cancers. Future research should focus on other tumor
types that have received less attention in QoL studies. We also
recommend that future researchers who are interested in
interrogating adaptation to adversity among couples also
consider including behavioral and neurobiological assessments
in addition to self-report measures. This study included a
9-month follow-up period, which was chosen to feasibly
complete recruitment and assessments within the 2-year grant
period. Furthermore, in order to retain sufficient resources to
enroll and follow as many couples who received a malignant
biopsy result as possible, we were not able to longitudinally
follow all couples who received a benign biopsy result.
Therefore, more prospective studies are needed with follow-up
schedules beyond the first year after a biopsy result, specifically
among couples who receive benign biopsy results. Finally,
although it is important to understand how individual and
relational functioning prior to biopsy predicts QoL following a
diagnosis, we acknowledge that this assessment time point is
not a true baseline of functioning as patients are undergoing
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biopsy as a result of abnormal screening findings and
symptomatic presentation (of which they and their spouses or
partners are aware).
Conclusions
A cancer diagnosis is a profound and often very stressful
experience for both patients and their partners. Spouses and
partners are by far the most common informal cancer caregivers,
helping patients manage disease symptoms, treatment side
effects, and emotional distress. To our knowledge, the Couples
Cope Study is the first study to prospectively examine QoL
among both patients and their spouses or partners from the
moment prior to a diagnostic biopsy through the year following
a malignant or benign diagnosis. The results of this study will
address a crucial gap in the literature and contribute to our
understanding of how individual well-being and relationship
quality contribute to QoL outcomes among couples facing
cancer and can inform our future efforts to provide effective
interventions and support earlier to couples facing a possible
cancer diagnosis.
Acknowledgments
Research supported by a John Templeton Grant (60699) awarded to PIM and EOC. PIM was also supported by a National Cancer
Institute Career Development Award (K01CA258955) and a National Institute of Minority Health and Health Disparities diversity
supplement (R01MD010440).
Data Availability
Data from this study are not publicly available due to ongoing analyses; however, deidentified data from this study will be made
available from the corresponding author upon reasonable request (as allowable according to institutional review board standards).
Authors' Contributions
PIM and EOC designed this study and acquired funding alongside FJP, JTM, BY, SMK, SDK, and SCF. JLT led participant
recruitment and screening, survey administration, and data management under the supervision of PIM and EOC. PIM, EOC,
SMW, JLT, RLN, and HNM developed the initial draft of this study. All authors were involved in the interpretation of findings
and participated in the paper preparation and approval.
Conflicts of Interest
None declared.
Multimedia Appendix 1
Baseline and follow-up study assessments.
[DOCX File , 19 KB-Multimedia Appendix 1]
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Abbreviations
CONSORT: Consolidated Standards of Reporting Trials
EHR: electronic health record
QoL: quality of life
Edited by A Mavragani; submitted 31.08.23; peer-reviewed by L Venderbos, S Basha, T Lund-Jacobsen; comments to author 02.01.24;
revised version received 11.03.24; accepted 12.03.24; published 18.06.24
Please cite as:
Moreno PI, Worch SM, Thomas JL, Nguyen RL, Medina HN, Penedo FJ, Moskowitz JT, Yanez B, Kircher SM, Kundu SD, Flury SC,
Cheung EO
Quality of Life in Patients and Their Spouses and Cohabitating Partners in the Year Following a Cancer Biopsy (the Couples Cope
Study): Protocol for a Prospective Observational Study
JMIR Res Protoc 2024;13:e52361
URL: https://www.researchprotocols.org/2024/1/e52361
doi: 10.2196/52361
PMID:
©Patricia I Moreno, Sarah M Worch, Jessica L Thomas, Rebecca L Nguyen, Heidy N Medina, Frank J Penedo, Judith T Moskowitz,
Betina Yanez, Sheetal M Kircher, Shilajit D Kundu, Sarah C Flury, Elaine O Cheung. Originally published in JMIR Research
Protocols (https://www.researchprotocols.org), 18.06.2024. This is an open-access article distributed under the terms of the
Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution,
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