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ONLINE EXCLUSIVE/RESEARCH BRIEF
Reciprocity for Patients
With Head and Neck Cancer Participating
in an Instrument Development Project
Margaret H. Crighton, MSN, RN, Andrew N. Goldberg, MD, and Sarah H. Kagan, PhD, RN
Key Points . . .
Purpose/Objectives: To examine reciprocity (i.e., a mu-
tual exchange of benefit) in study participation via a the-
matic analysis of field notes on study participation from a
The enrollment of subjects in clinical trials research results in
parent psychometric study.
investigator-participant relationships involving benefits to
Design: Qualitative.
both parties, or reciprocity. Reciprocity for patients involved
Setting: Head and neck surgery clinic in an urban tertiary
in observational, survey, or instrument development research
hospital.
has not been studied extensively and remains unclear.
Sample: Seven patients with head and neck cancer re-
cruited to participate in an instrument development
Benefits to patients participating in an instrument develop-
project.
ment project may include reassurance that their experiences
Methods: Symbolic interactionism was employed to
with cancer are common, opportunities for social interaction,
frame the examination of field notes from observations and
and contact with study nurses.
interactions with patients, as well as participant notes ac-
Interaction with study nurses sometimes leads to the identifi-
companying returned retest questionnaires. Analysis relied
on the constant comparative technique at the levels of
cation of clinically important information that warrants fol-
open and axial coding.
low-up with a treating physician. It also may enable patients
Main Research Variables: Participation in an instrument
to better understand their experience with head and neck can-
development project.
cer.
Findings: Four content themes emerged in the analysis:
A study nurse can be a mediator of reciprocity in study par-
Willingness to Help, Reassurance That the Deficits Patients
ticipation; this aspect of the role should be explored further.
Experience Are Common, Participation Provides Social
Contact, and Confirmation of Clinically Significant Findings.
A process theme, Unveiling the Experience, integrated the
content themes in relation to participation itself. The role of
the study nurse appears to be pivotal in this process.
Faden, & Schoch-Spana, 1996). They often believe that the
Conclusions: A notion of reciprocity in research partici-
cure will affect them (Roberts, Warner, & Brody, 2000). Pa-
pation is apparent. The role of the study nurse is an impor-
tients who participate in clinical research also have identified
tant element in the process of reciprocity. This role should
benefits of frequent testing and monitoring of disease
be explored to enhance study participation.
(Mattson, Curb, & McArdle, 1985). However, benefits for
Implications for Nursing: Implications, particularly for clini-
cal trial nurses, include recasting the benefits of participat-
those who participate in trials or projects that are not clinically
ing in research, better addressing preparation for patients
scheduled to receive treatment for head and neck can-
cer, and exploring and enhancing the role of the study
Margaret H. Crighton, MSN, RN, is a predoctoral research fellow
nurse.
in psychosocial oncology (National Institutes of Health IH 5-T32
NR07036-15) in the School of Nursing at the University of Pennsyl-
vania in Philadelphia; Andrew N. Goldberg, MD, is associate pro-
nrollment of subjects in clinical trials research is cru-
E
fessor of otolaryngology at the University of California, San Fran-
cial to the success of any study. Enrollment in clinical
cisco; and Sarah H. Kagan, PhD, RN, is associate professor of
trials results in the establishment of investigator-par-
gerontologic nursing in the department of otorhinolaryngology in
ticipant relationships that clearly involve reciprocity, or a
the School of Nursing at the University of Pennsylvania. This project
was funded by a grant from the Frank Morgan Jones Fund, Univer-
mutual exchange of benefit. Investigators unmistakably ben-
sity of Pennsylvania School of Nursing. (Submitted August 2001. Ac-
efit from patient participation, and participants in clinical trials
cepted for publication June 30, 2002.)
often view study participation as a personal treatment option,
as well as a means of contributing to a cure (Kass, Sugarman,
Digital Object Identifier: 10.1188/02.ONF.E127-E131
CRIGHTON VOL 29, NO 10, 2002
E127
based are less clear. What can be gained by people who par-
enrollment and data collection, which took place in the head
ticipate in observational, survey, or instrument development
and neck surgery clinic in an urban tertiary hospital. She ap-
projects?
proached eligible patients while they were in examining
Several authors have suggested that patients participating in
rooms waiting to be seen by their surgeons. To be eligible,
clinical research gain psychological and social benefits. Par-
patients had to be older than 18, fluent in English, available
ticipation has been shown to enhance self-esteem (Ruzek &
for retest within two weeks, able to participate by oral or
Zatzick, 2000; Seelig & Dobelle, 2001) and provide reassur-
nonoral means, able to complete a questionnaire indepen-
ance and peace of mind to subjects (Mattson et al., 1985; von
dently, at least one month postdischarge from primary treat-
Strauss, Fratiglioni, Jorm, Viitanen, & Winblad, 1998). These
ment for head and neck cancer, and able to take liquid or solid
psychological benefits have been linked to the social interac-
food by mouth.
tion that occurs between subjects and research staff members
Parent Study's Data Collection
during studies (von Strauss et al.).
This article reports a thematic analysis of field notes from
The study nurse was present in the head and neck surgery
an instrument development project. The purpose of the
clinic on days when physicians saw patients. Eligibility was
analysis was to examine study participation with a focus on
determined by reviewing the charts of those patients who
describing the nature of any reciprocal benefit voiced by
were to be seen on those days. After arrival of eligible pa-
participants. The materials for the analysis included an au-
tients to examining rooms, the study nurse approached them
dit trail maintained by the study nurse, as well as data con-
and inquired about their interest in participating in the par-
tributed by participants in the form of notes and letters. Be-
ent study. She remained in the room with each patient and
cause of the character of the data, interaction between the
was available to answer questions while the study materials
nurse and participants was an initial trigger and focus for the
were completed (see Table 1). This process generally took
analysis. The project was framed in symbolic interactionism,
1530 minutes. The study nurse asked patients if they would
a social psychological theory aimed at understanding mean-
be willing to participate in a retest of one of the instruments
ing derived from individuals' interaction with their environ-
by mail. If patients agreed, the study nurse sent the materi-
ments, because of the interaction inherent in study participa-
als with return postage to the subjects about two weeks later.
tion (Blumer, 1969). The parent project, "Development of a
A handwritten note reminding patients of their willingness
Chemosensory Questionnaire for Patients Treated for Head
to fill out the retest questionnaire accompanied the survey.
and Neck Cancer," was reviewed and approved by the insti-
Many participants responded to this note with handwritten
tutional review board of the University of Pennsylvania in
notes of their own. Participants often included personal com-
Philadelphia.
ments that inquired about the study nurse and offered clini-
When patients were asked whether they were interested in
cal information.
participating in the parent project to develop a chemosen-
Procedures for Secondary Project
sory questionnaire for patients treated for head and neck
cancer, they often answered with questions of uncertainty:
The study nurse was responsible for maintaining an audit
"What will this mean?" "Will I have to come back?" "Will
trail of the research process. The purpose of the audit trail was
it hurt?" How long will it take?" The literature suggests that
to monitor the quality of enrollment and consent procedures
inconvenience and personal cost are disadvantages of par-
and document comments from participants. It also tracked the
ticipating in clinical research (Mattson et al., 1985). Despite
numbers of patients who refused participation without includ-
some patients' initial hesitance, at the time of data analysis,
ing any identifying information about them.
97% of 120 invited patients agreed to participate. This high
rate of acceptance poses the question of what perceived re-
ciprocal benefits patients who participate in clinical research
Table 1. Study Materials
may have.
Questionnaire
Description
Theoretical Framework
Chemosensory questionnaire
A s s e s s e s taste and smell
Symbolic interactionism framed the exploration of commu-
(under development)
c h a n g e s in patients who
nication around study participation to examine reciprocity.
have been treated for can-
Symbolic interactionism is a social psychological theory that
cer of the head and neck.
frames human communication in terms of symbols, meaning,
Performance Status Scale for
Assesses the ability of pa-
and environment (Blumer, 1969). It relies on the notion of
Head and Neck Cancer Pa-
tients with head and neck
communication as an exchange of symbols and meaning in a
t i e n t s (List, Ritter-Sterr, &
cancer to eat and speak.
particular environment. Symbolic interactionism then lends
Lansky, 1990)
structure to understanding the phenomenon of nonclinical tri-
University of Michigan Head
Assesses the impact of head
als research participation when approached from the perspec-
a n d Neck Quality of Life
and neck cancer on four di-
tive of reciprocal exchange of benefit.
Questionnaire (Terrell et al.,
mensions of quality of life:
1997)
c o m m u n i c a t i o n , eating,
Methods
emotions, and pain.
Parent Study's Design, Sample, and Setting
12-Item Short-Form Health
Not specific to patients with
S u r v e y (Ware, Kosinski, &
head and neck cancer. As-
The study nurse for the parent study was a graduate nurs-
Keller, 1996)
sesses health-related quality
ing student with a clinical background of working with popu-
of life.
lations with HIV and cancer. She was responsible for subject
ONF VOL 29, NO 10, 2002
E128
Results
Data Analysis and Interpretation for the
Secondary Project
Five themes emerged from the analysis. Themes that re-
Data for the secondary project consisted of 21 documents;
flected the content of the patients' experiences and the ben-
14 of these were field notes and 7 were notes written by pa-
efits of participating included Willingness to Help, Reassur-
tients. The data were from the first year of the parent study,
ance That the Deficits Patients Experience Are Common,
during which time 120 of 200 participants (60%) were en-
Participation Provides Social Contact, and Confirmation of
rolled. To preserve confidentiality, specific demographic data
Clinically Significant Findings. The process theme was la-
were not associated with the audit trail. Documents were la-
beled Unveiling the Experience.
beled only with subjects' numbers.
Willingness to Help
Data analysis procedures are outlined in Figure 1. Data
were analyzed using a constant comparative technique at the
Many participants wrote statements indicating their desire
level of open coding to identify themes (Strauss & Corbin,
to be helpful with the project. One man had been disease-free
1990). Open coding involves a process of examining data
for more than five years when he completed the survey and
fragments for content. This first component of constant com-
said, "I would have liked to have filled this out when I had no
parative analysis readies data for successive levels of ab-
taste. ... It would have been more helpful." Others offered this
straction that move toward axial or preliminary theoretical
simple statement: "I hope I have been helpful." Patients
coding and inductive generation of concepts and theoretical
seemed to take their agreement to participate seriously, often
frameworks. Analysis for the secondary project began with
inconveniencing themselves to complete the study materials.
a review of all audit trail documents and patients' written
When unable to finish the forms after their appointments,
notes, which were scanned for content related to participa-
many participants asked, "Can I take it home to finish it?" If
tion. Twenty-one documents that commented on participa-
they did take the packet home, most (25 of 30, 83%) com-
tion were culled. This set comprised the text sample for this
pleted it and mailed it back to the study nurse. These partici-
analysis. Text from the field notes and materials written by
pants appeared to want to make a substantive contribution to
participants were broken into phrases in open coding. These
a project that would not benefit them directly but required a
codes were sorted by content and compared with previous
concerted effort to complete. This balance of contribution
codes as data were accumulated. As themes became appar-
versus inconvenience was not, however, elucidated by the
ent, the open codes were reviewed and compared again.
data available.
Variation in detail was excluded, and open codes were col-
The commitment to help was additionally supported by
lapsed into axial codes (Strauss & Corbin). Axial codes were
the orientation of comments toward future research involve-
reported by the nature of the code itself. Codes that de-
ment: "Should you take this [area of inquiry] further, I
scribed content or information that participants expressed as
would be willing to participate [in later studies]." One man
important were labeled as content themes. The code that
had ideas about what should be investigated next: "I believe
described process was labeled as such.
that we compensate for taste with sight and texture. Please
let me know if you are going to carry [the chemosensory
study] forward." These suggestions seemed to be an exten-
sion of helpfulness; participants held specific ideas that they
Review of audit trail documents and patient-written notes
appeared to express because involvement in the parent study
provided an opportunity to do so.
This theme also was reflected in the inclusion of identify-
21 documents commenting on participation
ing data that patients wrote or attached to returned retest ques-
tionnaires. The participants were cautioned, in keeping with
the protection of human subjects, not to include identifying
Open coding
information on study materials. Nonetheless, the patients who
Quantifying and qualifying experiences
enrolled in this chemosensory project seemed not to want
Filling in the survey is a therapeutic process.
anonymity. Some apparently wanted to assume ownership of
Thinking he or she is the only one
their contribution to the parent project.
Social contact during a difficult time
Emergence of clinically significant information
Reassurance That the Deficits Patients
Story to tell
Experience Are Common
Assuming ownership of the contribution he or she
Almost every participant, at some point while completing
is making to the project
study materials, would grunt, sigh, or utter "hmmm." When
Maintaining normalcy
asked whether everything was "OK," many replied with
phrases such as, "I thought it was just me!" or "I thought I was
the only one." One woman spoke at length about her struggle
Axial coding
Willingness to Help
with nausea, vomiting, and eating, then commented, "When
you fill out these things, you realize that what you're going
Reassurance That the Deficits Patients Experience Are Common
through is normal." Completing the study materials appeared
Participation Provides Social Contact
to confirm chemosensory and related symptom experiences
Revelation and Confirmation of Clinically Significant Findings
for some participants, suggesting that they had limited confir-
Unveiling the Experience
mation of the commonality of that experience prior to partici-
Figure 1. Data Analysis Procedures
pation.
CRIGHTON VOL 29, NO 10, 2002
E129
Participation Provides Social Contact
uncovering and confirming chemosensory issues and other
aspects of the head and neck cancer experience seemed to be
The third theme reflects the social interaction provided by
made clear by the communication of the content itself. In
study participation. As participants talked to the study nurse,
unveiling the participants' relevant experiences, the main
many described their experiences with head and neck cancer.
content themes emerged. This process of unveiling connected
Conversations that included exploration of chemosensory
the separate elements of benefit suggested in the content
change often led to discussions of the cumulative loss inher-
themes. These benefits to participants emerged during and as
ent in the challenge of current treatment protocols for head
a result of interacting with the study nurse and the study ma-
and neck cancer. This theme was revealed by participants who
terials.
expressed being unprepared and conveyed a sense of being
taken aback by symptoms. "They told me all this stuff would
Discussion
happen to me, but they didn't tell me how bad it would be."
This patient had undergone surgery and radiation and had lost
This analysis of audit trail documents to understand partici-
more than 70 pounds with severe nausea, vomiting, and com-
pation in nonclinical trial research and reciprocity for partici-
plications related to tube feedings. Although she had been in-
pants provokes several questions for the conduct of research
formed that such complications could arise, encountering
and for investigation of research participation itself. The con-
them stunned her.
tent themes imply specific benefit that is both altruistic and
One man, who had been cancer-free for more than four
directed towards patients' own interests. The interactive pro-
years, said the radiation oncologist told him that radiation to
cess of research participation imparts specific benefits for in-
the neck would be a little like a burn. He reported that his
dividual participants. The participants in the parent psycho-
experience was "like being sunburned from the inside out."
metric project offered information for the secondary study
Others described the toll that head and neck cancer and its
that suggests they valued the process and found reciprocal
treatment took on them. Several participants said, "I don't go
benefit--in particular, content imbedded in the process.
out like I used to." Others made comments such as, "My en-
These findings are congruent with conclusions offered by
ergy isn't what it was before." Many participants said, "I can-
Napholz (1998) and von Strauss et al. (1998). Napholz's ex-
not taste and smell like I used to. It's hard."
periences accruing a sample of ethnic minorities for an inter-
Although such comments are related to the commonality of
vention study revealed that subjects were more willing to par-
symptom experience, these expressions of individual experi-
ticipate when the interviewer created a safe environment and
ences seemed related to the presence of an educated listener,
took time to develop a rapport with them. Furthermore, the
the study nurse. This social contact may have been important
relationship between subject and interviewer fostered the
because of the study nurse's absence of a connection to fam-
interviewer's legitimacy. Von Strauss and colleagues exam-
ily and friends (who might not want to hear the details of un-
ined the benefits of participation to patients enrolled in epide-
pleasant experiences) or to the healthcare team (with whom it
miology research. The authors alluded to the importance of
might be difficult to explore the experience because discus-
the study personnel in successful study participation by older
sion takes extra time or requires extra attention).
adults. The researchers explained that they intended to provide
a pleasant and safe atmosphere for research and planned for
Revelation and Confirmation of Clinically
additional time with subjects to develop a rapport.
Significant Findings
Repeated literature searches found no nursing studies that
The study protocol mandated that if the study nurse iden-
specifically addressed participation in nonclinical trials re-
tified a clinically significant finding that a patient had not dis-
search or the benefits associated with it. However, two nurse
cussed with a treating clinician, she would solicit agreement
investigators have written methods papers that touch on some
to report the finding and communicate it immediately to the
of the content reflected in this analysis. Neufeld, Harrison,
treating surgeon and nurse. Some participants identified nu-
Hughes, Spitzer, and Stewart (2001) emphasized the impor-
tritional deficits and inadequate pain control that were contrib-
tance of study personnel (i.e., study nurses or research assis-
uting to a depressed mood. One said, "Loss of taste and smell
tants) who are credible in participants' eyes and capable of
is devastating." The man who made this statement belonged
effectively communicating and establishing trust with them.
to a family that valued mealtime. Another participant said that
Smith (1999), in his article addressing the benefits of keeping
because he no longer enjoyed eating, he could not fully par-
a reflexive journal in phenomenologic studies, also acknowl-
ticipate in an important family ritual, a loss that left him feel-
edged the importance of establishing a rapport with partici-
ing isolated and downcast: "If it were not for my dog, I would
pants. Smith also noted that participating in his study seemed
have ended it a long time ago." As a result of his cancer treat-
to be of therapeutic value and perhaps was part of the partici-
ment, he lost his voice and sense of taste. Despite the sever-
pants' healing from suffering.
ity of these losses, their psychosocial impact was unknown to
Napholz (1998) and von Strauss et al. (1998) suggested that
the treating surgeon. Study participation sometimes revealed
common concerns may exist in recruiting socially or physi-
clinically important findings that had been untreated. All par-
cally vulnerable individuals for research participation and
ticipants with unreported symptoms had positive reactions to
making the research process acceptable to such individuals.
intervention by the study nurse with treating clinicians.
Neufeld et al. (2001) placed great emphasis on the role that
study personnel play in the successful recruitment and reten-
Unveiling the Experience
tion of participants. Nurses who have clinical backgrounds
may be particularly suited to serve as study personnel. Edu-
The process theme emerged as patients consistently quali-
cated study personnel, time for interaction, and attention to
fied their answers to the survey questions orally and in writ-
clinically important but under-recognized phenomena all may
ing. During analysis of the data for content, the process of
ONF VOL 29, NO 10, 2002
E130
Implications for Research
be of consequence in developing the benefit of participation
in nonclinical trials research and creating reciprocity.
and Practice
Achieving reciprocity by participating in clinical research
is well acknowledged. African American, American Indian,
The content themes and notion of unveiling the experience
and Latinas (Napholz, 1998), patients with schizophrenia
imply some specific reciprocal benefit of participation in
(Roberts et al., 2000), elders in Sweden enrolled in a longi-
nonclinical trials research for these patients with head and
tudinal study (von Strauss et al., 1998), and patients enrolled
neck cancer. This was corroborated by the work of other in-
in cardiac-related clinical trials (Mattson et al., 1985) all
vestigators who have analyzed research participation (Neufeld
showed evidence of some hopeful and altruistic motivation.
et al., 2001; Smith, 1999). However, the notion of reciprocal
However, reassurance is a concept that does not appear fre-
benefit to patients participating in nonclinical trials remains
quently in the literature related to study participation.
virtually unexplored within nursing. The research community
Mattson and colleagues did note reassurance as a benefit of
currently is placing great emphasis on successful enrollment
participation resulting from increased exposure to medical
and retention of minority and other under-represented groups
information.
in research. Issues that emerged in this analysis may serve as
The commonality of research participants' deficits and
a starting point for specific investigation of research partici-
losses was not apparent in the research literature. Perhaps this
pation and the benefits it may hold for patients.
finding arose from the nature of chemosensory loss as an un-
The specific benefits described here suggest that interaction
derstudied phenomenon or from some characteristic of the
with study nurses may have therapeutic value beyond the ethi-
patient group studied. The theme of confirmation of clinically
cal conduct of clinical research. Exploration of this role and
significant findings also did not appear in the research litera-
its effects on patient outcomes and quality of life are under-
ture. These two areas of potential reciprocal benefit for pa-
explored and worthy of investigation. Attention to the inter-
tients participating in nonclinical trials research require con-
personal skills and clinical background of study personnel and
firmation through further investigation but imply that this area
time for interaction in excess of what may be required exclu-
requires careful attention in the conduct of nonclinical trials
sively for completion of study materials are important ele-
projects, both to avoid neglect of clinical information and to
ments of reciprocity in research participation. Development of
retain participants by reducing physical or psychosocial dis-
training programs for study personnel is an important consid-
tress.
eration as investigators strive to disclose all potential benefits
This analysis is limited by the nature and volume of data
of research participation and successfully recruit participants
and requires confirmation through replication of the aim in
for their studies.
other research projects with diverse samples of vulnerable
individuals. The findings would be strengthened by validation
Author Contact: Margaret H. Crighton, MSN, RN, can be reached
from participants who have completed nonclinical trials re-
at crighton@nursing.upenn.edu, with copy to editor at rose_mary@
search.
earthlink.net.
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