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RUNNING HEAD: Promoting posttraumatic growth in cancer patients
Promoting posttraumatic growth in cancer patients:
A study protocol for a randomized controlled trial of guided written disclosure
Valentina Cafaroa, Luca Iania, Massimo Costantinib, Silvia Di Leob
aDepartment of Human Sciences, European University of Rome, Rome, Italy,
valentina.cafaro@unier.it
aDepartment of Human Sciences, European University of Rome, Rome, Italy, luca.iani@unier.it
bPsycho-Oncology Unit, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy,
Massimo.Costantini@asmn.re.it
bPsycho-Oncology Unit, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy,
Silvia.DiLeo@asmn.re.it
Cite this article as:
Cafaro, V., Iani, L., Costantini, M., & Di Leo, S. (in press). Promoting post-traumatic growth in
cancer patients: A study protocol for a randomized controlled trial of guided written disclosure.
Journal of Health Psychology. doi: 10.1177/1359105316676332
Correspondence concerning this article should be addressed to either
Valentina Cafaro, Department of Human Sciences, European University of Rome, Via degli
Aldobrandeschi 190, 00163 Rome, Italy.
Email: Valentina.Cafaro@unier.it
or
Luca Iani, Department of Human Sciences, European University of Rome, Via degli
Aldobrandeschi 190, 00163 Rome, Italy.
Email: luca.iani@unier.it
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Promoting posttraumatic growth in cancer patients: A study protocol for a randomized
controlled trial of guided written disclosure
Abstract
This multicenter study investigates the efficacy of the guided disclosure protocol in promoting
posttraumatic growth, through meaning reconstruction, in cancer patients after adjuvant
chemotherapy. Participants will be randomized to guided disclosure protocol or to an active control
condition. Both conditions consist of three 20-minute writing sessions. Experimental participants
verbalize emotions, describe events and reflect on trauma effects. Control participants write about
their past week’s daily routine. Patients, blinded to treatment assignment, will complete
questionnaires at pre-, post-intervention and 6-month follow-up. This study will improve
knowledge concerning the effects of writing interventions on psychological health and well-being in
cancer patients.
Key words
Randomized controlled trial, posttraumatic growth, meaning, cancer, guided disclosure protocol,
writing intervention.
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Background
Cancer diagnosis and related treatment represent one of the most distressing events that
human beings can meet in their life. As a consequence, oncological patients can experience
depressive symptoms, anxiety and intrusive thoughts (Koopman et al., 2002; Christensen et al.,
2009). Their goals and priorities, taken for granted until that moment, are now potentially
unattainable and uncertainty governs every aspect of the persons’ existence; cancer is, in fact, a
shattering experience that violates the meaning system, which allows people to have the perception
of living in a coherent world (Fife, 2005; Park, 2010).
The meaning that individuals attribute to their lives guides their existence, and has the
function to provide a sense to their actions and goals (Frankl, 1967). Therefore, when a traumatic
experience – such as the diagnosis of a life threatening illness - cannot be integrated into the
person’s meaning system, since it violates his/her beliefs and goals, it may trigger a new search for
meaning. This can lead individuals to a meaning making process, restoring a more adaptive sense of
the world (including values, goals and priorities) and of themselves as worthy, thus allowing a
better adjustment to the cancer illness (Park, 2010).
The discrepancy between the appraised meaning of the traumatic event and the person’s
global meaning system can be reduced through assimilation (i.e., the meaning assigned to the event
is modified) or accommodation (i.e., the global meaning, namely goals and beliefs, is modified)
(Park and George, 2013). According to Joseph and Linley (2006), only the meaning created through
accommodation leads to personal growth. Authors specify the characteristics of growth following
trauma as: (1) enhanced relationships, (2) changed view of the self as more resilient, wise, and
strong, and (3) changed life philosophy that includes appreciation of life and renovates beliefs and
priorities. These aspects are part of the broader concept of Posttraumatic Growth, which also
includes new possibilities and spiritual change (PTG; Tedeschi and Calhoun, 1996). Therefore,
PTG implies the positive changes that people report as a result of experiencing traumatic events
(Park et al., 2010). Similar qualities are also related to the meaning making process; in fact, the
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aspects of growth following trauma have also been reported in the literature on sources of meaning
for cancer patients (e.g., relationships with friends and family, personal values, new goals and
priorities) where their relevance for growth and well-being is emphasized (Fleer et al., 2006;
Jaarsma et al., 2007; Schroevers et al., 2008). According to the above-mentioned studies, Park and
George (2013) have proposed a model where personal growth and benefit finding following trauma
are a consequence of the meaning made, which is a potential result of the meaning making process
(i.e., the resolution of the discrepancy between the view of the self and the world, before and after
trauma). However, the process through which individuals integrate the traumatic experience into
their meaning system can be difficult in absence of psychological resources facilitating pathways to
PTG (Neimeyer, 2006).
The hypothesis that trauma introduces discrepant information with the person’s model of the
world is not new, as Post-Traumatic Stress Disorder (PTSD) theories suggest that, in order to
integrate new information, it is necessary to change preexisting schemas (Horowitz, 1990; Park et
al., 2012). Calhoun and colleagues (2000), investigating the relationship between PTG and PTSD,
stated that the former represents an active effort to build new schemas, goals and meanings through
conscious thought; on the other hand, the latter derives from unconscious automatic rumination and
intrusive thoughts, as the way memory works to rebuild pre-trauma schemas (Janoff-Bulman and
Franz, 1997; Tedeschi and Calhoun, 1995). Recent studies with neurological evidences support this
hypothesis; indeed, greater PTG was correlated with greater left frontal activation in participants
who experienced severe motor vehicle accidents (Rabe et al., 2006). Authors suggested that the
activation of this area, reflecting approach-oriented strategies, might be central for the active
engagement in new goals and possibilities. Accordingly, a positive association between PTG and
activation in left central executive network areas related to prospective memory - useful for
pursuing life goals and priorities - and to working memory - important for deliberating through new
schemas construction - has been found in healthy participants who had undergone stressful events
(Fujisawa et al., 2015). Moreover, PTG was related to a stronger connection between areas
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responsible for memory and mentalization, resulting in greater social abilities that are important for
enhanced relationships. Synchronous neural interaction decreased in control veterans who
experienced more PTG after trauma (Anders et al., 2015). Authors argued that network
decorrelation allows the cognitive processing necessary for PTG. Moreover, the observed
decorrelation was stronger in medial prefrontal cortex areas related to specific functions important
for information restructuration and integration (e.g., decision making, executive control, expression,
encoding and inhibition of fear behavior).
Findings from literature on cancer patients highlight that cognitive-behavioral stress
management interventions, although not specifically targeting benefit finding, enhanced patients’
perception of benefits after breast cancer (Antoni et al., 2001). Tomich and Helgeson (2004), in
their study on positive changes following the trauma of cancer diagnosis, found that benefit finding
could be mediated by several patients’ characteristics such as stage of diagnosis (e.g., stage II
patients experienced more benefits than stage I patients), socio-economic status and ethnic group.
Literature on meaning and growth draws attention on the lack of interventions specifically
designed to increase meaning making and PTG in cancer patients (Henoch and Danielson, 2009;
Lee et al., 2004). A recent meta-analysis of psychological interventions targeting PTG after
traumatic events reported that none of the studies examined had PTG as a primary outcome
(Roepke, 2015). Nevertheless, novel interventions targeting specifically meaning and PTG as
primary outcomes, reported encouraging results with cancer patients (Garlan et al., 2010; Garlick et
al., 2011). Since these studies were not controlled randomized trials, they were excluded from the
meta-analysis leaving a dearth of evidence for their efficacy. Moreover, interventions conducted
soon after the traumatic event had the smallest effect sizes and were carried out mostly with cancer
patients (Antoni et al., 2001, Antoni et. al., 2006; Heinrichs et al., 2012; Penedo et al., 2006). This
may be due to the fact that recently diagnosed or under treatment patients are not yet ready to
process the trauma and report growth from their experience. Interestingly, another study with breast
cancer patients, not included in the meta-analysis because of the lack of a control group, increased
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both meaning and growth through an Expressive Writing (EW) intervention (Kállay and Bặban,
2008). EW, a technique implemented to promote well-being through the disclosure of deep thoughts
and emotions related to a traumatic event (Pennebaker and Beall, 1986), has often produced positive
effects on health (Baikie and Wilhelm, 2005; Pennebaker and Chung, 2007). Pennebaker (1997)
suggested that one of the possible mechanisms through which EW promotes health consists in a
meaning making process, which allows the person to assimilate the traumatic experience into a
preexisting meaning system. Park and Blumberg (2002) provided initial evidence supporting the
meaning making hypothesis; however, the EW protocol has not found substantial corroboration
among cancer patients. In fact, there is contradictory evidence about the efficacy of EW on
psychological symptoms and distress in this population (Jensen-Johansen et al., 2013). Recently, in
their review of EW in cancer patients, Merz and colleagues (2014) found that less than half of the
selected studies report significant effects on physical or psychological health. Moreover, studies
with significant effects had major methodological flaws and, given different procedures used within
EW interventions (e.g. different writing instructions), it is difficult to draw conclusions about which
component of this technique might promote health. Furthermore, the explanations of the
mechanisms through which EW might work are diverse, and none of these have yet found support.
The failure of EW in ameliorating psychological and physical health in cancer patients has been
confirmed by a meta-analytic work (Zachariae and O’Toole, 2015) in which the methodological
quality of the studies was not associated with their effect sizes. Authors suggested that future
research should investigate the effect of potential moderators and different writing approaches in
cancer patients, since even small clinical effect of a low-cost intervention could be relevant.
Let us return to the relation between PTG and meaning making: when a traumatic experience
violates global meaning, the activation of a meaning making process, when successful, allows
building a more adaptive global meaning (Park, 2010; Steger et al., 2015). This meaning made
integrates the traumatic event in a worldview where new goals and possibilities can be embraced;
this process could be facilitated by a writing intervention (Park and Blumberg, 2002). In fact, recent
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literature on trauma and personal growth highlights that writing could be a useful technique, if used
to promote both emotional expression and a more adaptive narrative reconstruction of the traumatic
event (e.g., Freda and Martino, 2014). Narrative reconstruction would trigger an active cognitive
and emotional processing, contrasting unconscious non-adaptive rumination (Triplett et al., 2012).
Accordingly, this process could promote personal growth by stimulating an active investment in the
future and building new and stable resources that will be useful in case of emerging difficulties
(Freda and Martino, 2015). This process would imply a double path: on the one hand, EW could
have a cathartic function by clarifying, releasing and regulating one’s emotions (Lepore and Smyth,
2002; Pennebaker and Chung, 2007). On the other hand, writing could stimulate the construction of
a new sense of meaning through the cognitive reappraisal of the cancer diagnosis and treatment: this
process would allow breaking the association between the event and its automatic emotional
reaction. As a consequence, rumination is transformed into an active mechanism aimed at building
more adaptive schemas of the self and the world, as well as establishing new goals and priorities
(Calhoun and Tedeschi, 2004; Tedeschi and Calhoun, 1995). This is consistent with the view that
growth is an active process that requires personal commitment (Calhoun et al., 2000; Joseph and
Linley, 2005).
The guided disclosure protocol (GDP), developed by Duncan and Gidron (1999), is a writing
intervention specifically focused on facilitating both emotional expression and cognitive processing
of traumatic events. Such intervention seems to be more complete than the original EW technique
(Pennebaker and Beall, 1986). In fact, it is not only focused on emotional expression, but also
guides individuals to describe traumatic events and to reflect on past, present and future effects of
trauma (Arden-Close et al, 2013). The benefits of GDP are supported by initial evidence (Gidron et
al., 2002). Applying the intervention to a sample of frequent clinic attenders, Gidron and colleagues
(2002) reported that participants in the experimental group, after writing for 15 minutes in three
consecutive days, showed less symptoms and attended less clinic visits compared to controls.
Martino and colleagues (2013) investigated the effects of GDP on psychological distress in parents
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of children treated for acute lymphoblastic leukemia. Participants wrote for three sessions every
15/20 days, while control group was assessed only for outcomes. Authors found that the
intervention reduced both psychological (e.g., anxiety, depression) and somatic symptoms within
the experimental group. A qualitative analysis, performed on the texts written by parents who
showed positive changes in psychological outcomes, highlighted the meaning-making mechanisms
leading to a reduced level of anxiety. These include how participants put the shattering experience
into words, reordered and reevaluated the events, connected their emotions to the targeted
experiences, and established a connection with the future (Freda and Martino, 2015). Differently,
other authors (e.g., Arden-Close et al., 2013) have not found evidence for the effectiveness of GDP
in perceived stress reduction and quality of life improvement in ovarian cancer couples; however,
the intervention has buffered the distressing effect of intrusive thoughts in experimental patients.
Their task consisted in writing about diagnosis and treatment for three consecutive days. A possible
reason for the lack of a significant effect on the main outcomes may be the short time gap between
sessions. Indeed, an intervention administered over a longer period of time may boost the process
that leads to growth (Roepke, 2015). Moreover, participants found that 15 minutes was not a
sufficient time to write, especially in day 1, expressing in this way their need for longer sessions. In
a study with breast cancer patients, aimed at reducing PTSD symptoms, participants assigned to the
writing protocol with 15/20 days’ time frame between sessions, reported a significant reduction in
intrusion and irritability compared to no-treatment controls (Martino et al., 2012).
According to the above empirical findings and to the specific characteristics of GDP (Duncan
and Gidron, 1999), the present study protocol aims at promoting meaning making, and
consequently, posttraumatic growth in cancer patients. To the best of our knowledge, no previous
studies have focused on meaning making interventions in order to promote positive changes after
the traumatic experience of cancer diagnosis and treatment. In fact, most studies assessing the
connection between meaning making and PTG are correlational, thus there is a lack of randomized
controlled trials (Henoch and Danielson, 2009; Lee et al., 2004; Roepke et al., 2014). Consequently,
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although GDP has been primarily adopted for PTSD symptoms reduction (Arden-Close et al., 2013;
Martino et al., 2013), the present study investigates the hypothesis that GDP promotes PTG through
the process of meaning making. In fact, given its focus on emotional disclosure and cognitive
reframing, GDP could promote the active process leading to PTG and to a reduction of automatic
intrusive thoughts. Moreover, the GDP writing task explicitly asks patients to reflect on those
aspects deemed as sources of meaning and that are also embraced by the concept of PTG; for
instance, participants are asked about changes in their worldview and in particular about their
priority and relationships. Also, they are asked how the illness can be a cause of changes in their
self-worth and personal strength. Therefore, GDP seems to be well-suited for the purpose of this
study.
If the intervention will produce the desired outcomes, oncological patients could find more
adaptive ways to cope with the traumatic event. Thus, cancer and related treatments could be
perceived not only as a shattering experience, but also reappraised as a possible resource for
positive personal changes.
The primary aim of this study is to assess the efficacy of the GDP in promoting posttraumatic
growth in stage I-III breast and colon cancer patients at the end of their adjuvant chemotherapy.
Secondary aims are: to evaluate the efficacy of the GDP in terms of intrusive thoughts and
avoidance reduction; to assess the efficacy of the GDP in terms of reduction of depression and
anxiety; and to investigate the relationship between constructed meaning and posttraumatic growth.
Methods
Study design
The study is a multicenter randomized controlled trial. Eligible patients who give their consent to
participate in the study will be randomized to receive the GDP intervention (experimental group) or
a control intervention (control group). Both groups will be assessed for study outcomes at baseline,
after the intervention and at 6-month follow-up.
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Ethical issues
The protocol was approved by the Ethics Committee of Reggio Emilia (code n. 2016/0012561), and
by the Ethics Committee of the other participating centers, i.e. Forlì (code n. 4562/2016 I.5/127)
and Cosenza (code n. 81, 15th July 2016). The trial was registered with ClinicalTrials.gov (Protocol
Record 2015/0024360).
Participants
Participants will be recruited in the Oncological Day Hospital (DH) of two Italian hospitals and one
cancer center:
• Scientific Research and Care Institute (IRCCS) Santa Maria Nuova Hospital of Reggio
Emilia – Oncology Unit
• Mariano Santo Hospital, Hospital Company of Cosenza – Division of Medical Oncology
• Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), Meldola
(FO) – Medical Oncology Unit
Eligibility criteria
Inclusion criteria:
1. a histologically confirmed stage I-III breast or colon cancer
2. adjuvant chemotherapy completed by no more than eight months
3. disease free (no evidence of metastatic disease)
4. aged 18 years or over
5. property of written and spoken Italian language.
Exclusion criteria:
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1. having received a structured psychological intervention performed by a psychologist or by a
psychiatrist, for at least six months during the last three years
2. having received a psychopharmacological treatment for a codified psychiatric disorder
(according to the DSM-V) during the last three years
Eligibility criteria will be assessed by reviewing the patients’ medical record and verified at the
time of recruitment.
The interventions
The experimental intervention (GDP). The experimental intervention consists of three 20-minutes
writing sessions where participants are firstly invited to recall chronologically the facts concerning
a traumatic event, and then to label the emotions related to those facts, appraise immediate changes
in priorities, reflect on their current feelings, and on coping mechanisms they have learned.
Moreover, they are asked to reflect on how the traumatic experience has changed their view about
life and themselves, teaching them to cope with other difficulties that may arise in the future.
The original GDP instructions were translated into Italian, and adapted to the specific
traumatic experience of cancer diagnosis and treatment.
Below, we report a synthesis of the tasks concerning each of the three writing sessions (see
Appendix). Participants are asked to:
1. describe memories concerning cancer illness in a chronological order, with an objective and
detached attitude.
2. describe: (a) thoughts and emotions perceived during the illness experience; (b) the impact
of illness on their daily lives, and how it has changed their attitudes toward life.
3. focus on their actual situation, think about the entire illness experience, and report on the
following aspects:
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- their present thoughts and feelings, and how those differ from the ones felt during the illness
experience.
- to what extent they have come to terms with, understand and appreciate themselves to have
dealt successfully with the illness.
- what they have learned from illness in terms of personal insights, knowledge and skills, and
how these resources could be useful in their future.
- how they will cope with other similar events in the future.
Participants are asked to find a quiet place and time in their home to write without being disturbed.
The first writing session will be performed two weeks after the initial assessment (T0), and the
following two sessions once every two weeks.
The control intervention. The control condition consists of three 20-minutes writing sessions,
in which participants are requested to write about events of their daily routine that happened during
the past week; they are also asked to focus on facts, with an objective and detached attitude. The
active control intervention is used to account for the possible improvements after GDP caused by a
placebo effect
As for the experimental group, participants are asked to find a quiet place and time to write
without being disturbed. The same time interval was used between sessions as for the GDP.
One day before each writing session, patients in both conditions will be contacted on the
telephone by the researcher, who will check their understanding of instructions included in the
booklet and remind them to perform the writing task. Failure to contact the patient will be recorded
in the patient form.
Procedures of recruitment and assessment
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Recruitment and baseline assessment (T0). Within each center, one or more health care
professionals (i.e., oncologists, nurses or psychologists) are responsible for the study. They will
participate as recruiters and evaluators and will be trained by the Steering Committee about study
aims and procedures, and provided with study materials. The preferred method of recruitment
involves the oncologist informing eligible patients, who attend DH for their medical consultation.
In case of impediments to recruitment (e.g., oncologists’ unavailability, medical consultation
scheduled beyond eight months after the end of chemotherapy, patients’ unavailability at the time of
medical appointment), a letter will be sent to eligible patients by the local representative group,
presenting general information about the study. Three to seven days later, a member of the study
group will call the patient by phone to give further information, and to verify his/her availability to
participate.
In both cases, patients interested in the study will meet the health care professional, who will
explain both the study aims and the writing tasks, providing them with an information sheet
accordingly to group assignment, and collecting socio-demographic data and clinical information
(i.e., age, sex, educational level, marital status, time since diagnosis, disease site and stage, and
treatment received). Patients, who agree to participate, will give their written consent. The health
care professional will administer baseline questionnaires, and then will contact the trial center for
randomization. Finally, a booklet containing written instructions, according to allocation group, will
be provided to participants that are blinded to treatment assignment and study hypotheses during the
entire study. Anonymity will be guaranteed for both written texts and outcomes assessment.
Post-intervention and follow- up assessments (T1 and T2). Participants will be re-assessed for the
study outcomes three months after baseline (T1), with a time tolerance of ± 15 days, whenever it is
possible during any medical consultation. In this occasion, the booklet containing the patient’s
written texts will be returned. Follow-up evaluation (T2) will be performed six months after the
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post-intervention assessment (with the same time tolerance of ± 15 days), whenever it is possible
during any medical consultation. A flowchart of the study procedures is reported below.
Insert Figure 1
Hypotheses of the study
Main hypothesis. We expect that, after the intervention, participants in the GDP group will have
higher scores on the Posttraumatic Growth Inventory (PTGI; Prati and Pietrantoni, 2006; Tedeschi
and Calhoun, 1996) as compared to the control group.
Meaning construction is deemed as the mechanism underlying the restructuring of more
adaptive schemas that lead to growth. Therefore, we expect that increased levels of PTG could be
mediated by constructed meaning (Hayes, 2013), measured by the Constructed Meaning Scale
(CMS; Fife, 1995; Giorgi et al., 2007).
Secondary hypothesis. We hypothesize that, after the intervention, participants in the GDP group
will have lower scores on the Impact of Events Scale (IES; Horowitz et al., 1979; Pietrantonio et al.,
2003) as compared to the control group. We also predict that participants in the GDP group will
have lower scores on the Hospital Anxiety and Depression Scale (HADS; Costantini et al., 1999;
Iani et al., 2014; Zigmond and Snaith, 1983) as compared to the control group.
Measures
Posttraumatic growth. The construct will be assessed using the Italian version of the Posttraumatic
Growth Inventory (PTGI; Prati and Pietrantoni, 2006). The structure of this 21-item questionnaire is
composed by five factors, partly different from the original version (Tedeschi and Calhoun, 1996).
The first factor (two items) relates to spiritual change. The second factor (seven items) describes a
change in philosophy of life and self-conception. The third factor (five items) relates to changes in
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relationships. The fourth factor (three items) reflects a discovery of new interests and values in life.
The fifth factor (three items) describes the discovery of personal resources available for themselves
and others. Respondents are asked to what extent they have experienced a change in their lives as a
result of their illness. Items are rated on a 6-point Likert scale (0 = I did not experience this change,
5 = I experience this change to a very great degree). Representative items are: “I have a better
understanding of spiritual matters” (spiritual change), “I can better appreciate each day” (change in
philosophy), “I more clearly see that I can count on people in times of trouble” (change in
relationships), “I developed new interests” (new interests and values in life), “I have more
compassion for others” (discovery of personal resources available for themselves and others).
Higher scores indicate higher levels of PTG.
Meaning. The Constructed Meaning Scale (CMS; Fife, 1995) is an 8-item questionnaire measuring
individual meaning as it is constructed in the context of life-threatening illness. The structure of the
CMS is composed by two factors: Disease as permanent damage and Process of adaptation. The
Italian version of the scale was validated in a sample of patients with chronic disabling disease
(Giorgi et al., 2007). Items are rated on a 4-point Likert scale (1 = strongly agree, 4 = strongly
disagree), with higher scores indicating higher levels of constructed meaning. Representative items
are: “I feel my illness is serious, but I will be able to return to life as it was before my illness”
(disease as permanent damage), and “I feel my illness has changed my life permanently so it will
never be as good again” (process of adaptation).
Psychological distress. The Impact of Event Scale (IES; Horowitz et al., 1979; Pietrantonio et al.,
2003) is a 15-item questionnaire measuring the distressing consequences of a traumatic event.
Specifically, it assesses two components of PSTD symptoms: intrusive thoughts and avoidance of
certain feelings, thoughts or situations. Respondents are asked to indicate, on a 4-point scale (1 =
never, 4 = often), the frequency with which they have experienced each reaction during the last
week. Representative items are: “I thought about it even when I did not mean to” (Intrusion), and “I
tried to remove it from my memory” (Avoidance). Higher scores indicate higher levels of distress.
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The Hospital Anxiety and Depression Scale (HADS; Costantini et al., 1999; Iani et al., 2014;
Zigmond and Snaith, 1983) is a 14-item questionnaire specifically developed to measure emotional
distress arisen from diagnosis and treatment in hospital outpatients settings. The scale is composed
by two dimensions assessing anxiety and depression. Items are rated on a 4-point scale indicating
the way respondents have felt over a one-week period prior to measurement. Representative items
are: “Worrying thoughts go through my mind” (Anxiety), and “I feel cheerful” (Depression; reverse
item). Higher scores indicate higher levels of psychological distress.
Treatment expectancy. Treatment expectancy, which can influence treatment outcomes (Boot et al.,
2013), will be measured at baseline by asking patients to what extent they expect improvement in
personal growth after the intervention (i.e. “Please indicate to what extent you think that writing
will help you to grow, finding new resources in yourself since the illness experience”). Responses
will be provided on a 7-point rating scale ranging between 1 (not at all) and 7 (very much). Higher
scores indicate higher positive expectations about treatment.
Sample size
Sample size was computed with a two-sided test using G power 3.1.3 (Faul et al., 2009). An effect
size of 0.36 was estimated (equally with both Hedges’s g and Cohen’s d) according to a recent
meta-analysis on the effect of psychological interventions on posttraumatic growth (Roepke, 2015).
In order to show an effect size of 0.36 with an alpha of 0.05 and a power of 0.80, a minimum of 123
subjects in both groups was required. This means that there is an 80% likelihood that the study will
detect a statistically significant effect if such exists, and allows us to conclude that the mean
posttraumatic growth score differs for GDP versus control groups.
Randomization
Eligible patients who agree to participate in the study will be randomly assigned to the GDP
condition or to the control condition with an allocation ratio 1:1. Randomization is carried out
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through a central phone randomization center using computer generated random numbers. After the
registration of the patient’s basic information, the trial center will attribute a unique code to the
included patient, and communicate to the professional the allocated condition. This code will be
reported in all the forms related to each patient.
Data analysis
A preliminary analysis will be performed to compare, at baseline, the differences of clinical (e.g.,
location of cancer and level of severity) and socio-demographic (age, sex, educational level and
marital status) data, as well as treatment expectancy, primary (i.e., PTGI) and secondary outcomes
(i.e., CMS, IES, HADS), between the two groups (GDP intervention vs. control intervention). After
that, a 2 X 3 mixed factorial design ANOVA will be performed for the primary outcome to
determine whether there will be significant change in posttraumatic growth in the intervention and
control groups at three and nine"months after baseline. If posttraumatic growth will be significantly
higher in the GDP group compared to the control group after the intervention, further analyses will
be performed to examine the effect of the intervention on the five specific factors of posttraumatic
growth. Successively, further ANOVAs will be carried out for each secondary outcome to examine
differences between groups at three and nine"months after baseline. The “between” factor is
intervention with two levels (yes/no) and the “within” factor is time with three levels (T0/T1/T2).
Adjusted analysis of variance with socio-demographic and clinical variables as covariant will be
performed in order to determine whether age, sex, educational level, marital status, cancer’s
severity and cancer’s location differences between groups could account for the effect. Finally, the
potential mediating role of constructed meaning on the effect of GDP will be examined according to
a regression-based approach. The use of ordinary least square regression models to estimate a
simple mediation model is becoming a common practice, which is deemed as appropriate as
structural equation modeling (Hayes, 2013; Kline, 2016; Lauriola and Iani, 2015, in press).
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Discussion
After the end of their adjuvant therapies, cancer patients frequently struggle to find a more adaptive
system of meaning, which could provide them the opportunity of experiencing psychological
growth. Despite the increasing interest for posttraumatic growth in health and positive psychology
literature (e.g., Lelorain et al., 2011; Tedeschi et al., 2015), there is a lack of interventions
specifically targeting posttraumatic growth with cancer patients (Henoch and Danielson, 2009).
According to its theoretical basis, the guided disclosure protocol has the potential to improve cancer
patients’ quality of life after treatments, giving them the possibility to find a new meaning in their
existence by reevaluating their experience of illness, not only as a permanent threat, but also as an
opportunity to grow. Therefore, this intervention, in line with the current research, aims at
promoting well-being, rather than just reducing distressing symptoms and/or monitoring for relapse
in disease-free patients.
This study intends to provide supportive evidence for the effectiveness of the guided
disclosure protocol in facilitating posttraumatic growth in cancer patients. Moreover, it investigates
the hypothesis that meaning construction, facilitated by the writing protocol, is the mechanism
through which posttraumatic growth could be promoted. To the best of our knowledge, this
hypothesis, which was firstly suggested by Pennebaker (1997), has never been tested in clinical
trials.
Results from this study will improve knowledge of whether and how this writing protocol
could trigger posttraumatic growth, and reduce distressing symptoms in cancer patients after
adjuvant chemotherapy. Finally, yet importantly, the potential clinical benefits of the guided
disclosure protocol implies little burden for its implementation in the hospital setting. Indeed, it is a
very efficient intervention both in terms of economic resources and time requested to practitioners
and patients.
Declaration of Conflicting Interests
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The Authors declare that there is no conflict of interest.
Authors’ contributions
Valentina Cafaro conceived the study. All authors contributed equally to the design of study.
Valentina Cafaro, Luca Iani, and Silvia Di Leo wrote the manuscript and equally contributed to the
manuscript revision. All authors read and approved the final manuscript.
Acknowledgements
We would like to thank Giovanna Artioli, Silvio Cavuto, Cristina Pedroni and Elisa Rabitti for their
valuable contribution in revising this study protocol, and Antonio Krase for English reviewing.
20
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Figure'1.!Flowchart*of*study*procedure.
*
Assessment for eligibility*
*
Randomization *
*
GDP protocol!Control intervention
*
Post-intervention assessment
(T1; 3 months after T0)*
*
Post-intervention assessment
(T1; 3 months after T0) *
*
Follow-up assessment *
(T2; 6 months after T1)*
*
Follow-up assessment*
(T2; 6 months after T1*
Exclusion: not meeting
inclusion criteria, refusal*
*
Baseline assessment (T0)*
Enrollement
Allocation
Follow-up
25
Appendix: Guided disclosure protocol
Day 1
Today we ask you to write about your illness. Please describe in chronological order such details as
where you were, what happened, sights and sounds, your surroundings and any action you took in
dealing with this stressful event.
What is important is that you describe the event with a journalistic language and as objectively as
you can without mentioning how you felt. Think of it as the narrative of a story where the character
is someone other than yourself. Try to explain what led to what.
Day 2
Today we ask you to please write about two aspects of the events you described last time.
(1) Please describe as well as you can remember the thoughts and feelings present throughout the
illness experience. Do not feel restricted, but allow yourself to write about the full extent of your
thoughts and feelings. What is important is that you write in the most direct manner as possible the
deepest thoughts and feelings and try to label them precisely.
(2) Please describe the impact that the illness had on day-to-day life. Please explore to what extent
these events changed your attitude/outlook on life (e.g., did it cause you to change priorities or
relationships?).
Day 3
Today, on the 3rd and last day of writing, we ask you to please write about your current view of the
illness experience described in previous sessions. To help you in this, try to distance yourself from
the event and think of the whole illness experience but, concentrate on such aspects as:
- Whether your thoughts and feelings at the present time differ from those you felt during the
illness experience.
- To what extent have you come to terms with, understand and regard yourself to have dealt
successfully with the illness.
- Describe what the illness has taught you in terms of personal insights, knowledge and skills and
comment on whether these could prove useful in the future.
- Whether you will be able to better cope with similar events in future as you have just been through
them.
- If you have additional information concerning the illness, which you feel you need to mention and
were not asked about, please write it.
