Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04843358 |
| Other study ID # |
14/2021 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
April 2021 |
| Source |
Sultan Qaboos University |
| Contact |
Mohammed S Al-Alawi, MD |
| Phone |
92281145 |
| Email |
alalawim[@]squ.edu.om |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background Breast cancer is the most common cancer affecting women globally. Additionally, it
is the most common cause of cancer mortality among women. Internationally, breast cancer is
the most frequently diagnosed cancer among women in 140 of 184 countries. Global registry
surveys also demonstrate that the incidence of breast cancer will increase by 46% and affect
more than 3,059,829 people by 2040. The rate of breast cancer deaths will increase by 58.3%
and affect more than 356,225 women. Psychologically, it has been shown that emotional
suppression experienced by some women with breast cancer is highly predictive of low quality
of life and psycho-somatic morbidities during the process of treatment. Such attitude towards
emotional suppression is thriving well in Arab societies where somatizing, as opposed to
psychologizing, distress is prevailing proclivity. Expressive writing may provide a tool to
meet such need. Taken together and given the lack of any study exploring EW effect of Quality
of life in women with breast cancer. The current study aims to examine the impact of
expressive writing on quality of life in a randomized controlled trial among cancer survivor
in Oman.
Hypothesis The primary hypothesis states that compared to writing about neutral topic,
expressive writing intervention will lead to a better improvement in quality of life among
breast cancer patients after two months of the intervention.
Objectives To assess the efficacy of 3 sessions EWI versus Writing about neutral topic, on
Quality of life of Breast Cancer Survivors at 1- and 2-month post intervention.
Method This study is a multicenter, prospective, double blind, parallel RCT with a 2-month
follow-up and will be carried out at Oman's comprehensive cancer care & research center and
Sultan Qaboos University Hospital, Muscat, Oman. Sixty four participants will be randomized
to 3 sessions EWI group or neutral topic writing group, using a fixed randomization schedule
allocating participant between the two intervention arms in a 1:1 ratio.
Description:
Background Breast cancer is the most common cancer affecting women globally. Additionally, it
is the most common cause of cancer mortality among women. Internationally, breast cancer is
the most frequently diagnosed cancer among women in 140 of 184 countries. Global registry
surveys also demonstrate that the incidence of breast cancer will increase by 46% and affect
more than 3,059,829 people by 2040. The rate of breast cancer deaths will increase by 58.3%
and affect more than 356,225 women.
In the Middle eastern countries, breast cancer is responsible for the highest prevalence rate
(21.9%), new incident (17.7%), and mortality (11.6%) caused by different types of neoplasms.
In Oman, the incidence rate of breast cancer nearly doubled between 1996 and 2015 from 13.6
to 26.9 per 100 000 women. According to recent data from Ministry of Health, breast cancer is
most of common cancer as it accounts for 24.4 percent of all registered cancer incidents in
the Sultanate. Such data herald several repercussion at individual and societal levels from
health as well as financial dimensions. Health related Quality of life of breast cancer
patient is one main concern to be addressed in this context. Health-related quality of life
refers to the extent to which one's usual or expected physical, emotional, and social
functioning are touched by the cancer or its treatment. The time of diagnosis, initial stages
of investigations, the treatment course, and the months following the end of treatment are
challenging times for patients both physically and emotionally. During these times,
uncertainties, difficulty to adjust and hampered quality of life are inevitable. Women
diagnosed with breast cancer are no exception and could endure several emotional and physical
challenges. Plethora of literature indicate that the survivorship time, after the surgery
undergoing chemotherapy and radiotherapy, is often comes with psychological problems and
reduced quality of life (QOL). The reasons for low quality of life among breast cancer
population can be conceived of as bio-psycho-social. From biological aspect, chemotherapy
side effects play a major a role. These include increased mental and physical symptoms such
as anxiety, nausea, constipation, and anemia. Consequently, these side effects can have
negative impact of on treatment of breast cancer. Perceived lack of social support, stigma of
breast cancer diagnosis, and poor self-image have been recognized as significant moderators
of quality of life among breast cancer women.
Psychologically, it has been shown that emotional suppression experienced by some women with
breast cancer is highly predictive of low quality of life and psycho-somatic morbidities
during the process of treatment. Such attitude towards emotional suppression is thriving well
in Arab societies where somatizing, as opposed to psychologizing, distress is prevailing
proclivity.
While recognizing the methodological hurdles in discerning and gauging such concepts of
emotional suppression , it remains pivotal to delve into interventions to help breast cancer
survivors to navigate through these challenges resulting from lengthy process of
investigation and treatment. Several psychotherapeutic interventions were tested including
Expressive Writing. Expressive Writing is one type of intervention aimed at improving emotion
regulation through emotional disclosure. According to the expressive writing intervention
(EWI) paradigm, it may be possible to improve both mental and physical health through
improving self-regulation of emotion-related experiences.
Many mechanisms have been put forward to explicate the effects of Expressive Writing.
Expressive writing may decrease individuals' distress by improving self-regulation of
emotions, behaviors, and physiological responses. In some way, expressive writings help the
person to connect thoughts to feelings. Furthermore, modulating autonomic arousal to cancer
related thoughts and feelings and cognitive processing of events into a coherent and
meaningful narrative have been suggested as mechanisms leading to desirable effect of EW.
According to the social integration model, expressive writing might encourage individuals to
seek social support, which, in turn, feeds in their psychological well-being. In 1986,
Pennebaker for the first time used Expressive writing (EW), which a brief emotional
disclosure experiment, with college students. st Pennebaker's paradigm for EW experiment
encouraged participants to disclose in writing about their trauma-related personally
distressing thoughts and feelings for 20 min over four consecutive days and had another group
to write about neutral topic. Emotional disclosure arm had shown enhanced well-being and
fewer medical visits following writing compared to those who wrote about neutral topics.
Pennebaker and Beall (1986) found that EW is a potentially effective intervention which was
later tested on various population and settings including, clinically ill patients and
healthy individuals. , , .
After Walker's first paper reporting the efficacy of EW with Breast cancer patients, several
trials have been launched based Pennebaker's paradigm to provide the unmet needs of this
population. , , , In 2006, Frattaroli J et al produced the largest meta-analysis of 146
randomized, controlled trials (RCTs) of different types of experimental disclosure among
clinical and healthly populations. The reported an overall effect (r = 0.075≈Cohen's d =
0.15) which was statistically significant. . Ten years later, another review of 20 RCT
indicated a significant small effect on improving physical cancer symptoms; however, the
effects on psychological and cognitive end points were not significant. However, subgroup
analysis showed a significant effect on health-related quality of life between the EW
intervention group and the usual care group. Specifically, looking at Breast cancer samples,
till the date of writing this background, there have been at least 15 clinical trials and two
systematic reviews that explored the rule of expressive writing in alleviating psychological
and physical distress among women with breast cancer at different stage of illness. , As with
many psychological Interventions, the results of the trials on the efficacy and effectiveness
of EW among breast cancer women have not been consistent. The possible reasons are
heterogeneous clinical samples, different stages of illness, difference in the Intervention
and control conditions, using various outcomes measures, lack of inclusion of a number of
mediators including presence/absence of social constraints. Social constraints are the
perceived insufficient social assistance resulting in a disinclination to express thoughts
and feelings about a specific stressor (e.g., people may respond by minimizing the
experience, acting uncomfortable when emotions are expressed, or simply avoiding the person
who is attempting to talk about the experience). Given the nature of Arab culture, where
social constraints are present13, one could expect that patients with breast cancer may not
have avenues to talk about their deep thoughts and feelings in relation to their illness.
Therefore, Expressive writing may provide a tool to meet such need. Taken together and given
the lack of any study exploring EW effect of Quality of life in women with breast cancer. The
current study aims to examine the impact of expressive writing on quality of life in a
randomized controlled trial among cancer survivor in Oman. Hypothesis The primary hypothesis
states that compared to writing about neutral topic, expressive writing intervention will
lead to a better improvement in quality of life among breast cancer patients after two months
of the intervention.
Objectives To assess the efficacy of 3 sessions EWI versus Writing about neutral topic, on
Quality of life of Breast Cancer Survivors at 1- and 2-month post intervention.
Methods Study Design This study is a multicenter, prospective, double blind, parallel RCT
with a 2-month follow-up and will be carried out at Oman's comprehensive cancer care &
research center and Sultan Qaboos University Hospital, Muscat, Oman. Participants will be
randomized to 3 sessions EWI group or neutral topic writing group, using a fixed
randomization schedule allocating participant between the two intervention arms in a 1:1
ratio.
Allocation, concealment, and randomization Block randomization sequence of 6 will be
generated using software that will allocate participants in a 1:1 ratio to balance the number
of the subjects in each arm. Allocation process will be conducted by centralized service at
SQUH with help of independent nurse who is not involve in the research. Participants
allocation sequence either in intervention or control arm will be concealed from the study
participants and the researchers before the beginning of the trial to avoid selection bias.
Each coded sealed opaque envelope which contained participant's treatment allocation will
opened by research assistant not involved in the study or the process of data collection or
analysis. All participants will have a code number allocated to them. The design of this
trial is double blind, the participant will be blinded to the name of the group allocated to.
They will be informed that they are participating in writing study for wellbeing in breast
cancer women and will be informed that the study aims to capture their inner experiences
through writing and will not be made aware of whether they are assigned to an experimental or
a control arms. The outcome assessor will be blind to the participant's allocation.
Sample Size The Superiority hypothesis parallel clinical trial model will be adopted to
calculate the required sample size in each arm to achieve a mean effect size of d = 0.8,
according to published literature, of EWI. Power analysis revealed that 30 participants per
group would yield 80% power to test the primary hypothesis with 5% type one error rate.
Considering 5% attrition rate, the total needed sample size will be 64.
Eligibility criteria
- Omani Women Having a breast cancer diagnosis stage, I and II
- Completing breast cancer surgery within 5 years
- Subsequently received adjuvant treatment including chemotherapy, hormonal treatment, or
Radiation therapy
- Being comfortable writing and speaking in Arabic Exclusion Criteria
- Nonconsenting
- Presence of severe physical illness
- Diagnoses with severe Mental or intellectual disorder
- Advanced case of breast cancer
- Un able to comply with trial protocol
- Presence of another cancer diagnoses
Measure Socio-Demographic Data. This questionnaire contains basic demographic information,
including age, marital status, number of children, living with nuclear or extended family,
employment, highest education, and presence of financial strain, presence of social support,
and presence of social constrain from disclosure.
Medical History Data. Participants will be asked to provide data in relation to their cancer,
including date of diagnosis, tumor site, stage of disease at diagnosis, treatments received,
and other concurrent chronic health problems and medications. This information will be
ascertained through review of patients' medical records Functional Assessment of Cancer
Therapy general scale: FACT-G V4 This 27-item measure examines the perceived quality of life
across four dimensions including physical, social, emotional, and functional well-being in
the past week. The scale was validated among various population of breast cancer survivors
globally. Versions of the FACT-G questionnaire are available in 45 different languages,
permitting cross-cultural comparisons of people from diverse backgrounds, adopting
translation methodology developed for the Functional Assessment of Chronic Illness Therapy
(FACIT) project into European, Asian, and African languages (www.facit.org). The internal
consistency reliability ranged between 0.71 and 0.82. The test-retest reliability within
24-48 h was found to be 0.80. , The Arabic version was psychometrically tested among
Jordanian cancer patients and proved to be valid and reliable tool. The FACT-G version 4 were
utilized in many clinical trials as it is easy to complete and demonstrates sensitivity to
the performance status and the extent of disease. Respondent rates the 27 items on the scale
where each item is rated from (0) not at all to (4) very much. The scores of physical
well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and
functional well-being (7 items) subscales range of 0-28, 0-28, 0-24, and 0-28, respectively.
The highest score of that could be obtained on FACT-G is 108 where the highest the scores the
better the quality of life of the patient. For the use in the current trail author obtain the
LICENSING AGREEMENT from the copy-write owner.
Manipulation check: After each writing session, participants will be asked specific questions
pertinent to how personal they feel their essays are and the degree to which they feel they
have expressed their deep emotions in the writings. Each of these questions was rated on a
7-point scale.
Primary endpoint - The difference in the mean scores change of FACT-G from baseline to the
end of second month between the two arms.
Secondary endpoint
- The difference in the mean scores change of FACT-G from baseline to the end of the second
month within each arm.
Procedure, recruitment, and consent The recruitment will start in August 2021 and end in
August 2024. Radiation and Medical Oncologists, breast surgeons and unite clark at Cancer
center and SQUH will be briefed about the trail for they help in referring eligible patients
to the trail. Participants who will be interested in participation will be contacted by the
trial coordinator who will explain the study and screen potential participants for
eligibility on the phone. Written informed consent will eventually obtained from all study
participants. Participants will complete a baseline assessment that covers data related to
clinical and socio-demographics , Medical and Surgical history and FACT-G. Given that
participants come from different regions in Oman and to increase the feasibility of the
intervention, assessments and experimental procedures will be performed via telephone in case
participant could not be seen in person. For the intervention part, a "writing package" will
be handed /emailed to every participant including blank paper with their identification
numbers to be used for the writing task according to their assignment. Once participant done
writing, they will scan and email back their writing to trail email address. After completing
Assessment 1, participant will be scheduled for 3 writing consecutive days on which she will
complete the writing task. In case participant is unable to schedule 3 consecutive days, 3
days will be scheduled proximally to each other within the same 1-week duration.
The process for the writing manipulation will as follows. On Day 1, a member of trail team
will call the participant at a designated time and give a brief introduction to the writing
task. Participant will be instructed to go to a quiet place in their house where no
interruptions is expected. Then, participants will receive detailed standardized sets of
instructions (as detailed below) based on existing work of Pennebaker. Thereafter,
participant will be informed to start writing immediately after hanging up the phone and to
write continuously for 20 min. The trail member will phone once 20 min lapsed. When writing
session ends, the study member will call the participants to ask whether they experience any
interruptions during the writing time. In case participant faces more than 5 min, she will be
directed to continue writing till completing the 20-min writing time. Once finished, the
participant will be asked to scan the writing paper and email it to trail email. Participant
will be debriefed at the end by asking if she has any question or concerns. Then the writing
time for the following day will be agreed upon. The above process will be repeated the second
and third writing sessions, except for the initial introduction given on day 1. Outcome
assessment with FACT-G will be conducted one and two months after finishing 3 writing
sessions. After finishing the study, all participants will be debriefed. To maintain rapport
with the participants and increase adherence to trial protocol, the same trail member will
perform baseline assessments and give writing instructions for the same participant. Outcome
assessment with FACT-G will be conducted one and two months after finishing 3 writing
sessions by a blind assessor.
