Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05156619 |
| Other study ID # |
060021-HMO-CTIL |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 26, 2021 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
January 2022 |
| Source |
Hadassah Medical Organization |
| Contact |
Shani Paluch-Shimon, MBBS, MSc |
| Phone |
+9722677755 |
| Email |
shanipal[@]hadassah.org.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The overall goal of the project is to characterize the diagnosis, care and outcomes of
advanced breast cancer in unique ethnic cohorts in greater Jerusalem, with a focus on the
Arab population and ultra-orthodox Jewish population and to improve and streamline care of
women from multi-ethnic backgrounds by further understanding barriers to healthcare access.
At completion, the collected data will enable planning of culturally appropriate and
strategic programs that are culturally tailored to improve the standard of care, outcomes and
healthcare access for women living with advanced breast cancer from these unique cohorts.
Target population: Ultra-orthodox Jewish and Arab patients with advanced breast cancer (ABC)
Objectives:
1. Clinical & psychosocial characterization of ultra-orthodox Jewish and Arab women
individuals ABC (including clinical characteristic & treatment, outcomes, access and
inclusion in clinical trials) along the advanced breast cancer journey
2. Evaluate and identify modes of access to care and barriers to breast cancer care for
this population - individually communally, cultural-religiously and professionally
(including healthcare professionals)
3. Develop a model for improving health care access and advocacy, tailored to each
communities needs
4. Apply the knowledge to developing education training and health promotion - including
for the individual, community leadership, and healthcare providers
5. Optimize access to clinical trial participation and reduce any disparities in clinical
trial recruitment and participation
6. Develop and tailor culturally appropriate psycho-social interventions to improve
psychological wellbeing and quality of life
Description:
Project design & methods
The project will include several key aspects with a mixed-methods approach including both
qualitative and quantitative data:
Part A - Data Collection
1. A retropective registry of all women with newly diagnosed breast cancer and advanced
breast cancer (either de novo or recurrent disease) documenting all clinical disease and
treatment characteristics and outcome
2. Gather institutional data on clinical trial recruitment and representation of the
ethnic-religious groups under-study. As this is assessed retrospectively, the
classification into ethnic-religious sub-groups will be determined by suburb of
residence (In Jerusalem ultra-orthodox Jewish and Arab populations in Jerusalem live in
distinct homogenous suburbs, distinct from those of the secular Jewish population - this
has been demonstrated to be a reliable approach in Jerusalem). Data will be collected on
patients recruited between 1/1/2012 until 30/6/2021.
3. Gather data on quality of life, general well-being, spiritual well-being, information
receipt along the advanced breast cancer journey for all patients with newly diagnosed
advanced breast cancer and compare between the different ethnic groups/cohorts
Part A.1 - Data Collection Methods
1. Data will be collected for a retropective registry of all women with newly diagnosed
breast cancer and advanced breast cancer (either de novo or recurrent disease) between
1.1.18-30.6.21 documenting all clinical disease and treatment characteristics and outcome.
Data will be collected from the "Mahar" electronic medical record based on lists of all new
intakes and all patients with newly recurrent disease that are maintained in the breast
oncology unit. Patient identity will be coded and saved anonymously in the data file.
Part A.2 - Data Collection (Appendix 2) Methods Patients documented in the Hadassah "Mahar"
to have participated in a clinical oncology trial between 1/1/2012 until 30.6.2021 will be
included. Patient identity will be coded and these details will be stored in a separate file.
The data collection file will include anonymized patient data. Data collection will include
data describing patients' socioeconomic status including gender, date and country of birth,
religion, neighborhood and family status. Clinical data about the oncological diagnosis,
management and course of disease as well data about the clinical trial intervention and
informed consent process will be collected.
Part A.3- Data Collection Quality of Life, Coping and Well-being Method Participants 200
women with metastatic breast cancer will be recruited to the study from Oct 2021 until June
2023. Inclusion criteria: (a) above 18 years old (b) newly diagnosed with metastatic breast
cancer or during the last 6 months prior to commencement of the study. Ultra-Orthodox and
Arab patients will be part of the study groups, while the secular and national religious
patients will serve as control group. Each woman will define her own ethnic/religious
identity.
Procedure Patients will be initially approached by the study coordinator during their clinic
visit or during their visit to the oncology daycare. They will explained on the study and
provide inform consent, which will be storage separately from the study's questionnaires.
Patients who have consented will complete a baseline demographics questionnaire (Appendix 3)
and all baseline and ongoing clinical data pertaining to their breast cancer diagnosis and
treatment will be collected. Patients will complete psycho-social questionnaires every three
months. This will be coordinate by study's coordinator. The questionnaires will be completed
using the Qualtrics questionnaire design tool using their personal mobile phone or study's
tablet.
Every three months the research coordinator will contact the participant through phone and
will either send link to her phone or schedule a meeting in the hospital in which she will
answer the questionnaires or answer the questionnaires by phone according to patient's
preference.
Some of the Questionnaires will be answered every three months (EORTC QLQ-C30, FACT-B, BDI,
FACIT-Sp, STAI) and some will be answered occasionally. The approximate time needed to answer
the questionnaire each time will be up to 30 minutes.
The schedule:
Time 1:
- EORTC QLQ-C30
- FACT-B
- BDI
- STAI
- FACIT-Sp
- Demographic questionnaire
- SBI-15R
- ECR-12
Time 2 (month 3):
- EORTC QLQ-C30
- FACT-B
- BDI
- STAI
- FACIT-Sp
- UCLA loneliness scale
- CPASS
- CISC
- Emotional Disclosure and Holding Back subscales
- RAS Time 3(month 6)
- CISC
- Emotional Disclosure and Holding Back subscales
- RAS
- QLQ -INFO25
- Brief Illness Perception Questionnaire
- MAC Time 4(month 9)
- EORTC QLQ-C30
- FACT-B
- BDI
- STAI
- FACIT-Sp
- SCS Time 5 (after month 12)
- EORTC QLQ-C30
- FACT-B
- BDI
- STAI
- FACIT-Sp
- SCS
Questionnaires:
The following questionnaires will be completed every three months:
Quality of Life - The EORTC QLQ-C30 was developed to assess QoL in cancer patients. The
30-item questionnaire includes five functional scales (physical, role, cognitive, emotional,
and social), a global quality of life scale, three symptom scales (fatigue, pain, and
nausea/vomiting), and several single-item symptom measures (dyspnea, loss of appetite, sleep
disturbance, constipation, diarrhea, and financial difficulties). Apart from two items of the
global quality of life scale scored on a 7-point scale ranging from 1 (very poor) to 7
(excellent), all items were scored on a 4-point scale ranging from 1 (not at all) to 4 (very
much). Higher scores in functioning scales represent a higher level of functioning; higher
scores in symptom scales as well as single items, represent a greater level of impairment.
Cronbach's α for this instrument was 0.927. There are an official Hebrew and Arabic versions
of the questionnaire Well-being - Functional Assessment of Cancer Therapy-Breast (FACT-B)
37-item (Version 4) scale, which contains subscales of physical, social, emotional, and
functional well-being in addition to the 10-item breast-specific subscale. The FACT-B total
score is the sum of scores of all five subscales. Each item is rated on a 5-point Likert
scale. Negatively worded items were recoded such that a higher score indicates as better.
There are an official Hebrew and Arabic versions of the questionnaire .
Depression - The Beck Depression Inventory BDI is the most often used self-rating instrument
for depressive symptoms. A 21-item self-report depression screening measure. Each item is
rated on a 4-point Likert-type scale ranging from 0 to 3, with higher scores indicating
higher levels of depression. The measures ask respondents to endorse statements
characterizing how they have been feeling throughout the past 2 weeks. The maximum total
score for all 21 items is 63. According to the BDI-II manual, scores of 0 to 13 denote
minimal depression, scores of 14 to 19 denote mild depression, scores of 20 to 28 denote
moderate depression, and scores of 29 to 63 denote severe depression. The questionnaire was
found numerous times valid and consistent. There are available Hebrew and Arabic versions of
the questionnaire Anxiety - The State-Trait Anxiety Inventory (STAI) is a psychological
inventory based on a 4-point Likert scale and consists of 40 questions on a self-report
basis. The STAI measures two types of anxiety: state anxiety - anxiety as a response to an
event, and trait anxiety - anxiety as a personal characteristic. For the current study we
will use only the state subscale. Higher scores represent higher levels of anxiety. The scale
was found to have high reliability Spiritual well-being - The FACIT-Sp has three sub-domains
of spiritual well-being, which help facilitate an in-depth exploration of the components that
constitute spiritual well-being (peace, meaning, and faith). The responses emphasized a sense
of meaning in life, harmony, peacefulness, and a sense of strength and comfort from one's
faith. It consists of 12 items on 5-point Likert-type scale to measure patient-reported.
There are an official Hebrew and Arabic versions of the questionnaire
Demographic and predisposition variables will be measured at Time 1:
Demographic questionnaire was developed for the study and consist of questions regarding
socio-demographic variables. It need to be translate into Arabic.
Religiosity - The Systems of Belief Inventory (SBI-15R) was designed to measure religious and
spiritual beliefs and practices, and the social support derived from a community sharing
those beliefs. The 15-item self-report measure is a revised and shortened form with two
dimensions: one with 10 items relating to beliefs and practices, and the second with five
items relating to the social support of the religious community. Each item is scored on a
four-point scale, ranging from 'strongly disagree' to 'strongly agree'. The score for the
total SBI-15 ranges from 0 to 45, with higher numbers indicating more religiosity. Cronbach's
alpha is 0.80.
Attachment orientations - participants will complete a shortened version of the Experience in
Close Relationships [ECR] Scale. This 12-item version [ECR-12] Likert - scale is based on a
previous Hebrew version of the questionnaire and was previously found to be highly reliable.
ECR-12 evaluates participants' attachment insecurities through two dimensions: anxiety (e.g.
" I need a lot of reassurance that I am loved by people close to me") and avoidance (e.g. "I
do not feel comfortable opening to other people") which construct two subscales. A high score
on each of the subscales indicates an attachment that is either more anxious or avoidable.
Relational variables will be measured at Time 2. Some of the questionnaire will be answered
only by participants that have a spouse.
Loneliness - The revised UCLA loneliness scale is the most widely used instrument to
empirically measure the level of loneliness. The UCLA loneliness scale consists 20-item
questionnaire that measures loneliness in adults. Each item is rated on a four-point
Likert-type scale. Positively worded items are reversed before scoring. Higher scores suggest
higher perceived loneliness . Hebrew version is available, but the questionnaire still need
to be translated into Arabic.
Perceived social support. The Cancer Perceived Agents of Social Support scale [CPASS; ] was
23 originally developed for Hebrew-speaking participants and consists of 12 items that assess
the degree to which a person perceives receiving support from four agents of support: spouse,
family, friends, and spiritual community. Three types of support given by each agent of
support are assessed, i.e., emotional support, cognitive support, and instrumental support.
Answers are given on a 5-point scale, with higher scores indicating higher levels of
perceived support. The CPASS has been shown to have adequate validity and reliability.
Questionnaires only for participants that have a spouse:
Contextual self-concealment. Functional Assessment of Cancer Therapy [CISC] consists of 13
items, assessing the frequency of self-concealment behavior in the context of couples coping
with a chronic illness. Its wording emphasizes the individual's efforts spent in actively
trying to conceal different matters related to the illness (e.g., medical information,
physical symptoms, feelings, and implications of the illness), using various methods (e.g.,
camouflaging illness symptoms, keeping secrets, etc.). Responses are coded on a 7-point
scale, ranging from 1 to 7, with higher scores indicating greater frequency of contextual
self-concealment. The CISC scale has shown acceptable psychometric qualities. Hebrew version
is available, but the questionnaire still need to be translated into Arabic.
Emotional disclosure and holding back of cancer-related concerns. This measure is a modified
version of a measure developed by Pistrang and Barker [1995], which was previously used among
cancer patients and their spouses. It assesses the degree to which cancer patients and
spouses talk to their partners about cancer related feelings and concerns (e.g., "How much
did you talk to your spouse/partner about this concern?"). It also assesses the extent to
which they hold back from doing so (e.g., "How much did you hold back from talking to your
spouse/partner about this concern?"). The questionnaire consists of 10 items, addressing
cancer-related concerns (e.g. patient's physical symptoms; cancer treatment; patient's sexual
functioning). For each item, respondents will be asked to refer to the past week and rate: a)
their level of disclosure, on a 6-point scale and b) their level of holding back, on a
6-point scale. A higher score on the disclosure/holding back subscales indicated a greater
level of disclosure/holding back, respectively. This measure has previously demonstrated
adequate reliability for both subscales. Hebrew version is available, but the questionnaire
still need to be translated into Arabic.
Relationship Assessment Scale (RAS) - The RAS is a short 7-item self-report inventory
designed to measure relationship satisfaction. This scale items are rated on a 5-point Likert
scale (e.g., "In general, how satisfied are you with your relationship?" and "To what extent
has your relationship met your original expectations?"). The RAS is unidimensional and has
demonstrated good internal co nsistency. Higher scores represented greater relationship
satisfaction. There are available Hebrew and Arabic versions of the questionnaire .
Coping Variables will be measured at Time 3 Information - EORTC Information questionnaire -
QLQ -INFO25 QLQ-INFO25 is a 25-item module contains four multi-item scales (information about
the disease, medical tests, treatments, and other services) and eight single items (e.g.,
places of care, self-help to get well, information channels, and information satisfaction and
usefulness). QLQ-INFO25 also includes two open questions allowing patients to write about
topics of their choice. The response format consisted of a four-point Likert scale (1 - not
at all, 2- a little, 3 - quite a bit, 4 - very much), except for the dichotomous (yes/no)
questions 51 and 52 and 54 and 55. The questionnaire found to be reliable and valid
self-reported instrument. It is used in cross-cultural observational and intervention
studies. The questionnaire still needs to be translated into Hebrew and Arabic. The
questionnaire will be translated for the current study in forward-backward method.
Illness Perception - Brief Illness Perception Questionnaire consists of nine items,
appraising cognitive illness representations, emotional representations and illness
comprehensibility. Eight items are rated on Likert scale from 0 to 10. The last item is a
causal open-response item, which asks patients to list the three main causal factors in their
illness. Responses to the causal item can be grouped into different categories allowing a
subsequent categorical analysis. The total score is generated by summing up the scores for
the Brief Illness Perception Questionnaire items with a reverse scoring of items 3, 4 and 7.
A higher total score reflects a more threatening perception of illness . There are available
Hebrew and Arabic versions of the questionnaire Adjustment to Cancer - The Mental Adjustment
to Cancer (MAC) Scale is a 40-item self-rating scale on Likert scale of 4 . The scale
consists of five subscales: fighting spirit, anxious preoccupation, fatalism, helplessness:
hopelessness and avoidance. Previous studies have suggested that the MAC scale has adequate
validity and reliability. There are an official Hebrew and Arabic versions of the
questionnaire Additional questionnaires will be delivered at Time 4 Self-Compassion-
Self-Compassion Scale (SCS) is 25 items and six subscales: Self-Kindness; Self-Judgement;
Common Humanity; Isolation; Mindfulness; Over-Identification . Respondents were instructed
with the sentence "how I typically act towards myself in difficult times" and are asked to
answer each item according to a 5-point scale. Subscale scores are computed by calculating
the mean of subscale item responses. Higher scores indicate greater self-compassion. In the
original version, the total score showed an excellent internal consistency. There are
available Hebrew and Arabic versions of the questionnaire
