Original Article Impact of Psychological Intervention on the Quality of Life of Primary Care Givers of Patients with Cancer : Preliminary Report in City based Cancer Hospital, India

Abstract

Background and Aim : Caring for an individual with cancer can lead to significant stress, anxiety and feelings of
sadness among primary caregivers, ultimately impacting their overall psychological and physical well-being. The
aim of this research was to assess if cancer primary caregivers who underwent Psychological Interventions (PI)
observed enhancements in their Quality of Life by decreasing levels of depression and anxiety.
Materials and Methods : A single-centre randomized control trial was conducted among 53 adult primary caregivers
aged >18 years of age to <65 years and those involved with their patients’ actual care not less than 12 hours per day,
between April, 2023 to August, 2023. All participants went through the assessment of QoL and Depression and
Anxiety levels by using validated tools. Participants were randomly assigned into two groups : Group-A (N=31),
participants receiving psychological support and Group-B (N=22), who did not receive any psychological support.The
intervention comprised five sessions. Following department protocol participants were followed-up based on 21,42,
63, 84 and 105 days. Participants completed primary outcomes (Anxiety, Depression and Quality of Life) before one
of each session to see the impact of each session. To identify the impact of PI, descriptive statistics were calculated
as the Mean±Standard deviation of the score of validated tools based on primary outcomes.
Results : A total of 53, female caregivers (61%) were more than male individuals (39%). About 60.57% of the
caregivers reported severe hampering of their QoL. The data showed significant improvements in outcomes measured
from pre to post and from post-to-follow-up as compared to Group-B counterparts (p<0.005). Group-A had statistically
significant improvements in QoL in 120 days’ follow-uptime, compared with Group-B, p=<0.01.
Conclusion : Under challenging circumstances during the period of cancer treatment, PI is a useful intervention
for standing continuous psychological support as it is associated with better Quality of Life for primary
caregivers. Further research examining factors influencing the outcomes of psychological intervention will be justified.

Full text

Vol 122, No 08, August 2024 Journal of the Indian Medical Association 29
Medica Superspecialty Hospital, Kolkata 700099
1MD, Senior Consultant and Adviser, Department of
Radiationoncology and Corresponding Author
2MA in Clinical Psychology, Consultant Phychooncologist,
Department of Oncology
3MS, Consultant, Department of Orthooncology
4MS, MCH, Head, Consultant, Department of Head and Neck
Cancer Surgery
5MD, Consultant, Department of Pain and Palliative
6MS, Consultant, Department of Surgical Oncology (Breast)
Received on : 12/07/2024
Accepted on : 30/07/2024
Original Article
Impact of Psychological Intervention on the Quality of Life of Primary
Care Givers of Patients with Cancer : Preliminary Report in City
based Cancer Hospital, India
Subir Gangopadhyay1, Arunima Datta2, Koushik Nandy3, Harsh Dhar4, Prathna Jayaseelan5,
Pooja agarwal6
Background and Aim : Caring for an individual with cancer can lead to significant stress, anxiety and feelings of
sadness among primary caregivers, ultimately impacting their overall psychological and physical well-being. The
aim of this research was to assess if cancer primary caregivers who underwent Psychological Interventions (PI)
observed enhancements in their Quality of Life by decreasing levels of depression and anxiety.
Materials and Methods : A single-centre randomized control trial was conducted among 53 adult primary caregivers
aged >18 years of age to <65 years and those involved with their patients’ actual care not less than 12 hours per day,
between April, 2023 to August, 2023. All participants went through the assessment of QoL and Depression and
Anxiety levels by using validated tools. Participants were randomly assigned into two groups : Group-A (N=31),
participants receiving psychological support and Group-B (N=22), who did not receive any psychological support.The
intervention comprised five sessions. Following department protocol participants were followed-up based on 21,42,
63, 84 and 105 days. Participants completed primary outcomes (Anxiety, Depression and Quality of Life) before one
of each session to see the impact of each session. To identify the impact of PI, descriptive statistics were calculated
as the Mean±Standard deviation of the score of validated tools based on primary outcomes.
Results : A total of 53, female caregivers (61%) were more than male individuals (39%). About 60.57% of the
caregivers reported severe hampering of their QoL. The data showed significant improvements in outcomes measured
from pre to post and from post-to-follow-up as compared to Group-B counterparts (p<0.005). Group-A had statistically
significant improvements in QoL in 120 days’ follow-uptime, compared with Group-B, p=<0.01.
Conclusion : Under challenging circumstances during the period of cancer treatment, PI is a useful intervention
for standing continuous psychological support as it is associated with better Quality of Life for primary
caregivers. Further research examining factors influencing the outcomes of psychological intervention will be justified.
[
J Indian Med Assoc
2024; 122(8): 29-35]
Key words
: Cancer, Primary Caregivers, Quality of Life, Depression and Anxiety.
Editor's Comment :


Psychological counseling is an essential resource for primary
non-medical caregivers of cancer patients. It addresses the
emotional and practical challenges of care giving, promotes
mental health and fosters a supportive community. By
prioritizing the well being of caregivers, we can enhance the
quality of care for cancer patients and ensure that caregivers
are able to sustain their vital roles over the long term.
Cancer is a life-threatening illness that is stressful
not only to the patients but also to the caregivers
in terms of how it might be experienced. During this
lengthy treatment period, which frequently lasts for
months or years, the patient and their Primary
Caregivers spends more time at the cancer centre than
at home. There are significant changes in the daily
routines of both parties and they need to work very
hard to adapt to the demands of this life-threatening
disease. The family feels obligated to work together
to support the patient after learning that a family
member has cancer9.
As is clear, daily practice reflecting the rise in
cancer cases in India over the past ten years, the
emotional anguish that it causes the family members,
and the difficulty in coping with the diagnosis of their
loved ones The patient’s primary caregiver is
responsible for making decisions, monitoring changes
in the patient’s condition, giving hands-on care,
adjusting care as needed, gaining access to resources,
negotiating with the healthcare system, providing
emotional support, and frequently securing funding for

Vol 122, No 08, August 2024 Journal of the Indian Medical Association
the treatment. The primary carer has a difficult
responsibility to complete both physically and
emotionally: juggling the care of the cancer patient
with his or her own daily routine20. Since ancient times,
providing care has been valued as a worthwhile
experience, but the effects on the carers themselves
are frequently disregarded. According to the Quality
of Life in LifeThreatening Illness-Family Carer Version
(QoLLTI-F) assessment, half of the carers in a recent
study on the Quality of Life (QoL) of carers had a bad
quality of life. The statistical results showed that
characteristics like gender, religion, location, financial
burden, lung cancer stage and kind, disability and
patient depression had a substantial impact on the
carers’ Quality of Life.
The Quality of Life of the patient’s primary
caregivers, a group that is frequently disregarded, is a
very important concern that has been addressed by
the widespread usage of this questionnaire and its
translation into many languages. The Turkish
translation of the English CQOLC yielded results that
were comparable to those of our study, suggesting
that there were some concerns that were shared by
families of cancer patients. It was also administered
alongside the World Health Organisation Quality of
Life Short Version (WHO-QoL-BREF) to breast and
Gynaecological cancer patients and validated to the
German version6. It demonstrated good reliability for
burden, disruptiveness, and financial concerns but low
reliability for positive adaptation. Utilising the same
CQOLC scale, similar studies were carried out in Korea
and the United Arab Emirates, with comparable results
on demographic comparisons6,15.
Previously many researchers in India have already
discussed about depression, death anxiety and stress
in cancer caregiver3,17,10 along with the burden the
caregivers have to go through16. Keeping these
psychological issues in mind, researchers have
discussed about psychosocial intervention for the
cancer caregivers’ better Quality of Life19,5,8.
After interacting with cancer caregivers, the most
common psychological issues seen were anxiety
(about losing loved ones), overprotectiveness, feeling
of failure to give best their loves ones who has cancer
and depression. Therefore, keeping all this factors in
mind we have developed a psychosocial intervention
in West Bengal for cancer caregivers for the first time.
As the concept of psychosocial intervention is still new
in West Bengal, we were unable to refer to previous
state-wise researches about effect of psychological
intervention on caregivers’ Quality of Life (QoL).
The objective of this study was to evaluate the
impact of Psychological Interventions (PIs) on the
quality of life of cancer primary caregivers, specifically
in terms of reducing their levels of depression and
anxiety.
MATERIALS AND METHODS
Study Design
:
This study was a randomized controlled trial
conducted at a tertiary cancer hospital in Eastern India
after receiving approval from the institutional review
board. Out of 149 cancer patients’ primary caregiver
between April, 2023 to August, 2023, only 66
participants were enrolled in the study after fulfilling
eligibility criteria. Participants were randomly assigned
by using computer generated random number to either
the Group-A (N=34), participants receiving
Psychological Intervention (PI) and Group-B (N=32),
did not receive any PI. Sample size was calculated
based on power 80% and alpha 0.05 and few patients
previously agreed to take part in study and refused
later. Hence, we omitted those participants leading to
sample size- Group-A=33 and Group-B=29. These
participants were screened using the Mini International
Neuro-psychiatric Interview (MINI) and those with the
diagnosis of first episode depression and anxiety (mild
or moderate severity) as per International Classification
of Diseases – 10th edition (ICD 10) criteria, as
confirmed by an experienced clinical psychologist were
included in the study. Those participants who received
a diagnosis other than depression and anxiety
[Group=A (N = 2) and Group=B (N=7)] were excluded.
Eligibility Criteria :
Inclusion criteria :
(1) Diagnosed cancer patients and undergoing
active cancer treatment
(2) No evidence of previous psychiatric illness
(3) Currently not enrolled in another PI study or
psychiatric support
(4) Age more than 18 years
(5) Able to understand, read and speak the Bengali
language. (Response from patients with oral cancer
who were unable to verbalize was recorded with help
of caregiver/ proxy)
Exclusion Criteria :
(1) Caregiver not staying with the patient for not
less than 12 hours per day.
(2) Those unable to complete the questionnaires
Experimental Group —
After initial screening, participants fulfilling eligibility
criteria were enrolled and explained about the study
protocol in face-to-face form. Informed written consent
was obtained and recorded in an official document form.
30

Vol 122, No 08, August 2024 Journal of the Indian Medical Association
Each participant was asked to complete the baseline
questionnaire (Bengali translated version for each study
tool was already validated and easily available):
demographic characteristics, Beck Depression
Inventory (BDI), Beck Anxiety Inventory (BAI), Caregiver
Quality of Life Index (CQoL-C). All these questionnaires
measured various dimensions of depression, anxiety,
and Quality of Life respectively. The psychologist
messaged all the patients as a reminder one day before
of each session and no reply from the patients was
translated to the number of drop-outs in the study. We
also noted the cause of the refusal to participate in
the study. This information helped to determine the
acceptability of the psychological support as well as
document the major barriers to participation.
Control Group —
In this group, they did not receive psychosocial
support on a regular basis. At first, clinical
psychologists assessed the psychological factors at
baseline by using a standardised questionnaire. Then
it was reassessed twice in a month with a 15-day’ gap
and continued up to 120 days.
Psychological Intervention :
This type of psychological support based on over-
the-phone communication consisted of five sessions,
each lasting 30-35 minutes. Before starting the
psychological sessions, the first clinical psychologist
assessed the psychological issues at baseline by using
the standardised questionnaires. Again, psychologists
used it before one day of each session to see the
impact of each session. The department protocol for
medical assessment was based on 21, 42, 63, 84,
and 105 days. So, we followed the same pattern to
make it easier.
Covered Areas of Psychological Intervention —
The intervention programme, held at a board room
in the Oncology Unit of the Hospital, was coordinated
by the coordinator. It comprised five face-to-face
sessions (once a week for a month) delivered by
experienced Psychologist. Each session was 40-45
minutes in length; a presentation of interactive content
followed by questions and discussion. Each session
had a specific theme: 1. Knowledge 2. Anxiety
management 3. Activities of daily life 4. Bonding with
patient 5. Develop social interaction (Table 1)
Data Collection :
Socio-demographic data were collected from both
groups followed by structured interviews.
Instruments
—
Structured Proforma : A structured proforma was
developed to assess the Socio-demographic and
clinical details of the study subjects.
Mini International Neuropsychiatry Inventory
(MINI):
MINI is a short structured diagnostic interview,
developed jointly by Psychiatrists and Clinicians in
the United States and Europe, for DSM-IV (Diagnostic
and Statistical Manual of Mental Disorders, American
Psychiatric Association - IVth Edition) and ICD-10
psychiatric disorders. With an administration time of
approximately 15 minutes, it is easy to administer18.
Caregiver Quality of Life Index : The CQoL-C is
a self-administered rating scale designed to assess
QoL issues in family caregivers of patients with cancer.
It had 35 QoL-specific items, each of which was graded
from 0 to 4 on the Likert scale, where “0” denoted “Not
at all,” “1” denoted “A little bit,” “2” denoted “Somewhat,”
“3” denoted “Quite a bit,” and “4” denoted “Very much.”
The maximum total score for the instrument is 140.
All 35 things were added together for a final score,
which was taken into consideration for analysis20.
Three separate translators (2 with medical background
and one with a master’s degree in Bengali) translated
the scale into Bengali and the final, approved version
was utilised to gather the data. The caregivers were
personally interviewed for the data collection. Test-rest
reliability was 0.95 and internal consistency was 0.90.
The instrument has good divergent validity. The
instrument is also responsive to changes in the health
state of the patient, as measured by the ECOG-PSR
(r=0.45).
Beck Depression Inventory (BDI) :
The original English version of BDI II consists of 21
Table 1 —
Psychological Intervention-Covered areas
No of Content
Session
In this first session, the content of the intervention
was explained, an evaluation was made of essential
information about respective cancer, from which
the patient is suffering.
Discuss the role of caregiver during critical
management of the patient
Advice on communication between caregiver and
patient (interactive daily activities) and Dealing with
the emotional aspect of caring his or her patients
(not to show overloaded sympathy which makes a
feeling of burden to patients)
Self-care: its importance and strategies to promote
self-care (develop social interaction)
Discuss and explain the common symptoms of the
patients during the whole curse of planned treatment
and dealing with the patients’ emotional changes.
Session 1
(21 days)
Session 2
(42 days)
Session 3
(63 days)
Session 4
(84 days)
Session 5
(105 days)
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Vol 122, No 08, August 2024 Journal of the Indian Medical Association
items to measure the severity of depression. Each
item is a list of four statements arranged in ascending
order of severity about a particular symptom of
depression which could be rated from 0 (symptom not
present) to 3 (symptom strongly present), with resulting
summary scores ranging from 0 to 63. The time
reference for the response set has 2 weeks. The
severity rating guidelines and cut-off scores suggested
by the authors for total scores of patients diagnosed
with major depression are 0-13 minimal; 14-19 mild;
20-28 moderate; and 29-63 severe. In the translation
and validation process, a validated Bengali version of
BDI II was produced to measure depression and its
severity among the Bengali population12.
Beck Anxiety Inventory (BAI) :
This scale is a self-report measure of anxiety. It
consists of 21 items. Internal consistency for the BAI
= (Cronbach’s α=0.92) Test-retest reliability (1 week)
for the BAI = 0.75. The severity rating guidelines and
cut-off score suggested by the authors for total scores
of patients diagnosed with anxiety are 0–21 low; 22-
35 moderate, and 36 and above potentially concerning
levels of anxiety7.
Consent form :
Informed verbal consent was obtained from all
participants and recorded in audio format.
Statistical analysis :
Descriptive statistics were used to summarize
participants’ demographic and clinical characteristics
of all the participants. Socio-demographic and BAI,
BDI, CQoL-C scores were categorized according to
two participated groups. Chi-square was applied to
observe comparability according to two cancer groups.
The overall mean values of each scale at baseline/day
on 21,42, 63, 84, 105 and 120 days of psychological
support course were calculated for both groups.
Repeated measure was used to define significance of
telephone based psychological support among
metastatic cancer patients through psychological
assessment score before, during and after
participation. Independent “t” test was used to define
the association between impact of telephone based
psychological support and emergency visit.
RESULTS
Demographic Information :
Table 2 depicts the baseline demographic and
clinical characteristics of the study participants. The
majority of them belonged to middle-class socio-
economic status (1000 to 2000 Indian rupees per capita
per month). Both the study groups were comparable
at baseline.
In the Group-A, the mean age of participants was
52.23±2.05 years. 51% were female primary
caregivers, 54% were residing in a rural area, 74%
were living with their spouse and 41% received up to
secondary education, 49% were working. Distribution
of participants according to the cancer site: from head
and neck (20%), from gyn-oncology (22%), from
gastrointestinal tract (3.5%) and from ortho-oncology
(15.5%). Their mean baseline levels were: for
depression- 43±1.13; for anxiety- 18±1.02 and for QoL-
55.7±1.11.
In the control group, the mean age of participants
was 51.07±2.19 years. 53% were female caregivers,
51% were residing in a rural area, 65% were living
with their spouse and 36.1% received secondary
education, 39% were unemployed. Distribution of
Table 2 —
Prevalence of demographic and clinico-
pathological details among participants
Demographic details Group A Group B p-value
(N=81) (N=72)
Age 52.23±2.05 51.07±2.19 1.13
Gender :
Male 49 % 53 % 1.12
Female 51 % 47%
Residence :
Rural 54% 51% 1.11
Urban 46% 49%
Relationship status :
Living with spouse 74% 65% 1.14
Living without spouse 26% 35%
Education :
Illiterate 9 % 6.5%
Primary Education 17% 20.1%
Secondary Education 41% 36.1%
More than secondary
education 33% 37.3% 0.098
Occupation :
Engaged with work 49% 50.4%
Unemployed 35% 39% 1.13
Home maker 16 % 10.6%
Family Income :
>500 13% 11%
1000-2000 49% 56% 0.07
>2000 38% 33%
Clinico Pathological (Diagnosis) :
Head and Neck Cancer 20% 16.5%
Gynaecological Cancer 22% 1 7.6% 1.01
GI and Thoracic cancer 3.5% 10.2%
Ortho-oncology 15.5% 17.1%
Treatment History : 1.42
Standard care Only 53% 54%
Standard care with
Palliative care 31% 30.2%
Palliative care Only 16% 15.8%
Psychological Variable :
Depression 43±1.13 44.2±1.07 1.32
Anxiety 18±1.02 19±1.22
QoL 55.7±1.11 56±1.14
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Vol 122, No 08, August 2024 Journal of the Indian Medical Association
participants according to the cancer site: from head
and neck (16.5%), from gyn-oncology (17.6%), from
gastrointestinal tract (10.2%) and from ortho-oncology
(17.1%). Their mean baseline levels were: for
depression - 44.2±1.07; for anxiety- 19±1.22, and for
psychological well-being- 56±1.14.
All groups were comparable in terms of socio-
demographic, clinico-pathological and psychological
variables.
Mixed model results demonstrated that overall
symptom severity for each individual psychological
factors- depression, anxiety and QoL (P<0.001) and
progressively improved over the course of treatment.
Statistically significant change in mean score has been
observed over different study time points. We observed
slight increase in mean scores- depression [44.2
versus
43
versus
39
versus
45
versus
31
versus
29]; anxiety
[18
versus
20
versus
14
versus
23 vs 22
versus
19]
and QoL [55.7
versus
55.3
versus
49.4
versus
50.2
versus
43.6] among Group-A. (Table 3)
DISCUSSION
The obtained results suggest that the
implementation of a psychological intervention in
primary caregivers enhanced their QoL and reducing
their psychological issues-anxiety and depression. A
repeated measure analysis conducted revealed that
psychological issues and overall QoL reported
significant differences in scores over the time frames
between the Group-A and Group-B. Supporting our
results, similar studies that conducted intervention
programmes and discussed positive significant impact
of a psychoeducation intervention on the QOL of
primary caregivers as well as and its dimensions
across the time points4,1,14,2. Following studies
measured caregivers’QoL using CQOLC, but different
psycho-educational intervention programmes were
evaluated1; administered the Caring for the Caregiver
Programme (CCP) among family caregivers of patients
with advanced cancer2. Another study had worked
among family caregivers of women with breast cancer
using COPE (creativity,
optimism, planning, and expert
information) and result was
same there11. The present study
results had contradicted from
those of using the COPE
intervention programme, who
reported a significant decline in
caregiver QoL13 and who
conducted FOCUS programme
for 134 dyads (only breast
cancer patients and their family
caregivers). Following the
results, there were no significant
difference in the dyads’ QoL
across the three time points
(from baseline to 6 months)13.
In respect to the
psychological intervention in the
first session, we provided the
primary caregivers- patient
psychological care-related
information and answers to their
concerns.After this session, we
went to take the assessment on
the caregiver’s Quality of Life,
following the test score report
their Quality of Life had not
statistically significantly
improved, but according to their
feedback they have understood
the importance of psychology in
Table 3 —
Distribution of psychological issues among participants during the time frame
Experimental Group Control Group p-Value
33

Vol 122, No 08, August 2024 Journal of the Indian Medical Association
oncology and they have become more aware of their
own psychological issues. Regarding the psychological
intervention during the second session, we provided
caregivers with information on how to manage cancer
patients during their critical condition. The motto of
this session is to give psychological support to help
caregivers respond effectively to critical challenges,
thereby helping them manage their anxiety and
depression. Upon reassessing the caregiver’s Quality
of Life, the obtained score report indicated that the
QoL of the caregiver has improved moderately
comparing with last session.In relation to the
psychological intervention during the third session, we
provided caregivers with advice on how to interact with
the patient and keep them engaged in family decisions.
The primary caregiver requires mental support as they
tend to become over protective towards the patient
due to the fear of losing them. For the wellbeing of the
patient’s mental health, the primary caregiver’s mental
wellbeing should be prioritised as well. Proper support
from the caregiver can often keep the patient happy
and give them hope which in turn can help the caregiver
too. After reassessing the caregiver’s Quality of Life,
the report states that the QoL of the caregiver has
improved significantly.With respect to the
psychological intervention in the fourth session, we
provided the caregiver with ways to develop social
interaction skills and knowledge about the patient’s
diagnosis and treatment. We also advised them to
join peer support groups if possible. After reassessing
the caregiver’s quality of life, the report states that the
QoL of the caregiver does not significantly improve due
to the unavailability of peer support group or cancer
support group according to diagnosis in West Bengal.
For the last psychological intervention session, the
psychologist discusses about the patient’s mental
health journey from the beginning of the cancer
diagnosis till the duration of standard care treatment.
The psychologist also discusses about the various
psychological issues that come up, such as, fear of
death, feeling of financial burden, unable to accept
present situation of the disease, believing that cancer
is the result of their own “karma”. After the final
reassessment of psychological issues, the reports
state that, unfortunately the Quality of Life does not
significantly improve due to the caregivers becoming
puzzled whether to take care of their physical health
or mental health.
The most important session during the whole
Psychosocial Intervention was the third session, as it
showed a very positive impact on the primary
caregiver’s QoL. This is due to the psychologist’s
advice given to the primary caregiver, through which
they take care of the patient by including them in
family decisions, having regular family meals and
including them in small household chores. It reduces
the patients feeling of being a ‘family burden’, which in
turn reflects on their health and behaviour, while also
decreasing the caregiver’s psychological issues,
anxiety and depression, manifesting through the
caregiver’s QoL.
The concept of Psychology in the field of Oncology
is still new in West Bengal, therefore, there is not much
research to refer to, but as per patients’ family
member’s responses, along with the primary treatment
they do take part in taking care of the patient’s and
their own psychological wellbeing.
CONCLUSION
In conclusion, our current randomized controlled
trial supports the use of psychological interventions
for primary caregivers of cancer patients, which might
be highly acceptable and effective in improving their
QoL and psychological outcomes in India. Future
studies will expand the sample pool, apply to primary
caregivers of patients with different cancer types and
investigate the cost-effectiveness of such
psychological interventions.
Disclosure Statement :
No potential conflicts of interest were reported by
the authors.
ACKNOWLEDGMENTS
The authors thank the Medica Oncology Hospital
for permission to conduct the study, the staff who
assisted in recruitment of participants, the nurses who
served as research assistants and the cancer patients
and their caregivers for their participation in this study.
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