| CTRI Number |
CTRI/2025/02/080729 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Burden, and Quality of Life of the Informal Caregiver and Its Relationship with Distress, Depression, and Anxiety of Cancer Patients Undergoing Chemotherapy in a Tertiary Cancer Centre: A Comparative Cross-Sectional Study. |
|
Scientific Title of Study
|
Burden, and Quality of Life of the Informal Caregiver and Its Relationship with Distress, Depression, and Anxiety of Cancer Patients Undergoing Chemotherapy in a Tertiary Cancer Centre: A Comparative Cross-Sectional Study. |
| Trial Acronym |
CB Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jisha Abraham |
| Designation |
Lecture, Psycho-Oncologist |
| Affiliation |
Malabar Cancer Centre |
| Address |
MALABAR CANCER CENTRE (POST GRADUATE INSTITUTE OF ONCOLOGY SCIENCES & RESEARCH), Moozhikkara (P.O), Thalassery, Kannur District, Kerala,India-670103
Kannur KERALA 670103 India |
| Phone |
04902399268 |
| Fax |
|
| Email |
jishasarah@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jisha Abraham |
| Designation |
Lecture, Psycho-Oncologist |
| Affiliation |
Malabar Cancer Centre |
| Address |
MALABAR CANCER CENTRE (POST GRADUATE INSTITUTE OF ONCOLOGY SCIENCES & RESEARCH), Moozhikkara (P.O), Thalassery, Kannur District, Kerala,India-670103
Kannur KERALA 670103 India |
| Phone |
04902399268 |
| Fax |
|
| Email |
jishasarah@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Amritha Jacob |
| Designation |
Fellow in Psycho-oncology |
| Affiliation |
Malabar Cancer Centre |
| Address |
MALABAR CANCER CENTRE (POST GRADUATE INSTITUTE OF ONCOLOGY SCIENCES & RESEARCH), Moozhikkara (P.O), Thalassery, Kannur District, Kerala,India-670103
Kannur KERALA 670103 India |
| Phone |
8129538108 |
| Fax |
|
| Email |
amrithamjacob@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar Cancer Centre, Thalassery, Kannur, Kerala |
|
|
Primary Sponsor
|
| Name |
Malabar Cancer Centre |
| Address |
Malabar Cancer Centre, Thalassery, Kannur Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jisha Abraham |
Malabar Cancer Centre |
Division of Psycho-oncology, Malabar Cancer Centre,
Kannur, Kerala Kannur KERALA |
04902399268
jishasarah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, Malabar Cancer Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Informal caregivers of cancer patients |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria for Patients
1. Individuals diagnosed with a diagnosis of malignancy for one month at least and is undergoing chemotherapy at Malabar Cancer Centre as day care or inpatient.
2. Patient is aware of the diagnosis and treatment.
3. Patients who can read, write, and understand Malayalam or English.
4. Patients who are undergoing curative or first-line palliative intent treatment.
5. An informal caregiver is present with the patient as bystander during chemotherapy.
Inclusion Criteria for Caregivers
1. Informal caregiver is aware of the diagnosis and treatment.
2. Informal caregiver who can read, write, and understand English or Malayalam.
3. Informal caregiver is supporting the patient for atleast one month.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Patient or informal caregiver with any known psychiatric or psychological conditions.
2.Patient or informal caregiver has not diagnosed with a neurological disorder, Alzheimer’s or brain tumour.
3. Patient or informal caregiver with a known history of sensory impairment or physical disabilities or Intellectual Disability.
Patient or informal caregiver with a history of alcohol or tobacco use for the last two weeks.
4.Patients with relapse/recurrence/second primary.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the CB, and CQoL of the informal caregivers of the cancer patients undergoing chemotherapy in the hospital. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the relationship of CB, & CQoL of the informal caregivers with the distress, depression, & anxiety among cancer patients undergoing chemotherapy in the hospital. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="188" Sample Size from India="188"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In
India, research on caregiver burden remains limited. This study will explore
caregiver burden, quality of life, and its relationship with distress,
depression, anxiety, and stress among cancer patients undergoing chemotherapy.
The
study aims to find the Caregiver Burden (CB), and Caregiver Quality of Life
(CQoL) of the informal caregivers and its relationship with distress,
depression, and anxiety among cancer patients undergoing chemotherapy in the
hospital. The primary objective of the study is to
find the CB, and CQoL of the informal caregivers of the cancer patients
undergoing chemotherapy in the hospital. The study sample will consist of
atleast 94 caregivers and their 94 patients who are undergoing chemotherapy at
Malabar Cancer Centre between the age of 18 and 70.
The
inclusion criteria for patients are individuals diagnosed with malignancy for
at least one month, undergoing chemotherapy at Malabar Cancer Centre, aware of
their diagnosis and treatment, able to read and understand Malayalam or
English, undergoing curative or first-line palliative treatment, and
accompanied by an informal caregiver during chemotherapy. For caregivers, the
inclusion criteria are awareness of the patient’s diagnosis and treatment,
proficiency in Malayalam or English, and providing support for at least one
month. The exclusion criteria for both patients and caregivers include any
known psychiatric or psychological conditions, neurological disorders, brain
tumors, sensory impairments, physical or intellectual disabilities, or a recent
history of alcohol or tobacco use. Additionally, patients with relapse,
recurrence, or a second primary are excluded.
Data
will be analyzed using SPSS version 29, with descriptive statistics
(frequencies, percentages, mean, median, SD, range), t-tests, ANOVA,
correlation, and Chi-square tests to assess relationships and associations
between variables. If applicable, logistic regression will be used to estimate
the impact of caregiver burden on the patient’s psychological outcomes. |