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Study Protocol

An observational, cross-sectional study to assess the quality of life (QoL) of family caregivers of patients diagnosed with cancer

[version 1; peer review: awaiting peer review]
PUBLISHED 23 Feb 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Globally, cancer has a major impact on society, and the burden continues to grow by exerting physical, emotional, and financial strain on patients, families, societies, and healthcare systems. Cancer greatly affects not only patients, but also their families. Family caregivers are invisible to healthcare teams, but play an important role in the recovery of cancer patients. Cancer can worsen a family caregiver’s health, impair social life, increase anxiety, and cause depression. It is important to identify and deal with various domains affected by cancer to enhance the quality of life (QoL) of family caregivers.

This is a prospective, observational, cross-sectional, questionnaire-based study, to assess the impact of cancer on the quality of life of family caregivers. The primary objective is to measure the effect of cancer diagnosis and its treatment on family caregivers’ quality of life using the CarGOQoL (CareGiver Oncology Quality of Life) questionnaire. The secondary objective is to determine the relationship between quality of life, socio-demographic variables, and cancer disease variables. Family caregivers who are associated with the care of cancer patients for at least two–three hours a day will be recruited in the study after signing the voluntary informed consent form. The CarGOQoL questionnaire will be used to record the responses from the participants. Domains such as psychological well-being, burden, relationship with healthcare, administration and finances, coping, physical well-being, self-esteem, leisure, social support, and private life will be recorded. Approximately 100 participants will be recruited for the study. Data analysis will be performed at the end of participant recruitment.

Healthcare and social workers can enhance the quality of life of family caregivers by using the results of the CarGOQoL questionnaire, and better understand the different domains of QoL impacted by cancer.

Keywords

Quality of Life, Cancer, Family Caregiver, CarGOQoL, Oncology, Breast, Lung, Oral, Cervix uteri, Colorectum

Introduction

Globally, cancer is a leading cause of death, accounting for nearly 10 million deaths in 2020. In men, the most common cancers occur in the lungs, prostate, colorectum, stomach, and liver. Breast, colorectum, lung, cervix uteri, and thyroid cancers are the most common in women.1,2 In India, the most common cancers are breast, oral, cervix uteri, lung, and colorectum.3,4 Cancer has a significant impact on society. The physical, psychological, and financial impact of cancer on patients, families, communities, and healthcare systems continues to rise.5,6

Cancer sufferers and their families are significantly affected directly or indirectly by cancer. The illness trajectory of cancer affects caregivers’ quality of life (QoL). Caring for cancer sufferers worsens caregiver’s health, impairs their social life, increases stress, and causes depression.7 According to recent research, family caregivers have higher rates of depression, anxiety, psychosomatic symptoms, limitations in roles and activities, marital conflict, and poor physical health. Family caregivers’ distress may impair their ability to care for the patient.8–12 The impact of cancer on family caregivers is becoming the subject of research.

The psychological and social dimensions of family caregivers were more affected than other dimensions of life. Daily life is altered, and caregivers struggle to adjust and respond to the demands.13,14 Family caregivers’ quality of life is highly influenced during the period of chemotherapy, radiotherapy and surgery and is often under reported.15 The economic burden on family and self-confidence of family caregivers is impacted due to the cancer.16 The job of caregiving is not easy, especially in developing countries, the quality of life of low and middle income family caregivers is affected severely due to the various needs of the patient.17

Managing self-care tasks, managing patients’ needs, and providing emotional support can lead to emotional distress and suffering. There are many causative factors responsible for the low quality of life in family caregivers. Quality of life questionnaires are recognized as efficient and effective tools for assessing the quality of life of family caregivers. Family caregivers are as important as patients but are usually ignored. The least attention is paid to family caregivers’ mental health, and many factors remain unidentified and untreated.

The aim of this study is to assess the impact of cancer (i.e., breast, lung, oral, cervix uteri, and colorectum cancer) on the quality of life of family caregivers who are involved in the care of patients for at least two to three hours per day. The CareGiver Oncology Quality of Life (CarGOQoL) questionnaire will be used to record the responses from caregivers. It has a longer recall period of four weeks and is easy to understand. The CarGOQoL questionnaire is a validated and reliable instrument for evaluating every aspect of family caregivers’ quality of life. The CarGOQoL questionnaire comprises 29 items that investigate 10 domains. The domains include psychological well-being, burden, relationship with health care, administration and finances, coping, physical well-being, self-esteem, leisure, social support, and private life.18

The CarGOQoL questionnaire provides important information to healthcare professionals about the QoL of family caregivers. This score will help in understanding the different domains and reducing the care burden of family caregivers.

Protocol

Study rationale

Family caregivers play an important role in supporting and providing care to patients with cancer during day-to-day activities. If the health of the family caregivers is adversely affected, it could interfere with their ability to meet the needs of the care receiver and might affect their treatment. The rationale behind this study is to determine the causative factors that affect the QoL of family caregivers of patients diagnosed with cancer. Limiting such causative factors by implementing proper strategic methods may lead to a reduction in the burden on the family caregivers, and patients getting all their necessary treatment needs met on time. The CarGOQoL questionnaire is an efficient and effective tool for assessing the quality of life of family caregivers.

Research question

What factors affect the QoL of family caregivers of patients diagnosed with cancer?

Aim

To assess the impact of cancer on QoL of family caregivers.

Objectives

Primary objective

  • 1. To measure the effect of cancer diagnosis and treatment on the QoL of family caregivers using the CarGOQoL scale.

Secondary objectives

  • 1. To determine the relationship between CarGOQoL and socio-demographic variables.

  • 2. To determine the relationship between CarGOQoL and cancer disease variables.

    • • Socio-demographic variables: age, gender, education, occupation, income, area of living etc.

    • • Cancer disease variables: type of cancer, duration of illness, and type of treatment etc.

Methods

Study design type

Prospective, observational, cross-sectional, questionnaire based study.

Sampling method

Non-probability: consecutive sampling method.

Study site

Department of Medical Oncology, Siddharth Gupta Memorial Cancer Hospital, A speciality unit of Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi (Meghe), Wardha, Maharashtra, India. Pincode - 442001.

Study duration

Approximately 6 months.

Study population

Family caregivers who are involved in the care of cancer patients for at least two to three hours per day.

Family caregivers will be enrolled from the Medical Oncology OPD (Outpatient Department) of Siddharth Gupta Memorial Cancer Hospital.

(Definition of family caregiver – family member who is closely related to the cancer patient and mostly involved in patient care. e.g. spouse, children, parents and siblings etc.)

Sample size

A minimum of 100 family caregivers will be enrolled.

Selection criteria

Inclusion criteria:

  • 1. Either sex (male/female).

  • 2. Age ≥ 18 years and ≤ 65 years.

  • 3. Family caregivers attending the OPD unit along with patients diagnosed with breast, lung, oral, cervix uteri, and colorectum cancers.

  • 4. Family caregivers involved in the care of cancer patients for at least 2 to 3 hours per day.

  • 5. Family caregivers willing to comply with the study protocol and complete the study assessment tools, such as questionnaires or interviews.

  • 6. Willing to give voluntarily informed consent.

  • 7. Family caregiver who knows English, Hindi or Marathi.

Exclusion criteria:

  • 1. Family caregiver who is illiterate.

  • 2. Unable to communicate properly.

  • 3. Cognitive impairment (having a history of prior or current psychiatric or neuropsychological disorders) which would limit their ability to complete the questionnaires.

  • 4. Physically disabled.

Study procedure & data collection

This is an observational, cross-sectional, questionnaire-based study and will be conducted at the Department of Medical Oncology, Siddharth Gupta Memorial Cancer Hospital, a speciality unit of Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi (Meghe), Wardha, Maharashtra, after obtaining an approval from the institutional ethics committee (IEC) of the Datta Meghe Institute of Higher Education and Research (DMIHER), Wardha, Maharashtra, India. The study will be conducted in compliance with all regulatory and ethical requirements, and participants’ details will be kept confidential throughout the study duration.

The duration for enrollment of study participants will be 6 months (26 weeks), and the participants will be enrolled from the Medical Oncology OPD. Once a suitable participant is found for the study, details about the study and its importance will be explained. The Participant Information Sheet (PIS) will then be given to read and understand.

After this, if the participant shows interest in participating in the study, then the Informed Consent Form (ICF) will be given for signature. Once the consent is signed, the participant will be screened according to inclusion and exclusion criteria using the Participant Screening Form (PSF) for eligibility.

After screening, if a participant is found to be eligible, he/she will be enrolled in the study, and a participant code will be assigned. Approximately 100 participants will be enrolled in this study. Their demographics and other details will be recorded in a Case Report Form (CRF).

A validated scale (i.e. CarGOQoL scale) will be administered through a formal interview to measure the QoL of a participant. Once the interview is completed, the participant is free to perform routine activities.

All participant data and other study-related documents will be stored in the Study Master File (SMF). After data collection from all participants, the data will be analyzed using simple descriptive statistics and other applicable statistical tests. The formulation of the results and conclusions will be drawn upon completion of the participant’s recruitment. Refer to Figure 1 for the study flow chart.

410797a7-cdc4-40af-8648-4d4a4b8e092e_figure1.gif

Figure 1. Study flow chart.

Data assessment & statistical analysis

Data will be assessed:

  • 1. To measure the effect of cancer diagnosis and treatment on the quality of life of family caregivers using the CarGOQoL scale.

  • 2. To determine the relationship between CarGOQoL and socio-demographic variables.

  • 3. To determine the relationship between CarGOQoL and cancer disease variables.

Data will be analyzed for the following domains – psychological well-being, burden, relationship with health care, administration and finances, coping, physical well-being, self-esteem, leisure, social support and private life by using the CarGOQoL scaling and scoring guidelines.

Simple descriptive statistics will be applied, such as sum, min, max, average, frequency distribution, and percentage distribution. Graphical representation of data in the form of tabulation, bar charts, and pie charts will be performed using Microsoft Excel Software.

Participant enrollment criteria

Participants are going to be recruited from Medical Oncology OPD (Out Patient Department) of Siddharth Gupta Memorial Cancer Hospital, A speciality unit of Acharya Vinoba Bhave Rural Hospital (AVBRH) according to the inclusion criteria.

It is a participant’s decision to be a part of the study and will be given a written informed consent document (ICD) to read and understand. All the details about the study and enough time will be given to decide whether or not to take part in the study.

Participant withdrawal criteria

The principal investigator (PI)/Co-PI will withdraw a participant from the study if the participant:

  • • Is in violation of the protocol.

  • • Requires early discontinuation for any reason.

  • • The investigators will also withdraw all participants if the study is terminated.

  • • The participant is free to withdraw from the study at any time point upon their request.

Sample size calculation

Formula for Qualitative Variable2,3

N=Z1−α/2           2×p×1−pd2

Z1-α/22 = Standard normal variate (at 5% type 1 error (P < 0.05) it is 1.96).

p = Expected proportion in population based on previous or pilot studies i.e. 7% (0.07).

d = Absolute error or precision i.e. 5% (0.05).

Calculation:

Sample sizeN=1.962×0.07×1−0.070.052
N=100

Hence, the minimum sample size required for the study is 100 family caregivers.

Dissemination

It will be published in an indexed journal.

Study status

The study is yet to begin.

Discussion

In this prospective cross-sectional study, we will assess the impact of cancer on the QoL of family caregivers using the CarGOQoL questionnaire. Cancer not only affects patients, but also affects family caregivers. According to the data from recent studies, family caregivers’ quality of life is impaired. Higher rates of depression, anxiety, psychological well-being, limitations in roles and activities, and poor physical health were observed, which negatively affected family caregivers’ overall quality of life.

The study carried out by Basavareddy, A. and Nidhi, V. concluded that all aspects of the family caregiver’s life are impacted, especially the social and psychological dimensions. The majority of caregivers experienced deterioration in overall physical health, coping problems, reduced focus, agony over the initial treatment, and interference with domestic tasks.19

Kondeti, A. et al. conducted a study on caregiving burden and satisfaction of family caregivers and observed that caregiving burden is higher in the lower-income group. The quality of life of male, unmarried, without employment and rural residents were impacted by the cancer and higher caregiving burden is observed.20 Study by Mishra, S. et al. on quality of life summarizes that among all caregivers, 70.22% indicated a mild-to-moderate burden, while 21.38% reported a moderate-to-severe burden.21

Study by Kocak, N. et al. concluded that the physical, social, psychological, and environmental domains of family caregivers were affected. It has been observed that the quality of life of female caregivers is lower than that of men.22 The study carried out by Gan, G.G. et al. concluded that family caregivers experience significant psychological distress and low quality of life. Comprehensive support is urgently needed for caregivers of cancer patients.23

After observing the results and conclusions of the above studies, we expect similar results in our study population. This study aims to identify the domains in which caregivers are affected and to find solutions for better management and improving family caregivers’ QoL.

Ethical considerations

The study protocol is approved by the Institutional Ethics Committee (IEC) of Datta Meghe Institute of Higher Education and Research (DMIHER), Sawangi (Meghe), Wardha, Maharashtra, India. Pin Code: 442001.

Ref. No.: DMIHER (DU)/IEC/2023/814.

This study will be conducted in compliance with the Study Protocol, ICH-GCP, Declaration of Helsinki, ICMR Guidelines, NDCT-2019 and its amendments. In addition, the study will be conducted in accordance with local regulations and ethical requirements. Participants’ details will be kept confidential.

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Chepuri GA and Mude GS. An observational, cross-sectional study to assess the quality of life (QoL) of family caregivers of patients diagnosed with cancer [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:143 (https://doi.org/10.12688/f1000research.142979.1)
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Comments on this article Comments (0)

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VERSION 1 PUBLISHED 23 Feb 2024
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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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