Information needs assessment and development of information booklet for patients with cancer receiving chemotherapy

A cross-sectional analysis

Abstract

Background: 

Patients with cancer require a wide variety of information during their illness. Identifying their need for information and providing education are vital responsibilities of nurses and physicians.

Objectives: 

We aimed to assess the information needs of patients with cancer receiving chemotherapy. We then aimed to develop and validate an information booklet, based on the needs assessment.

Materials and Methods: 

This study was conducted among patients with cancer visiting the day care center for chemotherapy at the Shirdi Saibaba Cancer Hospital and Research Center, Kasturba Medical College, a tertiary cancer center in Manipal, India. The information needs of the patients were assessed through a questionnaire. The chemotherapy information module developed was then given to five subject experts for validation.

Results: 

Between Dec 2018 and Feb 2019, we enrolled 245 patients in the study. Of these, 108 (44.1%) expressed a desperate need for information, 136 (55.5%) had a preferred need for information, and 1 (0.4%) did not require any information. The information considered as the absolute need to know by over half (52.7%) the participants was regarding the disease (severity, recurrence, malignancy, and effect on the body), followed by the side-effects of chemotherapy and their management (49%) and psychological support (45.3%).

Conclusion: 

Patients with cancer have the desire to be well informed about their disease, treatment, and side-effects. Education sessions can be planned to improve the chemotherapy-related knowledge of patients with cancer. Regular appraisal of the need for information among patients with cancer is critical, considering the changing needs of the health-care seekers. (Clinical Trials Registry-India number CTRI/2018/11/016378)

INTRODUCTION

In patients who have been diagnosed with cancer, the unavailability of adequate information regarding various aspects of their disease is often reported and is a matter of growing concern in the health-care setting. Most patients do not receive the requisite information or are provided with insufficient explanations about the cancer and its treatment.[¹] Providing adequate information to patients with cancer increases their satisfaction and improves their quality of care.[²] Additionally, providing detailed information to patients helps to prepare them for their treatment, increases the chance that they will adhere to treatment, and improves overall outcomes.[³] Patients should receive information that is individualized, timely, simple, and easy to understand.[⁴]

In a cross-sectional study by Mekuria et al.,[³] patients with cancer reported that the information they desired the most was regarding their specific type of cancer, followed by information regarding the side-effects of chemotherapy along with the possible management options, and finally, details of their prognosis and survival. Physicians were considered the most reliable source of information, followed by nurses. Patients with colorectal cancer expressed a lesser need for information compared to patients with prostate and breast cancer, indicating a distinct difference between the informational needs among patients with different types of cancer.[⁵] The three main areas of informational needs identified by the patients were prognosis, diagnosis, and management options.[⁶⁷⁸⁹]

In another survey of 269 patients with cancer, Meredith et al.[¹⁰] reported that almost 80% of the patients with cancer wanted as much information as possible from their health-care providers and 96% wanted to know whether they had been diagnosed with cancer, what the possibilities of recovery were, and the possible side-effects of the treatment. A confounding factor that impedes adequate provision of information by health-care providers to patients is that patients are often unable to clearly articulate what their needs are, which emphasizes the requirement for a systematic process to identify the needs of patients with cancer in the clinical setting. Knowledge about the patients' needs will facilitate the provision of targeted interventions.[¹¹] Overall, patients expressed dissatisfaction with the information that they had received.[¹²] Soon after the patients are made aware of the diagnosis of cancer, they encounter many new medical terminologies. This compounds their anxiety and prompts the search for information from various sources, which are not always reliable. Thus, the availability of adequate and accurate information will not only reduce the patients' anxiety, but will also help the patients and their relatives to better cope with the diagnosis, and navigate the treatment, side-effects, and post-treatment phases.[¹¹¹³¹⁴]

Physicians have a responsibility to disseminate reliable and relevant information to patients with cancer who are undergoing cancer treatment.[¹⁵] Nurses also play an important role as a source of information. Nurses' inputs regarding the various facets of cancer treatment benefit the patients and give comfort.[¹⁶]

We conducted this study to understand the information needs of patients with cancer receiving treatment at our chemotherapy day care unit, in order to help us fulfil these needs in a better manner.

MATERIALS AND METHODS

General study details

This was a descriptive survey conducted from December 2018 to February 2019 in the chemotherapy day care unit at the Shirdi Saibaba Cancer Hospital and Research Center, Kasturba Medical College, a tertiary cancer center in Manipal, India. Ethics committee approval was received (IEC No. 693/2018) on Oct 9, 2018 (Supplementary appendix 1). Written informed consent was taken from all the participants. The study was conducted according to the ethical guidelines established by the Declaration of Helsinki and other guidelines like Good Clinical Practice Guidelines and those established by the Indian Council of Medical Research. The study was registered with Clinical Trials Registry-India (CTRI/2018/11/016378). No funding was received for this study.

Participants

We included patients with cancer visiting the chemotherapy day care center who were receiving any cycle of chemotherapy. Those patients who had any severe symptom due to comorbid illnesses other than cancer or those who could not understand either English or Kannada (the local language) were excluded from the study. We also excluded patients with missing information or those whose questionnaires were incomplete. Only those questionnaires in which all the sections were completely answered were analyzed.

Aims/objectives

The primary objective was to assess the informational needs of patients with cancer coming to the day care chemotherapy center to receive treatment for their cancer. The secondary objective was to develop and validate an informational booklet based on the needs assessment from the first part of the study.

Study methodology

All the tools used in the study were prepared by the study investigators. These tools were given to seven domain experts from various fields such as medical oncology, clinical psychology, and nursing for validation. An agreement among all the experts with a score of 80% and above was considered for the preparation of the tools. The following data collection tools were used for the study.

Tool 1a: Sociodemographic pro forma

This tool was developed by the investigators to assess the sample characteristics. The tool comprised six items: age, sex, marital status, type of family, monthly family income, and education.

Tool 1b: Clinical pro forma

This tool was developed by the investigators to assess the clinical details of the patients. The tool comprised four items: the type of cancer, the stage of cancer, the chemotherapy drug regimen along with the number of chemotherapy cycles received, and comorbid illness.

Tool 2: Information needs questionnaire

This tool (Supplementary appendix 2) consisted of 31 item statements that were related to the patients' needs while on chemotherapy. Respondents had to mark their perception of each need under the headings, “Don't want to know,” “Would like to know,” and “Absolute need to know”. The information needs in the questionnaire were focused on the disease, treatment, chemotherapy side-effects, physical care, psychosocial support, and miscellaneous items which included financial support, follow-up schedule, and survival. “Don't want to know” was scored as 0 points, “Would like to know” as 1, and “Absolute need to know” as 2. The highest possible score was 62, and the minimum score was 0. The total scores were further arbitrarily classified as follows: 0–20: no information required, 21–40: preferred need for information, and 41–62: desperate need for information.

This questionnaire was translated into the local language, Kannada. The translated tool was given to two language experts, and back-translation was done from Kannada to English to check the accuracy of the translation. The translation was found to be precise.

Definitions

We defined information needs as all the information required by a patient with cancer, regarding the disease, treatment, and prognosis, measured by the Information Need Questionnaire. We developed an information booklet during the second phase of the study, which contained all the information regarding various aspects of cancer chemotherapy treatment, such as taking the blood tests, undergoing chemotherapy at day care, post chemotherapy side-effects, and their management.

Statistics

The sample size for this study was calculated using the estimation of proportion formula. Keeping the minimum sample size required at a 5% level of significance, having a Z value for 95% confidence of 1.96, and hypothesizing that the anticipated proportion of the information needs expressed by the participants as the “preferred need for information” would be 20%,[⁹] the required sample size was calculated as 245. Data analysis was carried out by using the Statistical Package for the Social Sciences (SPSS for Windows, version 16.0, released 2007; SPSS Inc., Chicago, IL, USA). Descriptive statistics were used to analyze the sociodemographic characteristics, clinical profile, and information needs of the patients with cancer; results were presented in frequencies and percentages. All 245 surveys were analyzed after the data collection. We did not perform any inferential statistics, and no tests of statistical significance were done.

RESULTS

The questionnaire was administered to 268 patients with cancer, of whom 245 patients agreed and completed the questionnaires. Thus, the response rate was 91.4% [Figure 1].

Figure 1: Flow diagram for selection of the patients with cancer

Demographic characteristics

Overall, the majority of the patients (145, 59.2%) were in the age group of 41–60 years, female (147, 60%), married (226, 92.2%), and living in a nuclear family (139, 56.7%). Most (189, 77.9%) had a family income above 20,000 per month and had studied up to higher secondary level (122, 49.8%).

Clinical characteristics

Over a quarter of the patients (68, 27.1%) had breast cancer and 96 (39.2%) had stage 2 disease. A combination chemotherapy regimen was planned in 116 (47.3%) patients. For 138 (56.3%) patients, the number of chemotherapy cycles received was between 1 and 5. The majority of the patients (190, 77.6%) did not have any comorbid illness [Table 1].

Table 1: Frequency and percentage (%) of the clinical profile of the participants (n=245)

Phase I: Assessing the information needs of patients

Information needs among patients with cancer

A total of 108 (44.1%) patients expressed a desperate need for information. The details are provided in Table 2.

Table 2: Frequency and percentage (%) of the patients with cancer who reported the need for information, along with the information need score (n=245)

Section-wise information needs distribution

Over half of the participants (129, 52.7%) expressed a desperate need for information regarding the disease and miscellaneous information. There was a preferred need for information regarding treatment (173, 70.2%), chemotherapy side-effects (125, 51%), venous thromboembolism (189, 77.1%), physical care (170, 69.4%), skin care (164, 66.9%), and psychological support (134, 54.7%) [Table 3].

Table 3: Frequency and percentage (%) of the section-wise information needs among patients with cancer (n=245)

Phase II: Development and validation of the information booklet

Preliminary collection of the content of the information booklet

The primary content of the information booklet was developed through a comprehensive literature review after assessing the participants' information needs through an information needs questionnaire. The literature review focused on the material that was already available on cancer, chemotherapy, and related factors.

Design of the information booklet

The information needs assessment showed that patients desired to know more about the chemotherapy side-effects and their management. After discussion with the experts, we developed a comprehensive information booklet that contained details about chemotherapy and the management of the side-effects of chemotherapy. Information regarding all these topics was collected from various literature sources. The content outline was divided into three broad topics including an introduction to chemotherapy, the common Side-effects of chemotherapy, and their management. Cartoon images were selected in order to pictorially represent the information. Discussions were carried out with the specialists, and the pre-final version was drafted, which consisted of the following sections:

1. Introduction to chemotherapy: This section provided information about chemotherapy and its indications.
2. Common side-effects of chemotherapy: This section provided information about the side-effects that commonly occurred during the course of chemotherapy.
3. Management of side-effects: This section discussed the management of the side-effects of chemotherapy with a special emphasis on physical care, skin care, psychological support, and other related information.

Assessment of content validity

The prepared final draft included all the contents as per the information needs expressed by the majority of the patients in the Phase I portion of the study. This draft was given to various specialists for validation. Validation was done through a questionnaire consisting of six items on comprehensiveness, relevance, content organization, and appropriateness of the illustrations. Validators were designated from different areas of cancer care to make the information booklet easy to understand and widely relevant. The criteria checklist was distributed to five validators who were the subject experts in the fields of medical oncology and medical and surgical nursing, and were practicing professionals, along with a cover note describing the purpose of the information booklet. The validators included (two assistant professors [medical–surgical nursing], one assistant professor [mental health nursing], and two medical oncologists. The scoring was based on the checklist. The item content validity index (I-CVI) was used to quantify the results [Table 4].

Table 4: Items and content validation of the information booklet

After finalizing the content validity, the information booklet was translated into the local language (Kannada). Both the versions were discussed with the experts to identify and resolve any inconsistencies in the content, and sentences in the booklet were modified accordingly to give the proposed information in as clear a manner as possible.

Validity report

Five validated responses were collected and analyzed. All the validators were in agreement with the four items [questions 1, 4, 5, and 6 in Table 4], whereas the other 2 items were approved by about 80% of them [questions 2 and 3 in Table 4]. Individual I-CVI and scale-level content validity index (S-CVI) for all the items were calculated and they ranged from 0.80 to 1, and 0.93, respectively (indicating excellent content validity) [Table 4].

The validators gave various suggestions regarding the portions of the booklet where they perceived the need for modification in the content and images. A suggestion was made to include a list of the normal range of blood laboratory values, which could serve as a ready reference for the patients to compare with, when they received their own laboratory values. Another suggestion was to enumerate the activities that needed to be restricted during chemotherapy and to specify which food items could be consumed in case of side-effects. One of the validators suggested the inclusion of some statistical details like the prevalence of chemotherapy-related side-effects in patients with cancer and the psychosocial impact of the occurrence of side-effects in the introduction part. All these suggestions were discussed with the experts along with an extensive discussion about the organization of the content, simplicity of the language, and relevance of the illustrations and were incorporated in the final version of the information booklet.

DISCUSSION

In this study, we found that 44.1% of patients with cancer expressed a desperate need for information regarding various aspects of cancer and chemotherapy. Our findings are in contrast to those reported by Meredith et al. in which 79% of the patients expressed that they wanted to know as much information as possible regarding cancer and chemotherapy, indicating increased information-seeking behavior among the population of Denmark compared to that of India.[¹⁰] In other studies as well, patients showed a great need overall for information.[¹⁰¹²]

We found that the highest priority information-related areas for patients with cancer included the disease (52.7%) and miscellaneous information (cost of treatment, follow-up) (52.7%), followed by side-effects (49%) and psychosocial information (45.3%). The findings of a systematic review by Tariman et al.[⁶] revealed that the top three information needs identified were prognosis, diagnosis, and treatment options. In another cross-sectional study by Mekuria et al.,[³] 67% of the patients with cancer considered information regarding the particular type of cancer, that is, the name of the cancer and the disease staging, to be the most important, followed by 63.3% who wanted information about the side-effects of chemotherapy and their management and 51.8% who desired information regarding prognosis (survival). Regardless of the number of cycles of chemotherapy, patients with breast cancer expressed the need to have a high level of information, mainly focusing on disease, treatment, physical care, tests, and psychosocial needs.[⁷⁹] Information requirements reported by most patients included details regarding the side-effects (60%), and patients demanded to receive as much information as possible (86.7%).[¹⁷] Similarly, McCaughan et al.[¹⁸] found that most patients expressed the desire to obtain all potential information about their disease and reported that the information provided was satisfactory. In order of decreasing importance, the information needs were regarding the illness, recovery, treatment, chemotherapy side-effects, and course of the disease.[⁸]

Assessment of the information needs of patients with cancer in the first phase of our study allowed us to organize ideas and develop the first version of the patient information booklet. The Phase I portion of the study revealed that most of the patients preferred to have access to as much information as possible. We then validated the information booklet for the use of the patients at our day care center chemotherapy unit. The information booklet was prepared both in English and the native language Kannada for ease of understanding. Earlier studies found that patients preferred to receive the information in their native language.[¹⁹²⁰] Other studies have reported that physicians were considered the most reliable source of information (88.8%), followed by nurses (34%).[³] Preference was given by the patients to one-to-one discussions with doctors and nurses.[⁸²¹] There was a requirement for providing patient- and family-oriented education which addressed the patients' requirements for information and ongoing care.[²²]

Our study was limited by the fact that we used purposive sampling in the selection of participants for assessment of the information needs. We collected the information needs from only patients; our study findings would have been better if caregivers were also involved in the data collection. While developing the information booklet, we did not involve the patients and caregivers; rather we only consulted the treating physician and nurses. However, our study included a heterogenous population, hence our results are generalizable.

CONCLUSION

Most patients prefer to obtain information regarding various aspects of cancer and chemotherapy, so it is important to provide them with all the information that they need. Physicians and nurses being frontline health-care workers should be aware of the patients' information needs to disseminate more accurate, relevant, and timely information to the patient and caregivers. Our study also highlights the requirements of the patients' needs and expected appropriate responses from the health-care workers on a more effective way of assessment of supportive care and adherence of patients to the treatment regimen, so that patients feel more secure and cooperate with the ongoing treatment. The information booklet will be a key resource for the physicians and nurses, with an aim to improve the quality of care in all areas including physical, psychosocial, and spiritual aspects.

Data sharing statement

Individual de-identified participant data (including data sheets) will not be shared

Author contributions

Conception or design of the work: SDV, RRP, KU; data collection: SDV, RRP; data analysis and interpretation: SDV, RRP, KU; drafting the article: SDV, RRP, KU critical revision of the article: RRP; final approval of the version to be published: all authors; accountability for all aspects of the work: all authors.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Acknowledgements

We would like to acknowledge the in charge and staff nurses of the day care center, Shirdi Sai Baba Cancer Hospital, KH Manipal, India, for their help and cooperation during data collection.