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 »  Abstract
 » Introduction
 » Methods
 » Results
 » Discussion
 » Conclusion
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  Table of Contents  
Year : 2016  |  Volume : 53  |  Issue : 2  |  Page : 339-344

Development and validation of a questionnaire to measure preferences and expectations of patients undergoing palliative chemotherapy: EXPECT questionnaire

1 Department of Clinical Hematology and Medical Oncology, Malabar Cancer Center, Moozhikkara, Kodiyeri, Thalassery, Kannur, Kerala, India
2 Department of Radiation Oncology, Malabar Cancer Center, Moozhikkara, Kodiyeri, Thalassery, Kannur, Kerala, India
3 Department of Surgical Oncology, Malabar Cancer Center, Moozhikkara, Kodiyeri, Thalassery, Kannur, Kerala, India
4 Department of Cancer Palliative Medicine, Malabar Cancer Center, Moozhikkara, Kodiyeri, Thalassery, Kannur, Kerala, India
5 Department of Division of Clinical Research and Biostatistics, Malabar Cancer Center, Moozhikkara, Kodiyeri, Thalassery, Kannur, Kerala, India

Date of Web Publication6-Jan-2017

Correspondence Address:
V M Patil
Department of Clinical Hematology and Medical Oncology, Malabar Cancer Center, Moozhikkara, Kodiyeri, Thalassery, Kannur, Kerala
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0019-509X.197735

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 » Abstract 

Objective: The objective was to design and validate the questionnaire for capturing palliative chemotherapy-related preferences and expectations. Design: Single arm, unicentric, prospective observational study. Methods: EXPECT questionnaire was designed to capture preferences and expectations of patients undergoing palliative chemotherapy. This questionnaire underwent a linguistic validation and then was tested in patients. Ten patients are undergoing chemotherapy for solid tumors who fulfilled the inclusion and exclusion criteria self-administered the EXPECT questionnaire in regional language. After filling this questionnaire, they self-administered quick questionnaire-10 (QQ-10). SPSS version 16 (IBM New York) was used for analysis. Completion rate of EXPECT questionnaire was calculated. The feasibility, face validity, utility and time taken for completion of EXPECT questionnaire was also assessed. Results: The completion rate of this questionnaire was 100%. All patients completed questionnaire within 5 min. The QQ-10 tool confirmed the feasibility, face validity and utility of the questionnaire. Conclusion: EXPECT questionnaire was validated in the regional language, and it's an effective tool for capturing patient's preferences and expectation from chemotherapy.

Keywords: Expectation, preferences, palliative chemotherapy

How to cite this article:
Patil V M, Chakraborty S, Jithin T K, Dessai S, Sajith Babu T P, Raghavan V, Geetha M, Kumar T S, Biji M S, Bhattacharjee A, Nair C. Development and validation of a questionnaire to measure preferences and expectations of patients undergoing palliative chemotherapy: EXPECT questionnaire. Indian J Cancer 2016;53:339-44

How to cite this URL:
Patil V M, Chakraborty S, Jithin T K, Dessai S, Sajith Babu T P, Raghavan V, Geetha M, Kumar T S, Biji M S, Bhattacharjee A, Nair C. Development and validation of a questionnaire to measure preferences and expectations of patients undergoing palliative chemotherapy: EXPECT questionnaire. Indian J Cancer [serial online] 2016 [cited 2022 Jul 4];53:339-44. Available from:

 » Introduction Top

Palliative chemotherapy in most solid tumors is given with the objective of improving survival, providing symptomatic relief and to maintain the quality of life (QOL).[1],[2],[3],[4] Food and Drug Administration approval for most of the chemotherapy agents were given when these agents had shown an improvement in overall survival, and only a few approvals were given for the ability maintain or improve functioning or QOL.[5],[6],[7],[8] The debate about the “value” of chemotherapy is likely to become fiercer in the near future given the costs incurred in the use of newer chemotherapeutic and targeted agents.[9],[10],[11]

American Society of Clinical Oncology (ASCO) has given benchmark for improvements in survival, which should be taken into consideration when trials are designed for newer palliative chemotherapeutic agents.[9] However in this debate about the cost and benefit, the opinion and the expectations of the patients undergoing chemotherapy is missing. A study done by Koedoot et al. in palliative care patients, irrespective of cancer site, demonstrated that increase in life expectancy was a preference for only 29.5% of patients.[12],[13] In the same study, it was also seen that those patients striving for QOL didn't opt for palliative chemotherapy.[12] A study by Kim et al. showed that in an incurable setting only 70% patients were willing for chemotherapy if they expected mild toxicity and this figure dropped to 46% if they expected severe toxicity.[14] The median survival threshold for accepting the chemotherapy with mild toxicity was 12 months, while it was 21 months for severe toxicity.[14] Expectations from palliative chemotherapy are reported in Western literature, but such data from developing countries is lacking. In addition given the socio-cultural and economic differences between India and Western countries, such data may not be extrapolated to our population. While there is a need to acquire more information about the patient expectations from cancer therapy, there is a lack of validated instruments for our setting. This is needed as the economic scenario, access to care and social milieu is different in Indian population when compared to the Western population.

Hence, the present study was designed to formulate an expectation questionnaire related to palliative chemotherapy in the Indian setting and its validation in local, regional language of the author's institute.

 » Methods Top

The project was initiated after obtaining requisite Institutional Review Board approval. The expectation and preference questionnaire was designed and tested in three stages. First stage was the development of the EXPECT questionnaire, second stage was linguistic validation of this questionnaire in local language and third stage was to study the completion rate, feasibility and utility of this questionnaire.

Stage 1 (development of EXPECT questionnaire)

A EXPECT questionnaire was drafted by the corresponding author in close collaboration with the other authors [Appendix 1 [Additional file 1]] and [Appendix 2 [Additional file 2]). The questionnaire was designed to know certain key preferences and expectations of patients undergoing palliative chemotherapy after in-depth counseling of the patients regarding their prognosis. The aim of this questionnaire was to give in depth insight in preferences and expectations of patients, which in future may be materialized to help in generating a patient preference/expectation related endpoint for measuring success or failure of new drugs and regimens.

This questionnaire was drafted in two sections. The initial section dealt with common questions trying to identify the primary preferences of patients for chemotherapy-related issues. Whether it was living long or symptom control? Then the subsequent questions dealt with the preferred minimum magnitude of benefit for which the patients are ready to undergo palliative chemotherapy.

The second section dealt with questions, which addressed key important aspects of patient's life while undergoing chemotherapy. These questions were exploring issues related to

  • Social life: The question addressed the expected time patient wanted to distribute between hospital, workplace and home
  • Side-effects: There were questions addressing the patient's maximum preference for side-effects related to mortality and side effect related to disturbance in daily life activities
  • Administration of chemotherapy: Patients preference for route of administration of chemotherapy was sought in one question
  • Economic issues and its consequences: Question dealt with the maximum finance the patients want to allot for his/her treatment. Subsequent question dealt with the amount of compromise the patients are willing to make if finances preclude the best available treatment
  • Participation in a clinical trial: Preferences of patient for participation in a clinical trial were sought in two questions.

Stage 2 (linguistic validation of questionnaire)

This included a translation of the questionnaire to local language with a forward-backward translation procedure. Initially, the questionnaire (E1) in English language was translated forwards to local language by two translators who were fluent in English as well as the native target language. The differences between the translations were reconciled and merged into a single forward translated questionnaire with inputs from both the translators. (M1) Then the forward translated questionnaire (M1) was back-translated from the local language to English by two different translators both of whom have a command over the native target language and English and hadn't seen the original questionnaire. The differences between the backward translated English questionnaires were reconciled and merged into a single backward English translated questionnaire (E2) with inputs from both the translators. This translated questionnaire (E2) was compared against the original English questionnaire (E1). As there was agreement between the original (E1) and backward translated English (E2) questionnaire, both E1 and M1 were considered linguistically validated in local language.

Stage 3 (completion rate and feasibility)

This was a single arm, unicentric, cross-sectional prospective observational pilot study conducted in the authors institute in March 2014. Target populations for this study were patients with a diagnosis of head and neck cancers, lung cancer, epithelial ovarian cancer, breast cancer or any other solid tumor attending the outpatient department fulfilling the following criteria.

Inclusion criteria for participants

  • Diagnosed with cancer of any stage
  • Eastern Cooperative Oncology Group performance status 0–2
  • Planned for palliative chemotherapy
  • No uncontrolled medical or surgical co morbidities
  • Knowledge of English and Malayalam
  • Able and willing to complete study questionnaire
  • Willing for written informed consent.

Exclusion criteria for participants

Newly diagnosed patients treated with radical intent.

Ten patients were recruited for this study. These 10 patients underwent detailed counseling about the disease status. The counseling was done regarding the diagnosis, staging, treatment options, chemotherapy efficacy details, chemotherapy side-effects details, chemotherapy cost details, patient assistance programs, and prognosis.

After counseling, within a protocol defined period, the patient's self-administered EXPECT questionnaire. After completion of this questionnaire, the patient's self-administered another questionnaire quickly questionnaire-10 (QQ-10). QQ-10 is a validated tool for evaluation of questionnaires regarding its feasibility, face validity, and utility.[15]

Statistical analysis

As this was a pilot study, a sample size of 10 was considered adequate. A questionnaire response was considered complete when 80% or more questions were answered. The completion rate would be calculated as the number of patients completing the questionnaire multiplied by 10. For feasibility, face validity and utility, the descriptive statistics of response to QQ-10 tool was done.

If the completion rate of 80% or above was achieved, then we would proceed with the same questionnaire with or without minor modifications to a large study for capturing chemotherapy expectations. If completion rate is below 80% then, the questionnaire would undergo major changes and would then be retested in a pilot study.

 » Results Top

Ten patients were included in this study. The median age was 50 years (32–67 years). There were three females and rest all were male patients. The completion rate was 100%. (All patients answered more than 80% of the questions applicable). Three patients (subject 1, subject 3 and subject 10) failed to answer one questions. This question serial number was 10 and belonged to the second section. This was a question enquiring for reasons for not participating in drug trials. On enquiry, all patients confirmed that the question was understood by them, but they didn't want to answer it. The questionnaire was completed within 5 min by all patients.

The responses of patients to the questions of QQ-10 are shown in [Figure 1]. It can be appreciated that the answers were affirmative for positive aspects regarding the questionnaire, while patients confirmed that the questionnaire lacked negative features. These responses show that the questionnaire was feasible and had face validity and utility.
Figure 1: Bar diagram depicting patient's responses to quick questionnaire-10. Each question is depicted on the Y-axis. X-axis depicts the percentage of patients. Each bar depicts affirmative response

Click here to view

 » Discussion Top

In countries like India, cancer is on the rise.[16] With the increase in cancer burden, the burden of patients receiving palliative chemotherapy is expected to increase. Palliative chemotherapy is a boon as it may increase life expectancy and reduce cancer-related symptoms.[2],[3] In recent times with the advent of targeted therapy, in many solid tumors its combinations with chemotherapy have become the standard treatment in most of the palliative anticancer treatment schedules.[17],[18],[19],[20],[21]

However, the magnitude of improvement caused by these agents and the access of these agents worldwide are questionable.[9],[10],[11] ASCO has now come up with a definition regarding “clinically meaningful outcome” as a benchmark for approval of newer therapies. In that review of “clinically meaningful outcome” surprisingly the patient's preferences or expectations were not taken into account.[9] Designing of trials even when they have positive outcome, if done without looking into patient's preferences, will have a high likelihood of failing to match patient's expectations. Having trials with “patient's expected primary outcome” would solve such issues.[22] For example in a trial if certain patient prefers improvement in QOL over improvement in survival, but the trial drug provides him with improvement in survival and decrement in QOL, then such trial drug even if it would have met its endpoint of improving survival it would fail on patients expectation. Only a few trial have explored patient's preference for chemotherapy-related issues.[23],[24],[25]

However, such trials related to preferences or expectation of the patient regarding chemotherapy can be done only if data regarding usual trends of patient's preferences or expectations is available. As majority of the Western population have insurance or national health coverage, the cost is not a limiting factor in cancer treatment. At the same time in low and middle income countries cost is a major issue.[26] Drugs such as trastuzumab and cetuximab which are part of standard treatment are received only by less than 5% of the eligible population.[26],[27] It is known that cancer treatment lands many patients in penury due to the lack of patient assistance and economic support.[28],[29],[30],[31] In addition, India has a different social and cultural environment which may further influence the patient preferences.

Patient preference influences the uptake of chemotherapy as shown in a study conducted by Koedoot et al.[12] In this study, patient preference for chemotherapy prior to consultation with the oncologist strongly influenced further receipt of chemotherapy. The authors concluded that patient's preferences should be known in order to ensure proper shared decision making.[12],[13] Hence, the EXPECT questionnaire was designed by the corresponding author with certain basic issues in mind. The questionnaire was supposed to capture what patient's basic expectation from chemotherapy that is either increase in life or control of symptoms, further it would know about the patient's preference about administration of the drug, side-effects, cost and their views on clinical trial participation. The high-face validity of this questionnaire as assessed by the QQ-10 tool shows that this instrument is successful in capturing this information. The questionnaire is self-administered and can be completed within 5 min by all patients. This tool in its present form was found to be feasible and well-accepted by the patient population. In the future, we plan to do a large study in some of the major subsites in solid tumor patients to capture their expectations.

 » Conclusion Top

EXPECT questionnaire was validated and was found to be feasible. It has clinical utility for use in future studies.

 » References Top

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Hurley JD, Riesch J. Cancer chemotherapy of solid carcinoma. Wis Med J 1961;60:297-300.  Back to cited text no. 3
McCall K, Johnston B. Treatment options in end-of-life care: The role of palliative chemotherapy. Int J Palliat Nurs 2007;13:486-8.  Back to cited text no. 4
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