Improving information to Italian cancer patients: results of a randomized study

F. De Lorenzo1,*, E. Ballatori2, F. Di Costanzo3, A. Giacalone4, B. Ruggeri2 and U. Tirelli4,§

1 AIMaC–Associazione Italiana Malati di Cancro, parenti e amici, Rome; 2 Dipartimento di Medicina Interna e Sanità Pubblica, Università degli Studi di L’Aquila; 3 U.O. Oncologia Medica, Azienda Ospedaliera Careggi, Florence; 4 Istituto Nazionale Tumori, Centro di Riferimento Oncologico, Aviano, Italy

Received 9 October 2003; revised 20 January 2004; accepted 27 January 2004


    ABSTRACT
 Top
 ABSTRACT
 Introduction
 Patients and methods
 Results
 Conclusions
 REFERENCES
 
Background:

It has been widely shown that the provision of adequate levels of information to patients does have a positive effect on quality of life by reducing anxiety and depression levels. The aim of this study was to show how Italian cancer patients rate the information they are given and whether the use of booklets and videotapes can improve their quality of life.

Patients and methods:

Cancer patients aged between 18 and 80 years who were about to receive their first chemotherapy course were randomized to fill in questionnaires on perceived quality of information, level of psychological distress, perceived severity and curability of the disease, and quality of life. The results were evaluated by means of statistical analyses.

Results:

Out of 328 consecutive patients enrolled in 21 cancer centers, 86–93% considered the booklets either ‘very useful’ or ‘useful’. The videotape was regarded as ‘quite’ or ‘much’ more complete than the booklets (87%). According to 81%/87% of patients, the information that had been given had improved their knowledge of the disease/chemotherapy either ‘a lot’ or ‘enough’.

Conclusions:

The information patients receive from the oncologist was rated the highest, as long as they were devoted enough time. Booklets and videotapes can partially overcome the lack of oral information given by medical doctors. A better informed patient does help the oncologist save time.

Key words: anxiety, booklets, cancer treatment, information, quality of life, videotape


    Introduction
 Top
 ABSTRACT
 Introduction
 Patients and methods
 Results
 Conclusions
 REFERENCES
 
Cancer patients are exposed to several stress situations at the time of diagnosis and during treatment. Surveys conducted at the Memorial Sloan-Kettering Cancer Center outpatient clinics have found that between 20% and 35% of patients demonstrate a significant level of distress [1].

The increased focus on the information given to cancer patients, which has become a major issue in recent years, has shown that informative programs do have a positive effect on a patient’s quality of life (QoL): information reduces anxiety and depression levels, establishes a true doctor–patient relationship and promotes a better adaptation to the disease [25]. In a randomized controlled multicenter study of 220 UK cancer patients receiving chemotherapy or radiotherapy, Thomas et al. [6] reported a significant correlation between response to information needs and a reduction of treatment-related anxiety.

It has been demonstrated that in the most developed countries, the majority of cancer patients desire as much information as possible and want to be involved in all aspects of their healthcare [711]. The most common questions deal with treatment-related side-effects, the drug(s) being administered and coping strategies. Information has to be in a hard copy, easy and comprehensible format and be given prior to treatment.

Written information can be read all over again, pondered, compared, assimilated and processed. The information received at the time of diagnosis can be integrated into the individual history and counteracts the ‘fear of the unknown’, which is the most important component of the psychological morbidity associated with the treatment of cancer. Educational materials, such as booklets, are very practical, since they can be read at home whenever the patient wants to, and be shared with friends, relatives and community health care workers [12, 13].

Videos have also been used as an information tool in cancer patients. The Hawaii Quality and Cost Consortium Project, which employs interactive videodisks to provide clear, unbiased information about the available treatment options, has shown that after viewing the disks, the patient becomes more actively involved in the decision-making process [14]. The patient’s satisfaction with video-recorded information and the decreasing effects this has on anxiety and depression are positively demonstrated [6, 15].

In Italy, studies on the patient’s awareness of the severity and curability of the disease have exhibited very clearly what effects poor information can have, which may be partly related to the inadequate process by which Italian cancer patients are informed [16, 17]. This has prompted us to perform a study in order to assess how Italian cancer patients rate the information they are given and also whether the use of booklets and videotapes, that have recently been made available, can improve their QoL.


    Patients and methods
 Top
 ABSTRACT
 Introduction
 Patients and methods
 Results
 Conclusions
 REFERENCES
 
In January 2001, AIMaC in collaboration with the Italian Association of Medical Oncology (AIOM) invited 50 major cancer centers, equally distributed throughout the country, to participate in this study.

In order to be eligible, consecutively randomized patients had to be between 18 and 80 years of age, have a histologically-confirmed diagnosis of neoplasia, be submitted for the first time to at least two chemotherapy cycles, be able to comprehend full information on the diagnosis, and be willing to receive full information on the disease and relevant treatment.

Immediately prior to the first chemotherapy session, each patient was asked by the medical oncologist whether he/she would be willing to receive more information on the disease and treatment he/she would receive. Each patient who agreed received a thorough explaination of the study protocol and was enrolled only after having signed the informed consent form and agreed to the collection and use of his/her personal data. The study protocol was approved by the ethical committee of each center. Exclusion criteria were as follows: unknown primary site of neoplasia; unwillingness to be fully informed about the disease; blindness; illiteracy; or serious cognitive or psychiatric disorders.

Patients were assigned to three arms according to centrally prepared randomization lists: group one received only oral information from the oncologist (OI); group two, verbal information supported by two booklets [produced by AIMaC and translated from those published by CancerBACUP (British Association of Cancer United Patients and their family and friends)], which contained information about both the type of tumor affecting the patient and chemotherapy (OI+B); group three, in addition to OI and B, also received a 20-min videotape about chemotherapy and radiotherapy (OI+B+VT). The script was written by R. Thomas [15] in collaboration with a multidisciplinary team, which included cancer patients, their relatives, doctors, nurses, radiographers and pharmacists, within a series of focus groups over 6 months. The video was designed to provide a comprehensive description of therapy: actual patients are shown receiving treatment whilst text on the screen lists the risk of side-effects. The English language version of the video was translated and adapted by AIMaC within the framework of a joint project with Dr Thomas [18].

Questionnaires on perceived quality of information, level of psychological distress, perceived severity and curability of the disease, and QoL (QoL) were submitted to the patients twice: at T0, ~30 min before the first chemotherapy cycle, and at T1, ~30 min before the following cycle.

The psychological distress inventory (PDI), a self-administered questionnaire developed and validated by Morasso et al. [19] on 434 Italian cancer patients, was used to measure the general emotional liability, and more specifically, (i) reactive anxiety to cancer and relevant therapies, such as inner tension and worry; (ii) reactive depression, such as sorrow, decreased energy, loss of self-confidence and interest; (iii) emotional reactions to changes in body image and disturbances of interpersonal and sexual behaviors. PDI consisted of 13 multiple-choice questions (‘not at all’, ‘a little’, ‘enough’, ‘very’) rated from one to four. The mean PDI value was calculated by dividing the total score by the number of responses given.

All patients had to evaluate the perceived quality of oral information; those in the OI+B and OI+B+VT groups were also asked questions on the effectiveness of the booklets and videotape.

Four self-administered visual analog scales (VAS), each consisting of a 100 mm long ruler (with gradations representing the worst at one end, and the best possible condition at the other) were submitted to each patient, who was asked to put a vertical mark on the point that best represented his/her actual condition. The VAS referred to QoL, perceived severity and curability of the disease, and degree of anxiety. The scores were evaluated in two different ways: the simple score (between 0 and 100) was assumed as variable, and considering only the two extreme values, 0–30 and 70–100, each patient was classified as ‘very good’ or ‘very bad’ with respect to his/her condition.

Since one of the assumptions underlying this study was that the booklets and/or the videotape are able to reduce psychological distress, the main end point of the study was the mean PDI score. Patients undergoing any chemotherapy cycle showed a mean PDI value of 30.9 [19] i.e. a mean value for response equal to 2.38 (30.9/13 items). Since our patients were to receive chemotherapy for the first time, a mean value of 2.3 was assumed. During follow up they showed a mean PDI value of 24.7 [19], equal to a mean value for response of 1.9 (24.7/13). Since chemotherapy would be given again at the second evaluation, we assumed cautiously that in the OI+B+VT patients the mean PDI value could be lowered to 2.00. Finally, the intermediate PDI value was assumed to be equal to 2.15 in the OI+B group. Hence, it was calculated that 480 patients would be sufficient to assure a probability of >80% to detect a significant difference among the three groups with an {alpha}-value equal to 5% referring to a two-tailed t-test.

A {chi}2-test statistical analysis was performed to compare two or more proportions, whereas a t-test was used to compare two means; when comparing three means, the significance levels were adjusted according to Bonferroni inequality.


    Results
 Top
 ABSTRACT
 Introduction
 Patients and methods
 Results
 Conclusions
 REFERENCES
 
From May 2001 to May 2002, 328 consecutive patients were enrolled in 21 oncological centers. However, 28 could not be evaluated because of a high number of responses missing; hence, the total study population included 300 patients. Unfortunately, a recruitment target of 480 patients was not achieved for two major reasons: on the one hand, information is still a sensitive subject in Italy, and on the other hand, lack of financial support (AIMaC is a volunteer-based association). The reduced enrollment did not introduce any bias; however, under the assumptions adopted in the patients and methods section, the power of the study decreased from >80% to ~70%.

With respect to the geographic area, the numbers of patient/participating center were as follows: 109/8 in Northern, 77/5 in Central and 114/8 in Southern Italy. The patient characteristics are outlined in Table 1.

At time T0, there was a high concordance between the quality of oral information and the perception of the time spent by the oncologist giving it: when the latter was ‘very satisfactory’/‘insufficient’, the quality of information was often ‘high’/‘poor’ (Table 2).

Between T0 and T1, the patients needed further information on the disease (54%) as well as on chemotherapy (56%). When the patients required further information, they turned generally to the oncologist (80%), but many also asked the family doctor (34%) or other cancer patients (28%).

With respect to curability and anxiety VAS, no significant differences were detected between the three arms (data not shown).

Some small differences in PDI and perceived severity of disease in favor of the two experimental arms (OI+B and OI+B+VT) can be seen in Table 3, whereas the percentage of patients who felt their QoL had improved differed significantly among the three arms (P <0.049). Pooling together the OI and OI+B groups, the percentage of patients with improved QoL was 40%, which is significantly lower than the percentage recorded in the third arm (55%; P <0.019).

To evaluate the utility of booklets, the OI+B and OI+B+VT arms were joined. The booklets were read by 91% of patients, of which 67% read them only once, 23% twice, 8% three times and 2% more than three times.

The booklets on the individual disease/treatment (chemotherapy) were considered ‘very useful’ 26%/31%, ‘useful’ 60%/62%, ‘not very useful’ 14%/7%, ‘not useful at all’ 1%/0%. The answers to the question ‘whether the information they gave had improved their knowledge of the disease/chemotherapy’ were as follows: ‘a lot’, 23%/23%; ‘enough’, 58%/64%; ‘a little’, 18%/12%; ‘not at all’, 1%/1%.

The videotape was watched by 78 of 99 patients (79%), of which 58 watched it only once, eight twice and three patients three times or more. Usually, it was watched with relatives (68%), and only 32% of patients watched it by themselves.

Finally, when the patients were asked to evaluate how complete, understandable and worrying the information given by the videotape was as compared to the booklets, their answers were as follows: ‘quite’ or ‘much’ more complete in 87% of cases and more comprehensible in 89%, whereas 78% of them considered it ‘not worrying at all’ or ‘a little’ worrying.


    Conclusions
 Top
 ABSTRACT
 Introduction
 Patients and methods
 Results
 Conclusions
 REFERENCES
 
Improvement of QoL in cancer patients undergoing chemotherapy is one the main goals of medical oncologists and volunteer-based associations. Besides reducing chemotherapy-related side-effects by clearly explaining to the patient what to expect and how to prevent or handle it, the information regarding diagnosis, treatment, side-effects, etc. is thought to be a tool through which cancer patients can be more involved in the decision-making process, which ultimately improves their QoL.

In Italy, cancer information is quite lacking in many settings: actually there are still patients who are not informed at all as far as diagnosis and treatment are concerned. This first study to assess the type and level of information given to cancer patients, and how to improve their QoL through new information tools. Actually, booklets and videotapes had never been used as sources of information until they were produced by AIMaC and made available through the major cancer centers.

First of all, this study shows that the quality of oral information is perceived to be very high when enough time has been spent with the patient by the oncologist, whereas it is judged unsatisfactory when the time spent by the oncologist is too short.

Moreover, there is a need for further information between the two chemotherapy cycles.

Our results exhibit that more patients in the OI+B+VT group feel their QoL had improved as compared with the OI and OI+B groups (P <0.02). This could be due to the ‘reassuring’ effect of the videotape: former cancer patients and survivors tell their own experience after they have managed to reduce and control treatment-related side-effects and to defeat the disease. Furthermore, the film can be watched together with relatives and friends (over two-thirds of the study population did). This may have decreased the VAS score of the perception of the seriousness of the disease.

Between T0 and T1, the booklets were read by >90% of patients and the videotape was watched by over 75% of the study population. About 85% of patients found the booklets useful or very useful, and only about 1% rated them as useless. Following this reading, the knowledge of the disease improved in >80% of patients. More than two-thirds of patients felt other cancer patients should read the booklets and >60% that their relatives should read them, too.

In conclusion, the study results show that when cancer patients are devoted enough time by the oncologist, then they rate oral information the best. Our results prove also that booklets and videotapes can partially overcome a lack of oral information and also help the patients understand better what questions they should ask. A better informed patient can help the oncologist save his/her time.


    Acknowledgements
 
The authors are very grateful to Ms Claudia Di Loreto, who has given her time, support and assistance in helping with the organization of the study, data collection, critical revision and editing of the manuscript.

The investigators and collaborating centers were as follows: Azienda Bolognini convenz. Università di Pavia, Alzano Lombardo (BG): G. L. Bonassi, G. Nastasi; Azienda Ospedaliera Borgo Trento, Verona: G. L. Cetto, P. Manno; Azienda Ospedaliera Cardarelli, Naples: M. Biglietto, G. Cartenì, T. Guida, M. C. Merla; Azienda Ospedaliera N. 1, Sassari: A. Contu, G. Baldino, M. Sannita; Azienda Ospedaliera S. Chiara, Pisa: F. Bonci; Azienda Ospedaliera S. Filippo Neri, Rome: P. Bonginelli, G. Gasparini; Casa di Cura ‘La Maddalena’, Palermo: A. Calafiore, V. Grasso, A. Moscato; Casa di Cura S. Maria–HSR, Castellanza (VA): I. Rampinelli, U. Scaglietti; Department of Medical Oncology, Università di Napoli Federico II, Naples: E. Matano; Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione G. Pascale, Naples: R. Casaretti; Istituto Nazionale Tumori, CRO Centro di Riferimento Oncologico, Aviano (PN): G. Di Gennaro; M. Tavio; Istituto S. Raffaele, Milan: E. Villa; Ospedale ‘Infermi’ di Rimini: C. Livi, A. Ravaioli; Ospedale Civile, Lamezia Terme (CZ): C. Aiello, E. Greco; Ospedale Civile, Vigevano (PV): G. Attardo Parrinello, D. Del Frate; Ospedale Fatebenefratelli, Rome: A. M. Di Giacomo, V. Zagonel; Ospedale S. Giovanni Molinette, Turin: A. Beano, M. Donadio; Ospedale S. Maria Goretti, Latina: M. D’Aprile, M. Moreschi; Policlinico di Siena, Siena: G. Francini, S. Marsili, S. Messinese; Policlinico Universitario ‘G. Martino’, Messina: M. Aragona, R. Talamo Rossi; Policlinico Universitario, Monserrato (CA): B. Massidda, M. T. Ionta.


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Table 1. Patient characteristics
 

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Table 2. Quality of information perceived by the patients (%) with respect to the time spent by the oncologist in giving information
 

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Table 3. Psychological distress and perceived severity of disease modifications
 

    FOOTNOTES
 
* Correspondence to: Prof. F. De Lorenzo, AIMaC, Via Barberini 11, 00187 Rome, Italy. Tel: +39-06-4825107; Fax: +39-06-42011216; E-mail: fdelorenzo{at}aimac.it Back

§ Investigators and collaborating centers are listed in the Appendix. Back


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 ABSTRACT
 Introduction
 Patients and methods
 Results
 Conclusions
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