Elaborating patient information with patients themselves: lessons from a cancer treatment focus group

Abstract

Objective  To assess the significance of patients' input in the elaboration of a patient information booklet.

Design  Qualitative study based on focus group discussions.

Setting  Centre Léon Bérard, a comprehensive cancer centre in the Rhône‐Alpes region of France.

Participants  (1) A multidisciplinary working group (oncologists, health economists and one clinical psychologist) wrote up initial information documents concerning possible breast cancer treatments. (2) A focus group comprised of patients with a history of breast cancer and healthy volunteers discussed their reactions to these documents.

Main outcome measure  Analysis of the focus group's reactions according to key themes predetermined by the working group and related themes introduced by the focus group itself.

Results  The focus group proposed numerous, significant modifications to answer requests for additional information, clarification and better readability in the information booklets.

Discussion/Conclusions  This qualitative analysis showed a significant input of patients' perspective in the elaboration of patient information. It is also an additional support to the feasibility and appropriateness of the focus group technique. The next stage will be to test whether information documents produced here conform to the needs of patients currently undergoing treatment.

Introduction

Since the beginning of the 1980s, numerous studies have brought evidence that most cancer patients say they want information. ¹ , ² , ³ , ⁴ , ⁵ However, which information should be given, and in what form? This is the question we address in this article.

Since the end of the 1990s, the official policy in France has been to encourage providing quality information to patients. ⁶ , ⁷ , ⁸ , ⁹ , ¹⁰ Nonetheless, in a majority of these texts, the means of elaborating such information remains unclear. Only a recent report by the ANAES, ¹¹ entitled ‘Informing patients: guidelines for physicians’ mentions the content of patient documents. Information should be ‘comprehensible for as many patients as possible; this implies submitting document projects to patients, either through patient associations or direct patient participation in the elaboration of the documents.’ Although the report does not specify how patients should participate in the elaboration of information documents, Coulter et al., ¹² in their guidelines for the development of quality information materials, state that developers should ‘involve patients throughout the process […]. The only way to find out what information patients need is to ask them. It is often a good idea to establish a focus group.’

Objective

Our goal was to elaborate information booklets concerning the possible forms of treatment for women recently diagnosed with breast cancer: surgery, radiotherapy, chemotherapy and hormone therapy. Four distinct information documents were elaborated.

A focus group comprised of women with a history of breast cancer and healthy volunteers explored patient needs and preferences pertaining to information.

In this article, we will review the principal methodological phases and results of the focus group discussions.

First, we present the participants. We explain how the focus group was constituted and how meetings were carried out. Then, we present results obtained for each theme, following the same order as during group sessions. We will discuss the participants' initial reactions upon reading the documents, as well as their comments on the content, comprehensibility and presentation of information. For each theme, comparisons will be made between extracts from the original and the modified information documents (elaborated from the group's input) in order to highlight the scope of the modifications brought by the focus group. Unfortunately, a full presentation of the documents in both their initial and modified versions is too long for being given here. Complete versions may be obtained on request to the authors.

Finally, the principal lessons from this work will be presented, and the advantages and drawbacks to our method discussed.

Working group

In 1997, we set‐up a pluridisciplinary working group comprised of oncologists, health economists and one clinical psychologist at the Centre Léon Bérard (CLB), a comprehensive cancer centre in the Rhône‐Alpes region of France. The group's objective was to carry out research concerning patient information and patient participation in medical decision‐making.

Focus group

In September 2000, two oncologists from the working group [one surgeon (AB) and one medical oncologist (TB)] asked patients who had been operated on for breast cancer more than 1 year before, for participation in a focus group to discuss patient information. Twelve patients seen for follow‐up over a 2‐week period were solicited. Only patients who had undergone surgery and radiation therapy, with or without chemotherapy and/or hormone treatment, were included. Their capacity to speak and read French fluently was also required. Five patients refused. Three did not state their reasons and two refused because they lived too far away from the CLB. Thus, seven out of 12 patients initially agreed to participate. One later cancelled out for she did not wish to discuss her disease and feared that her anonymity would not be preserved. Finally, one could not participate for family reasons.

We wanted to include healthy volunteers in the group for, like Barbour and Kitzinger, ¹³ we believe that sample similarities and differences are instructive. Indeed, healthy people being naive about the disease, they can point out items that are not perceivable to patients. Thus, two women were randomly selected from a database of healthy volunteers constituted for the purpose of a previous study performed in 1997. At that time, 150 women without cancer had responded to an announcement published in the press and broadcast on the radio. When contacted on the phone, both healthy volunteers readily agreed to participate in this study on information delivered to patients with breast cancer.

A total of seven women (five patients and two healthy volunteers) participated in the focus group, in accordance with the methodological guidelines set forth by Barbour and Kitzinger. ¹³

Patients' clinical and socio‐demographic data were collected from the computerized database at the CLB, whereas healthy volunteers' demographics were obtained from the database created in 1997.

Elaboration of documents

Clinicians of the working group (AB and TB) drew up general information documents concerning the various forms of treatments available for breast cancer patients (surgery, chemotherapy, radiotherapy and hormone therapy) and including presentation of treatment options. These documents, elaborated from clinical practice guidelines, ¹⁴ described the technique and side‐effects of each treatment. They were then read and commented by all members of the working group.

Elaboration of the focus group topic guide

The organizers of the focus group (NM and MM) elaborated a topic guide on the model of the guide developed by Coulter et al., ¹² with the aim of structuring focus group meetings as follows:

• • General introduction: (1) short introduction of organizers and participants, (2) explanation of the context for which documents were being elaborated, (3) objectives of the focus group, (4) explanation of the focus group ‘game rules’.
• • Collection of participants' opinions on the following themes: (1) initial reaction upon reading document, (2) content, (3) comprehension, and (4) presentation.

First contact with participants

One of the organizers (NM) contacted each member of the group by telephone to present the project outline. Following this, each participant was sent patient information booklets by post, along with a covering letter specifying that the objective of the focus group was to collect participants' comments and questions in order to improve the documents. Women were invited to read the documents attentively and annotate them, if desired. They were required to identify any information they considered not clear, too much developed, or missing. The letter also specified that the finalized documents would be given to patients at different stages of their disease and treatment, as they provide general information, including presentation of treatment options. Booklet concerning surgical procedures would be presented to the patient by the surgeon at the end of the first consultation, when the diagnosis of cancer is confirmed, while those concerning radiotherapy, chemotherapy and hormone therapy would be given during post‐surgery hospitalization, before starting treatments.

Schedule of meetings

• Three meetings were held with the participants and the two organizers (NM and MM). For logistic reasons, the first meeting took place at the CLB, although this choice might have been problematic, as a result of the potential deleterious psychological impact of the setting on participants. ¹³ Indeed, one patient verbalized her uneasiness at having to return to the cancer centre to take part in the focus group. Subsequently, the two following meetings were held outside the centre.

After obtaining the participants' consent, the three meetings were recorded on tape and detailed notes were taken.

The first two meetings (four hours each, including a half‐hour break) were carried out according to the topic guide.

During the first meeting, organizers and participants introduced themselves. Then, organizers emphasized the objective of the group, namely the interactive discussion of information documents for newly diagnosed breast cancer patients. The accent was placed on the fact that these documents would be elaborated according to the needs expressed by the participants, whether they had been treated for cancer or not. One of the organizers (NM) was in charge of leading the group discussions, and the other (MM) of taking notes and ensuring that the topic guide was respected.

Documents related to surgical procedures and radiotherapy were discussed at the first meeting; those related to chemotherapy and hormone therapy at the second.

The third meeting (two and a half hours) took place 6 weeks after the second meeting. Six participants were present; one patient was absent for professional reasons. The objective of the third meeting was to explore participants' reactions to the documents after modifications had been brought by the working group further to the previous two meetings. The surgical oncologist from the working group was present for the first hour of the meeting to explain why certain proposals of the group had been accepted and others not, for numerous clinical issues had been discussed during the first two meetings.

Analysis of the meetings

At the end of the first two meetings, two analysts (NM and MM) listened to and transcribed all of the tape recordings independently, then coded data separately according to theme, ¹⁵ in conformity with the topic guide. New themes brought up by the group were introduced when necessary. The coding process consisted of comprising, based on the written transcriptions, a list of comments made by each participant, and for each theme of the topic guide. The analysts initially created four lists, corresponding to: (1) participants' initial reactions upon reading the documents, (2) improvements suggested, (3) comprehension, and (4) reactions to presentation. Then a fifth list corresponding to new themes raised by the group was drawn. The analysts exchanged coding results, ensuring that participants' statements were anonymous, then compared and discussed them to reach a consensus. Information documents were then modified on the basis of the participants' reactions. Certain points discussed by the focus group were clinical issues; these were presented to the working group clinicians, who incorporated the desired modifications. At this stage, a first modified version of the documents was distributed to the members of the working group, who made additional corrections.

The corrected versions were mailed to participants with a letter inviting them to read the material attentively, and prepare questions and comments for the third meeting.

Following the third meeting, the two analysts listened again to the recordings independently, and took note of all modifications suggested by the participants. They then compared notes and came to an agreement on corrections that were finally integrated in the information documents. The remaining clinical questions were submitted to the working group clinicians, who decided upon the appropriate modifications. Final versions of the documents were then produced.

Results

Of the five patients, two were teachers (one university and one secondary school), two were office employees, and one was a retired elementary school teacher. Four had undergone lumpectomy, and one mastectomy. All patients had received radiotherapy, and three had received chemotherapy, including one case of adjuvant therapy. Only one patient had received hormone treatment.

As for the two healthy volunteers, one was a retired secondary school teacher and the other a retired office employee. The median age was 53 years.

Initial reactions after reading documents

Group members found information documents globally satisfactory at initial reading at home, although the general introduction and the chemotherapy document aroused various reactions on their part.

One healthy volunteer clearly manifested her strong disagreement with the use of the word cancer in the introduction:

[…] I felt like screaming when I read in the fourth line: ‘…to understand your treatment in case you have cancer.’ I don't want this word used in the booklet. It should speak of tumours, or whatever you like, but not cancer.

However, other participants had more moderate reactions; the use of this term did not shock the rest of the group, who felt that using another term would be hypocritical.

As the majority of the group was in favour of the original introduction, it was not modified.

Reactions concerning the chemotherapy document were mixed, depending on whether the participants had received chemotherapy or not. The women who only knew of chemotherapy through someone else's experience (e.g. a family member) felt they could not evaluate the document, and that words could not express the true experience of this treatment. Of the three patients who had undergone chemotherapy, two thought the document was valid, whereas the third patient felt it did not reflect the true reality of the treatment. Although the first two patients did not want the document to be too alarming, their words betrayed their feeling that the information provided did not really convey their experience of the treatment.

Missing information

Chemotherapy document According to the patients who had received chemotherapy, this document was incomplete; no reference was made to mouth ulcers, loss of taste and smell, stomach pains, digestive troubles or food allergies. Potential temporary aplasia was alluded to but not named, and its possible consequences, such as emergency hospitalization and antibiotic treatments, were not stated in enough details. In addition, the document did not indicate that implanted catheters require weekly dressing by a home‐nurse. According to them, this information would be reassuring and would enable patients to make necessary arrangements in advance.

One patient had not been aware that chemotherapy could lead to cardiac toxicity. Although she found this factor worrisome, she felt it was necessary to indicate this from the start. The working group's initial proposal had been to present this information in a complementary information leaflet given to patients who desired additional information. However, further to this comment, the working group decided to incorporate it in the main document.

Box 1 presents extracts from the original and the modified chemotherapy documents.

Table Box 1 .

Chemotherapy document – missing information

Extract from original document

[…] A catheter enables perfusions without having to make an injection in your veins at each cycle. It is kept in place  throughout the chemotherapy cycle and entails several constraints (weekly dressing, difficulty taking a bath). […]

You might feel like nausea or vomiting, though vomiting is rare, due to effective medical treatment now available.  You might feel somewhat tired after each course. Lastly, in rare cases, there may be a decrease in your white blood  cell count approximately 10 days after each administration. If you have a temperature, you will need to be hospitalised  for several days for antibiotic treatment.

Extract from modified document

–[…] A catheter also prevents leakage of the product outside the vein. It must be kept in place throughout the  chemotherapy cycle and entails several constraints (weekly sterile dressing by a home‐nurse, difficulty  taking a bath). […]

– Some patients vomit or feel nauseous for several hours following the perfusion, and up to 3–5 days following each  administration. However, the duration of troubles varies depending on the patient. Medication against vomiting will  be administered prior to each administration by way of intravenous perfusion, then orally during the next three days.  Feelings of nausea may persist.

– You may feel tired after each chemotherapy cycle.

– Certain patients complain of temporary memory troubles.

– In some cases, fingernails might turn black during the chemotherapy cycle and remain this way until completely  grown out. Special nail polish may be applied. Speak to your physician about this during one of the courses.

– Some patients may develop mouth ulcers during treatment, or experience loss of taste and smell.

– Other patients will complain of constipation or diarrhoea.

– Certain products can cause a slight loss of sensitivity in the fingers, or hearing troubles.

– Pre‐menopausal women may stop menstruating. This symptom increases as the patient approaches menopause.  Although sometimes temporary, this symptom is generally definite.

– Above and beyond certain doses, chemotherapy can be toxic for your heart. However, toxic doses have been perfectly  identified and will never be exceeded; it is extremely rare for chemotherapy to lead to heart complications or long‐term  congestive heart failure.

– Finally, in rare cases, there may be a decrease in the white blood cell count. When this count is at its  lowest (around 10 days after perfusion), there is a slight risk of infection with a temperature. Systematic blood tests  will be performed at this time. In case of a temperature, you must immediately return to the hospital for several days  for antibiotic treatment. A severe decrease in white blood cells (aplasia) is rare, and a temperature even more so.  Septicaemia (severe infection) is exceptional.

Radiotherapy document The document was judged incomplete by the patients who had undergone this treatment. It failed to mention burning sensations in the oesophagus, or fatigue, or to advise patients to wear clothes that would not be damaged by the fuxine dye during the first session.

Modifications made to this document are illustrated in Box 2.

Table Box 2.

Radiotherapy document – missing information

Extract from original document

Generally speaking, radiation is well tolerated. The only side‐effect you may experience is the equivalent of a ‘sunburn’ on the treated breast. This does not appear immediately and will heal within several days. Your physician can prescribe special ointments to alleviate burning sensations.

It is very important to keep the radiated region out of the sun for 1 year.

Extract from the modified document

[Idem above, plus …] Continue wearing cotton clothing as long as burning sensations persist. You may also experience discomfort swallowing (impression of sore throat) during the second week of treatment. Indicate this to your radiation therapist, who can prescribe soothing medication.

You may also feel tired at the end of the cycle.

Hormone therapy document The focus group felt that the two other positive effects of the hormone treatment (Tamoxifen) should be mentioned (decreased risk of myocardial infarction and osteoporosis). The working group's initial proposal had been to present this information in a complementary information leaflet for patients who desired additional information (Box 3).

Table Box 3  .

Hormone therapy document – missing information

Extract from original document

Side‐effects

These are very rare:

– Hot flashes are sometimes more intense.

– In very rare cases, you may experience phlebitis in your legs. Any pain in your calves should be mentioned to   your physician.

– Treatment increases the risk of uterine cancer to a very slight degree. Indicate any bleeding to your treating physician,   who will prescribe ultrasound examination.

Extract from modified document

Side‐effects

[Idem above, plus …]

– Certain women complain of headaches or dizziness.

Positive effects

In addition to the principal positive effect of Tamoxifen (decrease in the risk of relapse), this medication presents other advantages:

– Decreased risk of myocardial infarction.

– Decreased risk of osteoporosis.

Document on surgical procedures

A long discussion took place about the advantages and drawbacks of mastectomy and breast conservation (Box 4). One patient felt it was necessary to mention time intervals for relapse with the treatment options, since she believed this information to be relevant. However, another patient said that it was difficult to think ahead in such moments and that mentioning time intervals was superfluous. The first patient then regretted that the probability risks of metastasis with each of the two options had not been specified. The rest of the group questioned the necessity of this information. In the course of the discussion, participants hinted at the question of the evidence‐based status of treatment information. Two project organizers (NM and MM) further emphasized that information concerning mastectomy and breast conservation (cure, and relapse rate at 10 years) had been derived from clinical practice guidelines. ¹⁴

Table Box 4.

Surgical procedure document – level of detail

Table from original document
MASTECTOMY	BREAST CONSERVATION
Risk of relapse: 6–10% (1)	Risk of relapse: 5–15% (1)
Identical risk of metastasis with both methods
Advantages	Drawbacks	Advantages	Drawbacks
Radiation not necessary if there  are no relapse risk factors (2)	Mutilation	Better aesthetic aspect	Radiation necessary
(1) According to previous studies.
(2) These include size of the tumour (over 2 cm), grade 3 tumours, affected lymph nodes, absence of hormone receptors  in tumour, patients under 35 years.
Table from modified document
	MASTECTOMY	BREAST CONSERVATION
Local relapse at 10 years	6–10% (1)	5–15% (1)
Recovery rate	Identical with both methods
Advantages	Radiation not necessary if there  are no relapse risk factors (2)	Better aesthetic aspect
Drawbacks	Mutilation	Radiation still necessary
(1) Previous studies do not indicate identical figures.
(2) To be specified after complete analyses.

The clinicians in the working group judged that these two pieces of information were relevant to the debate on the advantages and drawbacks of the two surgical options (Box 4) and finally decided to (1) specify a timeframe for relapse rates, and (2) indicate that recovery rates were identical, regardless of the surgical procedure.

Terminology

Surgical procedure document The sentinel lymph node technique caught the group's attention. Numerous questions were asked, for this is a new technique that the patients did not know about. Most of them expressed a desire to find out more, but were disappointed by the poor explanations provided in the document. The document was modified in accordance (Box 5).

Table Box 5  .

Surgical procedure document – terminology

Extract from original document

This technique is only used for cancerous tumours less than 2 cm in size. It consists of injecting a weak radioactive liquid before the operation, followed by a blue liquid dye during the operation to mark and locate from one to five coloured lymph nodes. If one of the sentinel nodes seems large or hard, it is examined at the hospital laboratory during the operation. If it contains cancer cells, complete curettage is immediately carried out. If no cancer cells are discovered during examination of the sentinel lymph node, axillary curettage is not performed. If at least one of the lymph nodes contains cancer cells, complete curettage is carried out during a second operation, after results have been received.

Extract from modified document

Sentinel lymph node is the name of the lymph node(s) (one to five maximum), which is first affected when the lymph nodes contain cancer cells. It is also the first that captures products injected beneath the skin of the breast. A sentinel node is not necessarily cancerous.

This technique is only used for cancerous tumours less than 2 cm in size. It consists of injecting a weak radioactive liquid before the operation, followed by a blue liquid dye during the operation to mark and locate from one to five coloured lymph nodes. If one of the sentinel nodes seems large or hard, it is examined at the hospital laboratory during the operation. If it contains cancer cells, complete curettage (1) is immediately carried out. However, in most cases, this examination is not performed immediately. If no cancer cells are discovered at later examination of the sentinel lymph nodes, axillary curettage is not necessary. If any of the lymph nodes contains cancer cells, complete curettage is carried out during a second operation, after results have been received.

(1) Term defined in the surgical procedure document.

Radiotherapy document To speak of ‘radiation doctors’ rather than radiation‐therapists was considered childish by the entire group, although the clinicians' initial aim had been to avoid any confusion between X‐ray technicians and radiation‐therapists. Thus, the term radiation‐therapist was used, specifying in parentheses that this referred to the doctor who administered the radiation treatments.

Readability

One healthy volunteer found the page related to lymph nodes in the surgical procedure document confusing. One patient agreed with this viewpoint and tried to reformulate certain points. In the end, the focus group suggested improving the readability of the table presenting axillary lymph node curettage and the sentinel lymph node technique (Box 6).

Table Box 6  .

Surgical procedure document – readability

Extract from original document
Lymph node interventions
Axillary lymph node curettage consists of removing lymph nodes located in the armpit by means of a horizontal incision. All lymph nodes are not removed (average 12), those closest to the arm are left untouched.
Sentinel lymph node technique (cf. Box 5).
Sentinel lymph node technique (for tumours under 2 cm) or complete curettage
COMPLETE CURETTAGE		SENTINEL LYMPH NODE TECHNIQUE
In 99% of cases, no positive lymph nodes if over 10 are normal		In 95% of cases, no positive lymph nodes if sentinel node is normal
Advantages	Drawbacks	Advantages	Drawbacks
One operation	Pain, loss of sensitivity in arm, oedema in 25% of cases (swollen arm in 6%). Curettage is not of use in over 60% of cases	No pain or swollen arm	Two operations in 40% of cases
Extract from modified document
Lymph node interventions
Thirty to 50 lymph nodes are located in the armpit. This number varies from one patient to another. Some of these lymph nodes are located in the breast and the arm. The removal of lymph nodes is necessary to find out whether one or more of them contain cancer cells. Two methods may be used to examine lymph nodes: axillary lymph node curettage or the sentinel lymph node technique.
Axillary lymph node curettage consists of removing lymph nodes located in the armpit, with the exception of those situated closest to the arm, by means of a horizontal incision. In this procedure, all lymph nodes are not removed (average 12).
Sentinel lymph node technique (cf. Box 5).
	AXILLARY LYMPH NODE CURETTAGE	SENTINEL LYMPH NODE TECHNIQUE
Technique	If more than 10 lymph nodes examined are normal, there is a 99% chance that no lymph nodes are cancer positive	If the sentinel node is normal, there is a 95% chance that no lymph nodes are cancer positive
Advantages	One operation	No pain or ‘swollen arm’
Drawbacks	Pain, loss of sensitivity in arm, oedema in 25% of cases (swollen arm in 6% of cases).	Two operations in 40% of cases
	Curettage is not of use in over 60% of cases.

Document style

The group was not troubled by the personalized style of the documents, which only emphasized the fact that they were targeted at patients. Nonetheless, one patient found the general introduction slightly too abrupt and suggested using less direct phrasing. Consequently, the introduction was modified (Box 7).

Table Box 7  .

General introduction – style

Extract from original document

You have a breast anomaly for which a surgical  procedure is necessary.

Extract from modified document

This document is a reminder that will complete the  information provided by your surgeon at your first  consultation. A breast anomaly had been detected in  your analyses, and a surgical procedure will be  necessary.

Layout

One healthy volunteer and two patients considered that it was important to highlight the different points presented in the documents. Thus, the articulation of the general outline was made apparent in the surgical procedure document.

The group also wished to organize the information into three main sections: patient management, post‐surgery treatment, and general treatment. The presentation of tables concerning mastectomy vs. breast conservation and axillary lymph node curettage vs. sentinel lymph node technique was also modified. For the new version, please refer to Boxes 4 and 6.

Headings

One patient was uncomfortable with the pessimistic implication of the subheading ‘Complications related to surgical intervention’ in the surgical procedure document. She preferred ‘Possible complications related to surgical intervention’ to emphasize the fact that such complications are potential and not certain. Likewise, the subheading ‘Practicalities’ was replaced by ‘Patient management’, judged by the group as more relevant to the content of the paragraph.

Fonts

The group suggested using different fonts to discriminate between headings and subheadings. However, the font used for the main text (Trebuchet 11) was judged very readable.

Colour and paper quality

Various types of paper were presented to group members. Pastel colours were preferred on the ground that they have no particular connotation and are easy to read. The use of smooth, pliable paper and a practical format, such as small‐sized brochure, was suggested.

Illustrations

The group proposed that the illustration of a breast appear in the surgical procedure document to help women identify the terms used. We therefore integrated an illustration of a breast, designating the areola and the nipple.

In addition, we included photographs of women after mastectomy, after lumpectomy and after reconstruction. The photographs were taken by the surgeon of the working group, with the consent of patients concerned.

Related topics introduced by the focus group

The two analysts in charge of the coding process recorded four topics that had been spontaneously raised by the group, although they were not part of the topic guide: (1) the advantage of written documents, (2) communication problems between physicians and patients, (3) deciding who should distribute the document and (4) when.

Advantage of written documents

The group highlighted that written documents are easy to consult at any time, and help the patient assimilate any information that might have been misunderstood during the consultation with the physician.

By whom and when should the document be handed out?

All of the participants agreed that any member of the hospital team, not necessarily the surgeon, could distribute the documents related to radiotherapy, chemotherapy and hormone therapy. The patients affirmed that they had encountered no difficulty in identifying the various members of the medical staff and trusted them. Receiving these documents from another member of the staff might show the patient that the entire team is concerned with her welfare.

The question of knowing when to hand out the documents related to post‐surgery treatments aroused diverging opinions. Certain participants wondered whether it was necessary to inform patients of the treatments they might need while they were still waiting for results. Others affirmed that they would want to know the possibilities, regardless of the results, in order to be informed and anticipate. Finally, others wondered whether the quantity of information transmitted should have any relation to the patients cognitive capacities that may be altered by the traumatizing situation that she experiences.

Lessons learned from this work

First, our work confirms the methodological guidelines provided by Coulter et al. ¹² for the development of high‐quality information materials. These authors underlined that patient participation in the elaboration of information destined for them was necessary. Information elaborated solely by clinicians (in our case, a surgical oncologist and a medical oncologist), even if they are sensitive to communication problems between physicians and patients, cannot satisfactorily meet patients' expectations. In our study, group participants proposed numerous and significant modifications corresponding to requests for complementary information, clarification and better readability. Results concerning missing information in the chemotherapy and radiotherapy documents speak for themselves. Participants also called up subjects that had not been foreseen in the focus group topic guide, concerning the person who should remit the documents, for instance.

Secondly, when setting up a focus group, it is important to include healthy volunteers. As they have no personal experience of the disease, they can shed new light on questions that may not be perceivable to patients.

Thirdly, we noticed a considerable gap between the initial reactions of the participants (the documents are satisfactory) and the scope of the modifications they later suggested. This suggests that a simple questionnaire, even if addressed to members of the target population, is largely insufficient. Establishing focus groups, although possibly difficult to organize, is a truly effective method.

Methodology: advantages and drawbacks

• Qualitative methods often lead to the use of small non‐representative samples. However, statistical representativeness is not the objective of most studies involving focus groups. ¹³ For this study, we used ‘qualitative sampling’ ¹⁶ to make up a structured sample rather than a random one. As such, our sample included women who had suffered from various stages of breast cancer, and whose treatments and experiences varied, along with healthy volunteers. Nonetheless, it is important to note, first, that only one patient had hormone treatment, which can be considered limited feedback; second, that a certain socio‐professional homogeneity of the group was observed (two patients were teachers, and one patient and one healthy volunteer were retired teachers), which might have led to an overall high level of understanding.

Our study is retrospective and partially based on the narration of individual experiences. This method presents certain advantages, such as the hindsight of former patients regarding the disease, but also biases, such as forgotten events and the reformulation of experiences.

To counterbalance the limited feedback inherent to small groups such as the focus group described here, it would be interesting to enrich breast cancer patients' input via a review of the literature. Published surveys of patients' information needs, such as the one that was performed by Davey et al. ¹⁷ for elaborating cervical cancer screening information leaflets, would be of valuable interest in this setting.

Conclusion

Having access to quality information is a need that is strongly expressed by patients in North America and Europe. ¹⁸ In France, regulatory and legal texts, as well as initiatives in the field are multiplying to improve information materials for patients, and make them actors in their own health. Nonetheless, such information must be elaborated according to rigorous methodological guidelines, which include, first and foremost, patient participation.

It remains to be tested whether the documents produced here meet the needs and expectations of patients during the active phase of their disease. This will be the next stage of our work, that will be carried out among a sample of patients undergoing cancer treatment.

Acknowledgements

Nora Moumjid gratefully acknowledges financial support from the Association pour la Recherche sur le Cancer (post‐doc grant).

The authors would like to thank the patients and the healthy volunteers for their useful contribution to this work.

They would also like to thank Dr Anne Bataillard for valuable comments on an earlier draft of the paper.