Usefulness of the Leaflet-Based Intervention for Family Members of Terminally Ill Cancer Patients with Delirium

Abstract

Background and Objective:

Delirium in terminally ill cancer patients causes considerable distress to family members. The aim was to determine the family-perceived usefulness of a leaflet about delirium in terminally ill cancer patients.

Methods:

Family members received a leaflet about delirium designed for this study as a part of routine practice. Questionnaires were mailed to bereaved family members of cancer patients recruited from three palliative care units, one hospital palliative care team, and three specialized home care teams in Japan.

Results:

Among 235 family members, 16 questionnaires were returned as undeliverable, and responses were obtained from 169 bereaved family members (response rate 77%, 169/219). Of these, 22 were excluded because of missing data and 34 families reported they did not recognize that the patient had delirium, and thus 113 responses were finally analyzed. As a whole, 81% of the family members reported that the leaflet was “very useful” or “useful.” Many respondents noted that the leaflet “helped them understand the dying process” (84%), “helped them identify what they could do for the patient” (80%), “helped them understand the patient's physical condition” (76%), and “was useful in preparing for the patient's death” (72%).

Conclusions:

The leaflet about delirium was evaluated as useful for family members. This leaflet could help family members cope with a difficult situation by facilitating accurate understanding of the situation and by helping family members understand what they could do for the patient. More comprehensive intervention programs should be developed and tested in the future.

Introduction

Delirium occurs in 68% to 90% of terminally ill cancer patients just before death.^1,2 Delirium-related symptoms cause considerable distress to family members: They experience high levels of distress from both the agitation and cognitive symptoms of terminal delirium.^3–6

To our knowledge, despite the many interventions that have been proposed for family caregivers of cancer patients,^7,8 few studies have explored the effectiveness of each intervention specifically for delirium in terminally ill cancer patients.⁹ In previous studies,^10,11 we gathered potentially useful care strategies for relieving family distress of terminally ill cancer patients with delirium, including providing information about the pathology of delirium, explaining the expected course based on daily changes in the patient's condition, and relieving the family's care burden. Based on the results of these studies, we created a leaflet specifically designed to help families of terminally ill cancer patients with delirium (https://dl.dropbox.com/u/50169679/Figure.pdf).

The aim of this preliminary study was to determine the level of family-perceived usefulness of the leaflet about delirium in a terminally ill cancer patient.

Methods

A cross-sectional survey was used to determine the level of family-perceived usefulness of the leaflet. Participating institutional groups across Japan included three palliative care units, one palliative care team, and three specialized home care teams. The ethical and scientific validity of the study were confirmed by the institutional review boards of each of the participating institution.

Intervention

In the study periods, from 2009 to 2010, in addition to the usual practice of verbal discussion with the family, clinicians in the participating institutions used the leaflets about delirium as a part of routine practice, especially about the nature, causes, and implications of delirium in terminally ill cancer patients. The leaflet was constructed by a multidisciplinary team including palliative care physicians and nurses, and psychiatrists, and it was based on the results of previous studies.^10,11 Before the multicenter implementation, one half-day interactive workshop using an educational video was held for medical health care professionals from participating institutions.

Procedure

Questionnaires were mailed along with the leaflet to bereaved families, at least 6 months after the patient had died, and again after one month to families that had not responded to the first mailing. If the families did not want to participate in the survey, they were asked to return the questionnaire with “no participation” indicated, and the second questionnaire was not mailed to them. Completion and return of the questionnaire were regarded as consent to participate in the present study. We chose this interval from patient death to questionnaire completion so that family members would be past the immediate stages of grief, yet the death would not be too distant, thereby minimizing the risk of introducing a recall bias. Similar time periods were used in previous studies.^12–14

Primary treating physicians were asked to consecutively enroll families that met the following inclusion criteria: (1) bereaved adult family member of adult patients who died at the participating institutions from September 2009 to December 2010 and who had experienced delirium according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria¹⁵ during the last2 weeks before death (one family member per patient); (2) capable of replying to a self-reported questionnaire; (3) informed of cancer; and (4) no serious psychological distress determined by the primary treating physician. Family members of patients with preexisting symptomatic organic brain pathology (i.e., brain metastasis, cerebral infarction) or psychiatric disorders (i.e., psychosis, dementia) were excluded, because the psychiatric symptoms of the comorbidity may have influenced the results.

Measurements

A questionnaire was developed based on a review of the literature,^7–9,16,17 the results of our previous studies,^10,11 and discussions among the authors. Face validity was assessed by complete agreement of the authors and a pilot test involving five bereaved family members.

The primary endpoint of this study was the family-perceived usefulness of the leaflet. The level of family-perceived usefulness was evaluated by the question, “As a whole, how useful did you feel the leaflet was when you were informed by the physician about delirium?” Answers to this question were rated on a 4-point Likert-type scale ranging from 1 (not at all useful) to 4 (very useful). “Delirium” was paraphrased in the questionnaire as “the rapid development of difficulty concentrating, forgetfulness, disorientation in time and place, hallucinations and delusions, incoherent speech, clouding of consciousness and difficulties communicating, emotional instability, reversal of daytime and nighttime activities (drowsy during the day and wakeful at night), and inconsistent behavior, with these conditions changing even within one day,” similar to the definition used in our previous study.¹⁰ We carefully developed this section based on the DSM-IV criteria through complete agreement with liaising psychiatrists and palliative care specialists.¹⁰

In the survey, families were asked to report on 13 items based on their experiences after receiving the leaflet (Table 1). Family members were asked to rate their level of agreement with each of the 13 statements using a 5-point Likert-type scale with scores raging from 1 (disagree) to 5 (strongly agree).

Table 1.

Family Experiences about Using the Leaflet (n=113)

	Agree or strongly agree N (%)	95% confidence interval (%)
The leaflet:
Helped me understand the dying process	96 (84)	77–90
Helped me identify what I could do for the patient	91 (80)	72–87
Helped me understand the symptoms and why changes occur	89 (78)	70–85
Helped me understand the patient's physical condition	86 (76)	67–83
Was useful in preparing for the patient's death	82 (72)	64–80
Was useful in indicating when I should consult the doctor or nurse	79 (69)	61–78
Was useful in explaining the patient's condition to other family members	77 (68)	59–76
Was useful in indicating what I needed to do when the patient became more agitated	76 (67)	58–75
Explained what I wanted to know but found difficult to ask the nurse and/or doctor directly	69 (61)	52–70
Was useful in asking the doctor or nurse detailed questions while reading through it	66 (58)	49–67
Was useful in relieving my anxieties and worries	66 (58)	49–67
Was useful in making me feel that I had done all I could as a family member	66 (58)	49–67
Empathized with how I felt, such as acknowledging my fatigue and worries	63 (55)	46–65

We also collected background data. In addition, to confirm that the family had recognized delirium in the patient, we asked respondents whether they thought that the patient had delirium. We then excluded the responders of families who reported that they did not recognize the patient had delirium.

Statistical analysis

We described data distribution and calculated the 95% confidence intervals (CIs).

Results

Questionnaires were mailed to 235 bereaved family members, and 16 were returned as undeliverable. Responses were obtained from 169 bereaved family members (response rate 77%, 169/219). Of these, 22 were excluded because of missing data and 34 families reported they did not recognize the patient had delirium. Thus, all further analyses were performed on 113 responses. Table 2 summarizes the background of the patients and bereaved family members.

Table 2.

Background Characteristics of the Families

	N	%
Patients
Mean age (SD, years)	74 (10)
Sex (male)	69	61
Bereaved families
Mean age (SD, years)	57 (12)
Sex (male)	31	27
Relationship to patient
Spouse	47	42
Child	41	36
Parent	6	5.4
Sibling	2	1.8
Other	15	7.2
Mean interval from patient's death until survey (SD, median, months)	9.6 (3.5, 9.0)

Percentages do not add up to 100% because of missing data.

Total responses analyzed=113.

SD, standard deviation.

The family-reported usefulness of the leaflet about delirium was as follows: very useful, 33% (95% CI: 25–42; n=37); useful, 50% (40–59; n=56); slightly useful, 15% (10–23; n=17); and not useful, 2.7% (1–8; n=3). Date on family-reported experiences of usefulness of the leaflet about delirium can be seen in Table 1. With respect to the leaflet, more than 70% of respondents reported that they strongly agreed or agreed with: “helped me understand the dying process”; “helped me identify what I could do for the patient”; “helped me understand the symptoms and why changes occur”; “helped me understand the patient's physical condition”; and “was useful in preparing for the patient's death.”

Discussion

To our knowledge, the present study is the first multicenter survey to investigate the family-perceived usefulness of a leaflet specifically designed to help family members of terminally ill cancer patients with delirium.

The important finding of this study is the family-reported high levels of usefulness of the leaflet. Of the bereaved families surveyed, 81% reported that they felt that the leaflet was “very useful” or “useful.” The domains in which the leaflet intervention was perceived as being particularly useful were: “helped them understand the dying process”; “helped them identify what they could do for the patient”; “helped them understand the symptoms and why changes occur”; “helped them understand the patient's physical condition”; and “was useful in preparing for the patient's death.” Thus, the leaflet could help the family members cope with this difficult situation by: (1) providing them with accurate information about delirium, especially the nature of the dying process and delirium, and why these changes occur; and (2) coaching them in terms of what they could do for the patient. These findings are consistent with previous studies that highlighted the necessity of family support by providing the family with information about the pathology of delirium and coaching families as to what the families could and should do for patients.^10,11

The present study is preliminary and has major limitations. First, due to the moderate response rate, the responses obtained may not be representative of the entire population. Second, retrospective reporting by bereaved families could have caused recall bias. Third, some families reported that they did not recognize the patient had delirium, despite the primary treating physicians having confirmed the diagnosis. Thus, some family members might have not been able to understand and/or recognize delirium even though they were provided with both a leaflet and verbal explanation from the physicians. Fourth, the assessment instrument underwent no formal validation or reliability testing. Finally, because all patients received specialized palliative care, adherence to recommended care practice was generally high, and this may be responsible for the low sensitivity for intervention effects. Thus, the findings of the present study may not necessarily be applicable to other situations.

In conclusion, many family members of terminally ill cancer patients reported that the leaflet about delirium was very useful. This leaflet may help family members to cope with a difficult situation by facilitating accurate understanding of the situation and by helping these family members understand what they can do for the patient. More comprehensive interventions should be developed and tested in the future.

Footnotes

Acknowledgments

This study was supported by grants from the Ministry of Health, Labor, and Welfare of Japan. We would like to show our appreciation to Namba Miki, RN, Kaori Fukuda, RN, Meiko Kuriya, MD, Naoki Matsuo, MD, Takuya Shinjo, MD, Hiroshi Maeno, MD, Yoshikazu Chinone, MD, and Masayuki Ikenaga, MD, for carrying out this study.

Contributors: HO: conception and design, provision of the study material, collection of data, data analysis and interpretation, manuscript writing, and administrative support; TM: conception and design, provision of the study material, data analysis and interpretation, final approval of the manuscript, administrative support, and financial support; SU, RY, HH, TM, CT, and K.S: provision of the study material and final approval of the manuscript.

Author Disclosure Statement

There are no conflicts of interest.

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