Educación Al Paciente Para Reducir La Fatiga en El Cancer

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A patient education program is effective in reducing cancer-related fatigue: Amulti-centre randomised two-group waiting-list controlled intervention trial

Karl Reifa, Ulrike de Vries b,*, Franz Petermann b, Stefan Grres a

a Institute for Public Health and Nursing Research, University of Bremen, Germanyb Centre for Clinical Psychology and Rehabilitation, University of Bremen, Germany

Keywords:

Cancer-related fatigue

Patient education

Nonpharmacologic interventions

a b s t r a c t

Objective: To evaluate a patient education program that aims at reducing perceived fatigue in cancer

survivors.

Methods: In ten German centres, 261 patients with cancer-related fatigue were randomly assigned to

a patient education program consisting of 6 sessions 90 min or standard care. The primary outcome

measure was cancer-related fatigue. Data were analysed using analysis of variance (ANOVA) with

repeated measures.

Results: Patients in the intervention group showed statistically signicant reduction in cancer-related

fatigue (F 76.510, p < 0.001, h2 0.248). Secondary outcomes also showed signicant improve-

ments in all measures, including quality of life (F 29.607, p < 0.001, h2 0.113), general self-efcacy

(F 27.680, p < 0.001, h2 0.107), exercise self-efcacy (F 49.230, p < 0.001, h2 0.175), physical

activity (F 8.036, p < 0.001, h2 0.033), anxiety (F 33.194, p < 0.001, h2 0.125), depression

(F 24.604, p < 0.001, h2 0.096), and fatigue knowledge (F55.157, p


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psychoeducational interventions in cancer survivors has not been

established. Therefore, a patient education program was developed

by multidisciplinary collaboration using formative evaluation

methods. The program is named FIBS, Fatigue individuell bewl-

tigen e ein Selbstmanagementprogramm fr Krebspatienten(Coping with fatigue individually e a self-management program for

cancer patients). In this study, the aim was to determine whether

FIBS could improve the patientsCRF management.

Methods

A multi-centre randomised two-group waiting-list controlled

intervention trial was carried out. Our main hypothesis was:

Participation in the patient education program signicantly

changes the level of CRF in disease-free cancer survivors with

a follow-up period of 6 months. The study was approved by the

Ethics Committee of the University of Bremen.

Table 2

Topics and methods of the train-the-trainer seminar.

Session Topics Methods Materials Duration

1 Information about

cancer-related fatigue.

Principles of

communication, adult

education and lifelong

learning.

Lectures and discussions,

training in communication

skills and strategies.

Notebook, projector, ip

chart, materials

for metaplan method,

FIBS materials.

1 day

2 Principles of communication

and adult education. Group

leadership, group pedagogy

and group therapy.

Training in

communication

skills and strategies,

individual and group

exercises, role plays.

FIBS materials. 1 day

IG intervention group.

CG wait-list control group.

SD standard deviation.

Assessed for eligibility (n=327)

Excluded (n=66)

Not meeting inclusion criteria (n=37)

Declined to participate (n=24)

Other reasons (n=5)

Analysed (n=120)

Excluded from analysis (n=9)

Lost to follow-up (n=0)

Discontinued intervention (n=0)

Allocated to intervention (n=129)

Received allocated intervention (n=120)

Did not receive allocated intervention (n=9)

Declined to participate (n=3)Died (n=1)Other reasons (n=5)

Lost to follow-up (n=0)

Discontinued intervention (n=0)

Allocated to intervention (n=132)

Received allocated intervention (n=114)

Did not receive allocated intervention (n=18)

Declined to participate (n=3)Rehabilitation (n=1)Other reasons (n=14)

Analysed (n=114)

Excluded from analysis (n=18)

Allocation

Analysis

Follow-Up

Randomized (n=261)

Enrollment

Fig. 1. Flow diagram of the FIBS study.

K. Reif et al. / European Journal of Oncology Nursing 17 (2013) 204e213206


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Participants

Patients were eligible if they were 18 years or older and diag-

nosed with malignant tumours. They had to be in a stable condition

(ECOG Performance Status 0e

2) (Oken et al., 1982) at any timepoint following active treatment and remission of acute toxic side

effects. The patients CRF level had to be rated as moderate (4e6) or

severe (7e10) on a scale from 0 to 10 (National Comprehensive

Cancer Network, 2011). Patients were excluded if their life expec-

tancy was less than 12 months, if they had brain tumours or brain

metastases, cognitive disorders or psychiatric conditions. Patients

with depression were not excluded. Crucial inclusion factors were

a sufcient level of functioning and motivation to be able to

participate in a multi-part seminar.

Patients were recruited by their physicians who checked the

inclusion and exclusion criteria from July 2008 to March 2010 in 10

German centres covering urban and rural areas. All participants

received personal and written information about the study and

gave written informed consent.

Procedures

Computer-generated randomisation lists were used for con-

cealed allocation by central telephone calls. Data collection was

scheduled at baseline (t0), post-treatment (t1) and at a follow-up of6 months (t2).Baseline measures (t0) were obtained prior to ran-

domisation.Although the data entry and analysiswas performedby

blinded researchers, patients and tutors could not be blinded to

treatment allocation for practical reasons.

Intervention

The intervention was a structured patient education program

consisting of six weekly sessions 90 min designed for groups of 8

cancer survivors. The topics and methods of each session are pre-

sented in Table 1. FIBS aims at impacting on health-related self-

efcacy as it is known that knowledge by itself hasn t proved to

achieve behaviour modications. This was realized by imple-

menting a training of problem solving, including goal setting and

Table 3

Demographic and clinical characteristics of patients in intervention group (IG) and wait-list control group (CG). All data in n(%)unless otherwise stated. There were no

signicant differences between groups on any of the demographic/clinical variables at baseline.

IGn 120 CGn 114

Sex Female 97 (80.8%) 90 (78.9%)

Age Mean (SD) 57.78 (10.32) 57.52 (11.90)

Marital status Unmarried 10 (8.3%) 11 (9.6%)

Married 86 (71.7%) 71 (62.3%)

Divorced/separated 14 (11.7%) 23 (20.2%)Widowed 10 (8.3%) 9 (7.9%)

Education (school leaving certicate) Secondary school 71 (59.2%) 61 (53.5%)

Polytechnic secondary school 9 (7.5%) 10 (8.8%)

Advanced technical college certicate 14 (11.7%) 14 (12.3%)

A-level-exam 24 (20.0%) 29 (25.4%)

Vocational training/professional education None 6 (5.0%) 6 (5.3%)

Apprenticeship 68 (56.7%) 57 (50.0%)

Trade and technical schools 16 (13.3%) 10 (8.8%)

University of applied science 7 (5.8%) 10 (8.8%)

University 21 (17.5%) 22 (19.3%)

Other 2 (1.7%) 9 (7.9%)

Current occupation Working 49 (40.8%) 48 (42.1%)

Parental leave 1 (0.8%) 0 (0%)

Housewife/househusband 9 (7.5%) 8 (7.0%)

On apprenticeship 1 (0.8%) 0 (0%)

Unemployed 1 (0.8%) 4 (3.5%)

Invalidity pension 16 (13.3%) 17 (14.9%)

Retired 40 (33.3%) 36 (31.5%)

Other 3 (2.5%) 0 (0%)

Certied unt for work because of fatigue Yes 30 (25.0%) 25 (21.9%)

Duration: mean weeks (SD) 21.57 (22.96) 29.2 (24.9)

Rehabilitation Yes 92 (76.7%) 87 (76.3%)

Most prevalent initial diagnoses Breast cancer

76 (63.3%)

Breast cancer

61 (53.5%)

Colon cancer

8 (6.7%)

Leukaemia

6 (5.3%)

Prostate cancer

5 (4.2%)

Lymphoma

6 (5.3%)

Comorbidities Yes 72 (60.0%) 78 (68.4%)

Most prevalent comorbidities Depression 34 (28.3%) 33 (28.9%)

Hypertension 12 (10.0%) 30 (26.3%)

Diabetes 8 (6.7%) 4 (3.5%)

Duration of fatigue 6 months 112 (93.3%) 107 (93.9%)

Fatigue interventions None 37 (30.8%) 28 (24.6%)Information brochures 29 (24.2%) 23 (20.2%)

Internet 19 (15.8%) 18 (15.8%)

Self-help group 11 (9.2%) 7 (6.1%)

Psychotherapy 9 (7.5%) 7 (6.1%)

Sports 13 (10.8%) 23 (20.2%)

Other 2 (1.7%) 4 (3.5%)

IG intervention group.

CG wait-list control group.

SD standard deviation.

K. Reif et al. / European Journal of Oncology Nursing 17 (2013) 204e213 207


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evaluation, and other cognitive techniques into the program. We

utilized behaviour therapy-oriented strategies and techniques and

designed the program to be effective in the cognitive, emotional,and behavioural aspect. The structure of the sessions was sched-

uled so that short periods of lecture activity by the trainer and

longer periods of controlled participant activity alternated. In that

way all patients could express their thoughts and feelings on any

topic and the individual needs of patients could be taken into

account. Also, the subject matter could be easier kept in mind as it

was worked out by the patients themselves.

Between sessions, the patients were encouraged to keep

a diary, perform exercises and implement lifestyle changes. Two

additional meetings after 3 and 6 months were offered to patients

to share their experiences in daily life. The program was admin-

istered by nurses and psychologists but can also be carried out by

other health care professionals. The manual is published in

German (de Vries et al., 2011). Patients in the intervention group

(IG) were highly satised with the program (Reif et al., 2010). The

trainers were mostly nurses, but also psychologists worked as

trainers. All trainers attended a specialized train-the-trainer

workshop held by the authors to ensure that the program is

conducted in each centre in thesame way. Thetopics andmethods

of this seminar are shown inTable 2.

Patients in the control group (CG) were put on a waiting-list.

They participated in the program after the IG had completed

their follow-up.All patients received standard information on fatigue as

a lecture. For all patients medical care, e.g. routine follow-up,

continued as usual and no additional intervention was provided.

Outcome measures

CRF was measured by the Fatigue Assessment Questionnaire

(FAQ). The scale consists of 20 items: 11 items represent physical, 5

items affective and 3 cognitive fatigue; one item is about insomnia.

In addition, there are three visual analogue scales about fatigue

intensity and burden. Cronbachs alpha of the total scale was 0.90,

physical subscale 0.95, affective subscale 0.83 and cognitive

subscale 0.86 (Glaus and Mller, 2001).

Quality of life was measured with the EORTC QLQ-C30 ques-

tionnaire. It is a 30-item questionnaire that reects the multidi-

mensionality of the construct. It includes 5 functional scales, 3

symptom scales and a global health status scale. 6 single item side

effects scales are added. The questionnaire showed satisfactory

psychometric properties and was found to be useful for detecting

changes over time (Aaronson et al., 1993). The reliability

Table 4

Changes in Fatigue Assessment Questionnaire (FAQ) (primary outcome).

Group Pre-intervention Post-intervention Follow-up at 6 months Group time Partial eta -squ ared

Mean (SD) Mean (SD) Mean (SD) F p Group time

Total scale (range: 0e60) IG 42.42 (9.17) 27.88 (13.99) 22.85 (15.73) 76.510


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coefcients for the multi-item scales in a German population

ranged from 0.65 to 0.89 (Schwarz and Hinz, 2001). For this study,

the questionnaire was adapted to the survivors conditions and thus

reduced to 21 items, omitting acute disease specic items like

dyspnoea and nausea/vomiting.

General self-efcacy was assessed by using the General Self-

Efcacy Scale (Schwarzer and Jerusalem, 1995). It is a 10-item

questionnaire designed to assess optimistic self-belief that one

can perform on novel or difcult tasks or cope with adversity in

various domains of functioning. The scale has proved reliable and

valid. Cronbachs alpha ranged from 0.76 to 0.90. Criterion-related

validity is documented in numerous correlation studies (Scholz

et al., 2002).

Exercise self-efcacy was measured with the Physical Exercise

Self-Efcacy Scale. This 20-item instrument was developed to

assess efcacy beliefs in initiating and maintaining a regular

program of physical exercise even under unfavourable circum-

stances. Cronbachs alpha was 0.89 (Fuchs and Schwarzer, 1994).

The instrument was positively correlated with generalized self-

efcacy. Further evidence of validity is provided by the correla-

tion between the scale and the intention towards physical exercise

(Fuchs and Schwarzer, 1994).

Physical activity was measured by the Freiburg Questionnaire on

Physical Activity (FFKA) (Frey et al., 1999). Originally, the ques-

tionnaire consisted of 12 items. In consultation with the authors

those 4 items which measure the quality of sleep were omitted. An

estimate of energy expenditure was derived by multiplying hours

of reported activity by the average intensity expressed in metabolic

equivalent values for activities (MET) (Ainsworth et al., 2000). The

scale has satisfactory psychometric properties and allows a calcu-

lation of weighted MET hours per week. The test-retest-reliability

of subscales ranged between 0.751 and 0.998. Maximum oxygen

uptake correlated with sport activities, thus showing a good val-

idity (Frey et al., 1999).

Anxiety and depression were measured by the German version

of the Hospital Anxiety and Depression Scale (HADS-D) (Hinz and

Schwarz, 2002), consisting of 7 items on both subscales. Cron-

bachs alpha varied from 0.67 to 0.90 (Bjelland et al., 2002). The

sensitivity and specicity was approximately 0.80. Correlations

between HADS and other commonly used questionnaires ranged

from 0.49 to 0.83 (Hinz and Schwarz, 2002;Bjelland et al., 2002).

Since there were no scales for measuring CRF knowledge the

Fatigue Knowledge Test (F-WT) was developed. The concepts were

drawn from clinical recommendations with emphasis on self-care.

The items are based on a systematic review (de Vries et al., 2009).

The F-WT is a 34-item instrument with true/false questions con-

taining 9 items about etiology and signs of CRF, 6 items about

treatment, 3 items about exercise, 6 items about exercise motiva-tion, 5 items about scheduling daily activities and 5 items about

improvement of the sleep-wake rhythm. Cronbachs alpha calcu-

lated from our study was 0.82.

A questionnaire to measure the patients satisfaction was

developed, the Fatigue education satisfaction scale, based on

a scale for asthma education. The original scale contained 28 items.

Cronbachs alpha for the total scale was 0.92 and ranged from 0.47

to 0.91 for subscales (de Vries et al., 2008). This questionnaire was

modied for use in FIBS.

Statistical analysis

The sample size estimation was based on the FAQ. To detect

a clinically relevant difference of 4 points in the mean with 80%

power and a two-sided 0.05 signicance, 120 patients were needed

in each group. Data for the sample size estimation was determined

by research (Geinitz et al., 2004). Weanticipated an attrition of 20%,

giving a total n of 150 per group orn of 120 per group being ana-

lysed at t2.

We used a group-by-time two-way analysis of variance

(ANOVA) statistics with time as the repeated factor. Group-by-time

effects on changes in patients outcomes and partial eta-squared

(h2) values were calculated. The primary outcome measure was

CRF, all other outcomes were secondary. We considered results to

Table 7

Changes in Physical Exercise Self-Efcacy Scale.

Group Pre-intervention Post-intervention Follow-up at 6 months Group time Partia l eta -squa red


Planning phase (range: 1e4) IG 2.54 (0.81) 3.02 (0.86) 3.12 (0.84) 21.938


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be statistically signicant if the two-sidedp-values were less than

0.05.

All patients who completed the questionnaires were included in

the analyses regardless of their participation in the sessions

(intention-to-treat analysis). No interim analyses for efcacy or

futility were carried out, no stopping rules applied. All statistical

analyses were carried out using SPSS for Windows Release 18.

Results

327 patients were assessed for eligibility; 261 were randomised,

129 allocated to the IG and 132 to the CG. 120 patients attended the

program. All of these and 114 patients in the CG were analysed at

follow-up. 27 patients couldnt be analysed as there were no data

available (Fig. 1). No patient discontinued the intervention, but

some didnt attend all modules for different reasons (e.g. illness or

scheduling conicts). The mean participation rate was 4.3 modules

(n 104).

Table 3displays the baseline characteristics of the patients. All

characteristics were similar between groups. The patients were

predominantly women caused by numerous participation ofcertied Breast Units at hospitals. This also explains the high

prevalence of breast cancer patients. However, in total patients

with 29 tumour entities participated in the study. The most prev-

alent comorbidity was depression. Most patients had already taken

measures against CRF like information or sports.

Primary outcome measure

Our ndings suggest that the study population was highly

fatigued at baseline, scoring 42.42 (SD 9.17) in the IG and 41.68

(10.13) in the CG on the FAQ scale ranging from 0 to 60 (Table 4).

Likewise, the mean visual analogue subscale values 8.03 (1.57) in

the IG and 8.09 (1.34) in the CG on a scale of 0e9 indicate severe

subjective CRF burden. The values of the fatigue subscale of theQLQ-C30 conrm these results; they show a fatigue burden of 75.37

(19.39) in the IG and 73.29 (22.01) in the CG on a scale of 0e100

(Table 5).

In the IG, CRF was reduced to 22.85 (15.73) at t2. The CG showed

almost no change in CRF levels over time. In the repeated measures

ANOVA, this difference was statistically signicant for the group by

time interaction (F 76.51, p < 0.001). The partial h2 of 0.248

indicates a large effect. All subscales of the FAQ achieved statisti-cally signicant effects with partial h2 ranging from 0.09 (the

smallest effect in insomnia) to 0.238 (the largest effect in physical

fatigue) (Table 4).

Secondary outcome measures

The changes in the quality of life questionnaire QLQ-C30 indi-

cate a signicant improvement in the global health status in the IG

compared to the CG (Table 5). All functional and symptom scale

values as well as single items values increased signicantly. The

largest effect could be seen in the fatigue subscale: the IG showed

a reduction from 75.37 (19.39) to 40.74 (30.60) while the values in

the CG remained about the same (F 57.837, partial h2 0.2,

p < 0.001). This nding conrms the results of the FAQ.Self-efcacy was improved signicantly by the intervention, in

the general scale (Table 6) as well as in the physical exercise scale

(Table 7). However, physical exercise self-efcacy declined in the

CG over time, in the total scale as well as in all subscales. A similar

effect was found in the changes in physical activity (Table 8). Total

activity improved in the IG but declined in the CG. The group

difference indicated a small effect (F 8.036, partial h2 0.033,

p


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score of the Fatigue Knowledge Test showedan improvement in the

IG from t0 to t1 and remained roughly on this position until t2,

whereas the knowledge gain in the CG remained minimal, indi-

cating a signicant difference (Table 10).

Discussion and conclusion

This trial, designed and reported to meet CONSORT require-

ments (Schulz et al., 2010), introduces an education program for

fatigued cancer patients following therapy completion. In the

evaluation, the newly developed program FIBS proved superior to

standard information and care for patients on a wait-list. At base-line, participating patients were suffering from severe symptom

burden, and the majority of patients had already made multiple

attempts to combat fatigue.

Strengths and limitations

The major strengths of this study were the well-balanced

distribution of demographic and clinical characteristics at base-

line in both groups and the low dropout/withdrawal rate. All

patients who attended the sessions completed the questionnaires.

Moreover, patients with a wide range of educational backgrounds

participated in the study.

As a major limitation, the lack of blinding may have biased

estimated intervention effects, especially since the outcome vari-ables were patient-reported. CRF is recognized as a subjective

experience. It can be described most accurately by patient self-

report, and there are no objective measures of this variable.

Therefore, the results were susceptible to bias based on changes in

perception of the symptom. However, additional objective data can

be useful in the assessment of subjective symptoms. The inclusion

of the MET calculation can thus be seen as a strength of the study.

Another limiting factor may be the wait-list control design. The

current study is not able to discern specic therapeutic factors

operating in the patient education from general factors like social

interaction. The inclusion of comparison groups receiving the same

time and attention in future studies may help tease apart these

factors. On the other hand, some authors state that the true benet

of the educational interventions may be difcult todetect when thecontrol group is getting aid beyond standard care (Lagger et al.,

2010).

For future research using behavioural measures to determine

compliance with the intervention could be helpful. Implementation

delity is dened as the degree to which an intervention was

implemented as it was prescribed by the program developers.

Fidelity could be measured through self-report, ratings, and direct

observation and coding of audio- and video-tapes of actual

encounters, or patient interaction in terms of adherence to the

curriculum, dose or amount of program delivered, and quality of

delivery.

Under health economical aspects it could further be interesting

if the programme needs to be the current length or could be

shortened. Few people dropped out of the intervention group

suggesting they werending it benecial. However, we are not able

to make statements about which modules would be essential and

which redundant because the uctuation of the participants was

unsystematic. As far as possible we tried to nd out the reasons

why patients dropped out or did not attend all sessions. No patient

reported that the content, length or number of sessions were

negative. There were other reasons like personal problems with

time schedules. On the contrary, most patients found that the

seminar was too short.

Maybe answering the question of minimum effective dose of

patient education could be an interesting issue for further

research e

and we already tried to evaluate this in asthma-patient-education (de Vries et al., 2008).

Discussion

Treatment options for fatigued patients offered in medical care

are often insufcient and especially the psychosocial components

are often not addressed adequately. Survivors suffering from CRF

are a largely unrecognized and undertreated group.

Other intervention trials specic for fatigue generated similar

effectslike our trial but they were conducted during cancer treat-

ment. In 5 studies identied by a systematic review (Goedendorp

et al., 2009), 4 trials achieved a signicant effect in CRF (Armes

et al., 2007;Barsevick et al., 2004;Ream et al., 2006;Yates et al.,

2005). However, in only 2 of these studies the effect could bemaintained to follow-up. In contrast to our study, they were brief

interventions (3 sessions) and were administered individually, but

the contents were similar (information, self-care, activity

management, balancing between activities and rest). The study

without a signicant effect was probably underpowered (Godino

et al., 2006).

Studies evaluating educational interventions in cancer survivors

are rare and often utilize a general approach for quality of life, not

including fatigue as an outcome variable (Meneses et al., 2007;

Owen et al., 2005). In a trial with a fatigue endpoint, the CG

received standard print material, IG group 1 an additional peer-

modelling videotape, and IG 2 an additional videotape, two

sessions with a trained cancer educator, and informational work-

book. IG 1 improved in fatigue signicantly at 6 months comparedto the CG (Stanton et al., 2005). Another study applied a cognitive-

behavioural therapy approach resulting in small to medium effects

on CRF (Dolbeault et al., 2009). Both interventions differed signif-

icantly from our study as they focused on different techniques.

Our study adds a patient education program for cancer survi-

vors. The efcacy of the program can be explained by multiple

factors.

FIBS was designed to reduce CRF in cancer patients. In studies

identied by a Cochrane review (Goedendorp et al., 2009),

specic interventions for CRF had a higher probability of being

effective compared to interventions not specic for CRF.

FIBS was composed of CRF specic strategies that were

assumed effective as mentioned in the NCCN guideline

Table 10

Changes in Fatigue knowledge test (F-WT).

Group Pre-intervention Post-intervention Follow-up at 6 months Group time Part ial eta-sq uare d


F-WT total score (range: 0e34) IG 21.25 (5.12) 28.12 (4.77) 28.30 (4.89) 55.157


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(National Comprehensive Cancer Network, 2011) and in

recommendations from the Oncology Nursing Society

(Mitchell et al., 2007).

Advice on social support and support from other patients can

be a helpful component of effective interventions for CRF ( Fors

et al., 2010) and was therefore included in the FIBS program.

The sessions were designed so that patients could learn from

each other.

As depression is a major factor frequently associated with CRF

(Jacobsen et al., 2003), advice on strategies to overcome

depressive periods may have helped to ameliorate depressive

symptoms as well as affective fatigue.

Conclusion

Our education program designed for cancer survivors after

treatment had a positive impact on perceived fatigue and other

secondary variables. The effect could be maintained 6 months

following participation.

Practice implications

The program FIBS has aroused considerable interest by cancerpatients in Germany, since there is currently no other treatment

available. The results show that FIBS has the potential to ll this

gap. As the program was implemented for both sexes, for adults at

a wide range of ages, many cancer entities, and at levels of fatigue

from mild to severe, the results indicate that the entire range of

fatigued cancer survivors may benet from FIBS. Therefore, FIBS is

supposed to be a complementary intervention to individual coun-

selling for fatigue.

Counselling centres, cancer centres or specialized clinics could

provide the program. In our opinion, the course can be best carried

out by experienced oncology nurses, but also other health profes-

sionals like psychologists, physiotherapists or doctors can be

perfect trainers. The qualications of trainers depends less on their

profession than on personal suitability in dealing with cancerpatients and management of patient groups.

We developed a train-the-trainer seminar which is a prerequi-

site for all FIBS trainers. In our study, usually one trainer held the

program, but also other options were allowed, such as one trainer

in charge and additional trainers for special themes.

FIBS should be translated and evaluated in other countries than

Germany, including a control group receiving the same time and

attention like the intervention group.

Ethical approval

The study has been approved by the ethics committee of the

University of Bremen (Germany).

Funding

The study was funded from 2007 to 2010 by the German Federal

Ministry of Education and Research (FKZ: 01GT0605). The sponsor

was not involved in decisions about the study design; the collec-

tion, analysis and interpretation of data; the writing of the report;

or in the decision to submit the paper for publication.

Competing interests

The authors KR, UdV, FP, and SG declare no conict of interest.

The authors disclose no nancial and personal relationships with

other people or organisations that could inappropriately inuence

(bias) our work.

Study protocol

The study protocol has been published (Stuhldreher et al., 2008).

Registration

The trial was registered with ClinicalTrials.gov (Identier:

NCT00552552).

Statement

I conrm all patient/personal identiers have been removed or

disguised so the patient/person(s) described are not identiable

and cannot be identied through the details of the story.

Acknowledgements

The authors would like to thank the members of the Bremer

Krebsgesellschaft e.V. for their practical support in realizing the

initial idea and implementing the program. We would like to thank

all other participating centres as well: Brandenburgische Krebsge-

sellschaft, Bayerische Krebsgesellschaft, Universittsklinikum Jena,

Universittsklinikum Greifswald, Klinik fr Tumorbiologie in Frei-

burg, Klinikum Hanau, Klinikum Region Hannover, Krankenhaus

Ludmillenstift in Meppen, Praxis Phoenix in Neustadt am

Rbenberge.

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Educación Al Paciente Para Reducir La Fatiga en El Cancer