EAL

ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)

Citation:

Nourissat A, Vasson MP, Merrouche Y, Bouteloup C, Goutte M, Mille D, Jacquin JP, Collard O, Michaud P, Chauvin F. Relationship between nutritional status and quality of life in patients with cancer. Eur J Cancer. 2008 Jun; 44(9): 1,238-1,242.

PubMed ID: 18467087

Study Design:

Cross-Sectional Study

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To assess the global quality of life and its different dimensions as a function of the nutritional status of patients with cancer.

Inclusion Criteria:

Written informed consent provided
Patients 18 years old or more
An evolving cancer at different management stages.

Exclusion Criteria:

A primary skin, ocular or CNS tumor
Malignant hemeopathy
Patients not treated in the last two years
Patients not informed of their diagnosis
Patients unable to answer the questionnaire.

Description of Study Protocol:

Recruitment

Patients with cancer were recruited from hospitals in 23 departments and wards in six university hospitals in Clermont Ferrand and Saint Etienne France
The departments and wards included:
- Radiotherapy
- Oncology
- Pneumology
- Gynecology
- Hepato-gastroenterology
- ENT
- Urology
- Chest and digestive surgery
- Day hospital
- Oncology outpatient departments.

Design

Cross-sectional study.

Statistical Analysis

Statistical analyses were performed using SPSS version 12 software
The qualitative data were summarized as frequencies and percentages
Binary data were compared using a Chi or Fisher exact test
Quantitative data were summarized as means, standard deviations, medians and minimums, and maximums
Independent T-test was used to compare the means
Significance was set as 5%.

Data Collection Summary:

Timing of Measurements

Trained medical students spent two weeks in each department or ward collecting data from the patients' medical files and questioning and examining the patients
Nutrition Risk index and subjective classification based on the categories defined in Worksheet Five of the Patient-Generated Subjective Global Assessment (PG-SGA)
Quality of life was evaluated with the European Organization for Research and Treatment of Cancer questionnaire (EORTC-QLQ)
This is a questionnaire specifically developed for patients with cancer that is composed of 30 items assessing six functional areas (physical activities, emotional, cognitive, social and the global quality of life) and scales for nine symptoms (tiredness, nausea and vomiting, pain, dyspnea, sleeplessness, loss of appetite, constipation, diarrhea and financial difficulties)
A low score for the functional areas indicates impaired functional capacity and a low score for the symptom scales indicates absence of or low impact from the symptoms
A linear transformation was applied to each score, as recommended by the EORTC to obtain a value between zero and 100.

Dependent Variables

Nutritional status was measured using several indicators such as:

Weight loss since the start of illness or onset of initial symptoms
Weight loss over the last week, month and six months
Body mass index (BMI=weight/height²).

Description of Actual Data Sample:

Initial N: 907 patients (459 women and 441 men)
Attrition (final N): 907 patients (459 women and 441 men)
Age:
- Age 50 years or younger: 129
- Between 50 and 60 years: 269
- Between the ages of 60 to 70 years: 252
- Older than 70 years: 256
- Mean age: 62.3±11.6 years
Anthropometrics: 8.6% of patients had a BMI under 18.5
Location: Clermont Ferrand and Saint Etienne France.

Summary of Results:

Key Findings

The weight loss occurred over the two weeks prior to the study for 21.9%
A weight loss of more than 5% of their usual weight in the month preceding the study or more than 10% in the six months preceding the study was reported for 23.7% of the patients
A weight loss of at least 10% since the start of the illness was reported for 29.7% of the patients
A diagnosis of moderate or severe malnutrition using the subjective classification of categories on Worksheet 5 of PG-SGA was made for 43.4% of the patients
The Nutritional Risk Index (NRI) was not analyzed because only a few patients had an albuminemia (4.6%)
The mean quality of life score on a scale of one to 100 was 58.6
Patients who had lost less than 10% weight since the start of their illness had a significantly higher quality of life score compared with those who had loss more than 10% (62.8 vs. 48.8, P<0.001)
A significant difference in the quality of life score was observed between patients who had and those who had not modified their diet at the time of the study (65.3 vs. 52.5; P<0.001)
A significant association was observed between the Performance Status score and percentage weight loss (P<0.001).

Author Conclusion:

The association between weight loss and impaired quality of life in all areas was confirmed by this study. To improve the quality of life in patients with cancer, a nutritional intervention should be implemented as soon as cancer is diagnosed. The nutritional therapy should form part of the integral oncological support.

Funding Source:

Other:

Massif Central Agreement and grants from FEDER and FNADT

Reviewer Comments:

With a transversal study, it is not possible to identify the cause and the consequence: the weight loss or the quality of life.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	N/A

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	Yes
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	Yes
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	No
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	No
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	No
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes