ONC: Nutrition Status and Outcomes in Adult Oncology Patients (2013)
The purpose of the research was to investigate in cancer patients referred for radiotherapy:
- Quality of life (QOL), nutrition status and nutrient intake at onset and end of radiotherapy (RT)
- Effect of individualized nutrition counseling on nutrient intake over time, and whether nutrient intake influenced the patient's QOL
- Which symptoms might be indicative of poorer QOL and reduced nutritional intake.
- Oncology outpatient referred to the radiotherapy department of the study hospital between July 2000 and February 2001 for primary, adjuvant to surgery or palliative radiotherapy. Medical staff assessed patients' clinical variables; cancer location; and tumor, nodes, and metastases (TNM) staging prior to decision for radiotherapy planning
- No distant metastases.
- Terminally ill
- Renal failure (Creatinine higher than 532µmol per L)
- Congestive heart failure
- Hepatic failure (Bilirubin higher than 21µmol per L).
Recruitment
- All cancer patients referred to the outpatient Radiotherapy department of the study hospital between July 2000 and February 2001 were considered eligible
- No specific information on recruiting method was provided.
Design
- The study was designed as a prospective descriptive study
- The study design was approved by the University Hospital Ethics Committee
- Patients were classified as either high risk (HR) or low risk (LR) for nutritional problems
- Patients with head and neck cancers or GI cancers were classified as HR
- All other patients were classified as LR.
Intervention
Patients were nutritionally assessed by a research dietitian:
- Individualized dietary counseling was provided based on patients' current intakes
- No oral nutritional supplements or tube feedings were used during this study.
Statistical Analysis
- Study data was analyzed on the intent-to-treat principle
- Sample size was calculated according to Wittes; to increase statistical power, patients were divided into HR and LR categories
- Descriptive data were expressed as number and percentage, mean or median values
- Level of significance for all statistics was P<0.05
- Kruskal-Wallis analysis, the Mann-Whitney U-test, and student's T-test were used to analyze associations and differences between groups in QOL measures, nutrition status and nutrition intake
- Chi-square testing was used to compare frequencies
- Spearman and Kendal Tau methods were used to analyze correlations between nutrition intake or nutrition status and QOL scores
- Regression analysis was used to identify variables that influence nutrition intake and QOL.
Timing of Measurements
- Assessment of nutritional status, food intake and individual nutrition counseling needs were performed for each patient by a research dietitian at onset of radiotherapy, after two weeks of radiotherapy and at the end of radiotherapy
- Quality of life was evaluated at the onset of radiotherapy and at the end of radiotherapy.
Dependent Variables
- Variable 1: Nutritional status:
- Nutrition assessment was performed using Ottery's Subjective Global Assessment (SGA)
- SGA is validated for cancer patients
- Assessment addresses:
- Weight changes
- Symptoms, including anorexia, nausea, constipation, mucositis, vomiting, diarrhea, xerostomia, pain)
- Alterations in food intake
- Functional capacity
- Metabolic stress, including sepsis, neutropenic fever, use of corticosteroids
- Anthropometrics, including triceps skinfold, rib skinfold, muscle bulk and tone, ankle or sacral edema, presence of ascites
- Nutritional status is categorized as one of three degrees:
- Normal nutrition status
- Moderately malnourished
- Severely malnourished
- Nutrition assessment was performed using Ottery's Subjective Global Assessment (SGA)
- Variable 2: QOL:
- QOL was evaluated using two instruments due to significant differences in length of time required to complete them
- EUROQOL instrument:
- Non-disease specific
- EUROQOL describes and scores health states
- EUROQOL has two parts:
- Part One defines health in terms of five areas: Mobility, self-care, usual activities, pain and discomfort, anxiety or depression; combinations of these factors define a total of 243 possible health states
- Part Two asks the patient to record his or her perceptions of his or her overall health, using a visual analog scale with zero representing the worst possible health and 100 representing the best possible health
- EUROQOL has two parts:
- EORTC-QLQ C30, Version 3.0:
- Cancer-specific, 30-item questionnaire
- Includes five functional scales (physical, emotional, cognitive, social and role)
- Includes three symptom scales (fatigue, pain, nausea or vomiting)
- Includes six single items assessing symptoms and financial impact of disease
- Higher scores on the function scales indicate better functioning
- Higher scores on the symptom scales indicate more severe symptoms.
- Cancer-specific, 30-item questionnaire
Independent Variables
-
Dietary assessment:
-
Harris-Benedict was not used due to problems with accuracy
-
Height was copied from patient's identity card
-
Weight was measured using a Jofre floor scale
-
Basal energy requirements (BMR) were estimated using the World Health Organization formula for patients 18 to 60 years of age:
-
Men:
-
18 to 30 years: [64.4 x weight (kg) - 113 x height (m) + 3,000]
-
30 to 60 years: [19.2 x weight (kg) + 66.9 x height (m) + 3,769]
-
-
Women:
-
18 to 30 years: [55.6 x weight (kg) - 1,397.4 x height (m) + 146]
-
30 to 60 years: [36.4 x weight (kg) + 104.6 x height (m) + 3,619]
-
-
-
For patients more than 60 years of age, the Owen et al formulas were used
-
Men: [879 + (10.2 x weight (kg)) x 4.184]
-
-
Women: [795 + (7.18 x weight (kg)) x 4.184]
- Daily estimated energy requirements were calculated by multiplying BMR by an activity factor of 1.2
-
- Nutritional intake assessment:
- Was assessed by 24-hour food recall questionnaire
- Nutrient content was analyzed by DIETPLAN for Windows software (Forestfield Software Ltd 2001, Horsham, UK).
Control Variables
-
HR or LR cancer
-
Dietary counseling
-
Nutrition counseling took into account each patient's:
-
Current eating habits
-
Actual nutritional status
-
Need for increased intake to overcome deficits
-
Known food aversions
-
Reported symptoms
-
Diet adequacy, which determined variations in each patient's daily meal plan, diet nutrient content, type and amount of foods and appropriate diet texture.
-
-
Initial N
- N: 125 (83 males, 42 females)
- HR patients: 80
- LR patients: 45
Patient Groups and Cancer Staging
HR Cancers | N | Staging |
Esophagus | 6 | II (1); III (5) |
Stomach | 5 | I (1); II (2); III (2) |
Colorectal | 46 | I (13); III (28); IV (5) |
Base of tongue | 3 | IV (3) |
Salivary gland | 1 | III (1) |
Tonsil | 2 | II (2) |
Nasopharynx | 3 | III (3) |
Oropharynx | 3 | II (1); III (2) |
Larynx | 11 | I (1); III (3); IV (7) |
LR Cancers | N | Staging |
Prostate | 21 | II (15); III (3); IV (3) |
Breast | 7 | II (4); III (2); IV (1) |
Lung | 5 | II (2); III (2); IV (1) |
Brain | 4 | I (1); II (2); III (1) |
Gallbladder | 6 | II (1); IV (2) |
Uterus | 2 | II (1); III (1) |
Nutritional Status Prior to Therapy
- High-risk patients:
- Five of six esophageal cancer patients were moderately or severely malnourished
- Five of five stomach cancer patients were moderately or severely malnourished
- 12 of 23 head and neck cancer patients were moderately or severely malnourished
- Six of 46 colorectal cancer patients were moderately or severely malnourished
- Low-risk patients:
- 10 of 45 low-risk cancer patients were moderately malnourished
- No low-risk cancer patient was severely malnourished.
Attrition (Final N)
All data was analyzed on the intent-to-treat principle.
Age
63±11 years (33 to 86 years).
Anthropometrics
At beginning and at end of radiotherapy, high-risk patients were more likely to be malnourished (P<0.02).
Location
Lisbon, Portugal.
Findings
- Nutrition status:
- At onset and at end of radiation therapy, malnutrition (moderate and severe) was present more often in the high-risk group than the low-risk group (P=0.02)
- From beginning to end of radiation therapy, nutrition status remained stable in all but one high-risk head and neck cancer patient whose nutrition status deteriorated from moderately to severely malnourished
- Symptoms: From beginning to end of radiation therapy, only in high-risk patients did symptoms of diarrhea or anorexia increase in severity during radiotherapy (P=0.0001); no patients reported grade three o four symptoms
- Energy intake:
- At onset of radiotherapy, median energy intake of low-risk patients was higher than median energy intake of high-risk patients (P=0.002)
- In both high-risk and low-risk patients, baseline nutrition status was related to nutritional intake (P=0.007)
- Energy intake increased significantly in high-risk patients during radiotherapy (P<0.03), and patients attributed the increase to individualized nutrition counseling:
- Esophageal cancer: +275kcals (200 to 425)
- Stomach cancer: + 280kcals (185 to 400)
- Colorectal: +410 (352 to 545)
- Head and neck: +510 (358 to 785)
- Increase in energy intake in low-risk patients was not significant
- Overall quality of life measures:
- For all quality of life measures, and for overall quality of life, high-risk patients reported worse scores than low-risk patients, both at initial measurement (P=0.001) and at end of radiation therapy (P=0.01). Patients with esophageal, stomach, and head and neck cancers reported the lowest quality of life scores
- With the exception of pain and discomfort, all quality of life scores improved significantly from beginning to end of treatment; improvement was significant only in high-risk patients (P=0.004)
- Pain and discomfort during radiation therapy was associated with symptoms of greater severity:
- Anorexia (P=0.001)
- Diarrhea (P=0.002)
- Dysphagia (P=0.01)
- Odynophagia (P=0.04)
- Nutritional intake of high-risk patients improved throughout radiation therapy
- Pain and discomfort during radiation therapy was associated with symptoms of greater severity:
- Improvement of nutritional intake was identified as a major factor in the improvement in quality of life seen from beginning to end of radiation therapy for high-risk patients (R=0.78; P=0.001). In low-risk patients, no nutrition parameters were significantly associated with quality of life.
- Self-reported health status (SRHS) was significantly higher in low-risk than high-risk patients at outset of radiation therapy (P<0.03)
- At end of radiation therapy, SRHS improved in all groups, but the change was significant only for high-risk patients (P=0.01)
- In high-risk patients only, energy intake was associated with SRHS at both beginning and end of radiation therapy (R=0.47, P=0.001). Multi-variate analysis indicated that nutritional intake was associated with an increase in SRHS (R=0.72; P=0.001), demonstrating that increased energy intake promoted improved SRHS.
- Worse function scales were reported for high-risk patients with baseline malnutrition (these associations were also present at end of treatment):
- Global QOL (P=0.05)
- Physical (P=0.01)
- Role (P=0.02)
- Cognitive (P=0.02)
- Emotional (P=0.01)
- Social (P=0.01)
- Function scales were correlated with baseline energy intake for high-risk patients:
- Global quality of life (R=0.53, P=0.01)
- Physical (R=0.26, P=0.02)
- Emotional (R=0.29, P=0.01)
- At end of radiation therapy, multivariate analysis identified nutritional intake as the only variable associated with global quality of life (P=0.001), physical (P=0.03), role (P=0.01) and emotional (P=0.04) functions for high-risk patients
- Increase in high-risk patients' nutritional intake was correlated with the increase in global quality of life (R=0.78, P=0.001), physical (R=0.68, P=0.002) and emotional functions (R=0.67, P = 0.002).
The authors concluded that improved nutritional intake in high-risk cancer patients undergoing radiotherapy contributes to better quality of life, and that nutrition counseling during radiation therapy is a feasible and effective intervention to achieve improved nutritional intake.
University/Hospital: | University of Santa Maria |
- High-quality study highlighting the importance of nutrition intervention by a nutrition professional during radiation therapy
- Determination of high-risk and low-risk cancers made by researchers
- Quality of life measures depend largely on self-reports by patients.
Quality Criteria Checklist: Primary Research
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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) | N/A | |
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? | ??? | |
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) | Yes | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | No | |
3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | No | |
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.) | N/A | |
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%.) | No | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
4.4. | Were reasons for withdrawals similar across groups? | ??? | |
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? | N/A | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | N/A | |
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.) | ??? | |
5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | ??? | |
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? | ??? | |
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? | Yes | |
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)? | Yes | |
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? | N/A | |
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? | No | |
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? | ??? | |