EAL

ONC: Medical Nutrition Therapy and Nutrition Intervention in Adult Oncology Patients (2011)

Citation:

Isenring EA, Bauer JD, Capra S. Nutrition Support Using the American Dietetic Association Medical Nutrition Therapy Protocol for Radiation Oncology Patients Improves Dietary Intake Compared with Standard Practice. J Am Diet Assoc 2007; 107 (3): 404-412.

PubMed ID: 17324657

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

The purpose of this work was to determine the impact of nutrition intervention using the ADA MNT radiation oncology protocol compared with standard practice on dietary intake in ambulatory oncology patients receiving radiotherapy to the gastrointestinal or head and neck area.

Inclusion Criteria:

Had received at least 20 fractions of radiotherapy to the gastrointestinal or head and neck area at a private Australian radiotherapy facility during a 12-month period
Provided informed consent.

Exclusion Criteria:

Not described

Description of Study Protocol:

Recruitment

Subjects were recruited from a previous randomized controlled trial conducted in outpatients who received at least 20 fractions of radiotherapy to the gastrointestinal or head and neck area at a private Australian radiotherapy facility during a 12-month period.

Design

Prospective randomized controlled trial

Intervention

Patients were randomized to receive nutrition intervention (nutrition counseling following the ADA medical nutrition therapy protocol for radiation oncology) OR standard practice (general nutrition talk plus a booklet).

Statistical Analysis

T-tests or Mann-Whitney tests were used to calculate the mean change in outcomes and were compared by group
Paired t-tests were used to assess differences between estimated and actual energy and protein intakes at baseline
Repeated measures ANOVA used to assess differences between the nutrition intervention and standard group over time on an intent-to-treat basis
Statistical significance was reported at P<0.05 level (2-tailed), SPSS version 10 was used.

Data Collection Summary:

Timing of Measurements

Weight was measured to the nearest 0.1kg and height was measured to the nearest 0.1cm with a stadiometer following standard procedures
BMI was calculated from current weight and height using standard formula (kg/m²)
Nutritional status measured using valid and reliable scored patient generated-subjective global assessment (PG-SGA). Each subjects was classified as well-nourished (PG-SGA category A), moderately malnourished (PG-SGA category B), or severely malnourished PG-SGA category C and a numerical PG-SGA score was calculated.
PG-SGA is correlated with several objective parameters (percent weight loss, BMI, and measures of morbidity and has a high degree of inter-rate reproducibility).

Dependent Variables

Dietary intake was the primary outcome (assessed using a modification of the Burke diet history technique and measured at baseline, four, eight and 12 weeks after starting radiotherapy
Subjects were systematically asked about dietary intake during a typical 24-hour period then had to account for deviation such as on weekends and meals eaten away from home
Mean protein, energy and fiber were determined using computerized Australian food composition data
Total energy requirements were estimated using the Harris Benedict equation with an activity factor of between 1.2 to 1.5 and a stress factor of 1.2 was applied.

Independent Variables

Standard practice group (Subjects received general nutrition talk by the nurses as part of the planning stages for radiotherapy. They also received a nutrition and cancer booklet and a high kilocalorie protein supplement sample).
Intervention group (Subjects received regular and intensive nutrition counseling by a registered dietitian using the ADA medical nutrition therapy protocol). Dietetic consultations were conducted within four days of starting radiotherapy and then weekly for six weeks and then every two weeks for the remaining six weeks. Telephone interviews were conducted between the face-to-face nutrition counseling sessions. Educational handouts were used to help minimize treatment-related side effects. Individual tailored sample meal plans and recipe suggestions were also provided when requested during face-to-face interviews).

Description of Actual Data Sample:

Initial N: 78 men and women
Attrition (final N): 54 men and women
Age: 60.6±15.6 in the nutrition intervention group and 63.3±12.5 in the standard practice group
Ethnicity: Not described
Other relevant demographics: There were no significant differences between the nutrition intervention and standard practice groups and no differences in the level of symptoms experienced by the groups as indicated by the nutrition impact symptom section of the scored PG-SGA.
Anthropometrics: There were no significant differences in baseline characteristics (age, sex, BMI, nutritional status, tumor type, or radiotherapy treatment) between subjects who did or did not agree to take part in the study nor in those who did or did not complete the study.
Location: Queensland University of Technology Human Research Ethics Committee in Australia.

Summary of Results:

Key Findings

During the study, the nutrition intervention group had significantly higher mean energy (P=0.029) and protein intakes (P<0.001) compared with those in the standard practice group
Mean energy intake per kilogram of body weight was greater for the nutrition intervention group and ranged from 28 to 31kcal/kg per day compared with 25 to 29kcal/kg per day for the standard practice group over the 12-week period (P=0.022)
Although the repeated measures changes in fiber intake between the groups were not significant, there was a trend for the nutrition intervention group to have a higher fiber intake (P=0.083)
The nutrition intervention group also had a significantly smaller decrease and faster recovery in global quality of life (P=0.009) and physical function (P=0.012) over time compared with the standard practice group.

Author Conclusion:

This study demonstrated that nutrition intervention using the ADA MNT radiation oncology protocol resulted in improved dietary intake and quality of life and less deterioration in nutritional status when compared with standard practice in ambulatory oncology patients receiving radiotherapy to the gastrointestinal or head and neck area.

Funding Source:

Other:

Wesley Research Institute

Reviewer Comments:

The authors did report some limitations. First, there may have been some limited generalizability of these findings based on the sample size of 54 subjects and second the dietary intake was assessed by the diet history method. Accuracy is a problem with this method since there may be some errors in reporting or individual bias.

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?	No
	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?	No
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?	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?	N/A
	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%.)	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?	N/A
	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?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	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?	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)?	No
	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?	Yes
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