EAL

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

Citation:

Gupta D, Lis CG, Vashi PG, Lammersfeld CA. Impact of improved nutritional status on survival in ovarian cancer. Support Care Cancer. 2010 Mar; 18(3): 373-381.

PubMed ID: 19484479

Study Design:

Retrospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To investigate whether improvement in nutritional status after three months of treatment can impact survival in patients with ovarian cancer.

Inclusion Criteria:

Histologically confirmed diagnosis of ovarian cancer
No treatment at Midwestern Regional Medical Center (MRMC) while enrolled.

Exclusion Criteria:

Not described.

Description of Study Protocol:

Recruitment

Patients were recruited from Cancer Treatment Centers of America (CTCA) at Midwestern Regional Medical Center (MRMC) between January 2001 and May 2006.

Design

Retrospective cohort study.

Statistical Analysis

All data were analyzed using SPSS 11.5
Based on their SGA assessment at baseline and three months, patients were classified into four groups of SGA change:
- Well-nourished at baseline and three months
- Malnourished at baseline, well-nourished at three months
- Malnourished at baseline and three months
- Well-nourished at baseline, malnourished at three months.
These four categories of SGA change were compared with each other with respect to age at presentation, stage at diagnosis and prior treatment history using chi-square test or analysis of variance (ANOVA) as appropriate
The Kaplan-Meier or product-limit method was used to calculate survival
The log rank test statistic was used to evaluate the equality of survival distributions across different strata
A difference was considered to be statistically significant if the P-value was less than or equal to 0.05
Survival was evaluated using multi-variate Cox regression analysis after adjusting for age at presentation, prior treatment history and stage at diagnosis.

Data Collection Summary:

Timing of Measurements

All patients in this study were scheduled for a consultation with a dietitian
Prior to each consult, a dietitian reviewed the patient's history from the medical record and verified the patient's current weight. During the consult, the dietitians reviewed the SGA instrument with the patient to obtain answers to all the questions.
The dietitians also completed a physical exam, paying attention to loss of subcutaneous fat, muscle wasting, presence of ankle and sacral edema and ascites
After the consult, the dietitians ranked the patient's nutritional status as well-nourished (SGA A), moderately malnourished (SGA B) or severely malnourished (SGA C)
Patients received nutrition intervention according to an algorithm published by Ottery (2002)
Well-nourished patients received education on healthy eating during treatment including meeting protein needs and tips for managing nutrition impact symptoms. These patients were reassessed by a dietitian at each oncologist visit or inpatient admission.
Moderately to severely malnourished patients also received education on managing nutrition impact symptoms and meeting caloric and protein needs during treatment. Individualized recommendations were made for oral supplements as an option to help meet nutritional needs.
Recommendations were also made to the patients' oncologist for pharmacologic management of nutrition impact symptoms as appropriate, including appetite stimulants, prokinetic agents, antiemetics and so on.
Patients that could not meet their needs by mouth were referred to a gastroenterologist for home parenteral nutrition (HPN).

Dependent Variables

Nutritional status: Measured by SGA at baseline and three months. SGA is a clinical technique that combines data from subjective and objective aspects of medical history (weight change, dietary intake change, gastrointestinal symptoms and changes in functional capacity and physical examination).

Covariates

Age at presentation, stage of disease at diagnosis, prior treatment history and tumor response as assessed by CA125
Based on their CA125 assessment at baseline and three months, patients were classified into four groups of CA125 change:
- Normal (zero to 35U per ml) at baseline and three months
- High (more than 35U per ml) at baseline, normal at three months
- Normal at baseline, high at three months
- High at baseline and three months.

Description of Actual Data Sample:

Initial N: 98 ovarian cancer patients (all female)
Attrition (final N): 98 ovarian cancer patients (all female)
Age: Mean age at presentation was 55.3 years (range 31.3 to 82.5 years)
Anthropometrics: 46 patients were well-nourished (SGA A), 28 were moderately malnourished (SGA B) and 24 were severely malnourished (SGA C) at baseline. At three months, 63 patients were well-nourished (SGA A), 18 were moderately malnourished (SGA B) and 17 were severely malnourished (SGA C).
Location: Midwestern Regional Medical Center, Zion, IL.

Summary of Results:

Key Findings

Out of the 98 patients, 20 were newly diagnosed while 78 had received prior treatment.
The median age at presentation was 55.3 years.
At baseline, the median survival for SGA A (N=46) was 20.3 months while for SGA B/C (N=52) was 9.8 months (p=0.03).
At 3 months, the median survival for SGA A (N=63) was 19.9 months while for SGA B/C (N=35) was 3.7 months (p<0.001).
Patients with an improved nutritional status at 3 months had a significantly better survival than those with deteriorated nutritional status independent of age, stage at diagnosis, prior treatment history, and tumor response as determined by CA 125.

Author Conclusion:

The results from this study show that improvement in nutritional status is associated with better survival. The findings also lend support to the importance of aggressive nutritional intervention in improving patient outcomes in oncology. It is important to accurately assess and calculate nutritional requirements, choose correct methods of nutritional delivery and monitor or recognize nutrition-related complications in patients with ovarian cancer.

Funding Source:

Other:

Cancer Treatment Centers of America

Reviewer Comments:

A main limitation of this study was its retrospective nature and the data, which is not primarily intended for research. The authors mentioned that restricting the analysis to newly diagnosed patients (patients with no prior treatment history) would have been more accurate, since it would have allowed for evaluation of true overall survival time (time from the date of diagnosis to the date of death).

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)	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?	No
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	No
	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?	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)?	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