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

Citation:

Hammerlid E, Wirblad B, Sandin C, Mercke C, Edstrom S, Kaasa S, Sullivan M, Westin T. Malnutrition and food intake in relation to quality of life in head and neck cancer patients. Head & Neck. 1988; 20: 540-548.

 
Study Design:
Descriptive Study
Class:
D - Click here for explanation of classification scheme.
Quality Rating:
Neutral NEUTRAL: See Quality Criteria Checklist below.
Research Purpose:

To investigate whether the clinical stage of head and neck cancer or the nutritional status of the patient is reflected by the patient's quality of life.

Inclusion Criteria:

Cancer patients admitted to the Head & Neck unit during the time the study was taking place (specific time frame was not given).

Exclusion Criteria:
  • Patients were unable to complete the quality of life questionnaire or who did not wish to be included in the study
  • No other criteria were given.
Description of Study Protocol:

Recruitment

58 consecutive patients admitted to Head & Neck unit were invited to participate, or those 48 accepted.

Design

Patients were asked to answer two QOL questionnaires and record food intake for two days. Clinical status, treatment received and nutritional status were registered at the same time. At the two-year follow-up, any recurrence of disease and survival were noted.

Statistical Analysis

Descriptive statistics on Macintosh personal computer system used standard software (Abascus Concepts, Inc., Berkeley CA, 1992). Fisher's non-parametric permutation test used for comparison between groups. Fisher's Exact test used for comparison of proportions between groups. QOL scores  were calculated according to the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) scoring manual. The scale reliability was estimated with Cronbach's alpha coefficients. Construct validity of the scales was evaluated by examination of the correlation matrix of all multi-item scales. A comparison of this matrix with that of a corresponding Norwegian material was performed.

 

Data Collection Summary:

Timing of Measurements

Initial data collection and two-year follow-up.

Dependent Variables

  • Quality of life was measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and the Norwegian Head and Neck cancer questionnaire (diagnosis specific):
    • Physical functioning
    • Role functioning
    • Emotional functioning
    • Social functioning
    • Cognitive functioning
    • Global quality of life
    • Pain
    • Fatigue
    • Nausea and vomiting
    • Appetite loss
    • Financial difficulties
    • Swallowing difficulties
    • Problems swallowing food
    • Problems swallowing liquids
    • Taste changes
    • Dryness of mouth.

Independent Variables

  • Age
  • Gender
  • Type  of cancer:
    • Oral cavity
    • Larynx
    • Sinus
    • Skin
    • Esophagus or hypopharnx
    • Other.        

Control Variables

  • Nutritional status (poor nutritional status determined by two or more impaired nutritional parameters)
    • More than 5% weight loss related to disease
    • Anthropometry (arm muscle circumference, triceps skinfold) Swedish reference values used
    • Weight index less than 0.80 (actual weight divided by reference weight for height (reference was taken from a material of randomized middle aged and elderly men and women in Gothenburg)
    • Body mass index (normal values 20kg/m2 or more)
    • Serum albumin (reference range 36 to 50g per L; values less than 33g per L were considered to indicate malnutrition)
  • Food Intake: Two-day food record kept by the patient, patient's spouse or nurses. The dietitian was consulted if there was uncertainty about food record. Energy intake was calculated in total and separated out into carbohydrates, lipids and protein. Energy requirements for each individual was calculated according to Hessov (1980). Energy balance was estimated by subtracting energy intake from calculated energy requirement. Negative energy balance defined as energy intake less than 80% than calculated value for balance.
  • Stage of Cancer: I, II, III, IV                     
  • Survival at two-year follow-up.        
Description of Actual Data Sample:
  • Initial N: 48 of 58 consecutively admitted patients agreed  to participate (83%)
  • Attrition (final N): Data was collected all at one time, so their was no attrition
  • Age: 67 years (40 to 88 years); 36 men, 12 women
  • Ethnicity: Presumed Caucasian, northern European (ethnicity not specifically stated in article)
  • Anthropometrics: Average weights:
    • 69kg men, 53 kg women; significantly less than reference values
    • Mean weight loss was 5.2kg (0 to 20kg) for men and 6.5kg (0 to 15kg for women)
    • 39 of 45 patients were below reference weights (three did not complete tests for nutritional status)
    • 17 of 45 were less than 80% of reference weight
  • Location: Specific center where study took place is not given, but it can be presumed that it was at Sahlgrenska University Hospital,  Goteborg University, Goteborg, Sweden (study authors from the hospital).
Summary of Results:

Key Findings

(Note: This was a descriptive study; it was difficult to create a table of significant findings.)

Nutritional Parameters

Three patients did not complete tests of nutritional status.

  • Malnutrition: 23 out of 45 patients were determined to be malnourished
  • Mean weight loss: 5.2kg for men (zero to 20kg), and 6.5kg for women (zero to 15kg)
  • Majority of patients (39 out of 45) were below reference weight
  • 17 of 45 patients had a weight of less than 80% of weight index
  • Malnutrition was most common among patients not yet treated (four of five), and those with recurrent disease (seven out of 10). Only one patient who had finished treatment over one year earlier was malnourished.

Nutritional Status vs. Alive at Two-year Follow-up (Control Variable)

  • Eight of 23 (35%) malnourished patients were alive at the two-year follow-up
  • 14 of 22 (64%) well-nourished patients were alive at the two-years follow-up.

Nutritional Status vs. Stage of Cancer (Control Variables)

No impact of stage of disease upon nutritional status.

Food Intake (Control Variable)

  • 15 of 48 patients did not keep a food diary or accurate calculation of intake was not possible. 33 patients kept a useful food diary.
    • 23 had negative energy balance and 10 had positive energy balance
    • Malnourished patients demonstrated negative energy balance in 10 of 16 cases (62%)
    • 13 of 16 (81%) of well-nourished patients had negative energy balance
    • No significant difference between groups.

Quality of Life Variables (Dependent Variables) Compared to Malnutrition, Stage and Diagnosis of Cancer,  Food Intake and Survival

  • No correlation between stage of disease and global quality of life
  • Sage of disease did not affect nutritional status or survival rate
  • Significant correlation (R=0.66) between physical functioning and global quality of life
  • Malnourished patients scored worse for 12 of the 16 quality of life functions and symptoms, with the greatest differences for physical functioning, global quality of life and role functioning. None significant.
  • Patients with more than 5% weight loss vs. those with no weight loss scored worse for 11 of 16 quality of life functions.
    • Significant findings: Swallowing difficulties and problems swallowing food (P>0.01)
  • Patients with negative energy balance scored better than the group of patients with positive energy balance  for one of 16 quality of life functions/symptoms, but none were significant
  • At the two-year follow-up, 23 of 48 patients were alive. Survivors scored better than deceased patients for all 16 quality of life functions and symptoms. Significant items:
    • Appetite loss (P>0.01)
    • Problems swallowing (P<0.05)
    • Global quality of life  (P<0.05).
Author Conclusion:
  • The authors concluded that it is possible to measure a patient's quality of life with the questionnaires used and QOL tools should be used as a complementary tool in future prospective studies of head and neck cancer patients.
  • The study did not show a significant correlation with malnutrition, type or stage of disease with quality of life (the initial question being evaluated). The study size may have been too small to show a significant correlation between quality of life and nutritional parameters, or stage of cancer.
Funding Source:
University/Hospital: Goteborg University, Sweden
Not-for-profit
Swedish Cancer Society, Sweish Medical Research Couuncil, Assar Gabrielsson Foundation, King Gustav Jubilee Clinic Cancer Research Foundation, Arvid and Elisabeth Nilsson's Cancer Research Foundation, Swedish and Goteborg Medical Societies
Other non-profit:
Reviewer Comments:

This was a descriptive study of a very diverse group of head and neck cancer patients. There were not enough patients in any particular group  of similar patients (same diagnosis and stage of cancer) to make meaningful comparisons between nutritional status, stage of cancer and quality of life. There were suggestions of correlations, but none were significant. It would likely take a large, multi-center study to be able to get an accurate idea of whether nutritional status and stage of cancer  affects 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) 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? N/A
  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? N/A
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? N/A
  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? No
  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? No
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  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? N/A
  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? 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.) N/A
  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? N/A
  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? N/A
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? Yes
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? N/A
  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)? N/A
  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? 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? 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