ONC: Medical Nutrition Therapy and Nutrition Intervention in Adult Oncology Patients (2011)
Glare P, Jongs W, and Zafiropoulos, B. Establishing a cancer nutrition rehabilitation program (CNRP) for ambulatory patients attending an Australian cancer center. Support Care Cancer. 2011, 19: 445-454.PubMed ID: 20204419
To establish a multidisciplinary Cancer Nutrition Rehabilitation Program (CNRP) for the management of the anorexia-cachexia syndrome (ACS) in an Australian cancer center.
To determine what benefits and outcomes were achieved by patients following eight weeks of participation in the CNRP.
Patients were included if they had cancer known to be associated with the systemic inflammatory response and ACS (especially lung cancer, colorectal CA, and upper GI malignancy). Patients were targeted for recruitment if they were referred directly from the oncologist due to clinically apparent ACS, or if via a Malnutrition Screening Tool (MST) given in the waiting room of the clinic. No other formal inclusion/exclusion criteria was included.
Those that did not meet inclusion criteria were excluded.
Subjects were recruited from the Sydney Cancer Center, an oncology outpatient clinic of Royal Prince Alfred Hospital. Subjects were recruited one of two ways, either via direct referral from the oncologist if during their physical exam appointment they met the inclusion criteria for ACS, or if they received a positive screening (indicating malnutrition) via a screening tool (the Malnutrition Screening Tool (MST), at least two) which was passed out in the waiting room.
This was a prospective pre-post evaluation of the cohort.
Those enrolled into the study were initially evaluated by the physician, then the dietitian, and then the physical therapist. An individualized treatment program was created for each patient catering to their needs and included symptom management, supplements if needed, and strength training if needed; with the 'formal' program of treatment lasting eight weeks.
Descriptive statistics were used to evaluate the data. Odds ratios and 95% confidence intervals for factors predicting attendance at the two-month follow-up were calculated via a free online tool (www.hutchon.net/ConfidOR.htm). No formal categorical data analysis of these factors was performed.
Timing of Measurements
Measurements were made at baseline and on formal reviews at one, two, three and six months.
The two-month follow-up visit was the principle end-point of the treatment.
- Demographics and clinical details
- Weight (kg)
- Body composition analysis (BMI, fat percent, fat free mass), using the Tanita Body Composition Analyzer BC-418
- Nutritional assessment using the patient-generated subjective global assessment
- Laboratory parameters of inflammation (CRP, albumin) and calculation of the Glasgow Prognostic Scale (PG-SGA).
- Symptom assessment using Edmonton Symptom Assessment Schedule (ESAS)
- Performance status using Karnofsky Performance Status (KPS) score
- Six-minute walk test (6MWT)
- Handgrip strength (HGS) using a Jamar hand-held dynamometer
- Strength tests, one repetition maximum (if relevant).
The individualized treatment plan including symptom/medication management by the physician, oral nutritional supplements or omega 3 fatty acids recommended by the RD, and an individualized activity regimen prescribed by the physical therapist.
None specifically. No food or activity recalls were kept.
- Initial N: 58 persons were approached to be included in the study. Of those, 54 enrolled (41 enrolled within the first seven months, 12 enrolled in the final two months) and 39 completed all of the multidisciplinary baseline assessment.
- Attrition (final N): Of the initial 41 enrollees, 25 returned for the two-month reassessment. 16 dropped out before the eight-week reassessment.
- Age: Median age at baseline: 62 years old, range 24-85 years old
- Ethnicity: Not specified
- Other relevant demographics (at baseline):
- 36 males (68%), 17 females (34%)
- Cancer Sites: Lung 33%, colorectal 17%, Upper GI 17%, Hepatopancreatobiliary 15%, breast 7%, prostate 4%, other 7%
- KPS: Median score 70 with 100% of persons scoring above 50
- Treatments: Combined chemo/XRT 24%; chemo only 42%, XRT only 13%, no treatment 19%.
- Anthropometrics (at baseline):
|Baseline Nutritional and Functional Status|
|Initial weight (kg)||50||62.7 (35.9-95.3)|
|BMI (kg/m2)||50||21.45 (13-27.8)|
|Body fat percent||50||17.8 (2.4-38.3)|
|Weight loss (percent over six months)||46||10.2 (0-27)|
|SGA category||41||B (A-C)|
|PG-SGA score||41||13.5 (2-31)|
|Serum albumin (g/L)||41||38 (25-48)|
|Function, strength, endurance|
|6MWT (m)||30||441.5 (186-675)|
|HGS, left (kg)||29||25 (7.3-40)|
|predicted HGS (percent)||69.4 (32.5-127.6)|
|HGS, right (kg)||29||27.1 (8-43.2)|
|predicted HGS (percent)||73.9 (32.3-135.4)|
|ESAS score||34||36 (0-88)|
|CRP (mg/L)||32||31 (1-290)|
- Location: As listed in recruitment above.
- The drop out rate increased as time went by with 68% compliant at month one, 58% at month two, and only 12% by month six
- Those who stayed in the program for two months typically lost less weight, were better nourished, were more fit, and were less likely to have elevated CRP
- Of the 35 participants attending the baseline physical therapy assessment, over 90% of them reported that the CNRP was important to them.
Odds ratios and 95% confidence intervals for likelihood of returning for eight-week follow-up.
|Factor||Odds ratio||95% CI|
|ESAS score ≤30||6.3||0.6-62|
|Continuing anti-cancer treatment||4.7||1.3-16.2|
|Performance status ≥80%||3.3||0.7-15.3|
|Weight Loss ≤10%||3.3||0.7-15.3|
|Completed full assessment||2.5||0.6-9.5|
|Serum CRP ≤30||2.0||0.4-9.3|
|PG-SGA score ≤18||1.9||0.4-9.2|
|Serum albumin ≥35||1.5||0.4-6.3|
Due to the high dropout rate, only the results for the 25 patients who returned for the two-month reassessment were reported. Improvement was seen in endurance, strength, symptoms, and inflammatory markers. Significance statistics were not performed in this study. Those that participated appeared to maintain their functional status better and prevent further weight loss and have reduced symptoms.
- Due to the fact that most persons were recruited once clinical signs of cachexia was obvious, it is possible that participation in the program may show more benefit if patients participated before this decline was clinically evident (via use of a screening tool earlier on in their treatment).
- The largest factor contributing to attrition from the program was the number of appointments to participate and how they may have conflicted with ongoing treatment appointments.
The CNRP provided a regular and coordinated multidisciplinary approach to the management of anorexia and cachexia syndrome, and was achievable through the development of protocols and procedures.
Participants in the CNRP for two months shoed improved nutritional status and functional status, endurance, and strength with a decrease in reported symptoms and felt better supported.
|Government:||Cancer Institute of New South Wales Health Services Innovation Grants.|
Quality Criteria Checklist: Primary Research
|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)||Yes|
|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?||???|
|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?||N/A|
|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?||???|
|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?||N/A|
|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?||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?||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?||???|
|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?||No|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||???|
|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?||No|
|6.6.||Were extra or unplanned treatments described?||No|
|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?||???|
|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?||???|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||???|
|7.5.||Was the measurement of effect at an appropriate level of precision?||???|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||No|
|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?||???|
|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?||???|
|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)?||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?||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|