EAL

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

Citation:

Danielson B, Fairchild A. Beyond palliative radiotherapy: A pilot multidisciplinary brain metastases clinic. Support Care Cancer. 2011 Apr 9. doi: 10.1007/s00520-011-1149-1.

PubMed ID: 21479525

Study Design:

Non-Controlled Trial

Class:

D - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To determine the feasibility of a multidisciplinary palliative radiotherapy clinic to provide timely consultation and treatment and to optimize symptom control and quality of life (QOL) for patients with brain metastases.

Inclusion Criteria:

Histologic diagnosis of cancer
Radiographically confirmed brain metastases.

Exclusion Criteria:

Hematologic malignancies
Concurrent need for radiotherapy to another site.

Description of Study Protocol:

Recruitment

Prior to initiation, the Rapid Access Palliative Radiotherapy Program (RAPRP) brain metastases clinic was advertised by means of an email blitz to all physicians at the Cross Cancer Institute (CCI) in Edmonton, Alberta, Canada, as well as physicians at the associate cancer centers in Alberta. A presentation to introduce the clinic was made to the breast and lung tumor groups at CCI. All patients seen at the clinic were referred by physicians.

Design

Non-controlled trial

Blinding used

Intervention

Patients who met criteria for referral were scheduled for next available clinic. The multidisciplinary team (MDT) included radiation oncologist (RO), radiation therapist (RTT), registered nurse, nurse practitioner (NP), pharmacist, social worker (SW), occupational therapist (OT), and registered dietitian (RD). A clinic day flow:

Patient assessed by MDT
All eligible and interested patients are accrued to clinical trials
If appropriate, patient is simulated for radiotherapy, starting treatment same day
Patient completes satisfaction survey. Interim report faxed to patient's primary care physician.

Statistical Analysis

Descriptive statistics (percentages, medians, means and ranges) were used for demographic, referral, treatment, follow-up information and results of the patient satisfaction survey.

Data Collection Summary:

Timing of Measurements

All assessments took place at baseline, with a more limited follow-up assessment performed by telephone at one and four weeks after WBRT. The clinic ran weekly from August 5, 2009 to January 27, 2010.

Dependent Variables

Symptoms [patient-reported using the Princess Margaret Hospital (PMH) Brain Metastases Symptom Checklist]
QOL (patient-reported using the Euroqol EQ-5D questionnaire)
Patient satisfaction (patient-reported using a survey).

Independent Variables

Palliative whole brain radiotherapy (WBRT)
MDT assessment (OT, SW or RD).

Control Variables

Several physician-reported measures, including

General performance status (using the Karnofsky performance status)
Palliative performance status (using the Palliative Performance Scale)
Neurologic functions status (using the Radiation Therapy Oncology Group neurologic function classification)
Cognitive function (using the mini-mental state exam).

Description of Actual Data Sample:

Initial N: 44 patients referred
- 33 patients (75%) met criteria and seen in clinic, including 13 males (39.4%) and 20 females (69.6%)
- Reasons for referred patients no seen: Clinic fully booked (three), no pathologic diagnosis (two), patient required concurrent RT at another site (two), incorrect diagnosis (two), and already booked to see another RO (one)
Attrition (final N): 33 patients
Age: Median 66 years, range 37-85 years
Ethnicity: Not Applicable
Other relevant patient characteristics:
- 32 (97.0%) live in Alberta province, of which 1/3 lived in Edmonton
- Majority (60%) had a lung cancer primary
- Most (73%) had multiple brain metastases
- 2/3 had extra-cranial metastases
- 1/4 had progressive primary disease
- Majority (76%) had been started on a corticosteroid (dexamethasone) prior to referral
Anthropometrics: Not Applicable
Location: RAPRP at CCI in Edmonton, Alberta, Canada.

Summary of Results:

Key Findings

The median time from referral date to clinic date was six days (range, one to 12 days), with 76% seen within one week
29 of the 33 patients (88%) completed the patient-reported questionnaire
PMH Symptom Checklist: The most common symptoms reported were tiredness (70%), problems with balance/coordination (65.5%) and loss of memory (51.7%)
Euroquol EQ-5D QOL questionnaire: Patients reported the least problems with self-care and pain/discomfort (76%) and most of problems with usual activities (52%)
MDT assessment: 59% assessed. 15 patients (14%) by a SW, 12 (36%) by an OT, and 11 (33%) by a RD.

Reasons for Nutrition Assessment	No. of patients
Weight loss	8
Decreased appetite	8
Increased appetite/weight gain	1

30 of the 33 patients treated with WBRT, with 94% started their WBRT on clinic day
Patient satisfaction: 86% reported very satisfied with the clinic experience, and 97% would recommend the clinic to a patient in similar situation

Results of patient satisfaction survey

No. of patients

Overall clinic experience (n=29)

Very satisfied

Somewhat satisfied

25 (86.2%)

4 (13.8%)

MDT team useful (n=29)

Yes

Did not meet with MDT

Unsure

16 (55.2%)

12 (41.4%)

1 (3.4%)

Length of clinic (n=28)

Just right

Too long

23 (82.1%)

5 (17.9%)

Recommend clinic (n=29)

Yes

Unsure

28 (96.6%)

1 (3.6%)

Follow-up assessments: 45% completed at weeks one and/or four. 13 (39%) completed at one week and nine (27%) at four weeks. Most assessment were completed by patients, followed by caregivers and health care professionals.
In response to the question, "Do you think WBRT helped?", the responses were "unsure" (62%), "not at all" (15%) and "a lot" (15%) at week one. At four weeks, 1/3 were unsure, and 1/3 felt it had helped a little.
There were too few completed assessments to meaningfully analyze trends in ratings from the PMH symptom checklist and Euroqol EQ-5D questionnaire.

Author Conclusion:

The pilot RAPRP brain metastases clinic at the CCI was successful in providing patients with timely and multidisciplinary care and will continue to operate.

Limitations and considerations:

The follow-up assessments were completed in only a minority of patients, may be in part due to the poor prognosis and performance status of brain metastases patients
Due to poor physical health and a short survival, the study allowed patient caregivers to complete follow-up assessments for patients. However, the desire to obtain more complete data must be balanced with the recognition that there can be substantial differences between ratings provided by patients and their proxies.
To further improve the clinic experience: Adding to MDT a pharmacist, increasing the percentage of patients who undergo MDT assessments, and having more research studies available for patients to participate.

Funding Source:

Other:

This study had no sources of funding.

Reviewer Comments:

Too few assessments were completed at follow-up, making it difficult to evaluate effects of clinic visit. However, this might be acceptable given the natural of the study (a pilot), the natural of the disease process, and the objectives of the clinic.

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)	Yes

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?		???
	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?	N/A
	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?		N/A
	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.)	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?	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?	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?	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?	???
	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?	No
	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?	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?	N/A
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	N/A
	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?	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?	N/A
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?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	N/A
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	N/A
	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)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	No
	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