EAL

ONC: Radiation Therapy (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To describe the effect of specific variables (co-morbidity, nutritional intake, estimated adequacy of intake, radiation dose, side-effects, and social support) on selected outcomes (weight, functional status) in elderly breast and lung cancer patients receiving radiotherapy.

Inclusion Criteria:

Histologically confirmed lung or breast cancer
Age > = 60 years
Starting radiotherapy (prophylactic, curative, or palliative)
Can converse and read English
Physician approval for study participation

Exclusion Criteria:

Not Specified

Description of Study Protocol:

Recruitment Patients that met inclusion criteria were invited to join the study. There is no description as to how patients were initially identified.

Design Prospective observational study of elderly breast and lung cancer patients receiving radiotherapy with prophylactic, curative, or palliative intent.

The following were measured at the beginning (T1), middle (approximately week 3)(T2) and conclusion (approximately week 6) (T3) of radiotherapy and 3 moths post-radiation (T4):

Weight as measured on scale.
Functional status as measured by Karnofsky Performance S tatus (KPS), Physical and Instruments Activities of Daily Living (PADL & IADL) subscales of the Functional Assessment Inventory, and the Overall Health Rating (OHR) subscale of the Functional Assessment Inventory.
Nutritional intake as measured by 3 day food diary. Nutrient Analysis was performed by an RD using a computer program.
Estimated adequacy of intake as calculated from the average intake from the 3 day food diary and the estimated energy expenditure.

Co-morbidity was measured by self report at the beginning of the study.

Radiation dose was obtained from medical recods at conclusion of radiotherapy (T3)

Side-effects as measured by Dodd's Self care Behavior Log (S-C BL) daily througout radiotherapy and for a 2-week period at T4.

Estimated energy expenditure was determined by the Harris Benedict Equation and multiplied by an activity factor of 1.5.

Social support was measued at T1 using the Norbeck Social Support Questionnaire (NSSQ).

BMI was calculated at each timepoint from measured height and weight.

Blinding used (if applicable) Not applicable

Intervention (if applicable) Not applicable

Statistical Analysis Analysis was performed using the following tests

t-tests (interval level variables)
chi square (categorical variables)
Pearson's correlation coefficient
Repeated measures analysis of variance

Data Collection Summary:

Timing of Measurements: The following were measured at the beginning (T1), middle (approximately week 3) (T2) and conclusion (approximately week 6) (T3) of radiotherapy and 3 moths post-radiation (T4):

Weight as measured on scale.
Functional status as measured by Karnofsky Performance S tatus (KPS), Physical and Instruments Activities of Daily Living (PADL & IADL) subscales of the Functional Assessment Inventory, and the Overall Health Rating (OHR) subscale of the Functional Assessment Inventory.
Nutritional intake as measured by 3 day food diary. Nutrient Analysis was performed by an RD using a computer program.
Estimated adequacy of intake as calculated from the average intake from the 3 day food diary and the estimated energy expenditure.

Co-morbidity was measured by self report at the beginning of the study.

Radiation dose was obtained from medical recods at conclusion of radiotherapy (T3)

Side-effects as measured by Dodd's Self care Behavior Log (S-C BL) daily througout radiotherapy and for a 2-week period at T4.

Social support was measued at T1 using the Norbeck Social Support Questionnaire (NSSQ).

Dependent Variables

Variable 1: Weight as measured on scale at the beginning, middle and conclusion of radiotherapy and 3 moths post-radiation.
Variable 2: Functional status as measured by Karnofsky Performance S tatus (KPS), Physical and Instruments Activities of Daily Living (PADL & IADL) subscales of the Functional Assessment Inventory, and the Overall Health Rating (OHR) subscale of the Functional Assessment Inventory at the beginning, middle and conclusion of radiotherapy and 3 moths post-radiation.

Independent Variables

The following variables were examined as independent: co-morbidity, nutritional intake, estimated adequacy of intake, radiation dose, side-effects, and social support

Description of Actual Data Sample:

Initial N: 45 (16 males, 29 females)

Attrition (final N): Not described

Age: Mean 69.8 (range 61-86 years)

Ethnicity: White 91.1% (n=41)

Other relevant demographics:

Diagnosis
- Lung Cancer (n=26, 57.5%)
  - Stage I n=2
  - Stage III n=18
- Breast Cancer (n=19, 42.3%)
  - Stage III n=1
Radiation
- Mean dose radiation received to primary site: 4661 ± 1064 cGy
- Mean dose radiation received to secondary site: 4293 ± 1867 cGy
Side effects: mean number reported
- T1: 3.3 (n=27)
- T2: 2.5 (n=13)
- T3: 1.8 (n=8)
- Most common: fatigue, skin changes
Comorbidity:
- 81.4% reported at least one
- Arthritis: 53.3% (n=24)
- HTN: 48.9% (n=22)
- CVD: 42.2% (n=19)
- No significant differences between groups with and without comorbidities at any timepoint
Social Support
- T1: mean 7.5 individuals important to patient
- Functional Support Score: 149 ± 7.9
- Network Mean Score: 70.2 ± 37.8

Anthropometrics Not described

Location: San Francisco, CA; specific location not described

Summary of Results:

	T1	T2	T3	T4
CALORIC INTAKE OVER TIME
Caloric Intake (Kcal)	1,454 ± 487	1,411 ± 386	1,417 ± 419	1,280 ± 488
Caloric Intake (% BEE)	106.8 ± 33.4	107.7 ± 27.7	103 ± 28.7	102 ± 22.7
Caloric Intake (% BEEx1.5)	71.1 ± 22.3	71.5 ± 18.7	68.6 ± 19.2	67.9 ± 15.1
Carbohydrate (% Kcal)	46.9 ± 10.5	44.9 ± 7.8	44.6 ± 9.5	41.5 ± 8.7
Protein (% Kcal)	15.4 ± 5.3	16.7 ± 3.3	18.1 ± 4.1	18.8 ± 3.3
Fat (% Kcal)	34.9 ± 8.4	34.0 ± 6.1	34.7 ± 7.7	37.1 ± 7.2
FUNCTIONAL STATUS OVER TIME
KPS (%)	78.2 ± 17.6	78.6 ± 18.0	80.4 ± 18.3	85.7 ± 14.1
PADL	25.5 ± 1.2	25.6 ± 0.9	25.5 ± 1.2	25.8 ± 0.4
IADL	28.2 ± 1.5	28.5 ± 1.2	28.7 ± 0.7	28.8 ± 0.4
OHR	6.2 ± 2.4	6.2 ± 2.2	6.5 ± 2.9	6.7 ± 3.8

	T1	T2	T3	T4
Relationship Between Protein Calories and Weight/BMI
Weight T1	0.39^a
BMI T1	0.53^b
Weight T2	0.37^a	0.52^b
Weight T3	0.46^a	0.47^a	0.52^b
BMI T3	0.47^a	0.46^a
Relationship Between Carbohydrate Calories and Functional Status
IADL
T1	-0.35^a
T2	-0.47^a	-0.38^a
T3		-0.65^b	-0.61^b
T4	-0.59^a		-0.83^b	-0.67^a
PADL
T1
T2
T3	-0.53^a
T4			-0.60^a	-.066^a
KPS
T1	-0.39^a	-0.66^b
T2	-0.37^a	-0.39^a
T3	-0.37^a		0.40^a
T4			0.61^a

a p<= 0.05; b p<= 0.01

Other Results:

Caloric intake not significantly correlated with weight at T1 to T3; Caloric intake significantly correlated with weight at T4 (p=0.004)
Calories from protein significantly correlated with weight at T1 to T3 (p=0.02, p=0.004, p=0.01); Calories from protein not significantly correlated with weight at T4
Caloric intake at T2 significantly to KPS at T2 (p=0.02); Caloric intake inversely significant to IADL (P=0.02)
Carbohydrate intake inversely significant to 2 functional status measures at each time-point.
Protein intake significantly associated to KPS at T2 (p=0.03) and T4 (p=0.01)
No relationship between 3 dimensions of social support and weight

Author Conclusion:

Elderly patients with lung and breast cancer experienced a significant weight loss at midpoint and end of radiation therapy. Percentage of calories contributed by protein significantly positively impacted weight. There were no major disruptions in functional status during treatment.

Funding Source:

University/Hospital:

University of California, State University of California

Reviewer Comments:

Overall a well planned study that examined many important aspects of nutritional care of elderly cancer patients. The following information limited the results:

Data on weight and BMI at timepoints is not presented.
Incomplete information on demographics (stage, ethnicity)
No information on patient recruitment
No information on where the study took place

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
	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
	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
	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
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
	1.	Was the research question clearly stated?	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
	1.1.	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
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
	1.3.	Were the target population and setting specified?	Yes
	2.	Was the selection of study subjects/patients free from bias?	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
	2.1.	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
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	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
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
	3.	Were study groups comparable?	N/A
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
	3.1.	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
	3.2.	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
	3.3.	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
	3.4.	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
	3.5.	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
	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?	No
4.	Was method of handling withdrawals described?		No
	4.1.	Were follow-up methods described and the same for all groups?	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%.)	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%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	4.4.	Were reasons for withdrawals similar across groups?	No
	4.4.	Were reasons for withdrawals similar across groups?	No
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	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.	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
	5.1.	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.)	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
	5.3.	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
	5.4.	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
	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?	No
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		No
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	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
	6.2.	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?	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
	6.4.	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?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.6.	Were extra or unplanned treatments 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
	6.7.	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
	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.	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
	7.1.	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
	7.2.	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
	7.3.	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
	7.4.	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
	7.5.	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
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	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.	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
	8.1.	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
	8.2.	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
	8.3.	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
	8.4.	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)?	Yes
	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
	8.6.	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
	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.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	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.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes