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Table 2 Assessments and interventions

From: A randomized phase II study of nutritional and exercise treatment for elderly patients with advanced non-small cell lung or pancreatic cancer: the NEXTAC-TWO study protocol

 

Control arm

Intervention arm

Sessions

 

Time pointa

T1

T2/T3

T4

T1

T2/T3

T4

Detail of assessment/intervention

Nutritional sessions

30 min at T1

20 min at T2, T3, and T4

Assessments

•Food intake

â—‹

–

â—‹

â—‹

â—‹

â—‹

• Nutritional status (MNAd)

â—‹

–

â—‹

â—‹

â—‹

â—‹

• Nutritional checklistb

â—‹

–

â—‹

â—‹

â—‹

â—‹

•Skeletal muscle analysis

â—‹

–

â—‹

â—‹

–

â—‹

•Diet diary collection

–

–

–

–

â—‹

â—‹

Interventions

• Nutritional advice

–

–

–

â—‹

â—‹

â—‹

• Support for NISd management, food environment, and eating-related distress

–

–

–

â—‹

â—‹

â—‹

• ONSd prescriptionc

–

–

–

â—‹

â—‹

–

Exercise session

30 min at T1

20 min at T2, T3, and T4 each for A and B.

Assessments

• Assessment of physical function (Hand-grip strength, SPPBd)

â—‹

–

â—‹

â—‹

–

â—‹

• Exercise diary collection

–

–

–

–

â—‹

â—‹

• Assessment of physical activity

(Physical activity measurement, Physical activity interview)

â—‹

–

–

â—‹

â—‹

â—‹

• EORTC-QLQ-C30 questionnaire

â—‹

–

â—‹

â—‹

–

â—‹

Interventions

A. Home-based resistance training

      

• Prescription (T1) and modification (T2, T3, T4) of exercise program

–

–

–

â—‹

â—‹

â—‹

• Instruction of exercise procedures

–

–

–

â—‹

â—‹

â—‹

•Education of self-modification

–

–

–

â—‹

â—‹

â—‹

B. Physical activity promotive counseling

      

• Prescription of target daily step

–

–

–

â—‹

â—‹

â—‹

• Physical activity counseling

–

–

–

â—‹

â—‹

â—‹

• Education of fall prevention

–

–

–

â—‹

â—‹

â—‹

  1. aBaseline assessments were performed during the time between study entry and initiation of chemotherapy (T1 point). Subsequent assessments were at 4 ± 2 (T2 point), 8 ± 2 (T3 point), 12 ± 2 (T4 point) weeks after the study enrollment
  2. bNutritional checklist to collects information about presence or absence of nutrition impact symptoms, problems in food environment, or eating-related distress
  3. cA branched-chain amino-acids rich oral nutritional supplement (Inner Power®, Otsuka Pharmaceutical Co., Ltd., Japan) was provided one pack daily for 12 weeks
  4. dMNA Mini-nutritional assessment, NIS nutrition impact symptoms, ONS oral nutritional supplement, SPPB Short Physical Performance Battery