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Table 3 Overview of all measurements in the EFFECT trial

From: Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFECT study

 

T0

T1

T2

T3

Outcomes

Instrument

Baseline

Month 3 ± 14 days

Month 6 ± 14 days

Month 9 ± 21 days

Primary outcomes

 Cancer-related fatigue

EORTC QLQ-FA12

X

X

X

X

 Health-related quality of life

EORTC QLQ-C30

X

X

X

X

Secondary outcomes

 Patient-reported outcomes

  Breast cancer-specific symptoms

EORTC QLQ-BR45

X

X

X

X

  Depression and anxiety

Patient Health Questionnaire (PHQ-4)

X

X

X

X

  Sleep problems

Pittsburgh Sleep Quality Index (PSQI)

X

X

X

X

  Pain

Brief Pain Inventory Short Form (BPI-SF), PainDETECT, Pain Catastrophizing Scale (PCS)

X

X

X

X

  Quality of working lifea

Quality of Working Life Questionnaire for Cancer Survivors (QWLQ-CS)

X

X

X

X

  Subjectively measured physical activity

Modified version of the GODIN questionnaire

X

X

X

X

  Productivity loss

Productivity Cost Questionnaire (iPCQ)

 

X

X

X

  Healthcare resources consumption

Medical Consumption Questionnaire (iMCQ)

 

X

X

X

  Health-related quality of life

EQ-5D-5L

X

X

X

X

  Urinary incontinence

International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-UI SF)b

X

X

X

X

  Satisfaction with exercise interventiong

Self-developed questionnaire

 

X

X

X

 Physical measurements

  Physical performance

5-times sit-to-stand, short Fullerton Advanced Balance (S-FAB) scale

X

X

X

 

  Physical fitness

Steep Ramp Test (SRT), endurance cycle test, handgrip- and leg strength test, Cardiopulmonary Exercise Testing (CPET)c, Isokinetic and isometric peak torqued

X

X

X

 

  Objectively measured physical activity

Physical activity tracker (Fitbit Inspire HR)

X

X

X

X

  Muscle thicknesse

Ultrasonography

X

X

X

 

  Body composition

Bio-impedance, DEXAf

X

X

X

 

  Anthropometry

• Body weight

X

X

X

 

• Waist and hip circumference

X

X

X

 

• Height

X

   

  Resting heart rate and blood pressure

-

X

X

X

 

  Blood markers

Plasma, serum, buffy coat and peripheral blood mononuclear cells

X

X

X

 

Socio-demographic and medical data

 Socio-demographic data

Self-developed questionnaire

X

   

 Medical history and concomitant diseases

Medical records

X

X

X

X

 Cancer progress and treatment over the course of the study

Medical records

X

X

X

X

 Cancer characteristics and treatment history

Medical records

X

X

X

X

 Concomitant medication

Medical records

X

X

X

X

 Adverse events

Reports of patients, trainers, oncology nurses, physicians or medical records

X

X

X

X

 Overall and breast-cancer-specific survival and progression-free survival

Medical records and/or cancer registry

Up to 5 years after the 9-month intervention period

  1. aAdd-on measurement in the following clinical centers: UMCU, NKI, DKFZ, and ACU
  2. bAdd-on measurement in the following clinical center: ONK, UMCU, and NKI
  3. cAdd-on measurement in the following clinical center: KI and DSHS
  4. d,eAdd-on measurement in the following clinical center: KI
  5. fAdd-on measurement in the following clinical center: KI and ACU
  6. gOnly for the exercise group