The effect of (chemo- or bio)radiation on functional capacity, fatigue and quality of life in patients with head and neck cancer: a trial within cohorts, the VITAL study.

The effect of (chemo- or bio)radiation on functional capacity, fatigue and quality of life in patients with head and neck cancer: a trial within cohorts, the VITAL study. - Vitality in patients with head and neck cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50761

Enrollment

116

Registered

2022-01-26

Start date

2022-01-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer Physical performance

Interventions

The cohort + intervention group receives an exercise intervention for 10 weeks: 1 week before the start, 7 weeks during and 2 weeks after (C/B)RT. The experimental intervention consists of twice a w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with head and neck cancer who are scheduled for (chemo- or bio)radiation - Patients >=18 years of age - Patients with sufficient Dutch writing and reading skills - Karnofsky Performance status >60 - Able to walk >=60 m without a mobility aid - No contraindication for physical activity measured with the Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion criteria

Exclusion criteria: - Recurrence of HNC - Secondary HNC - HNC surgery

Design outcomes

Primary

Measure	Time frame
Physical performance, measured by the six minute walking test	—

Secondary

Measure	Time frame
- Muscle strength: measured by handgrip strength and microfet - Health related quality of life: measured by : the European Organisation for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the European Organisation for Research and Treatment for Cancer Quality of Life Questionnaire Head and Neck Module (EORTC-QLQ-HN43) and the EuroQol- Five Dimensions- Five Level (EQ-5D-5L) - Fatigue: measured by the Multidimensional Fatigue Inventory (MFI) - Body composition: measured by Body Mass Index (BMI) - Nutritional status: measured by the Short Nutritional Assessment Questionnaire (SNAQ) - Physical activity: measured by the Short Questionnaire to assess health enhancing physical activity (SQUASH) - Treatment tolerability - Health related costs: measured with Quality-Adjusted Life Year (QALY's)	—

Measure

Time frame

- Muscle strength: measured by handgrip strength and microfet - Health related quality of life: measured by : the European Organisation for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the European Organisation for Research and Treatment for Cancer Quality of Life Questionnaire Head and Neck Module (EORTC-QLQ-HN43) and the EuroQol- Five Dimensions- Five Level (EQ-5D-5L) - Fatigue: measured by the Multidimensional Fatigue Inventory (MFI) - Body composition: measured by Body Mass Index (BMI) - Nutritional status: measured by the Short Nutritional Assessment Questionnaire (SNAQ) - Physical activity: measured by the Short Questionnaire to assess health enhancing physical activity (SQUASH) - Treatment tolerability - Health related costs: measured with Quality-Adjusted Life Year (QALY's)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)