Patient Reported Outcomes Registry in Patient With Cancer Cachexia

Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02983500

Acronym

PROXie

Enrollment

253

Registered

2016-12-06

Start date

2016-08-28

Completion date

2019-07-24

Last updated

2020-08-07

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

Conditions

Metastatic Pancreatic Cancer, NSCLC, Metastatic

Keywords

Patient Reported Outcome (PRO)

Brief summary

Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.

Detailed description

The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia. Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively. These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage III/IV * Start of the first line palliative systemic treatment * Ability to read and understand German * Written informed consent

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Rate of patients with loss of > 5 % body weight	18 months

Secondary

Measure	Time frame	Description
Number of underweight patients	12 months	BMI \< 20 kg/qm at start or during observation.
General health-related quality of life assessment	12 months	At baseline, throughout and at the end of the study with SF 12 questionnaire.
Fatigue assessment	12 months	At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale).
Cachexia assessment	12 months	At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale).

Countries

Germany

Outcome results