Longitudinal Investigation of Cancer-related Fatigue

Cancer-related Fatigue Clinical Trial

— LIFT  

Official title:

A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03211273
• Other study ID #: LIFT
• Status: Withdrawn
• Start date: March 2019
• Est. completion date: June 2025

Study information

• Verified date: August 2019
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the LIFT study 2000 cancer patients will be recruited at 6 months after diagnosis and extensively surveyed over five years on factors that are associated with fatigue.

Description:

The LIFT study aims to comprehensively investigate characteristics, determinants, and long-term course of fatigue. In addition, information shall be gained on the current state of fatigue treatment and care in Germany and on the needs of affected patients.

Data will be collected by mailed or online questionnaires at 6, 9, and 12 months as well as 2, 3, 4 and 5 years post-diagnosis from 2000 cancer patients. Besides questionnaires on socio-demographic, clinical and patient reported outcomes, saliva samples will be collected in order to gain new insights into biological mechanisms. Moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. Tumor and cancer therapy data will be extracted from the Epidemiological Cancer Registry.

The results of the LIFT study aim to contribute to an improved, evidence-based and individualized treatment to avoid and ease cancer-related fatigue and will further promote patient-oriented offers and treatments.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age

• Diagnosed with a primary tumor of breast, ovarian, or colon cancer

• Time since first diagnosis is 4 - 6 months

• Having received or currently receiving at least one of the following treatments:

surgery, chemotherapy, radiotherapy, hormone therapy, or immune therapy.

• Able to understand and follow the study protocol.

Exclusion Criteria:

• Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
German Cancer Research Center	University Hospital Heidelberg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue severity	assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire)	from diagnosis to 1 year post-diagnosis
Primary	Impact of fatigue	assessed by the Brief Fatigue Inventory (BFI)	from diagnosis to 1 year post-diagnosis
Primary	State of fatigue management	Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue	from diagnosis to 1 year post-diagnosis
Secondary	Quality of life functions and symptoms	assessed by EORTC QLQ-C30	6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Secondary	Sleep problems	assessed by Pittsburgh Sleep Quality Index (PSQI)	6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Secondary	Depression	assessed by Patient Health Questionnaire (PHQ-9)	6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Secondary	Body mass index	calculated from weight and height	6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Secondary	Total physical activity	assessed by a questionnaire regarding walking, cycling, and exercise behavior	6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Secondary	Diurnal cortisol rhythm	assessed in saliva	1 year post-diagnosis
Secondary	Return to work	assessed by a questions regarding occupational issues	6, 12 months and 2, 3, 4, and 5 years post-diagnosis
Secondary	Hot flashes	assessed only for women	6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Secondary	Anxiety	assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7)	6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis