Clinical trial NCT03211273: Longitudinal Investigation of Cancer-related Fatigue
Official title: A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer-related Fatigue
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
First posted: 2017-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients newly diagnosed with breast, ovarian or colon cancer

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue severity
timeFrame: from diagnosis to 1 year post-diagnosis
measure: Impact of fatigue
timeFrame: from diagnosis to 1 year post-diagnosis
measure: State of fatigue management
timeFrame: from diagnosis to 1 year post-diagnosis
Secondary outcomes:
measure: Quality of life functions and symptoms
timeFrame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
measure: Sleep problems
timeFrame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
measure: Depression
timeFrame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
measure: Body mass index
timeFrame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
measure: Total physical activity
timeFrame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
measure: Diurnal cortisol rhythm
timeFrame: 1 year post-diagnosis
measure: Return to work
timeFrame: 6, 12 months and 2, 3, 4, and 5 years post-diagnosis
measure: Hot flashes
timeFrame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
measure: Anxiety
timeFrame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Other outcomes:
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