Clinical trial NCT04921644: Longitudinal Investigation of Cancer-related Fatigue and Its Treatment (LIFT Project)
Official title: Longitudinal Investigation of Cancer-related Fatigue and Its Treatment (LIFT Project)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer-related Fatigue
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: Wuerzburg University Hospital
name: Baden-Württemberg Cancer Registry
name: German Research Foundation
First posted: 2021-06-10
Enrollment: 1183
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 colon, rectum, liver, pancreas or lung cancer, malignant melanoma, breast or other gynecological cancers, prostate, kidney, bladder or thyroid gland cancer, non-Hodgkin lymphoma or leukemia.

Brief summary: The LIFT project aims to thoroughly investigate the current status of health care in Germany regarding cancer-related fatigue from the institutional, professionals' and patients' perspective.

Detailed description: The LIFT project aims to thoroughly investigate the current status of health care in Germany regarding fatigue from the institutional, professionals', and patients' perspective. With a multimodal approach including a comprehensive assessment of fatigue management and support offered by different institutions (uncertified hospitals, uncertified oncological practices, counselling units, certified cancer centers; n=350), a survey and qualitative interviews among practicing physicians ("Niedergelassene Ärzte"), hospital physicians, practicing psychotherapists with psycho-oncological focus, psycho-oncologists at hospitals, nurses at certified cancer centers and nurses at other hospitals (n=420), and a longitudinal clinical study among cancer patients (n=1400) as well as two focus groups with patient representatives (each n=6), the characteristics, patterns, and potential effects or shortcomings of the current fatigue management will be investigated. Furthermore, factors associated with patients' and health care professionals' knowledge about fatigue will be examined.

Concerning the longitudinal clinical study assessing the patients' perspective, online or paper-based questionnaires on socio-demographic, clinical and patient reported outcomes will be sent to the patients 6,9,12 and 24 months after diagnosis. 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 project shall provide a basis to identify and overcome shortcomings in the actual fatigue management in Germany, and, to eventually ameliorate this severe burden in cancer patients and survivors.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Newly diagnosed with a primary tumor of one of the following malignant neoplasms: colon (C18), rectum (C19-20), liver (C22), pancreas (C25), lung (C33-34), malignant melanoma (C43), breast (C50, only female), cervix (C53), endometrium (C54.1), ovaries (C56), prostate (C61), kidney (C64), bladder (C67), thyroid gland (C73), non-Hodgkin lymphoma (C82-88), leukemia (C91-C95)
* Having received or receiving at enrolment at least one of the following treatments: chemotherapy, radiotherapy, hormone therapy, targeted or immune therapy
* Able to understand and follow the study protocol

Exclusion Criteria:

* Carcinoma in situ
* Any additional malignant or unclear neoplasm before or since time of diagnosis of the considered primary tumor, except unspecified neoplasm of skin (C44)

Primary outcomes:
measure: Fatigue severity
timeFrame: 6 months after diagnosis to 2 years post-diagnosis
measure: Impact of fatigue
timeFrame: 6 months after diagnosis to 2 years post-diagnosis
measure: State of fatigue management
timeFrame: 6 months after diagnosis to 2 years post-diagnosis
measure: Knowledge, attitudes and beliefs regarding cancer-related fatigue
timeFrame: 6 months after diagnosis to 2 years post-diagnosis
Secondary outcomes:
measure: Quality of life functions and symptoms
timeFrame: 6 months after diagnosis to 2 years post-diagnosis
measure: Sleep problems
timeFrame: 6 months after diagnosis to 2 years post-diagnosis
measure: Depression
timeFrame: 6 months after diagnosis to 24 months post-diagnosis
measure: Body mass index
timeFrame: 6 months, 12 months and 24 months post-diagnosis
measure: Total physical activity
timeFrame: 6 months, 12 months and 24 months post-diagnosis
measure: Return to work
timeFrame: 6 months, 12 months and 24 months post-diagnosis
measure: Anxiety
timeFrame: assessed 6 months after diagnosis to 24 months after diagnosis
measure: Supportive Care Needs
timeFrame: assessed at t2 9 months post-diagnosis
measure: Social Support
timeFrame: at t1 (6 months post-diagnosis) and t3 (12 months post-diagnosis)
measure: Loneliness
timeFrame: at t1 (6 months post-diagnosis) and t4 (24 months post-diagnosis)
measure: Resilience
timeFrame: assessed at t1 6 months post-diagnosis
measure: Patient Activation
timeFrame: at t2 (9 months post-diagnosis)
measure: Posttraumatic growth
timeFrame: at t4 (24 months post-diagnosis)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Cancer Research Center
Study officials:
affiliation: German Cancer Research Center, Division of Physical Activity, Prevention and Cancer
name: Karen Steindorf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: German Cancer Research Center, Division of Physical Activity, Prevention and Cancer
name: Martina E. Schmidt, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychosomatics, Psychotherapy and Psycho-Oncology, Medical Hospital II, University Hospital Wuerzburg
name: Imad Maatouk, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: