Longitudinal Investigation of Cancer-related Fatigue and Its Treatment (LIFT Project)

NCT04921644 | Active Not Recruiting

• 1 other identifier: LIFT project
• Study Type: observational
• Target: 1,183
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (4)

• Fatigue severity

  assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire). The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much) with higher scores meaning a higher level of fatigue.

  6 months after diagnosis to 2 years post-diagnosis

• Impact of fatigue

  assessed by the Brief Fatigue Inventory (BFI). The BFI consists of an 11-point numerical rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine) with higher scores signifying higher intensity and impairment.

  6 months after diagnosis to 2 years post-diagnosis

• State of fatigue management

  Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue.

  6 months after diagnosis to 2 years post-diagnosis

• Knowledge, attitudes and beliefs regarding cancer-related fatigue

  Questionnaire assessing knowledge, attitudes and beliefs regarding cancer-related fatigue. The knowledge score consists of fatigue-related statements that should be rated as either right, wrong, or "dont know". The attitudes scale is composed of statements that should be rated on a 4-point likert scale. Higher scores indicate a greater agreement to the particular statement.

  6 months after diagnosis to 2 years post-diagnosis

Secondary Outcomes (13)

• Quality of life functions and symptoms

  6 months after diagnosis to 2 years post-diagnosis

• Sleep problems

  6 months after diagnosis to 2 years post-diagnosis

• Depression

  6 months after diagnosis to 24 months post-diagnosis

• Body mass index

  6 months, 12 months and 24 months post-diagnosis

• Total physical activity

  6 months, 12 months and 24 months post-diagnosis

Study Arms (1)

patient cohort

Newly diagnosed patients 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 recruited approximately 6 months after diagnosis and followed up to 2 years post-diagnosis. No intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• German Cancer Research Center: lead
• Wuerzburg University Hospital: collaborator
• Baden-Württemberg Cancer Registry: collaborator
• German Research Foundation: collaborator

Study Sites (1)

German Cancer Research Center

Heidelberg, Germany

Location

Related Publications (4)

• Wagner AS, Milzer M, Schmidt ME, Kiermeier S, Maatouk I, Steindorf K. Nurses' Knowledge of Cancer-Related Fatigue and the Coverage of This Subject in Nursing Training: A Cross-Sectional Study. J Nurs Res. 2025 Apr 1;33(2):e379. doi: 10.1097/jnr.0000000000000666.

  PMID: 40162696 DERIVED

• Wagner AS, Wehlen L, Milzer M, Schmidt ME, Kiermeier S, Maatouk I, Steindorf K. Physicians' perspectives on cancer-related fatigue management and their suggestions for improvements in medical training: a cross-sectional survey study in Germany. Support Care Cancer. 2024 Nov 14;32(12):788. doi: 10.1007/s00520-024-08978-2.

  PMID: 39537876 DERIVED

• Milzer M, Wagner AS, Schmidt ME, Maatouk I, Hermann S; Cancer Registry of Baden-Wurttemberg; Kiermeier S, Steindorf K. Patient-physician communication about cancer-related fatigue: a survey of patient-perceived barriers. J Cancer Res Clin Oncol. 2024 Jan 25;150(2):29. doi: 10.1007/s00432-023-05555-8.

  PMID: 38270814 DERIVED

• Milzer M, Wagner AS, Steindorf K, Kiermeier S, Schmidt ME, Maatouk I. Psycho-oncologists' knowledge of cancer-related fatigue and the targets for improving education and training: results from a cross-sectional survey study. Support Care Cancer. 2023 Jun 23;31(7):412. doi: 10.1007/s00520-023-07882-5.

  PMID: 37351639 DERIVED

Study Officials

• Karen Steindorf, Prof. Dr.

  German Cancer Research Center, Division of Physical Activity, Prevention and Cancer

  PRINCIPAL INVESTIGATOR

• Martina E. Schmidt, Dr.

  German Cancer Research Center, Division of Physical Activity, Prevention and Cancer

  PRINCIPAL INVESTIGATOR

• Imad Maatouk, Prof. Dr.

  Psychosomatics, Psychotherapy and Psycho-Oncology, Medical Hospital II, University Hospital Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: June 10, 2021
• Study Start: August 4, 2021
• Primary Completion: January 7, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 26, 2025

Record last verified: 2024-12

Locations

DE (1)