NCT03318224

Brief Summary

Fatigue is a major concern during and after cancer therapy with severe impact on quality of life. Yet, sound comparable data on fatigue prevalence, severity, and impact on daily life across different tumor entities is lacking. Furthermore, little is known about the current state of screening, counselling and treatment of fatigue. Thus, the FiX-Study aims to assess such data to identify patient groups with especial need for an improved fatigue management and treatment. A minimum of n=3000 patients about equally distributed about the 16 most common tumor entities shall be recruited between year 1 and 2 after primary cancer diagnosis via the cancer registry Baden-Württemberg. Data on fatigue (EORTC QLQ-FA12, BFI), quality of life (EORTC QLQ-C30), depression and anxiety (PAQ-4), and information about screening and treatment of fatigue will be assessed via self-reported questionnaires. Clinical data regarding tumor and treatment characteristics will be derived from the cancer registry. This trial is imbedded in a larger research agenda on fatigue and will provide the basis for the development of an individually-tailored fatigue program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,508

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

October 18, 2017

Last Update Submit

December 6, 2024

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (2)

  • EORTC QLQ-FA12

    12-item multidimensional fatigue questionnaire

    Assessment time point: about 1-2 years post-diagnosis

  • Brief Fatigue Inventory (BFI)

    Questionnaire on the impact of fatigue

    Assessment time point: about 1-2 years post-diagnosis

Secondary Outcomes (4)

  • EORTC QLQ-C30

    Assessment time point: about 1-2 years post-diagnosis

  • PHQ-4

    Assessment time point: about 1-2 years post-diagnosis

  • State of fatigue management

    Assessment time point: about 1-2 years post-diagnosis

  • Patient's believes and knowledge with regard to fatigue

    Assessment time point: about 1-2 years post-diagnosis

Interventions

none (observational study)OTHER

only assessments via questionnaires, no interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cancer patients who were diagnosed 1-2 years ago

You may qualify if:

  • ≥ 18 years of Age
  • Diagnosed with a primary tumor of one of the following malignant neoplasms (including in-situ carcinoma): stomach (C16, D00.2), colon (C18, D01.0), rectum (C19-20, D01.1-1.2), liver (C22, D01.5), pancreas (C25, D01.7), lung (C33-34, D02.1-2.2), malignant melanoma (C43, D03), breast (C50, D05, female only), cervix or ovaries (C53, D06), endometrium (C54.1, D07.0), ovaries (C56), prostate (C61), kidney (C64), bladder (C67, D09.0), non-Hodgkin lymphoma (C82-88), leukemia (C91-C95)
  • Time since first diagnosis is at least 1 year, maximal 2 years
  • Able to understand and follow the study protocol.

You may not qualify if:

  • Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor, except non-malignant, unspecified, or in-situ neoplasm of skin (C44 or D0.4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Cancer Research Center

Heidelberg, 69120, Germany

Location

Related Publications (3)

  • Schmidt ME, Hermann S, Arndt V, Steindorf K. Prevalence and severity of long-term physical, emotional, and cognitive fatigue across 15 different cancer entities. Cancer Med. 2020 Nov;9(21):8053-8061. doi: 10.1002/cam4.3413. Epub 2020 Sep 7.

    PMID: 32893501BACKGROUND

  • Schmidt ME, Bergbold S, Hermann S, Steindorf K. Knowledge, perceptions, and management of cancer-related fatigue: the patients' perspective. Support Care Cancer. 2021 Apr;29(4):2063-2071. doi: 10.1007/s00520-020-05686-5. Epub 2020 Aug 29.

    PMID: 32860177BACKGROUND

  • Schmidt ME, Blickle P, Steindorf K. Cancer-related fatigue: Identification of hallmarks to enable refined treatment approaches. Psychooncology. 2022 Dec;31(12):2169-2176. doi: 10.1002/pon.6061. Epub 2022 Nov 9.

    PMID: 36314131DERIVED

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 23, 2017

Study Start

November 30, 2017

Primary Completion

May 10, 2019

Study Completion

April 30, 2021

Last Updated

December 11, 2024

Record last verified: 2024-12

Locations

DE(1)