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Cancer-related FatigueNCT04921644

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

An observational study of Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer-related Fatigue
How many people
1,183 participants
Where
1 siteGermany
Study dates
4 Aug 2021to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • ≥ 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • German Cancer Research Center

    Heidelberg

Other trials in Germany

About this study

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.

Read the 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04921644
Study groupRoleWhat they receive
patient cohortNewly 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months after diagnosis to 2 years post-diagnosis

  2. 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.

    Measured: 6 months after diagnosis to 2 years post-diagnosis

  3. State of fatigue management

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

    Measured: 6 months after diagnosis to 2 years post-diagnosis

  4. 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.

    Measured: 6 months after diagnosis to 2 years post-diagnosis

Secondary outcomes (13)

  1. Quality of life functions and symptoms

    assessed by EORTC QLQ-C30 and 5 additional items derived according to the EORTC scoring manual assessing symptoms of fever, hot flashes, night sweat, polyneuropathy and distress of dependents caused by the diagnosis are added. The items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). A higher score corresponds to a higher level of symptoms/problems.

    Measured: 6 months after diagnosis to 2 years post-diagnosis

  2. Sleep problems

    assessed by Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of open and closed questions regarding characteristics of sleep and sleep quality. Some items are rated on a 4-point likert scale with higher scores meaning more sleep problems.

    Measured: 6 months after diagnosis to 2 years post-diagnosis

  3. Depression

    assessed by Patient Health Questionnaire (PHQ-9). The items are rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). A sum score is calculated, with higher scores meaning a higher level of depressive symptoms.

    Measured: 6 months after diagnosis to 24 months post-diagnosis

  4. Body mass index

    calculated from weight and height

    Measured: 6 months, 12 months and 24 months post-diagnosis

  5. Total physical activity

    assessed by a questionnaire regarding walking, cycling and exercise behavior

    Measured: 6 months, 12 months and 24 months post-diagnosis

  6. Return to work

    assessed by questions regarding occupational issues

    Measured: 6 months, 12 months and 24 months post-diagnosis

  7. Anxiety

    assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7). The items are rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). A sum score (ranging from 0 to 21) is calculated, with higher scores meaning a higher level of symptomatology.

    Measured: assessed 6 months after diagnosis to 24 months after diagnosis

  8. Supportive Care Needs

    assessed by the Supportive Care Needs Survey (SCNS-SF-34). The scale ranges from 1 (not applicable) to 5 (high need) with higher scores meaning a higher need of support.

    Measured: assessed at t2 9 months post-diagnosis

  9. Social Support

    assessed by the Illness-specific Social Support Scale (ISSS, German Version) among cancer patients. The 8 items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Sum scores for the items 1,3,6 and 8 (positive support) as well as for the items 2,4,5 and 7 (detrimental interaction) are calculated with higher scores meaning higher levels of positive support and detrimental interaction respectively.

    Measured: at t1 (6 months post-diagnosis) and t3 (12 months post-diagnosis)

  10. Loneliness

    assessed by three items of the University of California, Los Angeles (UCLA)-loneliness-scale. The response categories are 1 (hardly ever), 2 (some of the time) and 3(often). A sum score is calculated with higher scores meaning a higher level of loneliness.

    Measured: at t1 (6 months post-diagnosis) and t4 (24 months post-diagnosis)

  11. Resilience

    assessed by the Brief Resilience Scale (BRS). The six items are rated on a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). After reversing the coding of inverted items 2,4 and 6, the mean of the six items is calculated with higher scores meaning a higher level of resilience.

    Measured: assessed at t1 6 months post-diagnosis

  12. Patient Activation

    assessed by the Patient Activation Measure (PAM-13). Patients are supposed to rate their level of agreement to 13 statements on a 4-point-scale. A higher score corresponds to a higher level of patient activation.

    Measured: at t2 (9 months post-diagnosis)

  13. Posttraumatic growth

    assessed by Posttraumatic Growth Inventory (PTGI). The items are rated on a 6-point Likert scale ranging from 1 (not at all) to 6 (very strongly) with higher scores indicating a higher level of posttraumatic growth.

    Measured: at t4 (24 months post-diagnosis)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start4 Aug 2021
  3. Primary completion7 Jan 2023
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04921644
Sponsor's protocol ID
LIFT project
Status last verified
Dec 2024
First submitted
9 Apr 2021
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40162696

  • 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.

    PubMed 39537876

  • 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.

    PubMed 38270814

  • 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.

    PubMed 37351639

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue severity (time frame: 6 months after diagnosis to 2 years post-diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04921644, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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