Cancer-related FatigueLIFTNCT03211273
Longitudinal Investigation of Cancer-related Fatigue
An observational study of Cancer-related Fatigue, run by German Cancer Research Center.
Trial 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. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 breast, ovarian or colon cancer
Who may be able to join
- ≥ 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.
Who cannot join
- Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
About this study
Official title: A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)
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.
Read the 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.
- Conditions
- Cancer-related Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient cohort | Newly diagnosed breast, ovarian or colon cancer patients recruited 6 months post-diagnosis and followed up to 5 years post-diagnosis. No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity
assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire)
Measured: from diagnosis to 1 year post-diagnosis
Impact of fatigue
assessed by the Brief Fatigue Inventory (BFI)
Measured: from diagnosis to 1 year post-diagnosis
State of fatigue management
Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue
Measured: from diagnosis to 1 year post-diagnosis
Secondary outcomes (9)
Quality of life functions and symptoms
assessed by EORTC QLQ-C30
Measured: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Sleep problems
assessed by Pittsburgh Sleep Quality Index (PSQI)
Measured: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Depression
assessed by Patient Health Questionnaire (PHQ-9)
Measured: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Body mass index
calculated from weight and height
Measured: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Total physical activity
assessed by a questionnaire regarding walking, cycling, and exercise behavior
Measured: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Diurnal cortisol rhythm
assessed in saliva
Measured: 1 year post-diagnosis
Return to work
assessed by a questions regarding occupational issues
Measured: 6, 12 months and 2, 3, 4, and 5 years post-diagnosis
Hot flashes
assessed only for women
Measured: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Anxiety
assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7)
Measured: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study startMar 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211273
- Sponsor's protocol ID
- LIFT
- Acronym
- LIFT
- Status last verified
- Aug 2019
- First submitted
- 3 Jul 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)
- ClinicalTrials.gov ID
- NCT03211273
- Acronym / sponsor ID
- LIFT / LIFT
- Conditions
- Cancer-related Fatigue
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg
- Study start
- Mar 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient cohort | – | –Newly diagnosed breast, ovarian or colon cancer patients recruited 6 months post-diagnosis and followed up to 5 years post-diagnosis. No intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients newly diagnosed with breast, ovarian or colon cancer
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (1 listed)
- Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue severity
Time frame: from diagnosis to 1 year post-diagnosis
assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire)
Impact of fatigue
Time frame: from diagnosis to 1 year post-diagnosis
assessed by the Brief Fatigue Inventory (BFI)
State of fatigue management
Time frame: from diagnosis to 1 year post-diagnosis
Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue
9 secondary outcomes
Quality of life functions and symptoms
Time frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Sleep problems
Time frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Depression
Time frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Body mass index
Time frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Total physical activity
Time frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Diurnal cortisol rhythm
Time frame: 1 year post-diagnosis
Return to work
Time frame: 6, 12 months and 2, 3, 4, and 5 years post-diagnosis
Hot flashes
Time frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Anxiety
Time frame: 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer-related Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Active, not recruitingPhase 2/3
Methylphenidate and Exercise in Reducing Cancer-Related Fatigue in Patients With Prostate Cancer
Prostate Carcinoma
RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Brain Tumor, Pediatric, Cancer-related Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Fatigue, run by German Cancer Research Center.
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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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: from diagnosis to 1 year post-diagnosis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2019.