CancerTIRELESSNCT06511518
Cognitive Behavioral Therapy for Cancer-related Fatigue in Patients With Cancer Receiving Palliative Systemic Treatment
A study testing Cognitive behavioral therapy in people with Cancer and Palliative Treatment, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Cancer-related fatigue is highly prevalent in patients receiving treatment for gliomas or palliative systemic treatment for cancer and is experienced as one of the most burdensome symptoms affecting patients' daily functioning and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Palliative Treatment
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Jun 2024to 1 Feb 2028
- Phase
- Interventional
- 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
Who may be able to join
- Receive systemic treatment with palliative intent for a solid (non-brain) tumor
- Are ≥18 years old
- Are proficient in Dutch
- Report severe fatigue (Checklist Individual Strength, fatigue severity subscale [CIS-fatigue] score ≥35)
- A life expectancy of ≥6 months according to their oncologist
- Access to a device with internet
Show all 13Show fewer
- Histologically confirmed diffuse glioma WHO grade 2, 3, or 4
- No oncological treatment for at least two months prior to inclusion
- Are ≥18 years old
- Are proficient in Dutch
- Report severe fatigue (Checklist Individual Strength, fatigue severity subscale [CIS-fatigue] score ≥35)
- A life expectancy of ≥3 months according to their oncologist
- Access to a device with internet
Who cannot join
- Symptomatic brain metastases
- Dual immunotherapy
- Have a poor performance status (Karnofsky <70)
- Are currently receiving treatment for a mental disorder.
- Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself)
- Severe cognitive deficits
Show all 13Show fewer
- Glioma patients
- Signs of radiological or clinical tumor progression at the time of inclusion
- Corticosteroid use
- Have a poor performance status (Karnofsky <70)
- Are currently receiving treatment for a mental disorder
- Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself).
- Severe cognitive deficits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Medical Psychology
Amsterdam, North Holland, 1105AZ
Christine Henneman-Hoogeland, na, 020 - 566 4661, c.hennemanhoogeland@amsterdamumc.nl
About this study
Official title: Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment
Cancer-related fatigue is highly prevalent in patients receiving treatment for gliomas or palliative systemic treatment for cancer and is experienced as one of the most burdensome symptoms affecting patients' daily functioning and quality of life. From the KWF-sponsored TIRED trial, we concluded that cognitive behavioral therapy (CBT) is effective in reducing fatigue in cancer patients with severe fatigue during palliative systemic treatment and in glioma patients. However, in its current form, integration in routine medical care is difficult and scalability is a problem, as the intervention is time-intensive, requires face-to-face consults with a psychologists, and the availability of trained psychologists is limited.
The investigators expect that inter-CBT will integrate well into clinical practice and prove non-inferior in achieving a reduction in fatigue compared to face-to-face CBT as investigated in the TIRED and GRIP study. It is further expected that the interviews will provide useful information to implement this intervention.
Read more
The main aims to answer are:
- To determine the non-inferiority of CBT primarily led by nurese, compared with benchmark studies in which CBT was provided by psychologists, in its effect on reduction in cancer-related fatigue
- To adapt CBT delivery to the needs of patients treated with palliative intent and glioma (interdisciplinary web-based CBT for cancer-related fatigue.
- To investigate its feasibility by evaluating the practical workability, acceptability, and burden for patients and health care providers.
Participants will follow the 12 weeks CBT intervention online, mainly guided by their nurse. Participants will start with a face-to-face session with the psychologists, partly together with their nurse, to start with setting their treatment goals. Then, they will work on the modules that are applicable to them. During the CBT intervention there will be a face-to-face session with their nurse to discuss the progress of their goals. Finally, all participants will complete the therapy by realizing their treatment goals. The outcomes with respect to fatigue severity and participants' goals will be discussed by the nurse with the participant in the final, face-to-face sessions. The face-to-face sessions will take 30 to max. 45 minutes, except for the first session, which will take one hour of which the nurse will be present during 15 minutes.
Researchers will compare the outcomes of the study to a benchmark study where CBT was provided by psychologists in its effect on reduction in cancer-related fatigue.
- Conditions
- Cancer, Palliative Treatment
- Being tested
- Cognitive behavioral therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Cognitive behavioural therapy (CBT) is a therapy that can help you manage your problems by changing the way you think and behave.
| Study group | Role | What they receive |
|---|---|---|
| Benchmark study | Other | The results will be compared to a benckmark consisting of a historical study population from the TIRED trial and the GRIP trial in which CBT was delivered by psychologists specialized in CBT. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue severity will be measured using the subscale fatigue severity (8 items, 7-point Likert scale) of the Checklist Individual Strength (CIS-fatigue).
The CIS-fatigue has shown to be sensitive to change, has good reliability and discriminative validity. Scores range from 8 to 56. A score of ≥35 indicates severe fatigue. Change = (week 14 score - baseline score).
Measured: Screening, baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Secondary outcomes (6)
Fatigue will be assessed with the symptom scale Fatigue ((3 items, 4-point Likert scale) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0).
The EORTC QLQ-C30 is developed for use in clinical trials in cancer patients. Total scores on each subscale are linearly converted to a 0 to 100 scale. Higher scores indicate more fatigue. Change = (week 14 score - baseline score).
Measured: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Quality of Life will be measured using the subscale global health status/QoL (2 items, 7-point Likert Scale) of the EORTC QLQ-C30.
The EORTC QLQ-C30 is one of the most commonly used HRQoL instruments in the palliative setting and is known to be a reliable and valid measure of the quality of life of patients with cancer. A high score indicates good HRQoL. Change = (week 14 score - baseline score).
Measured: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Functional impairment will be measured using the subscales emotional functioning (4 items, 4-point Likert scale) and physical functioning (5 items, 4-point Likert scale, range 0 to 100) of the EORTC QLQ-C30.
Raw scores for both subscales are convertible to a score of 0 to 100. A high score represents a high level of functioning. Change = (week 14 score - baseline score).
Measured: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Functional impairment will be assessed with the work and social adjustment scale (WSAS)
Raw scores for both subscales are convertible to a score of 0 to 100. A high score represents a high level of functioning. Change = (week 14 score - baseline score).
Measured: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Healthcare consumption
In order to estimate the healthcare costs related to fatigue we will compare the therapist time spent per patient within the TIRELESS project with the time spent per patient within the benchmark study (TIRED study).
We will use an adapted version of a questionnaire on health consumption and productivity loss (TiC-P). At baseline, patients will be asked about their healthcare consumption over the past 4 months.The healthcare consumption during the four months of the intervention (study participation) will then be compared to the four months preceding the intervention. A group of 25 patients who are severely fatigued and eligible for study participation, but who do not want to participate will be asked if they are willing to complete the TiC-P at the same time points (T0, T1, T2) as the study participants. We then will compare health care consumption of these two groups.
Measured: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Usability of the e-health platform will be assessed using the System Usability Scale (SUS)
The System Usability Scale is a 10-item questionnaire rated on a 5-point Likert scale. The total SUS score ranges from 0 to 100, with higher scores indicating better perceived usability.
Measured: T1: week 14 after T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start3 Jun 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, Hans Knoop, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511518
- Sponsor's protocol ID
- NL85495.018.23
- Acronym
- TIRELESS
- Status last verified
- Jun 2026
- First submitted
- 23 Feb 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gorter M, Rottgering JG, Belgers V, Blom MEC, Thomassen B, De Witt Hamer PC, Niers JM, Kouwenhoven MCM, Bienfait HP, Gathier CS, Compter A, Geurts M, Snijders TJ, van de Ven PM, Douw L, Knoop H, Klein M. Bayesian adaptive randomized trial of blended cognitive behavioral therapy for severe fatigue in stable diffuse glioma. Neuro Oncol. 2026 Mar 1;28(3):693-703. doi: 10.1093/neuonc/noaf256.
PubMed 41208030Poort H, Verhagen CA, Peters ME, Goedendorp MM, Donders AR, Hopman MT, Nijhuis-van der Sanden MW, Berends T, Bleijenberg G, Knoop H. Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer. BMC Cancer. 2017 Jan 28;17(1):81. doi: 10.1186/s12885-017-3076-0.
PubMed 28129746van der Pas HB, Braamse AMJ, Boon E, Bromberg JEC, Bosmans JE, Klein M, Nieuwkerk P, van der Rijt CCD, van der Vorst MJDL, de Witt Hamer PC, van Zuylen L, Knoop H. TIRELESS study protocol: non-inferiority study of nurse-led web-based cognitive behavioral therapy for cancer-related fatigue in patients with incurable cancer. BMC Cancer. 2026 Jul 28;26(1):1281. doi: 10.1186/s12885-026-16426-z.
PubMed 42919196
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment
- ClinicalTrials.gov ID
- NCT06511518
- Acronym / sponsor ID
- TIRELESS / NL85495.018.23
- Conditions
- Cancer, Palliative Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 22 Jul 2024 (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.
Cancer-related fatigue is highly prevalent in patients receiving treatment for gliomas or palliative systemic treatment for cancer and is experienced as one of the most burdensome symptoms affecting patients' daily functioning and quality of life. From the KWF-sponsored TIRED trial, we concluded that cognitive behavioral therapy (CBT) is effective in reducing fatigue in cancer patients with severe fatigue during palliative systemic treatment and in glioma patients. However, in its current form, integration in routine medical care is difficult and scalability is a problem, as the intervention is time-intensive, requires face-to-face consults with a psychologists, and the availability of trained psychologists is limited.
The investigators expect that inter-CBT will integrate well into clinical practice and prove non-inferior in achieving a reduction in fatigue compared to face-to-face CBT as investigated in the TIRED and GRIP study. It is further expected that the interviews will provide useful information to implement this intervention.
The main aims to answer are:
- To determine the non-inferiority of CBT primarily led by nurese, compared with benchmark studies in which CBT was provided by psychologists, in its effect on reduction in cancer-related fatigue
- To adapt CBT delivery to the needs of patients treated with palliative intent and glioma (interdisciplinary web-based CBT for cancer-related fatigue.
- To investigate its feasibility by evaluating the practical workability, acceptability, and burden for patients and health care providers.
Participants will follow the 12 weeks CBT intervention online, mainly guided by their nurse. Participants will start with a face-to-face session with the psychologists, partly together with their nurse, to start with setting their treatment goals. Then, they will work on the modules that are applicable to them. During the CBT intervention there will be a face-to-face session with their nurse to discuss the progress of their goals. Finally, all participants will complete the therapy by realizing their treatment goals. The outcomes with respect to fatigue severity and participants' goals will be discussed by the nurse with the participant in the final, face-to-face sessions. The face-to-face sessions will take 30 to max. 45 minutes, except for the first session, which will take one hour of which the nurse will be present during 15 minutes.
Researchers will compare the outcomes of the study to a benchmark study where CBT was provided by psychologists in its effect on reduction in cancer-related fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benchmark study | Other | Behavioral: Cognitive behavioral therapyThe results will be compared to a benckmark consisting of a historical study population from the TIRED trial and the GRIP trial in which CBT was delivered by psychologists specialized in CBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Receive systemic treatment with palliative intent for a solid (non-brain) tumor
- Are ≥18 years old
- Are proficient in Dutch
- Report severe fatigue (Checklist Individual Strength, fatigue severity subscale [CIS-fatigue] score ≥35)
- A life expectancy of ≥6 months according to their oncologist
Key exclusion criteria (13 listed)
- Symptomatic brain metastases
- Dual immunotherapy
- Have a poor performance status (Karnofsky <70)
- Are currently receiving treatment for a mental disorder.
- Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyCognitive behavioural therapy (CBT) is a therapy that can help you manage your problems by changing the way you think and behave. | Behavioural | Benchmark study |
Primary outcome
Fatigue severity will be measured using the subscale fatigue severity (8 items, 7-point Likert scale) of the Checklist Individual Strength (CIS-fatigue).
Time frame: Screening, baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
The CIS-fatigue has shown to be sensitive to change, has good reliability and discriminative validity. Scores range from 8 to 56. A score of ≥35 indicates severe fatigue. Change = (week 14 score - baseline score).
6 secondary outcomes
Fatigue will be assessed with the symptom scale Fatigue ((3 items, 4-point Likert scale) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, version 3.0).
Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Quality of Life will be measured using the subscale global health status/QoL (2 items, 7-point Likert Scale) of the EORTC QLQ-C30.
Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Functional impairment will be measured using the subscales emotional functioning (4 items, 4-point Likert scale) and physical functioning (5 items, 4-point Likert scale, range 0 to 100) of the EORTC QLQ-C30.
Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Functional impairment will be assessed with the work and social adjustment scale (WSAS)
Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Healthcare consumption
Time frame: Baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)
Usability of the e-health platform will be assessed using the System Usability Scale (SUS)
Time frame: T1: week 14 after T0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 41208030Gorter M, Rottgering JG, Belgers V, Blom MEC, Thomassen B, De Witt Hamer PC, Niers JM, Kouwenhoven MCM, Bienfait HP, Gathier CS, Compter A, Geurts M, Snijders TJ, van de Ven PM, Douw L, Knoop H, Klein M. Bayesian adaptive randomized trial of blended cognitive behavioral therapy for severe fatigue in stable diffuse glioma. Neuro Oncol. 2026 Mar 1;28(3):693-703. doi: 10.1093/neuonc/noaf256.
- Results publication: PubMed 28129746Poort H, Verhagen CA, Peters ME, Goedendorp MM, Donders AR, Hopman MT, Nijhuis-van der Sanden MW, Berends T, Bleijenberg G, Knoop H. Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer. BMC Cancer. 2017 Jan 28;17(1):81. doi: 10.1186/s12885-017-3076-0.
- Derived from this study: PubMed 42919196van der Pas HB, Braamse AMJ, Boon E, Bromberg JEC, Bosmans JE, Klein M, Nieuwkerk P, van der Rijt CCD, van der Vorst MJDL, de Witt Hamer PC, van Zuylen L, Knoop H. TIRELESS study protocol: non-inferiority study of nurse-led web-based cognitive behavioral therapy for cancer-related fatigue in patients with incurable cancer. BMC Cancer. 2026 Jul 28;26(1):1281. doi: 10.1186/s12885-026-16426-z.
- TIRED trial, historical benchmark studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Cancer and Palliative Treatment, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. 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 Netherlands. 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?
Contact Hans Knoop, Prof. (020 5666932, hans.knoop@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue severity will be measured using the subscale fatigue severity (8 items, 7-point Likert scale) of the Checklist Individual Strength (CIS-fatigue). (time frame: Screening, baseline (T0), week 14 after T0 (T1) and week 26 after T0 (T2)). 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 NCT06511518, which also lists 3 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 15 Jun 2026.