Postcancer FatigueNCT01096641
An Explorative Study on Physiological and Neurophysiological Determinants of Fatigue in Cancer Survivors
A study testing immediate CBT and Delayed CBT in people with Postcancer Fatigue, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Postcancer fatigue is a severe and invalidating problem, impairing quality of life. About 20 to 40% of the patients remain fatigued, at least one year after successful cancer treatment. Fortunately, there is an effective treatment for postcancer fatigue; cognitive behavior therapy. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Postcancer Fatigue
- What is being tested?
- immediate CBT and Delayed CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Oct 2012
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated for a malignant solid tumour.
- Completion of treatment for cancer minimal 1 year ago
- Single treatment modality surgery permitted
- Current hormonal therapy permitted
- Disease-free, as defined by the absence of somatic disease activity parameters.
- Age between 19 and 65.
- Age at disease onset minimal 18 years
Who cannot join
- Brain tumour in the past
- Current psychological or psychiatric treatment.
- Physical comorbidity which could explain the fatigue.
- Contra-indication for MR examinations (e.g. claustrophobia).
- Treatment with anti-depressive drugs, anti-epileptic drugs, benzodiazepines.
- Insufficient command of the Dutch language to fill out questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Postcancer fatigue is a severe and invalidating problem, impairing quality of life. About 20 to 40% of the patients remain fatigued, at least one year after successful cancer treatment. Fortunately, there is an effective treatment for postcancer fatigue; cognitive behavior therapy. However, no cause for postcancer fatigue has been identified yet. The aim of the study is to identify factors that (partly) cause postcancer fatigue to improve the theoretical understanding of fatigue and to improve the diagnostics of fatigue, predict therapy outcome, and facilitate other treatment options.
In this study, disease-free fatigued cancer patients, who finished treatment for cancer at least one year and maximally ten years ago, will be approached for this study. They will be compared to non-fatigued patients.
Read more
First, a baseline assessment will take place. Magnetic resonance imaging of the brains will be performed to assess brain volume and magnetic resonance spectroscopy will be performed to measure the concentrations of specific substances in the brains. Changes in the volume of parts of the brains have been observed in (non-cancer) patients with the chronic fatigue syndrome (CFS), in comparison with healthy controls. In addition, abnormal concentrations of specific substances have been observed in patients with CFS compared to healthy controls. To assess muscle fatigue, a two-minute endurance test of the upper arm will be administered at maximal voluntary contraction. Next to differences in the brains, CFS patients showed (central) muscle fatigue. A maximal exercise test on a bicycle will be performed to assess physical fitness. Physical activity in fatigued cancer survivors is decreased, compared to healthy controls. It is not known whether physical deconditioning originated during the cancer treatment is the reason why these patients are still less active. In addition, patients and controls will wear an actometer for two weeks to register baseline daily physical activity and for an additional 5 days after the maximal exercise test, to assess the effect of exercise on the daily physical activity. Finally, patients and controls will complete standardized questionnaires and will perform neurological/psychological tests, like a reaction time test and a short time memory task, at baseline.
The results of the non-fatigued and the fatigued patients will be compared at baseline. For the non-fatigued participants, the study will be finished after the baseline measurements. The fatigued participants will start with cognitive behavior therapy immediately after the baseline measurements or after 6 months, depending on the randomization.
At the end of the therapy, after six months, or after 6 months of waiting for cognitive behavior therapy, a second assessment will take place, comparable to the baseline measurements. These results will be compared with the baseline situation to analyze the effect of cognitive behavior therapy on the (possible) causes of postcancer fatigue.
Read the detailed description
Fatigue after curative treatment for cancer is a severe and invalidating problem. 20-40% of disease-free cancer patients mention fatigue as a frequent complaint, impairing quality of life. In search for (neuro)physiological factors determining fatigue, our centre has recently demonstrated the presence of morphological differences in the brains of non-cancer patients with the chronic fatigue syndrome (CFS) compared with healthy volunteers. Both in patients with CFS and in fatigued patients with neuromuscular diseases we showed that fatigue has a central neurophysiological component (so-called central activation failure). Others have shown that chronic fatigue is associated with altered brain metabolism. Studies with proton MR spectroscopy (1H MRS) have demonstrated a higher choline to creatine ratio in the brains of chronically fatigued patients. This suggests increased cell membrane turnover. Also reduced levels of N-acetylaspartate-creatine ratio (NAA/Cr) in the right hippocampus have been observed in these patients, which suggests a decrease in functional axons. Finally, elevated ventricular lactate was observed, which suggests changes in brain glucose metabolism. Actigraphy has shown that actual physical activity in fatigued cancer survivors is decreased compared to healthy controls. It is not known whether physical deconditioning originated during the actual cancer treatment is the reason why these patients are still less active. Until now no other (neuro)physiological factors have been identified explaining fatigue in cancer survivors. Recently we have shown that Cognitive Behaviour Therapy (CBT) especially designed for fatigued cancer patients is an effective treatment.
Aim: To identify and measure (neuro)physiological factors of fatigue in fatigued cancer survivors and to determine the role of these factors in the maintaining of fatigue. The identification of (neuro)physiological factors of persistent fatigue can help to improve the diagnostics of fatigue, predict therapy outcome and facilitate other treatment options. Finally, if (neuro)physiological characteristics of fatigue can be influenced by CBT it will enhance our understanding of the mechanism causing fatigue.
Research questions: 1) What are characteristic (neuro)physiological factors of fatigue in disease-free cancer patients? 2) To which degree can these factors be influenced by Cognitive Behaviour Therapy?
Design: In this explorative study fatigued disease-free cancer patients (n=57), who finished treatment for cancer at least one year and maximally ten years ago, will be approached for this study and asked for informed consent. They will be compared to age and sex matched non-fatigued patients (n=21). First, a base-line assessment will take place, which includes magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) to assess brain morphology and brain metabolites, respectively. To assess peripheral and central fatigue a two-minute endurance test will be administered at maximal voluntary (isometric) contraction (MVC). During the test changes in EMG and force indicate peripheral fatigue, while central fatigue is studied by the twitch interpolation technique. A maximal exercise test will be performed to assess physical fitness and deconditioning. At baseline patients will also be given an actometer which will register daily activity during two weeks. Further, the actometer will register daily activity up to five days after the maximal exercise test. Finally, at baseline patients will fill out a standardized questionnaire, including the Checklist Individual Strength and a self-observation list to assess fatigue severity. Then, the fatigued patients start immediately with Cognitive Behaviour Therapy (CBT). At the end of the therapy, after 6 months, a second assessment will take place in this group of patients. The assessment consists of the same measurements as at baseline. The results will be compared with the baseline situation to analyze the effect of CBT on the (neuro)physiological parameters.
Relevance of this study: Fatigue long after treatment for cancer is a frequently occurring problem, which has important consequences for quality of life in these patients. Identification of characteristic (neuro)physiological factors of fatigue in disease-free cancer patients may not only serve a theoretical understanding of this invalidating condition, but may also provide an objective biological marker that could support the diagnosis and follow-up of treatment. The identification of (neuro)physiological factors which play a role in fatigue after cancer may aid in the early recognition of patients who are at risk for developing fatigue and may lead to early intervention and/or different treatment strategies.
- Conditions
- Postcancer Fatigue
- Being tested
- immediate CBT, Delayed CBT
- Keywords
- Fatigued disease-free Cancer Patients, cancer treatment finished > one year and < ten years ago
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate CBTBehavioural
After the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behaviour Therapy, especially designed for fatigued cancer patients
Delayed CBTBehavioural
After the baseline assessment the fatigued patients will be randomized: this group is to be placed on a waiting list. After 6 months, a second assessment will take place in the group of fatigued patients who received CBT immediately after randomization. This assessment will include the same measurements as at baseline. The fatigued patients on the waiting list will then start with CBT.
| Study group | Role | What they receive |
|---|---|---|
| Fatigued patients: Immediate start CBT | Other | After the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behaviour Therapy, especially designed for fatigued cancer patients. At the end of the therapy, after 6 months, a second assessment will take place.This assessment will include the same measurements as at baseline. Receives: Behavioral: immediate CBT |
| fatigues patients: delayed CBT (after 6 months) | Other | The fatigued patients on the waiting list will start with CBT after 6 months Receives: Behavioral: Delayed CBT |
| non-fatiqued controls | No intervention | Non-fatigued control group. This group is not included in the randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Possible (neuro)physiological determinants of postcancer fatigue
MRI to assess brain morphology; MRS to assess brain metabolite concentrations; sEMG and force registration to assess central and peripheral muscle fatigue; maximal exercise test to assess physical condition; actometer measurements and self-observation list to assess daily activity and symptoms; standardized questionnaires to assess fatigue severity and general health; neurological tests to assess information processing and motor speed; screening of blood and urine to find possible explanations for postcancer fatigue.
Measured: The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postcancer FatigueStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H.W.M. van Laarhoven, Md, Principal investigator, University Medical Centre Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096641
- Sponsor's protocol ID
- FICS 20084002
- Status last verified
- Jun 2012
- First submitted
- 30 Mar 2010
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller F, Wijayanto F, Abrahams H, Gielissen M, Prinsen H, Braamse A, van Laarhoven HWM, Groot P, Heskes T, Knoop H. Potential mechanisms of the fatigue-reducing effect of cognitive-behavioral therapy in cancer survivors: Three randomized controlled trials. Psychooncology. 2021 Sep;30(9):1476-1484. doi: 10.1002/pon.5710. Epub 2021 May 3.
PubMed 33899978Ter Veer E, Prinsen H, Sprangers MAG, Zwinderman KAH, Bleijenberg G, van der Pouw Kraan TCTM, de Vries IJM, Wierenga EA, van Laarhoven HWM. Interferon Gamma-Induced Protein (IP-10) as Potential Biomarker for Cancer-Related-Fatigue: Results from a 6-month Randomized Controlled Trial. Cancer Invest. 2018;36(7):371-377. doi: 10.1080/07357907.2018.1499933. Epub 2018 Sep 6.
PubMed 30188739Prinsen H, Heerschap A, Bleijenberg G, Zwarts MJ, Leer JW, van Asten JJ, van der Graaf M, Rijpkema M, van Laarhoven HW. Magnetic resonance spectroscopic imaging and volumetric measurements of the brain in patients with postcancer fatigue: a randomized controlled trial. PLoS One. 2013 Sep 11;8(9):e74638. doi: 10.1371/journal.pone.0074638. eCollection 2013.
PubMed 24040301Prinsen H, Bleijenberg G, Heijmen L, Zwarts MJ, Leer JW, Heerschap A, Hopman MT, van Laarhoven HW. The role of physical activity and physical fitness in postcancer fatigue: a randomized controlled trial. Support Care Cancer. 2013 Aug;21(8):2279-88. doi: 10.1007/s00520-013-1784-9. Epub 2013 Mar 22.
PubMed 23519566Prinsen H, Bleijenberg G, Zwarts MJ, Hopman MT, Heerschap A, van Laarhoven HW. Physiological and neurophysiological determinants of postcancer fatigue: design of a randomized controlled trial. BMC Cancer. 2012 Jun 18;12:256. doi: 10.1186/1471-2407-12-256.
PubMed 22708881
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study on Physiological and Neurophysiological Determinants of Fatigue in Cancer Survivors
- ClinicalTrials.gov ID
- NCT01096641
- Acronym / sponsor ID
- FICS 20084002
- Conditions
- Postcancer Fatigue
- Keywords
- Fatigued disease-free Cancer Patients, cancer treatment finished > one year and < ten years ago
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 31 Mar 2010 (estimated)
- 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.
Postcancer fatigue is a severe and invalidating problem, impairing quality of life. About 20 to 40% of the patients remain fatigued, at least one year after successful cancer treatment. Fortunately, there is an effective treatment for postcancer fatigue; cognitive behavior therapy. However, no cause for postcancer fatigue has been identified yet. The aim of the study is to identify factors that (partly) cause postcancer fatigue to improve the theoretical understanding of fatigue and to improve the diagnostics of fatigue, predict therapy outcome, and facilitate other treatment options.
In this study, disease-free fatigued cancer patients, who finished treatment for cancer at least one year and maximally ten years ago, will be approached for this study. They will be compared to non-fatigued patients.
First, a baseline assessment will take place. Magnetic resonance imaging of the brains will be performed to assess brain volume and magnetic resonance spectroscopy will be performed to measure the concentrations of specific substances in the brains. Changes in the volume of parts of the brains have been observed in (non-cancer) patients with the chronic fatigue syndrome (CFS), in comparison with healthy controls. In addition, abnormal concentrations of specific substances have been observed in patients with CFS compared to healthy controls. To assess muscle fatigue, a two-minute endurance test of the upper arm will be administered at maximal voluntary contraction. Next to differences in the brains, CFS patients showed (central) muscle fatigue. A maximal exercise test on a bicycle will be performed to assess physical fitness. Physical activity in fatigued cancer survivors is decreased, compared to healthy controls. It is not known whether physical deconditioning originated during the cancer treatment is the reason why these patients are still less active. In addition, patients and controls will wear an actometer for two weeks to register baseline daily physical activity and for an additional 5 days after the maximal exercise test, to assess the effect of exercise on the daily physical activity. Finally, patients and controls will complete standardized questionnaires and will perform neurological/psychological tests, like a reaction time test and a short time memory task, at baseline.
The results of the non-fatigued and the fatigued patients will be compared at baseline. For the non-fatigued participants, the study will be finished after the baseline measurements. The fatigued participants will start with cognitive behavior therapy immediately after the baseline measurements or after 6 months, depending on the randomization.
At the end of the therapy, after six months, or after 6 months of waiting for cognitive behavior therapy, a second assessment will take place, comparable to the baseline measurements. These results will be compared with the baseline situation to analyze the effect of cognitive behavior therapy on the (possible) causes of postcancer fatigue.
Detailed description
Fatigue after curative treatment for cancer is a severe and invalidating problem. 20-40% of disease-free cancer patients mention fatigue as a frequent complaint, impairing quality of life. In search for (neuro)physiological factors determining fatigue, our centre has recently demonstrated the presence of morphological differences in the brains of non-cancer patients with the chronic fatigue syndrome (CFS) compared with healthy volunteers. Both in patients with CFS and in fatigued patients with neuromuscular diseases we showed that fatigue has a central neurophysiological component (so-called central activation failure). Others have shown that chronic fatigue is associated with altered brain metabolism. Studies with proton MR spectroscopy (1H MRS) have demonstrated a higher choline to creatine ratio in the brains of chronically fatigued patients. This suggests increased cell membrane turnover. Also reduced levels of N-acetylaspartate-creatine ratio (NAA/Cr) in the right hippocampus have been observed in these patients, which suggests a decrease in functional axons. Finally, elevated ventricular lactate was observed, which suggests changes in brain glucose metabolism. Actigraphy has shown that actual physical activity in fatigued cancer survivors is decreased compared to healthy controls. It is not known whether physical deconditioning originated during the actual cancer treatment is the reason why these patients are still less active. Until now no other (neuro)physiological factors have been identified explaining fatigue in cancer survivors. Recently we have shown that Cognitive Behaviour Therapy (CBT) especially designed for fatigued cancer patients is an effective treatment.
Aim: To identify and measure (neuro)physiological factors of fatigue in fatigued cancer survivors and to determine the role of these factors in the maintaining of fatigue. The identification of (neuro)physiological factors of persistent fatigue can help to improve the diagnostics of fatigue, predict therapy outcome and facilitate other treatment options. Finally, if (neuro)physiological characteristics of fatigue can be influenced by CBT it will enhance our understanding of the mechanism causing fatigue.
Research questions: 1) What are characteristic (neuro)physiological factors of fatigue in disease-free cancer patients? 2) To which degree can these factors be influenced by Cognitive Behaviour Therapy?
Design: In this explorative study fatigued disease-free cancer patients (n=57), who finished treatment for cancer at least one year and maximally ten years ago, will be approached for this study and asked for informed consent. They will be compared to age and sex matched non-fatigued patients (n=21). First, a base-line assessment will take place, which includes magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) to assess brain morphology and brain metabolites, respectively. To assess peripheral and central fatigue a two-minute endurance test will be administered at maximal voluntary (isometric) contraction (MVC). During the test changes in EMG and force indicate peripheral fatigue, while central fatigue is studied by the twitch interpolation technique. A maximal exercise test will be performed to assess physical fitness and deconditioning. At baseline patients will also be given an actometer which will register daily activity during two weeks. Further, the actometer will register daily activity up to five days after the maximal exercise test. Finally, at baseline patients will fill out a standardized questionnaire, including the Checklist Individual Strength and a self-observation list to assess fatigue severity. Then, the fatigued patients start immediately with Cognitive Behaviour Therapy (CBT). At the end of the therapy, after 6 months, a second assessment will take place in this group of patients. The assessment consists of the same measurements as at baseline. The results will be compared with the baseline situation to analyze the effect of CBT on the (neuro)physiological parameters.
Relevance of this study: Fatigue long after treatment for cancer is a frequently occurring problem, which has important consequences for quality of life in these patients. Identification of characteristic (neuro)physiological factors of fatigue in disease-free cancer patients may not only serve a theoretical understanding of this invalidating condition, but may also provide an objective biological marker that could support the diagnosis and follow-up of treatment. The identification of (neuro)physiological factors which play a role in fatigue after cancer may aid in the early recognition of patients who are at risk for developing fatigue and may lead to early intervention and/or different treatment strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fatigued patients: Immediate start CBT | Other | Behavioral: immediate CBTAfter the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behaviour Therapy, especially designed for fatigued cancer patients. At the end of the therapy, after 6 months, a second assessment will take place.This assessment will include the same measurements as at baseline. |
| fatigues patients: delayed CBT (after 6 months) | Other | Behavioral: Delayed CBTThe fatigued patients on the waiting list will start with CBT after 6 months |
| non-fatiqued controls | No intervention | –Non-fatigued control group. This group is not included in the randomization. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Treated for a malignant solid tumour.
- Completion of treatment for cancer minimal 1 year ago
- Single treatment modality surgery permitted
- Current hormonal therapy permitted
- Disease-free, as defined by the absence of somatic disease activity parameters.
Key exclusion criteria (6 listed)
- Brain tumour in the past
- Current psychological or psychiatric treatment.
- Physical comorbidity which could explain the fatigue.
- Contra-indication for MR examinations (e.g. claustrophobia).
- Treatment with anti-depressive drugs, anti-epileptic drugs, benzodiazepines.
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 |
|---|---|---|
| immediate CBTAfter the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behaviour Therapy, especially designed for fatigued cancer patients | Behavioural | Fatigued patients: Immediate start CBT |
| Delayed CBTAfter the baseline assessment the fatigued patients will be randomized: this group is to be placed on a waiting list. After 6 months, a second assessment will take place in the group of fatigued patients who received CBT immediately after randomization. This assessment will include the same measurements as at baseline. The fatigued patients on the waiting list will then start with CBT. | Behavioural | fatigues patients: delayed CBT (after 6 months) |
Primary outcome
Possible (neuro)physiological determinants of postcancer fatigue
Time frame: The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition)
MRI to assess brain morphology; MRS to assess brain metabolite concentrations; sEMG and force registration to assess central and peripheral muscle fatigue; maximal exercise test to assess physical condition; actometer measurements and self-observation list to assess daily activity and symptoms; standardized questionnaires to assess fatigue severity and general health; neurological tests to assess information processing and motor speed; screening of blood and urine to find possible explanations for postcancer fatigue.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
- Derived from this study: PubMed 33899978Muller F, Wijayanto F, Abrahams H, Gielissen M, Prinsen H, Braamse A, van Laarhoven HWM, Groot P, Heskes T, Knoop H. Potential mechanisms of the fatigue-reducing effect of cognitive-behavioral therapy in cancer survivors: Three randomized controlled trials. Psychooncology. 2021 Sep;30(9):1476-1484. doi: 10.1002/pon.5710. Epub 2021 May 3.
- Derived from this study: PubMed 30188739Ter Veer E, Prinsen H, Sprangers MAG, Zwinderman KAH, Bleijenberg G, van der Pouw Kraan TCTM, de Vries IJM, Wierenga EA, van Laarhoven HWM. Interferon Gamma-Induced Protein (IP-10) as Potential Biomarker for Cancer-Related-Fatigue: Results from a 6-month Randomized Controlled Trial. Cancer Invest. 2018;36(7):371-377. doi: 10.1080/07357907.2018.1499933. Epub 2018 Sep 6.
- Derived from this study: PubMed 24040301Prinsen H, Heerschap A, Bleijenberg G, Zwarts MJ, Leer JW, van Asten JJ, van der Graaf M, Rijpkema M, van Laarhoven HW. Magnetic resonance spectroscopic imaging and volumetric measurements of the brain in patients with postcancer fatigue: a randomized controlled trial. PLoS One. 2013 Sep 11;8(9):e74638. doi: 10.1371/journal.pone.0074638. eCollection 2013.
- Derived from this study: PubMed 23519566Prinsen H, Bleijenberg G, Heijmen L, Zwarts MJ, Leer JW, Heerschap A, Hopman MT, van Laarhoven HW. The role of physical activity and physical fitness in postcancer fatigue: a randomized controlled trial. Support Care Cancer. 2013 Aug;21(8):2279-88. doi: 10.1007/s00520-013-1784-9. Epub 2013 Mar 22.
- Derived from this study: PubMed 22708881Prinsen H, Bleijenberg G, Zwarts MJ, Hopman MT, Heerschap A, van Laarhoven HW. Physiological and neurophysiological determinants of postcancer fatigue: design of a randomized controlled trial. BMC Cancer. 2012 Jun 18;12:256. doi: 10.1186/1471-2407-12-256.
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.
H.W.M. van Laarhoven, Md principal investigator
University Medical Centre Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate CBT and Delayed CBT in people with Postcancer Fatigue, run by Radboud University Medical Center 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Jun 2012. 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?
Results are not available in the source record.
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?
Possible (neuro)physiological determinants of postcancer fatigue (time frame: The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition)). 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 NCT01096641, which also lists 5 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 22 Jun 2012.