Chronic FatigueCVONCOSNCT07042607
The Role of Dysfunctional Schemas and Acceptance Regarding Chronic Fatigue in Oncology Patients After Treatment
An observational study of Chronic Fatigue, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
The role of dysfunctional schemas and acceptance regarding chronic fatigue in oncology patients after treatment This scientific cross-sectional study is at the intersection of medical psychology and oncology and will address the role of dysfunctional schemas and acceptance in the development of fatigue symptoms after… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue
- What is being tested?
- not appicable
- How many people
- 118 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Jan 2023to 31 Jul 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All oncology patients (18 up to and including 70 years of age), at least 6 months to no later than five years after the last curative treatment and have had no other oncology treatment thereafter (except hormone therapy)
Who may be able to join
- All oncology patients (18 up to and including 70 years of age ), at least 6 months to no later than five years after the last curative treatment and have had no other oncology treatment thereafter (except hormone therapy). The type of oncology treatment (chemotherapy, radiotherapy, immunotherapy or hormone therapy) and the type of cancer they have had are diverse. Subjects recruited should have a good command of the Dutch language in connection with optimal reading and answering of the questionnaires.
Who cannot join
- Exclusion criteria for participation are a psychotic disorder and current substance dependence.
Trial locations and contacts
1 site in 1 country.
About this study
The role of dysfunctional schemas and acceptance regarding chronic fatigue in oncology patients after treatment
This scientific cross-sectional study is at the intersection of medical psychology and oncology and will address the role of dysfunctional schemas and acceptance in the development of fatigue symptoms after treatment for cancer.
Read the detailed description
Cancer is potentially a deadly disease, but early detection and modern available treatments have increased survival rates in recent decades. Increasing attention is being paid to the well-being of survivors. One of the side effects of long-term curative treatment of cancer, is chronic fatigue. Fatigue has a major impact on daily life and thus on the patient's quality of life.
This study deals with patients who still suffer from chronic fatigue 6 months to two years after (intentionally curative) cancer treatment. Defined in English as chronic cancer-related fatigue (CCRF). The role of acceptance and dysfunctional schedules in maintaining chronic fatigue after cancer will be investigated.
The question is whether oncology patients with dysfunctional schedules after treatment are more likely to maintain CCRF than oncology patients in whom these dysfunctional schedules are present to a lesser extent. From the literature, we chose to examine the dysfunctional schema Relentlessly strict standards/extremely high demands. Exploratively, we also examine the dysfunctional schemas Abandonment/Instability and Self-Sacrifice.
If the above schemas are indeed associated with higher levels of CCRF, we then ask what role acceptance of fatigue plays on the aforementioned correlation. We hypothesize that acceptance plays a mediating role in the correlation between dysfunctional schemas and fatigue: Dysfunctional schemas hinder acceptance of fatigue. Next, we hypothesize that the lower the degree of acceptance, the higher the perceived fatigue will be.
In addition to mediation, a moderating role of dysfunctional schemas could also be hypothesized. Therefore, the second hypothesis hypothesizes that there is a negative relationship between acceptance and fatigue, but only when the relevant dysfunctional schemas are present at low levels. When these dysfunctional schemas are present to a high degree, the relationship between acceptance and fatigue changes. Most likely, the dysfunctional schemas reduce the beneficial influence of acceptance.
- Conditions
- Chronic Fatigue
- Being tested
- not appicable
- Keywords
- dysfunctional schema, acceptance, chronic fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not appicableOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| not appicable | not appicable Receives: Other: not appicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
The Individual Stress Strength Checklist measures subjective fatigue and behavioral aspects related to it. It consists of 20 statements that examine how the respondent has felt over the past two weeks, indicating to what extent the statement applies to him/her. It measures a picture of fatigue that includes fluctuations over time. Four subscales are distinguished. The scoring method is on a 7-point Likert scale. A cut-off point for the total score is 76, indicating problematic fatigue. For the subjective fatigue subcategory, Normal = a score below 27. A score of 27 or higher is an indication of abnormal fatigue. A score of 35 or higher is considered an indication of severe fatigue.
Measured: Baseline
Dysfunctional schema
The Young Schema Questionnaire-S3 (YSQ-S3) provides insight into dysfunctional schemas that may be underlying patients' psychological problems. The YSQ-S3 consists of 90 items (statements) measuring 18 schemas including the dysfunctional schemas of ruthless standards/excessive demands, self-sacrifice and abandonment. The method of scoring is on a 6-point Likert scale. After taking the YSQ-S3, the average of all scores per scale is calculated for high predictive value. For most schema scales, a mean score of 2.5 or higher usually appears to fall in the clinical range. The cut-off value for Self-sacrifice and Compassionate norms/extreme demands is around a mean of 3. Internal consistency is adequate for all 18 scales: Cronbach's α=0.70
Measured: Baseline
Acceptance
The Freiburg mindfulness Inventory-Short Form (FMI-SF) is a questionnaire consisting of two subscales: Presence (attention to experiences of the present moment) and Acceptance (an accepting attitude toward experiences). The FMI-SF has the advantage of being a short list of 14 questions that can be applied in a clinical setting. The items can be scored from 1 (rarely) to 4 (almost always). Both the FMI-14 as a whole (Cronbach's α = .85) and the factors Presence (Cronbach's α= .74) have adequate internal consistency, providing support for the reliability of the scale and subscales.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start17 Jan 2023
- Primary completion1 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne van der Zijden, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042607
- Sponsor's protocol ID
- METCZ20220084
- Acronym
- CVONCOS
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dysfunctional Schemas and Acceptance Regarding Chronic Fatigue in Oncology Patients After Treatment
- ClinicalTrials.gov ID
- NCT07042607
- Acronym / sponsor ID
- CVONCOS / METCZ20220084
- Conditions
- Chronic Fatigue
- Keywords
- dysfunctional schema, acceptance, chronic fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Jun 2025 (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.
The role of dysfunctional schemas and acceptance regarding chronic fatigue in oncology patients after treatment
This scientific cross-sectional study is at the intersection of medical psychology and oncology and will address the role of dysfunctional schemas and acceptance in the development of fatigue symptoms after treatment for cancer.
Detailed description
Cancer is potentially a deadly disease, but early detection and modern available treatments have increased survival rates in recent decades. Increasing attention is being paid to the well-being of survivors. One of the side effects of long-term curative treatment of cancer, is chronic fatigue. Fatigue has a major impact on daily life and thus on the patient's quality of life.
This study deals with patients who still suffer from chronic fatigue 6 months to two years after (intentionally curative) cancer treatment. Defined in English as chronic cancer-related fatigue (CCRF). The role of acceptance and dysfunctional schedules in maintaining chronic fatigue after cancer will be investigated.
The question is whether oncology patients with dysfunctional schedules after treatment are more likely to maintain CCRF than oncology patients in whom these dysfunctional schedules are present to a lesser extent. From the literature, we chose to examine the dysfunctional schema Relentlessly strict standards/extremely high demands. Exploratively, we also examine the dysfunctional schemas Abandonment/Instability and Self-Sacrifice.
If the above schemas are indeed associated with higher levels of CCRF, we then ask what role acceptance of fatigue plays on the aforementioned correlation. We hypothesize that acceptance plays a mediating role in the correlation between dysfunctional schemas and fatigue: Dysfunctional schemas hinder acceptance of fatigue. Next, we hypothesize that the lower the degree of acceptance, the higher the perceived fatigue will be.
In addition to mediation, a moderating role of dysfunctional schemas could also be hypothesized. Therefore, the second hypothesis hypothesizes that there is a negative relationship between acceptance and fatigue, but only when the relevant dysfunctional schemas are present at low levels. When these dysfunctional schemas are present to a high degree, the relationship between acceptance and fatigue changes. Most likely, the dysfunctional schemas reduce the beneficial influence of acceptance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| not appicable | – | Other: not appicablenot appicable |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All oncology patients (18 up to and including 70 years of age), at least 6 months to no later than five years after the last curative treatment and have had no other oncology treatment thereafter (except hormone therapy)
Key inclusion criteria (1 listed)
- All oncology patients (18 up to and including 70 years of age ), at least 6 months to no later than five years after the last curative treatment and have had no other oncology treatment thereafter (except hormone therapy). The type of oncology treatment (chemotherapy, radiotherapy, immunotherapy or hormone therapy) and the type of cancer they have had are diverse. Subjects recruited should have a good command of the Dutch language in connection with optimal reading and answering of the questionnaires.
Key exclusion criteria (1 listed)
- Exclusion criteria for participation are a psychotic disorder and current substance dependence.
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 |
|---|---|---|
| not appicableno intervention | Other | not appicable |
Primary outcome
Fatigue
Time frame: Baseline
The Individual Stress Strength Checklist measures subjective fatigue and behavioral aspects related to it. It consists of 20 statements that examine how the respondent has felt over the past two weeks, indicating to what extent the statement applies to him/her. It measures a picture of fatigue that includes fluctuations over time. Four subscales are distinguished. The scoring method is on a 7-point Likert scale. A cut-off point for the total score is 76, indicating problematic fatigue. For the subjective fatigue subcategory, Normal = a score below 27. A score of 27 or higher is an indication of abnormal fatigue. A score of 35 or higher is considered an indication of severe fatigue.
Dysfunctional schema
Time frame: Baseline
The Young Schema Questionnaire-S3 (YSQ-S3) provides insight into dysfunctional schemas that may be underlying patients' psychological problems. The YSQ-S3 consists of 90 items (statements) measuring 18 schemas including the dysfunctional schemas of ruthless standards/excessive demands, self-sacrifice and abandonment. The method of scoring is on a 6-point Likert scale. After taking the YSQ-S3, the average of all scores per scale is calculated for high predictive value. For most schema scales, a mean score of 2.5 or higher usually appears to fall in the clinical range. The cut-off value for Self-sacrifice and Compassionate norms/extreme demands is around a mean of 3. Internal consistency is adequate for all 18 scales: Cronbach's α=0.70
Acceptance
Time frame: Baseline
The Freiburg mindfulness Inventory-Short Form (FMI-SF) is a questionnaire consisting of two subscales: Presence (attention to experiences of the present moment) and Acceptance (an accepting attitude toward experiences). The FMI-SF has the advantage of being a short list of 14 questions that can be applied in a clinical setting. The items can be scored from 1 (rarely) to 4 (almost always). Both the FMI-14 as a whole (Cronbach's α = .85) and the factors Presence (Cronbach's α= .74) have adequate internal consistency, providing support for the reliability of the scale and subscales.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
Related trials for Chronic Fatigue
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Not yet recruiting
Impact of Nurse-Led Pulmonary Rehabilitation on Dyspnea, Fatigue and Self-Efficacy in COPD Patients
Chronic Obstructive Pulmonary Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue, run by Zuyderland Medisch Centrum 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 1 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: finished, as of the sponsor's last update on 28 Aug 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Baseline). 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 2025.