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Completed

NCT Number: NCT07042607

The Role of Dysfunctional Schemas and Acceptance Regarding Chronic Fatigue in Oncology Patients After Treatment

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marianne van der Zijden

Heerlen, Limburg, 6438 HH, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria

for participation are a psychotic disorder and current substance dependence.

Treatment and study plan

not appicable

Other

no intervention

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Registry information

Acronym: CVONCOS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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