NCT07042607

Brief 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 treatment for cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

August 19, 2024

Last Update Submit

August 27, 2025

Conditions

Keywords

dysfunctional schemaacceptancechronic fatigue

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    Baseline

Study Arms (1)

not appicable

not appicable

Other: not appicable

Interventions

no intervention

not appicable

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marianne van der Zijden

Heerlen, Limburg, 6438 HH, Netherlands

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
drs

Study Record Dates

First Submitted

August 19, 2024

First Posted

June 29, 2025

Study Start

January 17, 2023

Primary Completion

July 1, 2025

Study Completion

July 31, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations