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Quality of Life of Patients With Desmoid-type Fibromatosis (QUALIFIED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04289077
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
Radboud University
The Netherlands Cancer Institute
Information provided by (Responsible Party):
C. Verhoef, Erasmus Medical Center

Brief Summary:

Rationale: Desmoid-type fibromatosis (DTF) is a rare, histologically benign, soft tissue tumour. Although incapable of metastasizing, the clinical course is unpredictable and can be aggressive because of local invasive growth. Various treatments are available including; surgical resection, radiotherapy, hormonal therapy and chemotherapy. Nowadays there is a trend towards a more conservative strategy with a wait and see policy because of high recurrence rates after surgical resection. Health-related quality of life (HRQL) is a corner stone in treatment choice and can be used during the disease for monitoring the impact of the disease on physical, psychological and social level. Additionally, HRQL can be in important endpoint for future clinical trials. Today, no HRQL-tools are available which capture the needs of DTF patients. The hypothesis is that patients with DTF have issues on several HRQL domains including physical, social and emotional well-being. For this reason we developed a list of items based on previous research. This study aims to evaluate HRQL issues experienced by DTF patients.

Purpose: Multi-centre, cross-sectional, observational study to measure HRQL of DTF patients and to evaluate the prevalence of the experienced problems.


Condition or disease Intervention/treatment
Desmoid Tumor Desmoid-type Fibromatosis Other: Questionnaires

Detailed Description:

Objectives: The primary objective is to evaluate HRQoL problems in adult DTF patients. The secondary objectives are: 1) to compare the level of HRQoL of DTF patients to the general population, 2) to identify patient subgroups who are at risk for developing certain HRQoL problems, 3) to evaluate patient preferences regarding their health care needs for DTF.

Outline: All patients, aged above 18 years, with a histopathological proved DTF tumour and sufficient Dutch language skills who have received their last check-up in the hospital within the last five years (April 2014). Patients treated in one of the participating centres, will be asked to fill out a set of questionnaires (baseline questionnaire, health care utilization, decision making, EORTC QLQ-C30, DTF-specific questionnaire, and the EQ-5D-5L). Patients will only have to fill out these questionnaires once.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Evaluation of Health-related Quality of Life Issues Experienced by Patients With Desmoid-type Fibromatosis
Estimated Study Start Date : August 6, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with histopathological proven DTF Other: Questionnaires
- Baseline questionnaire, version 1.0, October 29 2019, (Dutch) - Health care utilization, version 1.0, October 29 2019, (Dutch) - Decision-making, version 1.0, October 29 2019, (Dutch) - EORTC QLQ-C30, version 3.0, (Dutch) - DTF-QoL, version 1.0, October




Primary Outcome Measures :
  1. EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0) [ Time Frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation. ]
    Each question will be scored: not at all (1), a little (2), quite a bit (3), very much (4). The scores of the EORTC-QLQ30 will be calculated using a Likert scale from 1-4. The scoring manual of the EORTC will be followed. After linear transformation, all scales and single item measures range in score from 0-100. Scores for each scale will be reported as mean (SD), or as median (IQR). A higher score on the functional scales and global quality of life means better functioning and HRQoL, whereas a higher score on the symptom scales means more complaints. The EORTC QLQ-C30 summary score will be calculated using the mean scores of the function scales and the reversed mean scores of the symptom scales and represented as the mean of the combined 13 QLQ-C30 scale scores (financial impact and global health status excluded). A higher summary score represented a better outcome.

  2. DTF-QoL questionnaire (Desmoid-type fibromatosis Quality of Life Questionnaire) [ Time Frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation. ]
    The scores for each item of the DTF-QoL will be calculated using a Likert scale from 1-4. The scores of each item will be calculated as mean ± SD, or as median (IQR). These scores (median or mean) will be reported per item.

  3. EQ-5D-5L questionnaire (EuroQol five-dimensional questionnaire; version 1.0) [ Time Frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation. ]
    Measures health-related quality of life on five dimensions of health: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. Additionally two questions aim to rank a patients' health (scale 0-100, with 100 representing a better health). Each of the five dimensions can be divided into five levels of perceived problems: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4) and extreme problems (level). Health states can be converted into single index values. The outcomes will be reported as frequency (proportion) of reported problems for each level and for each dimension. The Visual Analogue Scale (VAS) data will be presented as a mean value (SD). In case of skewed data, median values and IQR will be used.


Secondary Outcome Measures :
  1. EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0) [ Time Frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation. ]

    See primary outcome 1 for a detailed description of the EORTC QLQ-C30 questionnaire.

    The median or mean values for each scale of the EORTC QLQ-C30 from DTF patients will be compared to the median or mean scores per scale of the general population.


  2. Baseline questionnaire (version 1.0) [ Time Frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation. ]

    Subgroups will be created based on the information of the baseline questionnaire and will encompass: sex (male, female), age groups (categorized based by the median age and/or quartiles), primary treatment type (surgical resection, systemic treatment, radiotherapy, local treatment (e.g. cryoablation), ethnicity, educational level, relationship status, job demands, comorbidities, tumour location, and tumour recurrences.

    Outcomes of this questionnaire will be descriptive and are expressed as numbers with corresponding percentages.

    Mean or median scores of each scale (EORTC QLQ-C30, version 3.0), items (DTF-QoL, version 1,0) or frequency scores (EQ-5D-5L, version 1,0) will be calculated for each relevant subgroup.


  3. Healt care utilization questionnaire (version 1.0) [ Time Frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation. ]
    The health care utilization questionnaire contains the following topics: satisfaction with received care, frequency of visits to the general practitioner / specialist, satisfaction with the follow-up schedule, preferences and needs for receiving care in a DTF expert centre, receiving additional care of support from professionals (medical and non-medical). Outcomes will be descriptive and reported in numbers and corresponding frequencies per answer option.

  4. Decision making questionnaire (version 1.0) [ Time Frame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation. ]

    Six questions were designed to obtain information on how patients make medical decisions, what their current role is and what their preferred role, and one question regarding their awareness of their choices, the benefits and risks of certain treatment and whether they received support an advice are designed. Two questions were designed to gain insight into the reasons for choosing an active form of treatment.

    Outcomes of this questionnaire will be descriptive and expressed as numbers with corresponding percentages.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients, aged ≥18 years, diagnosed with a histopathological proven DTF, regardless of disease stage and received treatment(s) who have received their last check-up of their DTF in one of the participating hospitals the hospital between October 2014 and October 2019.
Criteria

Inclusion Criteria:

  • Aged 18 years and older
  • Histopathological proven DTF, regardless of disease stage or treatment.
  • Diagnosed between January 1990 and October 2019, with a visit to the hospital for their DTF (between October 2014 and October 2019)
  • Sufficient Dutch language skills
  • Competent to complete a questionnaire
  • Written informed consent

Exclusion Criteria:

• Familial adenomatous polyposis (FAP)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289077


Contacts
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Contact: A.W. Schut, MD 010-7041223 a.schut@erasmusmc.nl
Contact: M.J.M. Timbergen, MD 010-7041223 m.timbergen@erasmusmc.nl

Locations
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Netherlands
3. Antoni van Leeuwenhoek Ziekenhuis (AVL) / The Netherlands Cancer Instituut , Amsterdam, The Netherlands Not yet recruiting
Amsterdam, Netherlands, 1066 CX
Contact: W. van der Graaf, MD, PhD         
Radboud University Medical Center (MC), Nijmegen, The Netherlands Not yet recruiting
Nijmegen, Netherlands, 6525 GA
Contact: H. Bonenkamp, MD, PhD         
Erasmus MC Cancer Institute Recruiting
Rotterdam, Netherlands, 3015 GD
Sponsors and Collaborators
Erasmus Medical Center
Radboud University
The Netherlands Cancer Institute
Investigators
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Principal Investigator: C. Verhoef, MD, PhD Erasmus Medical Center
  Study Documents (Full-Text)

Documents provided by C. Verhoef, Erasmus Medical Center:
Publications:

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Responsible Party: C. Verhoef, Prof. dr. C. Verhoef, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04289077    
Other Study ID Numbers: MEC-2019-0816
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by C. Verhoef, Erasmus Medical Center:
Health-related quality of life
Quality of life
Additional relevant MeSH terms:
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Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms