Transdiagnostic Oncology Program in Primary Care
TOP
The Transdiagnostic Oncology Program (TOP): a Combined Lifestyle Intervention to Improve the Quality of Life of Cancer Survivors - a Before-and-after Pilot Study in Primary Care
1 other identifier
observational
35
1 country
2
Brief Summary
The goal of this observational study is to learn about how cancer survivors experience a relatively new 12-month interdisciplinary aftercare program called the Transdiagnostic Oncologic Program (TOP). TOP is an innovative program offered as part of routine family-doctor care among several practices in the province Drenthe, the Netherlands. It is coordinated by the family doctor and caried out by an interdisciplinary team, consisting of the family doctor, a physiotherapist, nutritionist, and optionally a psychologist. The main questions this study aims to answer are:
- Is TOP feasible and acceptable?
- Does TOP lead to improvements in quality of life in cancer survivors? Patients who were eligible for the program (n=54) were asked to participate in research as well. Everyone who participated in TOP (n=19) agreed to participate in this study as well. Those who declined participation (n=35), were asked to serve as controls, of which 16 agreed to do so.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 30, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedFebruary 10, 2025
February 1, 2025
1 year
January 30, 2025
February 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility and satisfaction.
Feasibility of the intervention was assessed through attrition and attendance rates and through several questions on an evaluation form at post-intervention (T2), including adverse effects. Serious adverse events were also inquired by the GP. Satisfaction with the intervention was assessed with the same evaluation form at T2.
From baseline to the end of the program, after 1 year.
Change in quality of life
Quality of life (QoL) was measured with the validated European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC QLQ-C30). From this, global health status, an overall indicator of quality of life, as well as five functioning scales (physical, emotional, cognitive, social and role) and three symptom scales (fatigue, nausea and vomiting, and pain) were used.
From baseline to the end of the program, after 1 year.
Secondary Outcomes (5)
Change in fatigue
From baseline to the end of the program, after 1 year.
Change in mental symptoms
From baseline to the end of the program, after 1 year.
Change in happiness
From baseline to the end of the program, after 1 year.
Change in work ability
From baseline to the end of the program, after 1 year.
Change in work accommodations after work resumption
From baseline to the end of the program, after 1 year.
Study Arms (2)
Cancer survivors taking part in the program
Eligble cancer survivors who agreed to take part in TOP and in the study.
Cancer survivors serving as controls
Eligble cancer survivors who declined to take part in TOP, but agreed to take part in the study. They serve as a convenience control group.
Interventions
The "Transdiagnostic Oncology Program" (TOP) is a 12-month interdisciplinary aftercare program aimed at improving cancer survivors' quality of life by addressing common clinical issues. In the first three months, participants attended two weekly 1-hour exercise sessions led by physiotherapists. Once a week, this was followed by 1-hour mind-body therapy for stress reduction. A dietitian provided an initial group session on nutrition and advised at least two personal consultations. Between months 3-6, exercise was reduced to once weekly, with encouragement to continue independent exercise and relaxation. A second informational session on stress and sleep hygiene was given. After six months, participants continued independently, meeting the family doctor quarterly to evaluate progress. For the participants who experienced some psychological problems, sessions with a psychologist at an institute specialized for psycho-oncology, were available.
Eligibility Criteria
Participants were recruited through an e-referral program called "Zorgdomein", local papers and flyers in the waitingroom of eleven primary care clinics in Drenthe, the Netherlands. In addition, two of them (Kloosterveen and Gezondheidscentrum Assen-Oost, Assen, the Netherlands) screened their caseload for potentially eligible participants by using the International Classification of Primary Care (ICPC) code for oncology. Sixty potential participants were approached by the family doctor. The participants who were eligible and interested were called the 'intervention group' (n=19) and allocated to one of the two training locations based on where they lived. The others (n=35), who indicated no interest, were asked to serve as part of a convenience control group, called 'control group'. Sixteen of them agreed to do so. All participants agreed to participate and signed an informed consent form before starting the study.
You may qualify if:
- being between ≥18 and ≤ 75 years old
- having been diagnosed with cancer at least 6 months ago and/or have been long-term stable.
You may not qualify if:
- having severe physical risks due to cancer treatment and / or comorbidities
- currently undergoing intensive chemotherapy or other treatment
- having cognitive or psychosomatic complaints that interfere with successful participation
- having skin cancer, except for melanomas with metastasis
- having a life expectancy of \<1 year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lentis Psychiatric Institutelead
- Dokter Drenthecollaborator
- University Medical Center Groningencollaborator
- Kloosterveen, Assencollaborator
- Gezondheidscentrum Assen-Oost, Assencollaborator
Study Sites (2)
Gezondheidscentrum Assen-Oost
Assen, Drenthe, Netherlands
Kloosterveen
Assen, Drenthe, Netherlands
Related Publications (1)
Booij SH, Pieper A, Wester CD, Bultmann U, Waarsenburg EC, Hoenders HJR. The Transdiagnostic Oncology Program (TOP): a multidomain lifestyle intervention to improve the quality of life of cancer survivors - a before-and-after pilot study in primary care. BMC Cancer. 2025 Nov 10;25(1):1745. doi: 10.1186/s12885-025-15063-2.
PMID: 41214573DERIVED
Related Links
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior researcher
Study Record Dates
First Submitted
January 30, 2025
First Posted
February 5, 2025
Study Start
January 1, 2019
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share
The informed consent form did not include permission for sharing data with third parties. Therefore, we are legally not allowed to do so as long as the data remains pseudonymized."