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Transdiagnostic Oncology Program in Primary Care

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06809452
Acronym
TOP
Enrollment
35
Registered
2025-02-05
Start date
2019-01-01
Completion date
2020-01-01
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Survivor

Keywords

cancer survivor, family-doctor led aftercare program, lifestyle intervention, transdiagnostic, general practitioner, interdisciplinary

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.

Interventions

BEHAVIORALTransdiagnostic Oncologic Program

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.

Sponsors

Dokter Drenthe
CollaboratorUNKNOWN
University Medical Center Groningen
CollaboratorOTHER
Kloosterveen, Assen
CollaboratorUNKNOWN
Gezondheidscentrum Assen-Oost, Assen
CollaboratorUNKNOWN
Lentis Psychiatric Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Eligibility criteria for the program and for the study were the same, with the exception that participants were willing to sign informed consent to participate in the study. Inclusion criteria: * being between ≥18 and ≤ 75 years old * having been diagnosed with cancer at least 6 months ago and/or have been long-term stable.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and satisfaction.From baseline to the end of the program, after 1 year.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.
Change in quality of lifeFrom baseline to the end of the program, after 1 year.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.

Secondary

MeasureTime frameDescription
Change in happinessFrom baseline to the end of the program, after 1 year.Happiness, a specific aspect of quality of life, was measured with the happiness index (HI).
Change in fatigueFrom baseline to the end of the program, after 1 year.Fatigue was comprehensively assessed by the validated Dutch version of the Multidimensional Fatigue inventory (MFI); the MFI-20.
Change in work accommodations after work resumptionFrom baseline to the end of the program, after 1 year.Work accommodations after work resumption was assessed with six contextual items. Participants who resumed work at one of the assessments (T0, T1, T2) were asked to specify any work accommodations.
Change in work abilityFrom baseline to the end of the program, after 1 year.Work ability was assessed by a validated single-item question from the work ability index (WAI).
Change in mental symptomsFrom baseline to the end of the program, after 1 year.Mental symptoms were assessed with the 21-item Depression, Anxiety and Stress Scale (DASS-21), which is a reliable and validated questionnaire.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026