Clinical trial NCT06809452: Transdiagnostic Oncology Program in Primary Care
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Survivor
Keywords: cancer survivor
family-doctor led aftercare program
lifestyle intervention
transdiagnostic
general practitioner
interdisciplinary
Lead sponsor: Lentis Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Dokter Drenthe
name: University Medical Center Groningen
name: Kloosterveen, Assen
name: Gezondheidscentrum Assen-Oost, Assen
First posted: 2025-02-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Feasibility and satisfaction.
timeFrame: From baseline to the end of the program, after 1 year.
measure: Change in quality of life
timeFrame: From baseline to the end of the program, after 1 year.
Secondary outcomes:
measure: Change in fatigue
timeFrame: From baseline to the end of the program, after 1 year.
measure: Change in mental symptoms
timeFrame: From baseline to the end of the program, after 1 year.
measure: Change in happiness
timeFrame: From baseline to the end of the program, after 1 year.
measure: Change in work ability
timeFrame: From baseline to the end of the program, after 1 year.
measure: Change in work accommodations after work resumption
timeFrame: From baseline to the end of the program, after 1 year.
Other outcomes:
Locations:
city: Assen
country: Netherlands
facility: Gezondheidscentrum Assen-Oost
state: Drenthe
city: Assen
country: Netherlands
facility: Kloosterveen
state: Drenthe
Study officials:
References: