Transdiagnostic Oncology Program in Primary Care

NCT ID: NCT06809452

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Survivor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cancer survivors taking part in the program

Eligble cancer survivors who agreed to take part in TOP and in the study.

Transdiagnostic Oncologic Program

Intervention Type BEHAVIORAL

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.

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transdiagnostic 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dokter Drenthe

UNKNOWN

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Kloosterveen, Assen

UNKNOWN

Sponsor Role collaborator

Gezondheidscentrum Assen-Oost, Assen

UNKNOWN

Sponsor Role collaborator

Lentis Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sanne Booij

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gezondheidscentrum Assen-Oost

Assen, Drenthe, Netherlands

Site Status

Kloosterveen

Assen, Drenthe, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Related Links

Access external resources that provide additional context or updates about the study.

https://www.dokterdrenthe.nl/patienten/zorg-voor-jou/top

Information page about TOP for clients from primary care practices in Drenthe

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M17.218911_TOP2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cancer Survivors Program
NCT07253987 RECRUITING NA