AzTrials
AzTrials

Cancer SurvivorTOPNCT06809452

Transdiagnostic Oncology Program in Primary Care

An observational study of Cancer Survivor, run by Lentis Psychiatric Institute at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cancer Survivor
What is being tested?
Transdiagnostic Oncologic Program
How many people
35 participants
Where
2 sitesNetherlands
Study dates
1 Jan 2019to 1 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • being between ≥18 and ≤ 75 years old
  • having been diagnosed with cancer at least 6 months ago and/or have been long-term stable.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Gezondheidscentrum Assen-Oost

    Assen, Drenthe

  • Kloosterveen

    Assen, Drenthe

Other trials in Netherlands

About this study

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

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.
Conditions
Cancer Survivor
Being tested
Transdiagnostic Oncologic Program
Keywords
cancer survivor, family-doctor led aftercare program, lifestyle intervention, transdiagnostic, general practitioner, interdisciplinary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transdiagnostic Oncologic ProgramBehavioural

    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.

Study groups in NCT06809452
Study groupRoleWhat they receive
Cancer survivors taking part in the programEligble cancer survivors who agreed to take part in TOP and in the study.
Receives: Behavioral: Transdiagnostic Oncologic Program
Cancer survivors serving as controlsEligble cancer survivors who declined to take part in TOP, but agreed to take part in the study. They serve as a convenience control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to the end of the program, after 1 year.

  2. 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.

    Measured: From baseline to the end of the program, after 1 year.

Secondary outcomes (5)

  1. Change in fatigue

    Fatigue was comprehensively assessed by the validated Dutch version of the Multidimensional Fatigue inventory (MFI); the MFI-20.

    Measured: From baseline to the end of the program, after 1 year.

  2. Change in mental symptoms

    Mental symptoms were assessed with the 21-item Depression, Anxiety and Stress Scale (DASS-21), which is a reliable and validated questionnaire.

    Measured: From baseline to the end of the program, after 1 year.

  3. Change in happiness

    Happiness, a specific aspect of quality of life, was measured with the happiness index (HI).

    Measured: From baseline to the end of the program, after 1 year.

  4. Change in work ability

    Work ability was assessed by a validated single-item question from the work ability index (WAI).

    Measured: From baseline to the end of the program, after 1 year.

  5. Change in work accommodations after work resumption

    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.

    Measured: From baseline to the end of the program, after 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06809452
Sponsor's protocol ID
M17.218911_TOP2
Acronym
TOP
Status last verified
Feb 2025
First submitted
30 Jan 2025
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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."

Publications

  • 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.

    PubMed 41214573

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer Survivor, run by Lentis Psychiatric Institute at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and satisfaction. (time frame: From baseline to the end of the program, after 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06809452, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in