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Completed

NCT Number: NCT06809452

Transdiagnostic Oncology Program 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.

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Key information

Conditions

Cancer Survivor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gezondheidscentrum Assen-Oost, Assen, Drenthe, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdiagnostic Oncologic Program

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.

Primary outcomes

  1. Feasibility and satisfaction.

    Time frame: 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.

  2. Change in quality of life

    Time frame: From 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 outcomes

  1. Change in fatigue

    Time frame: From 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.

  2. Change in mental symptoms

    Time frame: From 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.

  3. Change in happiness

    Time frame: From 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).

  4. Change in work ability

    Time frame: From 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).

  5. Change in work accommodations after work resumption

    Time frame: From 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.

Sponsors and collaborators

Lead sponsor

Lentis Psychiatric Institute

Other

Collaborators

  • Dokter Drenthe
  • Gezondheidscentrum Assen-Oost, Assen
  • Kloosterveen, Assen
  • University Medical Center Groningen

Registry information

Official study 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

Acronym: TOP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2025
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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