Transdiagnostic Oncology Program in Primary Care (TOP)

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.

Study Overview

• Status: Completed
• Conditions: Cancer Survivor
• Intervention / Treatment: Behavioral: Transdiagnostic Oncologic Program

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Netherlands
  • Drenthe
    • Assen, Drenthe, Netherlands
      • Gezondheidscentrum Assen-Oost
    • Assen, Drenthe, Netherlands
      • Kloosterveen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
Cancer survivors taking part in the program; Eligble cancer survivors who agreed to take part in TOP and in the study.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to the end of the program, after 1 year.
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.	From baseline to the end of the program, after 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue	Fatigue was comprehensively assessed by the validated Dutch version of the Multidimensional Fatigue inventory (MFI); the MFI-20.	From baseline to the end of the program, after 1 year.
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.	From baseline to the end of the program, after 1 year.
Change in happiness	Happiness, a specific aspect of quality of life, was measured with the happiness index (HI).	From baseline to the end of the program, after 1 year.
Change in work ability	Work ability was assessed by a validated single-item question from the work ability index (WAI).	From baseline to the end of the program, after 1 year.
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.	From baseline to the end of the program, after 1 year.

Collaborators and Investigators

• Sponsor: Lentis Psychiatric Institute
• Collaborators: University Medical Center Groningen; Dokter Drenthe; Kloosterveen, Assen; Gezondheidscentrum Assen-Oost, Assen

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cancer survivor; lifestyle intervention; interdisciplinary; transdiagnostic; general practitioner; family-doctor led aftercare program
• Other Study ID Numbers: M17.218911_TOP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No