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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Change in quality of life
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Change in work accommodations after work resumption(From baseline to the end of the program, after 1 year.)
- Change in fatigue(From baseline to the end of the program, after 1 year.)
- Change in mental symptoms(From baseline to the end of the program, after 1 year.)
- Change in happiness(From baseline to the end of the program, after 1 year.)
- Change in work ability(From baseline to the end of the program, after 1 year.)
Investigators
Sanne Booij
Senior researcher
Lentis Psychiatric Institute