Clinical trial · Interventional
Individual Follow-up After Rectal Cancer - Focus on the Needs of the Patient
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
With an increasing number of rectal cancer (RC) survivors, we see a rising attention to the late adverse effects following treatment of RC. Late adverse effects that are highly prevalent and negatively impact patients' symptom burden and quality of life are: bowel-, urological and sexual dysfunctions; psychological distress; fear of recurrence. The current follow-up program primarily focuses on detection of recurrence, with less attention to late adverse effects. In a patient-led follow-up program, the surveillance for recurrent disease is combined with detection and treatment of late adverse effects and supportive survivorship care. The follow-up involves a high degree of patient-involvement, aiming at meeting the individual patient's needs. The patient-led follow-up programme is based on a standardized patient-education in order to enforce the patients to assess and respond sufficiently to symptoms and health problems. In case of symptoms and concerns, the patients are instructed to consult a health professional for adequate assistance and intervention. The intervention is tested in a multicenter randomized trial, comparing the patient-led follow-up to standard routine follow-up, involving prescheduled outpatient visits.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-led follow-up | Behavioral | — | UNRESOLVED |
| Standard follow-up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient-led follow-up
- description
- Participants in the experimental arm are enrolled in a patient-led follow-up program, based on patient-education and self-referral, in addition to recommendations from national guidelines for follow-up.
- interventionNames
- Behavioral: Patient-led follow-up
- type
- ACTIVE_COMPARATOR
- label
- Standard follow-up
- description
- Participants in this control group follow standard care for follow-up after rectal cancer treatment, as described in local and national guidelines.
- interventionNames
- Other: Standard follow-up
Primary outcomes (1)
- measure
- Health-related quality of life and symptom burden
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * rectal resection for primary rectal adenocarcinoma * R0/R1 resection (radical resection of the tumour) Exclusion Criteria: * metastatic disease * synchronous cancer * not able to understand Danish language * severe cognitive deficit, i.e. dementia * residual life expectancy less than two years * concurrent participation in other scientific studies which affect frequency and content of the follow-up program
References
Publications (1)
- BACKGROUNDHovdenak Jakobsen I, Juul T, Bernstein I, Christensen P, Jensen FS, Johansen C, Lindhardt Larsen S, Laurberg S, Madsen MR, Thorlacius-Ussing O, Vind Thaysen H. Follow-up after rectal cancer: developing and testing a novel patient-led follow-up program. Study protocol. Acta Oncol. 2017 Feb;56(2):307-313. doi: 10.1080/0284186X.2016.1267400. Epub 2017 Jan 9. PMID 28068158