Individual Follow-up After Rectal Cancer - Focus on the Needs of the Patient

Summary

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

• Rectal Neoplasms

Interventions

BEHAVIORAL

Patient-led follow-up

1. Patient-education, with information about signs of recurrent disease (alarm-symptoms), potential late effects, and how these can be managed. 2. The patients are instructed to contact a specialist nurse in case of alarm-symptoms, concerns or other problems related to the cancer disease throughout the entire follow-up period. The specialist nurse responds to the referrals, according to a standardized algorithm. In addition, all patients receive: * CEA and CT of the chest, abdomen and pelvis at 1 and 3 years after surgery * perioperative clean colon colonoscopy, and then every 5 years until the age of 75 years Only for patients with a stoma: \- access to stoma care by specialist nurses

OTHER

Standard follow-up

Patients with sphincter-preserving resection: \- outpatient visits incl. rectoscopy at 6, 12, 18, 24 and 36 months Patients with rectal amputation and a permanent stoma: * outpatient visits at 3, 12 and 36 months * access to stoma care by specialist nurses All patients: * CEA and CT of the chest, abdomen and pelvis at 1 and 3 years after surgery * perioperative clean colon colonoscopy, and then every 5 years until the age of 75 years

Sponsors & Collaborators

• Danish Cancer Society

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Aarhus University Hospital

  lead OTHER

Principal Investigators

• Søren Laurberg, Prof. Dr.Med · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-26

Primary Completion

2021-08-31

Completion

2021-08-31

Countries

• Denmark

Study Locations