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

NCT03622437 | Completed

• 1 other identifier: R97-A6511-14-S23
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Aftercare; Follow-up; Patient Involvement; Patient-reported Outcomes (PRO)

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life and symptom burden

  Full name: The Trial Outcome Index (TOI), which is a subscale within the Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire. Construct: The FACT-C measures health related quality of life. Five subscales can be derived from the questionnaire: physical wellbeing subscale, family/social wellbeing subscale, emotional well-being subscale, functional well-being subscale and a colorectal cancer-specific subscale. The TOI combines the physical, functional and cancer-specific subscales, which are considered likely to change by an intervention being tested. Scale range (minimum and maximum scores): 0-84 Which values are considered to be a better or worse outcome: The higher the score, the better the QOL. Indicate how subscales are combined (summed, averaged etc.): The TOI is calculated by summing the scores from the physical, functional and colorectal cancer-specific subscales.

  Measured at 3 years after primary surgery

Secondary Outcomes (14)

• Bowel Function for patients without a stoma

  Measured at 3 years after primary surgery

• Bowel Function for patients without a stoma - shape and type of the stool

  Measured at 3 years after primary surgery

• Stoma Function for patient with a colonostomy

  Measured at 3 years after primary surgery

• Urinary Function

  Measured at 3 years after primary surgery

• Sexual Function for females

  Measured at 3 years after primary surgery

Study Arms (2)

Patient-led follow-up

EXPERIMENTAL

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.

Behavioral: Patient-led follow-up

Standard follow-up

ACTIVE COMPARATOR

Participants in this control group follow standard care for follow-up after rectal cancer treatment, as described in local and national guidelines.

Other: Standard follow-up

Interventions

Patient-led follow-up BEHAVIORAL

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

Patient-led follow-up

Standard follow-up OTHER

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

Standard follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• rectal resection for primary rectal adenocarcinoma
• R0/R1 resection (radical resection of the tumour)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Danish Cancer Society: collaborator
• Herning Hospital: collaborator
• Aalborg University Hospital: collaborator
• Randers Regional Hospital: collaborator

Study Sites (4)

Aalborg University Hospital, Department of Surgery

Aalborg, 9000, Denmark

Location

Aarhus University Hospital, Department of Surgery

Aarhus C, 8000, Denmark

Location

Herning Hospital, Department of Surgery

Herning, 7400, Denmark

Location

Randers Regional Hospital, Department of Surgery

Randers, 8930, Denmark

Location

Related Publications (1)

• Hovdenak 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 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Søren Laurberg, Prof. Dr.Med

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student, registered nurse

Model Details: Participants are randomized (1:1) into either intervention or control group. This is done by block randomization, stratifying by center, sex and treatment type (± postoperative oncological treatment and ± temporary ileal stoma).

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: August 9, 2018
• Study Start: February 26, 2016
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

DK (4)