Clinical trial NCT03622437: Individual Follow-up After Rectal Cancer - Focus on the Needs of the Patient
Official title: Individual Follow-up After Rectal Cancer - Focus on the Needs of the Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Aftercare
Follow-up
Patient Involvement
Patient-reported Outcomes (PRO)
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Herning Hospital
name: Aalborg University Hospital
name: Randers Regional Hospital
First posted: 2018-08-09
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Recruitment:

Patients are included from colorectal surgical departments in Aarhus, Randers, Herning and Aalborg. These centres cover one third of all Danish rectal cancer patients.

Patients are approached at the postoperative visit in the outpatient clinic where they are presented for the pathology results, approximately 2 weeks after primary surgery. The doctor provides short oral information about the study and hand out written information.

Following that, a research nurse makes contact with the patient by telephone a few days later, in order to clarify whether the patient wants to participate or not. Participation requires written informed consent and baseline information from the patient prior to randomisation.

Sample size:

An initial estimation of sample size showed, that a total of 334 participants were needed in order to obtain statistically significant results (alpha 0.05, beta 0.20, SD 13, minimally important difference 4 points on the TOI-score). The assumed standard deviation (SD) used for this estimation was based on studies where setting and populations differ substantially from ours.

Therefore, an interim analysis of the main-outcome (Trial Outcome Index - TOI) has been performed in order to determine a more precise SD. In an updated sample size estimation, the following preconditions are listed: 10.4 SD, 0.05 alpha-value, 0.20 beta-value, an expected difference of 4 points on the TOI-scale and an expected total drop-out of 30%.

Furthermore, additionally 15% are added to the sample size, due to the assumption that the outcome data will be non-parametric. Thus the conclusion from the updated sample size estimation is that a total of 324 participants are needed in order to obtain statistically significant results.

Drop-out is defined by: verified metachronous recurrence, metastasis or other primary cancer, death, emigration from the participating regions or if a participant leaves the study.

Data:

Most data is collected using questionnaires, administered by the patient (Patient-reported outcome measures -PROM's).

Patients are asked to complete a questionnaire at baseline (time of inclusion), and then at 12 and 36 months after surgery. The questionnaires consists of questions regarding symptom burden and quality of life, specific symptoms, patient activation, self-efficacy, patient involvement, patient information and needs in the follow-up period, and how they have been met by the Health care system.

Data regarding recurrence of cancer and mortality is collected from the Medical charts, while data regarding socioeconomic factors is derived from national registers and data on comorbidity is extracted from the national clinical database for colorectal cancer surgery.

Finally, data on health care utilisation in the follow-up period will be collected from national registers, in combination with information from patient records (limited access).

Statistical analysis:

Outcomes will be analyzed using methods for repeated measurements, and survival analysis. Any difference between the two allocation groups will be significance tested, and adjusted for covariates, using multiple regression analysis.

Differences in demographics between the two groups will be calculated and significance tested using a chi2-test (dichotomous and categorical data) and t-test (numerical data).

Quality-adjusted life years will be calculated using standard health economic methods and in collaboration with an expert in health economics.

Study timeline:

Development of the intervention was performed during the second half of 2015. Inclusion of patients in the RCT was initiated in February 2016, and is expected to be complete by the 31st of July 2018.

With a three-year follow-up period, the final results from the study will be analyzed and ready for publication by the end of 2021.

Ethical considerations:

The risks and ethical concerns related to the project are limited, but there are some potential concerns. Removing routine follow-up could lead to a delay in detecting asymptomatic local recurrences. However, patients having symptoms with the opportunity of self-referral may get an earlier detection of recurrence.

Answering the questionnaire could remind participants about their disease and lead some patients to unpleasant or stressful situations.

Patients agreeing to participate should feel secure in whatever group they are randomized to follow.

The study follows the ethical principles in the Helsinki Declaration, and is reported and approved by The National Committee on Health Research Ethics as required.

Data is handled and stored, according to national law and only anonymised results will be published. The study is reported and approved by the Danish Data Protection Agency.

Eligibility criteria: 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

Primary outcomes:
measure: Health-related quality of life and symptom burden
timeFrame: Measured at 3 years after primary surgery
Secondary outcomes:
measure: Bowel Function for patients without a stoma
timeFrame: Measured at 3 years after primary surgery
measure: Bowel Function for patients without a stoma - shape and type of the stool
timeFrame: Measured at 3 years after primary surgery
measure: Stoma Function for patient with a colonostomy
timeFrame: Measured at 3 years after primary surgery
measure: Urinary Function
timeFrame: Measured at 3 years after primary surgery
measure: Sexual Function for females
timeFrame: Measured at 3 years after primary surgery
measure: Sexual Function for males
timeFrame: Measured at 3 years after primary surgery
measure: Chronic pain
timeFrame: Measured at 3 years after primary surgery
measure: Fatigue
timeFrame: Measured at 3 years after primary surgery
measure: Fear of Cancer Recurrence
timeFrame: Measured at 3 years after primary surgery
measure: Psychological Distress
timeFrame: Measured at 3 years after primary surgery.
measure: Self-efficacy
timeFrame: Measured at 3 years after primary surgery
measure: Patient involvement
timeFrame: Measured at 3 years after primary surgery
measure: Patient information and sense of security
timeFrame: Measured at 3 years after primary surgery
measure: Cost-benefit - QALY's
timeFrame: Measured at 1 year after primary surgery
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Department of Surgery
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital, Department of Surgery
city: Herning
country: Denmark
facility: Herning Hospital, Department of Surgery
city: Randers
country: Denmark
facility: Randers Regional Hospital, Department of Surgery
Study officials:
affiliation: Aarhus University Hospital
name: Søren Laurberg, Prof. Dr.Med
role: STUDY_CHAIR
References:
citation: 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.