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

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ClinicalTrials.gov Identifier: NCT03622437
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Danish Cancer Society
Herning Hospital
Aalborg Universitetshospital
Randers Regional Hospital
Information provided by (Responsible Party):
Ida Hovdenak Jakobsen, Aarhus University Hospital

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.


Condition or disease Intervention/treatment Phase
Rectal Neoplasms Behavioral: Patient-led follow-up Other: Standard follow-up Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Individual Follow-up After Rectal Cancer - Focus on the Needs of the Patient
Actual Study Start Date : February 26, 2016
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: Patient-led follow-up
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
  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


Active Comparator: Standard follow-up
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

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




Primary Outcome Measures :
  1. Health-related quality of life and symptom burden [ Time Frame: Measured at 3 years after primary surgery ]

    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.



Secondary Outcome Measures :
  1. Bowel Function for patients without a stoma [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: The Low Anterior Resection Syndrome Score (LARS-score).

    Construct: Assessment of bowel dysfunction following a low anterior resection for rectal cancer

    Scale range (minimum and maximum scores): 0-42

    Which values are considered to be a better or worse outcome: The higher the score, the more severe symptoms of bowel dysfunction

    Indicate how subscales are combined (summed, averaged etc.): no subscales are used.


  2. Bowel Function for patients without a stoma - shape and type of the stool [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: The Bristol Stool Scale

    Construct: Assessment tool of the form of human faeces, and classification into seven stool types.

    Scale range (minimum and maximum scores): type 1-7

    Which values are considered to be a better or worse outcome: Types 1 and 2 indicate constipation. Types 3 and 4 indicate the ideal stools. Type 5 indicates slight diarrhea. Types 6 and 7 indicate diarrhea.

    Indicate how subscales are combined (summed, averaged etc.): no subscales are used.


  3. Stoma Function for patient with a colonostomy [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: 'The colostomy impact score'.

    Construct: measures impact from colostomy dysfunction on quality of life

    Scale range (minimum and maximum scores): The colostomy impact score ranges from 0 to 38 points.

    Which values are considered to be a better or worse outcome: A score of ≥ 10 indicates major colostomy impact.

    Indicate how subscales are combined (summed, averaged etc.): no subscales are used


  4. Urinary Function [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: 'The male/female lower urinary tract symptoms' (ICIQ-FLUTS/ICIQ-MLUTS)

    Construct: Evaluates male/female lower urinary tract symptoms and impact on quality of life

    Scale range (minimum and maximum scores): The ICIQ-FLUTS It is scored on a scale from 0-16 for symptoms of filling, 0-12 for voiding symptoms and 0-20 for incontinence symptoms. Range of the total score is 0-48. The ICIQ-MLUTS is scored on a scale from 0-20 for voiding symptoms and 0-24 for incontinence symptoms. The range of the total score is 0-44.

    Which values are considered to be a better or worse outcome: Higher scores indicate greater impact of individual symptoms for the patient

    Indicate how subscales are combined (summed, averaged etc.): For both the ICIQ-FLUTS and the ICIQ-MLUTS, the total score is calculated by summing the scores from the subscales.


  5. Sexual Function for females [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: 'The Sexual Function - Vaginal Changes Questionnaire' (SVQ)

    Construct: measures sexual and vaginal problems in gynaecological cancer, although it is assumed that rectal cancer patients experience similar problems due to changes in pelvic physiology and in the nervous innervation.

    Scale range (minimum and maximum scores): The measure includes 20 core-items and 7 change-items. Out of these, 13 questions are only filled-out if the responder is sexually active. A total score will not be reported. Items 1-3 and 21-23 are combined into a subscale evaluating sexual interest and relations, with a range from 6-21.

    Which values are considered to be a better or worse outcome: Higher values indicate better outcome

    Indicate how subscales are combined (summed, averaged etc.): The subscale for sexual interest and relations is calculated by summing the scores from the items 1-3 and 21-23.


  6. Sexual Function for males [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: 'The International Index for Erectile Function' (IIEF) for males.

    Construct: measures the effects from erection problems on sex life

    Scale range (minimum and maximum scores): 6-75

    Which values are considered to be a better or worse outcome: higher scores indicate better outcome.

    Indicate how subscales are combined (summed, averaged etc.): no subscales are used


  7. Chronic pain [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: 'The Chronic Pain Score after Rectal Cancer Treatment'

    Construct: The score measures chronic pain in the pelvic area following treatment for rectal cancer.

    Scale range (minimum and maximum scores): 0 to 46 points.

    Which values are considered to be a better or worse outcome: Scores from 0-4 indicate no pain; 5-20 indicate minor pain; ≥ 21 indicate major pain

    Indicate how subscales are combined (summed, averaged etc.): No subscales are used


  8. Fatigue [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: The Multidimensional Fatigue Inventory (MFI-20)

    Construct: evaluates five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.

    Scale range (minimum and maximum scores): 20-100

    Which values are considered to be a better or worse outcome: Higher total scores correspond with more acute levels of fatigue.

    Indicate how subscales are combined (summed, averaged etc.): no subscales are used


  9. Fear of Cancer Recurrence [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: The Fear of Cancer Recurrence Inventory (FCRI)

    Construct: multidimensional measure for fear of recurring cancer. Includes seven subscales, of which one (severity subscale) is considered a short-form subscale.

    Scale range (minimum and maximum scores): 0-168

    Which values are considered to be a better or worse outcome: higher values indicate worse outcome

    Indicate how subscales are combined (summed, averaged etc.): The short-form subscale is calculated by summing values from items 9-17. The total score is summed by all item values.


  10. Psychological Distress [ Time Frame: Measured at 3 years after primary surgery. ]

    Full name: 'The Hospital Anxiety and Depression Scale' (HADS)

    Construct: measures anxiety and depression in a general medical population of patients

    Scale range (minimum and maximum scores): 0-21

    Which values are considered to be a better or worse outcome: Scores of 0-7 are considered normal, 8-10 borderline and 11 or over indicate clinical 'caseness'.

    Indicate how subscales are combined (summed, averaged etc.): The score is divided into a depression scale and an anxiety scale - both scales range from 0-21.


  11. Self-efficacy [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: The patient activation measure (PAM)

    Construct: measures the patient's knowledge, skills and confidence for self-management.

    Scale range (minimum and maximum scores): The 13 items have a calibrated scale range from 38.6 to 53.0 (on a theoretical 0-100 point scale)

    Which values are considered to be a better or worse outcome: PAM segments people into one of four progressively higher levels of activation.

    Indicate how subscales are combined (summed, averaged etc.): no subscales are used.


  12. Patient involvement [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: Patient involvement

    Construct: measures the patient's experience of being involved by health care professionals during follow-up

    Scale range (minimum and maximum scores): 6-60

    Which values are considered to be a better or worse outcome: higher scores indicate better outcome.

    Indicate how subscales are combined (summed, averaged etc.): no subscales are used


  13. Patient information and sense of security [ Time Frame: Measured at 3 years after primary surgery ]

    Full name: Patient information and sense of security

    Construct: measures the patient's experience of receiving adequate information and help during follow-up

    Scale range (minimum and maximum scores): 5-25

    Which values are considered to be a better or worse outcome: higher scores indicate worse outcome.

    Indicate how subscales are combined (summed, averaged etc.): no subscales are used


  14. Cost-benefit - QALY's [ Time Frame: Measured at 1 year after primary surgery ]
    QALY's derived from 'The EuroQol 5-dimensional health state measurement'. Data from national health care registries are also utilised



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622437


Contacts
Contact: Ida Hovdenak Jakobsen, MHS +4530740281 idajak@rm.dk
Contact: Therese Juul, PhD +4578465115 therjuul@rm.dk

Locations
Denmark
Aalborg University Hospital, Department of Surgery Recruiting
Aalborg, Denmark, 9000
Contact: Inge Bernstein, PhD       i.bernstein@rn.dk   
Contact: Helle Vindfeldt Rasmussen, RN       hvr@rn.dk   
Aarhus University Hospital, Department of Surgery Recruiting
Aarhus C, Denmark, 8000
Contact: Ida Hovdenak Jakobsen, MHS    30740281    idajak@rm.dk   
Contact: Therese Juul, PhD       therjuul@rm.dk   
Herning Hospital, Department of Surgery Recruiting
Herning, Denmark, 7400
Contact: Anders Husted Madsen, PhD       andemads@rm.dk   
Contact: Susie Lindhardt Larsen, RN       susie.lindhardt.larsen@vest.rm.dk   
Randers Regional Hospital, Department of Surgery Recruiting
Randers, Denmark, 8930
Contact: Anne-Sofie Kannerup, PhD       annekann@rm.dk   
Contact: Rikke Krogh Demming, RN       rikkdemm@rm.dk   
Sponsors and Collaborators
Aarhus University Hospital
Danish Cancer Society
Herning Hospital
Aalborg Universitetshospital
Randers Regional Hospital
Investigators
Study Chair: Søren Laurberg, Prof. Dr.Med Aarhus University Hospital
  Study Documents (Full-Text)

Documents provided by Ida Hovdenak Jakobsen, Aarhus University Hospital:
Study Protocol  [PDF] February 7, 2016
Statistical Analysis Plan  [PDF] February 7, 2016
Informed Consent Form  [PDF] January 6, 2016


Publications:
Responsible Party: Ida Hovdenak Jakobsen, PhD-student, registered nurse, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03622437     History of Changes
Other Study ID Numbers: R97-A6511-14-S23
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ida Hovdenak Jakobsen, Aarhus University Hospital:
Aftercare
Follow-up
Patient Involvement
Patient-reported Outcomes (PRO)

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases