GI Consequences Economic Evaluation

NCT02647450 | Completed

• 1 other identifier: CCR 4447
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

An estimated 90,000 patients are suffering from long term gastrointestinal problems after cancer treatments, and whilst the National Cancer Survivorship Initiative have been working to develop specific pathways of care, these pathways lack in both specialised tariff funding and awareness. This study aims to assess the economic and personal impact on patients suffering from stomach and/or bowel problems after cancer treatment prior to referral to the Gastrointestinal and Nutrition Team (GIANT) at the Royal Marsden Hospital. All patients referred to the GIANT service (including private patients but excluding re referrals) will be offered participation in the study. The study will consist of a 9 page patient retrospective questionnaire, asking questions about investigations and medications prescribed over the past year, as well as costs and methods of trying to treat their symptoms themselves, and the personal cost to themselves of their symptoms through loss of work and emotional impact. As this questionnaire asks patients questions about the past year, and thus can be difficult to answer accurately, patient answers will be validated for reliability by sending a 1 page questionnaire to their GP asking the same questions about clinic visits concerning stomach/bowel problems, investigations and medications prescribed in the past year. Once this data is collected from the participants, and the study has finished, the average cost of clinical interventions, economic impact, and personal impact, will be calculated. The results from this study will be useful in helping to show the economic burden of GI symptoms, and will provide evidence as to the economic benefit of specialised clinics for the consequences of cancer treatment; highlighting the need for a nationally recognised algorithm for management.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Cost of Intervention

  The total estimated cost calculated per patient of clinical intervention for gastrointestinal problems caused by cancer treatment 1 year prior to referral to the GI and Nutrition Team. This will include number of GP visits, number and type of prescribed medicines and dietary supplements, number and type of investigations, number of visits to A\&E, number of inpatient days, and number of visits from other healthcare professionals.

  6 month

Study Arms (1)

GIANT Clinic Group

Patients are required to have been refereed to the GI and Nutrition team Clinic at the Royal Marsden Hospital. In the clinic they will be assessed for their symptoms using the Gastrointestinal Symptom Rating Scale (GSRS).

Other: GIANT Completed patient

Interventions

GIANT Completed patient OTHER

Patients identified in the GIANT clinic and who fulfill the inclusion criteria will be sent a 9 page questionnaire. Upon receipt the questionnaire will be sent to the patient's GP for validation.

GIANT Clinic Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients cured of cancer and are experiencing GI symptoms due to radio or chemotherapy during the last one year.

You may qualify if:

• Age over 18 years.
• Past history of malignant disease.
• They are able to give informed consent to participate.
• Patients with longer term consequences of cancer treatment, defined as patients with symptoms referred 3 months or more after the end of their cancer treatment.

You may not qualify if:

• They have been re-referred to the GIANT clinic, having previously been discharged following treatment.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jervosie Andreyev, MBBS, Phd

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

GB (1)