GI Consequences Economic Evaluation

Cancer Clinical Trial

— GICEE  

Official title:

An Exploratory Assessment of the Cost Impact of Managing GI Consequences of Cancer Treatment Outside of a Specialist Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647450
• Other study ID #: CCR 4447
• Status: Completed
• Phase: N/A
• First received: January 5, 2016
• Last updated: January 29, 2018
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2018
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The number of people who survive cancer has tripled in the past 30 years; however, chronic physical consequences of treatment for cancer adversely affect the quality of life of 20-25% of survivors. The largest group of patients reporting debilitating chronic side effects are those treated with radiotherapy alone or in combination with other treatments for pelvic cancer. Gastrointestinal symptoms are the most common chronic physical side effects reported, and have the greatest effect on daily activity. Overall, 50% of patients report that that their gastrointestinal symptoms affect their quality of life, and 20-40% state that this effect is moderate or severe. Such problems include chronic faecal incontinence (up to 60% of patients) after radiotherapy for prostate or rectal cancer (53, 54), and chronic loose stool (47%), defaecatory urgency (29%), or chronic abdominal pain (17%) after radiotherapy for gynecological cancer.

In 2010, the UK National Cancer Survivorship Initiative Vision challenged professionals to develop new models of care for patients because "the needs of cancer survivors are not being met, that being 'cured' of cancer does not necessarily equate with being well and that chronic consequences of treatment can have a devastating impact on daily life". The National Cancer Survivorship Initiative accepts that currently there is limited access to specialist services, despite an estimated 90,000 people in the UK experiencing long-term gastrointestinal problems as a consequence of cancer treatment. Furthermore, recent surveys of clinical oncologists and gastroenterologists concur with this sentiment, highlighting a lack of available expertise; with two UK audits of gastroenterology consultants and oncologists demonstrating no improvement in provision of specialist services between 2003 to 2010. Whilst NHS Improvement has developed stratified pathways of care, the Roadmap for Recovery report created recently by the Anthony Nolan Bone Marrow Transplant charity underlined the ongoing issue of lack of specialised commissioning of services for complex consequences of cancer treatment. It is estimated that £40 million (DoH) is wasted annually in futile and dangerous treatments for Pelvic Radiation Disease alone; academic estimates suggest this is closer to £80 million . Furthermore the incapacitating affects of GI symptoms leads to both loss of productivity and huge social costs. Currently there is no NHS tariff payable for GI consequences of cancer treatment; however the mean cost per completed episode of care by the GIANT (Gastrointestinal and Nutrition Team) service was calculated, amounting to an average cost of £1563 per patient. This can be compared to a tariff of £14,800 per woman treated with chemo-radiation for cervical cancer, and a cost in excess of £45,000 for a person with rectal cancer treated with long course chemo-radiation followed by surgery and adjuvant chemotherapy. With specialist clinics lacking, it can be assumed that the majority of people living with GI consequences of cancer treatment are being treated by their GPs; however, the Quality and Outcomes Framework by which GP Surgeries are measured and awarded financial incentives includes no domain or measure for gastrointestinal problems; and there have been no studies into the cost of managing patients with GI problems as a consequence of cancer treatment outside of the GIANT service. This exploratory study is a step in this direction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• GIANT Completed patient
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.

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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