CancerGICEENCT02647450
GI Consequences Economic Evaluation
An observational study of Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer
- What is being tested?
- GIANT Completed patient
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients cured of cancer and are experiencing GI symptoms due to radio or chemotherapy during the last one year.
Who may be able to join
- 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.
Who cannot join
- They have been re-referred to the GIANT clinic, having previously been discharged following treatment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: An Exploratory Assessment of the Cost Impact of Managing GI Consequences of Cancer Treatment Outside of a Specialist Clinic
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.
Read the detailed 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.
- Conditions
- Cancer
- Being tested
- GIANT Completed patient
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIANT Completed patientOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: GIANT Completed patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jervosie Andreyev, MBBS, Phd, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647450
- Sponsor's protocol ID
- CCR 4447
- Acronym
- GICEE
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2016
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Assessment of the Cost Impact of Managing GI Consequences of Cancer Treatment Outside of a Specialist Clinic
- ClinicalTrials.gov ID
- NCT02647450
- Acronym / sponsor ID
- GICEE / CCR 4447
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GIANT Clinic Group | – | Other: GIANT Completed patientPatients 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients cured of cancer and are experiencing GI symptoms due to radio or chemotherapy during the last one year.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- They have been re-referred to the GIANT clinic, having previously been discharged following treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIANT Completed patientPatients 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. | Other | GIANT Clinic Group |
Primary outcome
Cost of Intervention
Time frame: 6 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jervosie Andreyev, MBBS, Phd principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of Intervention (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.