Core Outcome Measures in Effectiveness Trials

Core Outcome Research Measures in Anal Cancer (CORMAC)

General Information

Summary:
Anal cancer was once thought to be an uncommon malignancy occurring in elderly individuals – but in the past 20 years, its clinical presentation has changed considerably. Treatment of anal cancer is complex: initial treatment is chemo-radiotherapy, but local relapse occurs in approximately 20% - cases in which radical salvage surgery is considered. Overall, these treatments are associated with considerable short and long-term morbidities.

There have been several trials and studies of interventions in patients with anal cancer, and these underpin current clinical practice. However, for each of these studies, several different endpoints have been reported. Lack of standardisation in reporting makes it very difficult to truly discuss likely outcomes of treatment with patients in the clinic i.e. informed consent.

The overall aim is to develop a core outcome set for the treatment of anal cancer which reflects the interests of patients, clinicians, commissioners, and trialists in order to facilitate decision-making by all stakeholders.

Link to protocol: http://bmjopen.bmj.com/content/7/11/e018726

Contributors:
Ms Rebecca Fish (Clinical research MD fellow)
Professor Andrew Renehan (supervisor and CI)
Professor Paula Williamson (supervisor)
Dr Caroline Sanders (supervisor)

Further Study Information

Current Stage:
Ongoing
Date:
October 2015 - October 2017
Funding source(s):
NIHR

Health Area

Disease Category
Cancer

Disease Name
Anal cancer

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Chemotherapy
Radiotherapy
Surgery

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

Four work packages will be undertaken over 2 years:
• WP1: A systematic review of the literature on anal cancer treatments will be performed to identify a comprehensive list of clinical, patient-reported, healthcare 'process', resource, composite and surrogate outcomes reported in trials of the treatment of anal cancer.
• WP2: Semi-structured interviews with anal cancer survivors will be used to identify additional outcomes to supplement the long-list.
• WP3: Surveys of key stakeholders (patients, clinicians, commissioners) in three rounds of Delphi methodology will refine the outcome long-list into a core outcome set.
• WP4: Consensus meetings with key stakeholders will ratify the core outcome set.


Stakeholders Involved

Clinical experts
Consumers (patients)
Patient/ support group representatives
Service commissioners
Service providers

Study Type

COS for clinical trials or clinical research
COS for practice
Recommended outcome measures (measurement)

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