None listed
Conditions
Brief summary
Patients who are diagnosed with colorectal cancer often have other health problems as well as their cancer. These concurrent medical conditions (comorbidity) can impact on the treatment that is recommended for them, and on their recovery from their cancer. In addition, people with a lot of additional health problems may find cancer treatment more difficult to tolerate. International research has examined the impact of Comprehensive Geriatric Assessment on patients who are receiving chemotherapy. Studies have shown that people undergoing this assessment have fewer serious side effects from the chemotherapy. We are proposing a large, multi-centre study looking at the impact of a slightly broader intervention aimed at managing comorbidity in patients with colorectal cancer who are undergoing surgery, chemotherapy, or both. Prior to embarking on such a large study we need to test the appropriateness and acceptability of our screening tools and “road test” our comprehensive medical (geriatric) assessment, and so we are conducting pilot study where we aim to test these tools and determine feasibility of the study.
Interventions
This is a non-randomised sequential cohort study with a control phase followed by an intervention phase and finally a qualitative phase to fully assess study feasibility. Patient diagnosis date will determine whether they are invited to participate within the control or intervention phase of the study. All patients who consent will be screened for comorbidity by completing a health questionnaire (taking up to 30 minutes) and medical note review by a research nurse. The nurse will assess the p
This is a non-randomised sequential cohort study with a control phase followed by an intervention phase and finally a qualitative phase to fully assess study feasibility. Patient diagnosis date will determine whether they are invited to participate within the control or intervention phase of the study. All patients who consent will be screened for comorbidity by completing a health questionnaire (taking up to 30 minutes) and medical note review by a research nurse. The nurse will assess the patient’s eligibility to be referred to the intervention using defined decision-making criteria. Patients within the intervention arm who are identified as being eligible will be invited to attend a Comprehensive Medical Assessment (CMA) completed by a study specific Geriatrician within Older Persons’ Health outpatient clinics single session. Each CMA will take 30-60 minutes to complete. The CMA will be tailored to each patient, will cover a) assessment and management of comorbidity; b) assessment and management of polypharmacy; c) evaluation of mental health with a particular focus on depression; and d) review of functional and psychosocial issues, and will result in patient specific care plans. On-going geriatrician management will be determined on a case by case basis. Geriatrician clinical notes and letters will be reviewed to obtain study data pertaining to each patients specific care plan, and to assess intervention fidelity.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients with newly diagnosed colorectal adenocarcinoma who have undergone or who are planned to undergo major resection, Metastatic relapse of colorectal adenocarcinoma, as judged by histological confirmation of relapse or as confirmed by a specialist multi-disciplinary team meeting (MDTM), Undifferentiated carcinoma (grade 4) with clinical features consistent with colorectal cancer (and confirmed by a MDTM) will be permitted,
Exclusion criteria
Histological or cytological diagnosis of cancer type other than adenocarcinoma, Adenocarcinoma or colon or rectum with polypectomy or local excision as only treatment, Unable to give informed consent, Not able to comply with study procedures and/or follow up. Locally recurrent rectal cancer without metastatic relapse, Life expectancy less than three months from diagnosis.
Outcome results
None listed