None listed
Conditions
Brief summary
.The primary purpose of this pilot trial is to assess the feasibility of running screening and comprehensive medical assessment (CMA) sessions to reduce the co-existing health conditions of colorectal cancer patients. Who is it for? You may be eligible to participate in this study if you have been diagnosed with colorectal adenocarcinoma or metastatic colorectal adenocarcinoma for which a major resection has been planned or carried out. Study details All participants in this study will be asked to complete a screening questionnaire to identify any co-existing health conditions, and to provide a list of all current medications. Patients with co-existing conditions will then attend a one hour comprehensive medication assessment session with a geriatrician in which these conditions will be discussed and referrals made to specialists as required. This trial is primarily assessing the feasibility of carrying out the screening and CMA sessions and researchers will investigate the response rates of questionnaires and numbers of eligible patients. It is hoped that this study will provide information on whether such a program is feasible, with the aim of reducing co-existing health conditions in colorectal cancer patients and thus increasing quality of life.
Interventions
Potential patients will complete a screening tool (questionnaire) to identify any comorbidities (administered by the Research Nurse). Patients will also be asked to identify all current medications, patient notes will be reviewed to identify all medications on admission, and patients GP will be contacted to identify accuracy of prescription. medications will be entered into the Lexi-Comp online interaction checker, a printout of potential interactions will be provided to the study clinician.
Potential patients will complete a screening tool (questionnaire) to identify any comorbidities (administered by the Research Nurse). Patients will also be asked to identify all current medications, patient notes will be reviewed to identify all medications on admission, and patients GP will be contacted to identify accuracy of prescription. medications will be entered into the Lexi-Comp online interaction checker, a printout of potential interactions will be provided to the study clinician. Patients identified via the screening tool are invited to attend a comprehensive medical assessment "CMA" (approximately one hour, attendance at an outpatient clinic, or, carried out whilst an inpatient if appropriate). This will include: Geriatrician led medical assessment of comorbidity with medical optimisation, investigations or further referrals where indicated and treatment of medical comorbidity: - assessment of mental health status with referral as necessary; - analgesia and pain management review, assessment of impact on BP, cognisiton, balance and mood; - assessment of ECOG status; - social circumstances review; - referral to OT, physio, social work, dietician and palliative care as appropriate; - follow up appt at three months from assessment or when indicated (if < 3 months) (Assessment of inpatients is intended to focus on offering advice on comorbidity management, not issues pertaining directly to surgical management.) Strategies to monitor adherence are not applicable to this study.
Sponsors
Dr Christopher Jackson
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients with newly diagnosed colorectal adenocarcinoma who have undergone or who are planned to undergo major resection OR Metastatic relapse of colorectal adenocarcinoma, as judged by histological confirmation of relapse or as confirmed by a specialist multi-disciplinary team meeting (MDTM) OR 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 of colon or rectum with polypectomy or local excision as only treatment; Treatment acuity such that intervention not able to be administered without potentially compromising patient outcome (e.g acute or sub-acute bowel obstruction, incipient perforation, major GI haemorrhage); Unable to give informed consent; Not able to comply with follow up; Locally recurrent rectal cancer without metastatic relapse; Life expectancy less than three months from diagnosis.
Outcome results
None listed