Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark

Cancer Clinical Trial

Official title:

Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072733
• Other study ID #: Oncogeriatric feasibility
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: April 7, 2017
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict complications to cancer treatment within a three months period.

Description:

Aim:

The study aims 1)to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity and 4)to investigate the ability of CGA to predict complications to cancer treatment within a three months period.

Method:

All patients referred to the oncology Departement aged 70 years or more with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer, Living in the Central Denmark Region (Region Midt) are offered af Comprehensive Geriatric Assessment (CGA) on the day of the visit to the oncology outpatient Clinic. Prior to the first visit to the oncology department, the patients are informed that a CGA is planned..The CGA will take place at the outpatient clinic. The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment.

Outcome:

1. The possibility of offering CGA to elderly cancer patients in a larger area, the proportion of patients offered CGA by the oncogeriatric team compared to the actual number of elderly cancer patients assessed by oncologists during a three months period.

2. The number of frail vs. vulnerable vs. fit persons is estimated from hospital records and the CGA observations. Their dependency in Activities of Daily Living (ADL) and Instrumental Activities og Daily Living (IADL), their cognitive, depressive and nutritional status and the medication problems are registered as well as the changes in patient´s medication.

3. The impact of CGA on the oncologist´s treatment plan.

4. The Complications, defined as discontinuation of treatment, hospitalization for other reasons than planned cancer treatment, or death, within the first three month following CGA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 130 Years

Eligibility

Inclusion Criteria:

• 70 years or older

• Patients from Central Denmark Region (Region Midtjylland)

• Lung cancer, Upper Gastrointestinal Cancer, cancer of head and neck and Colo-Rectal Cancer

• referred for assessment of treatment to the oncological department at Aarhus University Hospital.

Exclusion Criteria:

Patients referred to specialized palliative care at the first visit to the oncological outpatient clinic.

Related Conditions & MeSH terms

• Cancer
• Elderly

Intervention

Other:
• Comprehensive geriatric assessment
Intervention is planned to be based on the findings of the geriatric assessment and could include optimizing on comorbidity, planning of physical exercise, improvement of the social situation and nutritional status.

Locations

Country	Name	City	State
Denmark	Geriatric Department Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of CGA on the oncologist´s treatment plan	To analyse the association between the oncologist´s initial treatment plan (standard dose, reduced dose or supportive/palliative/no treatment) and the CGA conclusion (fit, vulnerable or frail) Pearson´s Chi-squared-test or Fisher´s Exact test is used.; In a subgroup analysis on the non-agreed category data on the CGA conclusion and the oncologist´s initial treatment plan. And furthermore to compare the oncologist´s final treatment intensity to the CGA recommendations Pearson´s Chi-squared-test or Fisher´s Exact test are used	3 months
Other	Complications	Description of the proportion of patients who is available for CGA presented in percentage. Proportion of patients missed for CGA due to organisational issues or rejection to participate in the geriatric evaluation is presented in percentage.	3 months
Primary	Feasibility	Description of the proportion of patients who is available for CGA presented in percentage. Proportion of patients missed for CGA due to organisational issues or rejection to participate in the geriatric evaluation is presented in percentage.	3 months
Secondary	frailty status	Patient characteristics according to CGA status is presented in percentage	3 months