Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03881137 |
| Other study ID # |
SI0303150406 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 8, 2019 |
| Est. completion date |
June 10, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Sykehuset Innlandet HF |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This cluster randomized controlled pilot study is designed to test the feasibility, and
potential effect of a multicomponent, community-based intervention aiming to improve quality
of life (QoL) and function for older patients receiving radiotherapy (RT), and thereby reduce
the needs for professional help. The intervention will be based on geriatric assessment and
management (GAM), i.e. systematic assessment and management of physical, mental and
functional problems frequently occurring in the elderly. It will target individual patients
according to needs and be carried out in collaboration between hospital and community
services from start of RT until 8 weeks post-treatment.
Description:
Background:
Older cancer patients (> 65 years) represent the majority of the cancer population, and their
number grows due to an aging population. These patients often present with a multiplicity of
problems. They frequently suffer from physical- or mental health comorbidities, and are often
frail with impairment in mobility, daily life functioning and cognition. When diagnosed with
cancer and in need of therapy, they are at substantial risk of complications and functional
decline.
Geriatric assessment with management (GAM) has documented success in improving outcomes in
older patients with other diseases than cancer. Thus, GAM is strongly recommended as an
approach to optimize treatment and care for older cancer patients. Evidence for the potential
benefits is still scarce and in particular for older patients receiving radiotherapy.
Although GAM has been proven successful in other contexts, there is no universally accepted
recipe for how such an intervention should be performed and implemented. To be feasible and
efficient, adjustments according to patient population, health care organization and
available resources are necessary. The present study will be conducted to provide the
evidence needed for a subsequent definitive evaluation of a GAM intervention for older
patients receiving radiotherapy in a larger RTC, aiming at improving quality of life (QoL)
and function, and thereby reduce the burden for the patients, their families and the society.
The detailed objectives are to:
1. assess the potential short- and long-term effect of the intervention on global QoL and
physical functioning for older cancer patients receiving RT
2. assess the feasibility of the intervention
1. at the patient level (recruitment, compliance and adherence)
2. at the organizational level (structures facilitating or impeding implementation and
collaboration across sectors and between professionals)
3. study the use of health care services and related costs in the intervention and control
group
Methods:
The study emerges from Innlandet Hospital Trust and will be conducted in cooperation with
Trondheim University Hospital, and 30 municipalities in the catchment area of Innlandet
Hospital Trust, and Trondheim Municipality. The intervention is developed by an
interdisciplinary, experienced research group in close collaboration with user
representatives, hospital- and primary health care professionals. It is based on experience,
results and preliminary results from foregoing studies by our study group (including
NCT03071640 and NCT01742442) and focus group interviews with health professionals.
The design is cluster-randomized, randomizing municipalities and city districts. Patients
will be recruited at the radiotherapy units at Innlandet Hospital Trust (primary study
center) and Trondheim University Hospital (second study center). Anticipated number of
participants from the two hospitals is 102 patients and 60 patients, respectively.
Eligible, consenting patients will be included by the start of radiotherapy (RT), and enter
the control or intervention groups in accordance with the assignment of the municipality or
city district in which they reside. They will be followed with study specific assessments for
one year after end of RT, and for survival for five years.
Assessments:
By the time of inclusion, demographic and medical characteristics (including cancer
diagnosis, stage of disease, former and ongoing tumor treatment, ECOG performance status, RT
treatment aim (palliative or curative), and comorbidity. Detailed information about the RT
schedule will be registered by the end of RT.
Patient reported outcomes (EORTC QLQ-C30 and EQ-5D-5L) will be assessed at baseline, by the
end of RT, and thereafter 4, 8, 16, 32 and 52 weeks after RT. Physical performance tests,
i.e. Short Physical Performance Battery (SPPB), Timed Up and Go (TUG), grip strength and
one-legged balance test, will be applied at baseline and 8 and 16 weeks after the end of RT.
Cognitive function will be tested at baseline using the MiniCog.
To evaluate the cost-effectiveness of the intervention in comparison to control (standard
care), detailed information on the patients' use of health care services (home based and
institutional care) will be registered throughout the intervention period and during
follow-up (one year, week 52).
Feasibility will be assessed by a process evaluation, aiming to identify facilitators and
barriers for a successful implementation, using mixed methodology. Measures recommended for
each patient's intervention plan will be consecutively registered, as will patients'
compliance and adherence through weekly contact with the coordinating nurse (log notes).
Further data will include interviews with patients and providers. Questionnaires to involved
primary health care nurses and other relevant professionals will also be applied.
