The primary aim of this study is to investigate the effects on PA, sleep, stress, health and QoL of a tailored eHealth intervention for cancer patients when embedded in oncological care. Additional aims are to gain insight into the cost-…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in PA, sleep, stress-levels, health and QoL are the main study outcomes
during this study and are measured via online questionnaires at 0, 3 and 6
months. In addition, accelerometer measurements are performed at 0 and 6 months
to assess PA and sleep.
Secondary outcome
Cost-effectiveness, cost-utility and use and appreciation of the eHealth
intervention are secondary outcomes of the study and are assessed through
online questionnaires and intervention log data. Additionally, use and
feasbility of implementation protocols for embedding the intervention in
practice by HCOs and HCPs is a secondary outcome of this study, which is
assessed through online questionnaires and semistructured interviews among HCPs
in the intervention group.
Background summary
Sufficient physical activity (PA), good sleep quality and paying attention to
stress-management is extremely important for cancer patients during and after
treatment, since these behaviors have a positive impact on physical and mental
functioning, health, quality of life (QoL), treatment outcomes and reduce side
effects. However, insufficient attention is currently paid to lifestyle support
within oncological care which is often due to lack of time, knowledge and
skills among health care professionals (HCPs). Therefore, there is an urgent
need for accessible lifestyle interventions where HCPs can refer cancer
patients to in a time-efficient way. Tailored electronic health (eHealth)
interventions are considered a viable solution for this purpose.
Study objective
The primary aim of this study is to investigate the effects on PA, sleep,
stress, health and QoL of a tailored eHealth intervention for cancer patients
when embedded in oncological care. Additional aims are to gain insight into the
cost-effectiveness, use and appreciation of the intervention and the use and
feasibility of implementation protocols for embedding the intervention in
practice by health care organizations (HCOs) and HCPs.
Study design
Randomized controlled trial applying a parallel two group (intervention vs
usual care) design with repeated measures across 3 occasions (0, 3, 6 months)
with HCOs as unit of randomization.
Intervention
The intervention group receives access to a tailored online eHealth
intervention targeting the behaviors PA, sleep and stress-management.
Participants are referred to the intervention by their HCP in the hospital,
rehabilitation centre or physiotherapy practice. The control group receives
care as usual and receives access to an online lifestyle intervention after
completion of the study.
Study burden and risks
No risks are associated with participation since it concerns a behavioral
eHealth intervention study targeting PA, sleep and stress-management and not a
medical or pharmacological intervention study. The burden associated with study
participation is considered small since participants are asked to fill in three
online questionnaires and wear two times an accelerometer for four days over a
period of six months. The potential benefits of the intervention outweigh the
burden associated with participation in this study since it is expected that
the intervention will improve PA, sleep, stress-management, health and QoL.
Valkenburgerweg 177
Heerlen 6419 AT
NL
Valkenburgerweg 177
Heerlen 6419 AT
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
a. Patients who are diagnosed with cancer from the moment of diagnosis up until
one year after completing the primary treatment for cancer (e.g. radiotherapy,
chemotherapy, surgery)
b. Patients undergoing primary treatment for cancer are treated with a curative
intent
c. Aged 18 years or older
d. Able to read and speak Dutch
e. Having a PC/tablet and internet
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
a. Having a serious medical, psychiatric or cognitive disease that would
interfere with participation (e.g. Alzheimer*s disease, blindness, sever
obesity (BMI>=35))
b. Being in the palliative phase
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN61846887 |
| CCMO | NL88212.096.25 |