The primary objective of this research is to gain insight into the short term (6 months) and long term (12 months) effects of the blended care protocol on cancer survivors* lifestyle behaviours. The secondary goal of this research is to gain insight…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes at baseline, 6 months and 12 months are effects on lifestyle
behaviors:
1) Physical activity: the amount of minutes per week of moderate physical
activity, number of muscle strengthening exercises
2) Smoking
3) Alcohol use
4) Diet: weekly intake of vegetables, fruit, fiber and fish
Secondary outcome
Secondary outcomes at 6 months are biomarkers:
- Blood pressure
Secondary outcomes at baseline, 6 months and 12 months are:
- Experienced distress (depression and anxiety)
- Experience fatigue
- Health related quality of life
Secondary outcomes at 6 months are:
- Disease burden
- Medical consumption
- Productivity costs
- QALY*s
- Appreciation and use of the intervention
Background summary
In our ageing society, diagnoses of cancer will be more common each year. With
an expected 116.500 diagnoses in 2030 (GLOBOCAN, 2020), the next decade will
have more than 1 million people will be living with cancer or its consequences
in the Netherlands (KPMG, 2018). Even though early detection and new treatment
methods are leading to improved chances of survival, cancer survivors have a
high risk for recurrence and comorbidity. This puts them at a priority for
prevention (Overholser & Callaway, 2018). Moreover, treatment often has
physical and or psychological consequences that interfere with their return to
normal life.
In order to support these survivors the Cancer After Care Guide has been
developed. The Cancer Aftercare Guide is an eHealth intervention that promotes
a healthy lifestyle and teaches self-management skills to deal with the
consequences of cancer. Earlier research has proven the Cancer After Care Guide
to be effective in improving diet and physical activity (Kanera et al., 2016)
and reducing fatigue and depression (Willems et al., 2017). Since 2018 the
Cancer After Care Guide has been available via kanker.nl (Dutch national
website about cancer), however only a small number of patients has used the
program.
In their 2015 Oncology Standpoint, the Dutch College of General Practitioners
(NHG, 2015) stated that GP involvement is crucial to meet patients* demand for
cancer aftercare. They further stress the importance of self-management and
patient engagement in cancer aftercare. In order to increase reach of the
Cancer Aftercare Guide and support structural integration of cancer aftercare
in the general practice, a blended care protocol has been developed. This study
will investigate the effects of the blended care protocol on survivors*
lifestyle behaviors primarily. Secondary outcomes are the effects of the
blended care protocol on survivors* quality of life and health related costs to
evaluate cost-effectiveness of the program. In a previous research on the
Cancer Aftercare Guide cost-effectiveness was not evaluated.
Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality
Worldwide for 36 Cancers in 185 Countries
Kanera, I. M., Bolman, C. A., Willems, R. A., Mesters, I., & Lechner, L.
(2016a). Lifestyle-related effects of the web-based Kanker Nazorg Wijzer
(Cancer Aftercare Guide) intervention for cancer survivors: a randomized
controlled trial. Journal of cancer survivorship : research and practice,
10(5), 883-897. https://doi.org/10.1007/s11764-016-0535-6
KPMG in opdracht van KWF Kankerbestrijding. Toekomstverkenning betere kwaliteit
van leven, 2018
Overholser, L. S., & Callaway, C. (2018). Preventive Health in Cancer
Survivors: What Should We Be Recommending?. Journal of the National
Comprehensive Cancer Network : JNCCN, 16(10), 1251-1258.
https://doi.org/10.6004/jnccn.2018.7083
Willems, R. A., Bolman, C. A., Mesters, I., Kanera, I. M., Beaulen, A. A., &
Lechner, L. (2017a). Short-term effectiveness of a web-based tailored
intervention for cancer survivors on quality of life, anxiety, depression, and
fatigue: randomized controlled trial. Psycho-oncology, 26(2), 222-230.
https://doi.org/10.1002/pon.4113
Study objective
The primary objective of this research is to gain insight into the short term
(6 months) and long term (12 months) effects of the blended care protocol on
cancer survivors* lifestyle behaviours.
The secondary goal of this research is to gain insight into the effects of the
blended care protocol on blood pressure, as well as psychosocial distress,
fatigue and health-related quality of life. Additionally, the
cost-effectiveness of the intervention will be evaluated based on burden of
disease, medical consumption, sick days, the presence of co-morbidity and
QALY*s.
Furthermore, the blended care protocol, the usage of the website and the
different modules of the Cancer Aftercare Guide will be evaluated by means of a
process evaluation.
Study design
This research will be carried out by means of a randomised clinical trial
(RCT). A clinical trial will be executed to compare the experiment group and
waiting list control group. General practices that participate in the study
will be randomly assigned to either intervention of control group. General
practices will invite their patients to participate in the study by means of an
information letter and informed consent. In case patients want to partake in
the study they are requested to send a signed copy of the informed consent to
the reseachers. Once the informed consent is processed by the research team,
the participant will receive a link and login code to the online baseline
questionnaire. Meanwhile GPCs will be informed about which patients agreed to
participate in the experiment. After completing the baseline questionnaire,
participants in the intervention group will be invited for a first consultation
with the GP or PN. This is the start of the blended care intervention. The
blended care intervention consists of an intake consultation and a follow up
consultation 6 weeks later. The consultations will be held either by a general
practitioner or a practice nurse. After the intake consultation participants in
the intervention group will be encouraged to use the online Cancer Aftercare
Guide. During the follow up consultation participants will discuss their
progress with the online Cancer After Care Guide receive personal counselling
regarding the interpretation of the lifestyle advice given by the program.
Participants in the control group will only partake in the online
questionnaires and the blood pressure measurement during the course of the
study. GPCs in the control group will offer their patients care as usual. Care
as usual means that participants in the control group have access to all normal
health care, including eHealth interventions such as the existing Cancer
Aftercare Guide program. They are free to use this program, albeit at their own
initiative. Participants from the control group will be informed about and
encouraged to use the Cancer After Care Guide after the last measurements at 12
months. Blood pressure will be measured with all participants at 6 months.
Every participant will receive an online questionnaire at baseline, 6 months
and 12 months.
The design of the study is as displayed below:
E: T0 x T1 x T2 -
C: T0 - T1 - T2 x
E: experimental group
C: control group
Measurements:
T0: baseline: lifestyle physical activity, diet, smoking behaviour and alcohol
consumption), level of distress, fatigue and health-related quality of life
(health related QoL)
T1: 6 months after first measurement: lifestyle physical activity, diet,
smoking behaviour and alcohol consumption), blood pressure, level of distress,
fatigue and health-related quality of life (health related QoL), health-related
costs, process evaluation.
T2: 12 months after first measurement: lifestyle physical activity, diet,
smoking behaviour and alcohol consumption), level of distress, fatigue and
health-related quality of life (health related QoL)
X: use of the online Cancer Aftercare Guide program
-: no use of the online Cancer Aftercare Guide program
Intervention
The experimental group receives the blended care intervention. The blended care
intervention consists of:
One consultation with the general practitioner or practice nurse in which
participants will be motivated to start using Cancer Aftercare Guide;
One consultation with the general practitioner or practice nurse, which will
take place 6 weeks after the first consultation and in which the participant
will receive personal counseling with interpreting the lifestyle advice
received in the Cancer Aftercare Guide;
Use of the Cancer Aftercare Guide up until 6 months after the first
consultation. The Cancer Aftercare Guide will provide personally tailored
information within different modules:
• Physical Activity
• Diet
• Smoking
• Alcohol use
• Psychological complaints as a consequence of cancer such as distress or
fatigue
•(Disease) Self-Management.
•Problem solving skills (coping mechanisms)
•Return to work and social relationships
The modules consist of textual information and advice, video clips (in which
former cancer patients tell their story) and assignments/exercises. The
assignments have been based on evidence-based methods, such as CBT,
mindfulness, modelling, action planning and coping planning. Participants in
the experimental group are free to decide to what extent they use the online
Cancer Aftercare Guide. Participants will be referred to modules that cover
subjects that are most useful to them, based on the baseline questionnaire.
They are free to follow modules of their own choice and decide whether or not
they complete the assignments. Participants will use the program independently.
In case of questions they will be referred to the research team. Under no
conditions medical advice is given in the online program. For medical questions
we will always refer to the specialist providing treatment. Participants in the
control group are informed about and encouraged to use the online Cancer
Aftercare Guide program after the last measurement at 12 months.
Study burden and risks
There are no risks of negative consequences related to this research.
Participants in the intervention group are free to decide to what extent they
partake in the online Cancer Aftercare Guide. Moreover, all participants (both
the intervention as well as the control group) are allowed to stop
participation at any time.
The participant load of two visits to the general practitioner and practice
nurse in the timeframe of 2 months is minimal. The participant load of
undergoing blood pressure measurement within a timeframe of 6 months is
minimal. Participant load for filling out questionnaires at 3 time points
within 12 months is minimal.
Furthermore, we expect that the use of the intervention will contribute to a
healthy lifestyle, will have positive effects on participants* quality of life
and will reduce the experienced distress and fatigue in participants. The
personal contact with the general practitioner or practice nurse that results
from this protocol is a desirable side effect..
Participants of the control group will only fill out questionnaires and undergo
blood presurre measurements. Besides that they will receive care as usual. They
will not be withheld from care (neither from seeking additional professional
support if they wish to do so). After the final measurements at 12 months are
completed, participants in the control group will be informed about and
encouraged to use the online Cancer Aftercare Guide program.
Valkenburgerweg 177
Heerlen 6401DL
NL
Valkenburgerweg 177
Heerlen 6401DL
NL
Listed location countries
Age
Inclusion criteria
a) Patients who have successfully completed the primary treatment for cancer
(e.g. radiotherapy, chemotherapy, surgery) and were treated with curative
intent, with the last treatment to have been between 6 weeks ago and 3 years
ago, or belong to a watchful waiting condition (e.g. option for prostate cancer
patients)
b) 18 years of age and older
c) Able to read and speak Dutch
d) Without a serious medical, psychiatric or cognitive disease that would
interfere with participation
e) Internet access and at least minimal internet experience
f) Access to a computer or tablet
Exclusion criteria
a) Patients with a serious medical, psychiatric, or cognitive disease that
would interfere with participation (e.g. Alzheimer*s disease, blindness);
b) Patients who did not complete primary treatment or who were not treated with
curative intent
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 | ISRCTN12451453 |
| CCMO | NL80166.096.21 |