Motivating (former) cancer patients to increase their physical activity: The computer tailored OncoActive+ project.

Cancer and its treatment largely affects life expectancy of individuals and
results in an increased level of fatigue, emotional distress, depression and a
reduced level of Quality of Life (QoL). The problem is increasing as cancer
incidence is expected to rise with 40% to 123.000 new cases per year by 2020.
It is important to invest in interventions that reduce the negative effects of
cancer and its treatment and help to prevent recurrence of cancer and other
(chronic) diseases. Being physically active enough is an important goal in
reaching this. Therefore the computer-tailored OncoActive+ project will be
developed. The aim of the project is to stimulate physical activity in (former)
cancer patients and to support and advise them during this process. The program
is individually oriented and largely self-regulated; the patient participates
in the program without guidance from caregivers.

To develop and evaluate the OncoActive+ project that aims to increase the
amount of physical activity of (former) cancer patients. The main goal of this
study is to test the effect of the intervention on physical activity behavior,
as well as the usability and appreciation of the program, the effect on quality
of life and fatigue. The proven effective Active+ program (developed for over
fifties) is the base of the OncoActive+ program. Because it is a
computer-tailored program, everyone gets personal advise and information,
specified to i.a. type of cancer and treatment phase.

Phase I (not applicable for this METC submission): Preparation and adapting the
Active+ into OncoActive+ to the needs of (former) colon/prostate cancer
patients, based on literature and interviews with (former) colon and prostate
cancer patients, oncologists, physiotherapists, physiologists, oncology nurses,
cancer-related PA group coaches.
Phase II (applicable for this METC submission): Small scale pre-test (n=12) and
pilot study (n=20) on respectively the material and techniques, and the
usability and validity of the adapted OncoActive+ among (former) colon and
prostate cancer patients.
Phase III (applicable for this METC submission): The study is a randomized
clinical trial. The trial will be carried out to compare the experimental group
with the waiting list control group. Outcome measurements are physical activity
(accelerometer data), self-reported physical activity, fatigue and quality of
life and are taken at baseline, and after 3,6, and 12 months. In total, 428
(former) patients will be initially included by oncologist and oncology nurses
of hospitals and radiotherapy centres. The control group will have access to
the intervention after the last measurements at 12 months.
Phase IV (applicable for this METC submission): The project ends with a report
and distribution of the outcomes, and an implementation inventory for
large-scale distribution of OncoActive+.

Outline of the RCT design:

E: M1(Acc1+V1)--> A1-->A2-->M2(V2+PE1)-->A3-->M3(Acc2+V3+PE2)-->M4(Acc3+V4+PE3)
C: M1(Acc1+V1)--> M2(V2)--> M3(Acc2+V3)-->M4(Acc3+V4)

E Experimental group
C Control group
M Measurement (1=baseline, 2= after 13 weeks, 3= after 6 months, 4= after 12
months)
Acc Participants wear an accelerometer in the week before the questionnaires
are filled out
V Questionnaires (PA behaviour, quality of life, psychosocial experience,
fatigue, mental adjustment to cancer, and use of health care)
A Advise 1 (after 2 weeks) and 2 (after 8 weeks) based op V1; 3 (after 3
months) based on V2, with ipsative feedback
PE Process evaluation

The OncoActive+ intervention consists of several components
- Subjects in the experimental group receive an computer-tailored physical
activity advise three times during the 4 months of the intervention. The advise
is based on the completed questionnaires in which personal features, physical
activity behaviour, and the psychological determinants of physical activity of
the subject are processed. Furthermore, the intervention is personalized for
environmental determinants by giving advise on possibilities for physical
activity and initiatives in the environment.
- Participants will receive a pedometer to set PA goals.
- The intervention will be integrated in a website with further information, a
users forum, online physical exercises and the possibility to consult an
expert.
The intervention aims to raise awareness on the lack of physical activity, and
to stimulate initiation and maintenance of physical activity.

There are no risks and detrimental consequences related to the study and
intervention. Participants in the experimental group can decide for themselves
when and how often they make use of the intervention. The advice texts are
developed in cooperation with experts like oncologists, physiotherapists,
physiologists, oncology nurses, and cancer-related PA group coaches. Moreover,
all the participants (in the experimental group and in the control group) can
stop their participation in the study at any time. The burden of filling out
four questionnaires and wearing an accelerometer for in total 3 weeks in a
period of 12 months is minimal. In addition, expectation is that the use of the
intervention will have positive effects on endurance and quality of life.
Participants in both groups receive their usual health care. They won*t be
refrained from care (including extra professional care they would like to
seek). The participants in the control group will receive access to the
intervention (the online or written advise, the pedometer and use of the
website) at the end of the study period.