|- candidate number||15776|
|- NTR Number||NTR4296|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-nov-2013|
|- Secondary IDs||NOU 2012-5585 KWF Kankerbestrijding (funding source)|
|- Public Title||The OncoActive+ project.|
|- Scientific Title||Motivating (former) cancer patients to increase their physical activity: The computer tailored OncoActive+ project.|
|- hypothesis||The developed OncoActive+ intervention will be an easily accessible physical activity intervention for (former) colon and prostate cancer patients as the user defines when and how to be physically active. OncoActive+ has the potential to easily reach broad patient populations with low (personnel) costs, and it is therefore low in demand of health care providers. If proven effective, the feasibility of the intervention will be examined among relevant organizations in order to come up with an end product that is useable in practice. In the future OncoActive+ might also be useful for other cancer types|
|- Healt Condition(s) or Problem(s) studied||Bowel cancer, Prostate cancer, Quality of life, Physical activity, Computer-tailoring|
|- Inclusion criteria||- Diagnosed with colon/prostate cancer.|
- 18 years or older
- Able to read and speak Dutch
- The patient needs to be under primary treatment (radiotherapy, chemotherapy, surgery) for prostate or colon cancer, while the survivors need to have successfully completed the main treatment up to one year ago.
|- Exclusion criteria||- Patients with a serious medical, psychiatric, or cognitive disease that would interfere with participation (e.g. Alzheimerís Disease, and severe obese (BMI>35)). |
- Any operation must have taken place at least six weeks ago. When operations are planned in the future, patients only can be included when the operation has taken place at least six weeks ago.
- Patients in de palliative phase will be excluded.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||12-dec-2013|
|- planned closingdate||31-mei-2017|
|- Target number of participants||450|
|- Interventions||Before the intervention will be tested for effectiveness with a randomized controlled trial (RCT), the intervention already effective proven Active+ program will be adapted through a literature review and interviews with experts and (former) prostate and colon cancer patients. Intervention material will be tested, and a pilot study will be executed. During the RCT subject in the experimental group receive an physical activity advise (either online or through written letters) three times during the 4 months of the intervention. The advise is based on the completed questionnaires in which personal characteristics, physical activity behaviour, and the psychological determinants of physical activity of the subject are processed. It aims to raise awareness on the lack of physical activity, and to stimulate initiation and maintenance of physical activity. Furthermore, the intervention is personalized for environment determinants by giving advise on possibilities for physical activity and initiatives in the environment. The intervention will be offered both online and written. In addition, a website with further information will be developed, as well as an users forum and the possibility to consult an expert. Participants of the control group receive their usual health care. They wonít 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 and use of the website) after the end of the study period.|
|- Primary outcome||Objective physical activity (accelerometer data) en subjective physical activity, specified to work, ADL, sport an leisure time (SQUASH).|
|- Secondary outcome||Health related quality of life, anxiety and depression, fatigue, adjustment to cancer, and appreciation and use of the intervention.|
|- Timepoints||Both primary and secondary measurements will be measured at baseline, after 3 months, after 6 months and after 12 months. |
|- Trial web site||www.oncoactief.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. L. Lechner|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. L. Lechner|
|- Sponsor/Initiator ||Open University of the Netherlands, Faculty of Psychology, Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|- Publications||Golsteijn RHJ, Bolman C, Volders E, Peels DA, de Vries H, Lechner L. OncoActief: een gerandomiseerd onderzoek naar de effectiviteit van een computer-getailorde interventie ter bevordering van fysieke activiteit bij (voormalige) prostaat- en darmkankerpatiŽnten. Nederlands Tijdschrift voor Oncologie 2015;12:84-88.|
|- Brief summary||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.
The OncoActive+ project aims to increase the amount of physical activity of (former) colon and prostate cancer patients. The proven effective Active+ program (developed for over fifties) is the base of the OncoActive+ program. OncoActive+ tries to stimulate physical activity through personal advises and information, specified to i.a. type of cancer and treatment.
Subjects in the experimental group receive an physical activity advise three times during the 4 months of the intervention. The advise is based on the completed questionnaires in which personal characteristics, physical activity behaviour, and the psychological determinants of physical activity of the subject are processed. It aims to raise awareness on the lack of physical activity, and to stimulate initiation and maintenance of physical activity. Participants will receive a pedometer to set PA goals. The program is individually oriented and largely self-regulated; the patient participates in the program without guidance from caregivers.
The main goal of this study is to test the effect of the intervention on physical activity behavior (accelerometer, self-reported). Secondary goals are to test the usability and appreciation of the program, and the effect on quality of life and fatigue. The primary and secondary outcomes will be measured at baseline, after 3 months, after 6 months and after 12 months.
|- Main changes (audit trail)||29-apr-2014: METC approval: yes - AB
10-mrt-2015: Patient status: open; trialwebsite www.oncoactief.nl; publication; wijziging type: 2 of meer arms en gerandomiseerd type- EB|
|- RECORD||27-nov-2013 - 10-mrt-2015|