|- candidate number||12166|
|- NTR Number||NTR3375|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-mrt-2012|
|- Secondary IDs||NOU2011-5151 KWF Kankerbestrijding|
|- Public Title||Lifestyle change, self-management, and problem solving in daily life in cancer survivors; an online portal for change and support.|
|- Scientific Title||The effectiveness and evaluation of an online cancer aftercare intervention concerning lifestyle change, self-management, and problem solving in cancer survivors.|
|- hypothesis||Aftercare treatment for cancer survivors does not meet their needs. Neglected psychosocial problems, lack of disease self-management or efficient social support, and unhealthy lifestyles may adversely affect long term quality of life or even oncology outcomes. There is a need for follow-up service responsive to the needs of cancer survivors. The online cancer aftercare portal will provide online tailored modules on dealing with distress, obtaining social support, disease self-management, and personalized information on optimizing healthy lifestyles. The online intervention is hypothesized to improve disease self-management, experienced social support and lifestyles. Furthermore, participating in the online cancer aftercare portal is hypothesized to lead to a better quality of life and lower levels of psychosocial distress in cancer survivors.|
|- Healt Condition(s) or Problem(s) studied||Selfmanagement, Social support, Life style, Quality of life, Psychosiocial problems, Cancer survivors, Tertiary prevention, Aftercare|
|- Inclusion criteria||1. 18 years of age or older;|
2. Patients who were previously diagnosed with cancer;
3. Successful completion of the main treatment period, up to one year ago;
4. People who receive aftercare (e.g., preventive hormonal therapy) or medical check-ups are allowed to participate;
5. No cancer during last medical check-up;
6. Patients with all types of cancer are allowed to participate; no groups are excluded (on condition that the main treatment period is successfully completed);
7. Ability to speak and read the Dutch language;
8. Access to the web and minimal internet experience (monthly access).
|- Exclusion criteria||Patients with a serious medical, psychiatric, or cognitive disease that would interfere with participation.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2013|
|- planned closingdate||1-jun-2015|
|- Target number of participants||800|
|- Interventions||Cancer survivors in the experimental group who enter the online portal receive general information on dealing with distress, obtaining social support, disease self-management, and optimizing healthy lifestyles. They are free to fill out a questionnaire on personal needs which will lead them to tailored advice about the mentioned topics. Also information about possible other helpful interventions and social workers is provided. Cancer survivors in the experimental group are free to enter the online portal as often as they want during one year. |
The waiting list control group will be provided with access to the online intervention after the last measurement.
|- Primary outcome||1. The extent of psychosocial distress;|
2. Health related quality of life in patients.
Psychosocial distress will be measured with the General Health Questionnaire – 12 item version (GHQ-12) and the Hospital Anxiety and Depression Scale (HADS). Quality of life will be measured with the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30). Both primary outcomes will be assessed at all time points.
|- Secondary outcome||1. Lifestyle behaviors;|
2. Coping behaviors;
3. Self-management & problem solving behaviors;
5. Perceived social support.
Physical activity will be measured with the SQUASH; a validated physical activity measure. Smoking behavior will be measured with a validated 7-days recall questionnaire. Alcohol consumption will be measured with a standardized scale to assess the amount of alcohol consumption. Dietary behaviors will be measured by validated food frequency questionnaires on respectively saturated fat-intake and vegetable and fruit consumption. Habit strength will be measured by means of the Self-Report Habit Strength Index. Self management is operationalized as problem-solving. It will be measured using the SPSI-R, a self-report questionnaire. Empowerment will be measured with a short validated questionnaire. The questionnaire will be adapted for the specific situation of cancer survivors. Perceived social support will be measured with the SSL-I. Perceived peer support will be measured with SSL-D and SSL-I subscales that will be developed for the purpose of the study. All secondary outcomes will be assessed at all time points.
|- Timepoints||Both primary and secondary outcomes will be measured at baseline, after 3 months, after 6 months, and after 12 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Linda Küsters|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. L. Lechner|
|- Sponsor/Initiator ||University Maastricht (UM), Open University the Netherlands|
(Source(s) of Monetary or Material Support)
|KWF Kankerbestrijding, Netherlands Laboratory for Lifelong Learning (NELLL)|
|- Brief summary||In the Netherlands 83.000 new cancer cases occur each year. Fortunately, improved treatments increase the chance to survive and to cure. This also means that a growing number of patients has to live with the aftermath of the disease, and has to (re)gain a healthy lifestyle balance as well as self management. The Health Council of the Netherlands concluded that current aftercare for cancer survivors is insufficient. Plans were presented to develop and implement a survivorship care plan for cancer survivors in the Netherlands. The Association of Comprehensive Cancer Centers defined this plan into the Guideline Recovery From Cancer. That guideline pleads a broad programmatic approach for oncology aftercare in which self care of patients needs to be stimulated and facilitated.
The current project closely fits to this guideline. The first step for developing a survivorship care plan is to study how cancer patients experience health service after regular treatment has ended and what needs they have to cope better with surviving cancer. Following this needs assessment, adapted to the specific needs of cancer survivors, an e-learning and e-coaching intervention will be developed. Cancer survivors can obtain personalized information, self-assessments and tailored advice, support and training, making it easier to successfully adapt to their new situation. Online tailored modules will be provided on dealing with distress, obtaining social support, disease self-management, and personalized information on medical aspects in aftercare. In addition cancer survivors could obtain personalized information on optimizing healthy lifestyles (physical activity, nutrition, smoking, alcohol).
The project’s primary aims are to study short (3 and 6 months) and long term (12 months) health related effects of the online portal on survivors’ psychosocial distress and quality of life (QoL). Furthermore, process aspects of usage and evaluation of different modules of the online portal will be studied. Secondary aims are to study effects in lifestyle behaviors, coping behaviors, self-management & problem solving behaviors, empowerment, and perceived social support. A randomized clinical trial will be performed to compare the intervention group to a control group receiving the intervention after the study period (waiting list control group).
|- Main changes (audit trail)|
|- RECORD||29-mrt-2012 - 19-feb-2013|