To assess the impact of access to feedback and access to an internet-based self-management intervention after primary treatment of lymphoma by increasing self-management and decreasing distress. We hypothesise that patients who have access to…
ID
Source
Brief title
Condition
- Lymphomas NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
self-management and psychological distress.
Secondary outcome
Anxiety and depression, health care utilization, psychological empowerment,
health-related quality of life (HRQoL) generic and specific, symptoms, illness
perceptions, personal control, coping, satisfaction with information provision,
remoralization, and fatigue.
Background summary
Since cancer patients survive longer, health-related quality of life (HRQoL)
and other patient reported outcomes (PROs) are more and more recognized to be
important. Particularly because many lymphoma survivors continue to face
physical and psychosocial problems after completion of primary treatment. There
is increasing recognition to improve information disclosure and cancer
survivorship care. Providing web-based feedback on patient reported outcomes to
patients has the potential to help detect unmet needs and symptoms leading to
better control and monitoring of such issues, serve as a guide to discuss
issues (empowerment), and facilitate individualized information provision and
care. To diminish anxiety, depressive symptoms, emotional processing symptoms,
and physical symptoms, interventions with cognitive behavioural therapy aspects
through E-health has been proven to be effective as for example shown by the
internet-based self-management BREATH intervention for breast cancer patients.
However, no evidence exists concerning the access to feedback and access to an
internet-based self-management intervention on adjustment after cancer for
patients with lymphoma.
Study objective
To assess the impact of access to feedback and access to an internet-based
self-management intervention after primary treatment of lymphoma by increasing
self-management and decreasing distress. We hypothesise that patients who have
access to feedback and/or the self-management website will report higher
self-management and lower levels of distress, whereby we expect the effect to
be larger for the patients who have access to both the feedback and
internet-based self-management intervention.
Study design
Randomized controlled trial (RCT). The impact of access to feedback on PROs
(study arm 2), and the impact of access to feedback plus access to a
self-management intervention (study arm 3) will be compared to usual care
(study arm 1).
Intervention
Feedback will be provided on quality of life, fatigue, emotional, physical,
cognitive and social functioning, physical complaints, anxiety and depressive
symptoms, coping and self-management. If patients prefer, they will also have
access to a mean score of other people with lymphoma and to a mean score of a
normative population of people without cancer.
The self-management website will focus on psychological problems (such as
anxiety and depressive symptoms), emotional processing issues, social problems
(such as work resumption and reactions to the environment), and physical
problems (such as fatigue, pain and sexuality).
Study burden and risks
There are no risks involved for the participating patients of this study.
Participants are asked to complete a questionnaire at 4 different points in
time: baseline (i.e. 6-12 months after diagnosis), 16 weeks, 1 and 2 years
after baseline. This study aims to contribute to efforts to improve adjustment
after primary treatment for patients with lymphoma.
Godebaldkwartier 419
Utrecht 3511 DT
NL
Godebaldkwartier 419
Utrecht 3511 DT
NL
Listed location countries
Age
Inclusion criteria
All patients (men and women) that are newly diagnosed with Hodgkin or non-Hodgkin lymphoma in one of the participating hospitals and were 18 years or older at time of diagnosis.
Exclusion criteria
Unable to complete a Dutch questionnaire.
Patients with severe psychopathology or dementia.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL54096.028.15 |
OMON | NL-OMON27749 |