The main goal of the study is to determine the (cost-) efficacy of this online psychological intervention for partners of cancer patients on psychological distress. To obtain insight in possible determinants of the effects of the intervention on…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychologische distress door de ziekte van de partner
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate the effectiveness of two
versions of the online course *Hold on, for each other* in comparison to a
waiting list control condition in terms of a decrease in psychological distress.
Psychological distress in partners of cancer patients was chosen as primary
outcome because it is important in several ways. Firstly, psychological
distress negatively impacts the quality of life of partners of cancer patients
themselves (e.g. Northouse et al., 2010; Hilton et al., 2008; Kuijer et al.,
2004; Stenberg et al., 2010). Secondly, psychological distress can have a
negative impact on the formal care that most partners provide for the cancer
patients. Depression, anxiety and fatigue may render the partner unable to
provide the support needed, resulting in greater burden on health and social
services (Northouse et al., 2010). Thirdly, psychological distress in the
partner may have indirect negative effects on the recovery of cancer patients.
Partner*s depressed mood can result in emotional inaccessibility, distancing or
criticism and may thus negatively affect the emotional support available to the
cancer patients, which might inhibit effective management of the illness or
hamper psychosocial adjustment of the cancer patient (Northouse et al., 2010;
Ussher et al., 2009).
Secondary outcome
The secondary objective of this study is to evaluate the effectiveness of the
online course *Hold on, for each other* in comparison to a waiting list control
condition in terms of an increase in (positive) mental health, health-related
quality of life and general health, and a decrease in depressive symptoms and
caregiver burden. Other objectives of this study is are (1) to evaluate if
psychological flexibility, self-compassion, mastery, supportive behaviour,
posttraumatic growth and resilience are mediators in the effects described in
the other objectives; (2) to determine the cost-efficacy of the online
intervention *Hold on, for each other* and (3) to obtain insight in possible
determinants of the effects of the intervention on psychological distress in
partners of cancer patients; potential predictors include socio-demographics
(age, gender, education, working situation, family situation), disease-related
characteristics of the patients (sort, stage, duration and treatment of cancer)
partner*s health (physical and mental health, resilience) and the psychological
impact of the partners* role as a caregiver (caregiver strain, communication
and posttraumatic growth).
Background summary
Every year 90.000 patients are diagnosed with cancer and it is estimated that
400.000 patients and 280.000 partners live with cancer. Prevalence rates are
expected to almost double in the next 10 years. There is consistent evidence
that partners of cancer patients are at risk of experiencing anxiety,
depression, fatigue and sleep problems. Recent studies have shown that clinical
levels of psychological distress are highly prevalent in partners of cancer
patients and can even be higher than in people with cancer themselves. On the
basis of the need for evidence-based, supportive interventions for partners of
cancer patients and the limited availability of such interventions in current
practice in the Netherlands, the University of Twente developed the online
intervention *Hold on, for each other*, that is based on a promising
theoretical framework and that is easily accessible (requiring minimum time,
positively framed, online).
Study objective
The main goal of the study is to determine the (cost-) efficacy of this online
psychological intervention for partners of cancer patients on psychological
distress. To obtain insight in possible determinants of the effects of the
intervention on psychological distress in partner of cancer patients, potential
predictors include socio-demographics, disease-related, psychological, social
factors and caregiving burden measured at baseline.
Study design
A prospective randomized controlled trial will be carried out with three
parallel groups:
1) Experimental condition 1: Web-based intervention *Hold on, for each other*
with feedback from a counsellor once a week. Participants are involved from
entry/intake until the last measurement for 12 months. There are four
measurement points.
2) Experimental condition 2: Web-based intervention *Hold on, for each other*
with automatic feedback from a virtual counsellor. Participants are involved
from entry/intake until the last measurement for 12 months. There are four
measurement points.
3) Waiting list control condition: Participants will be on a waiting list for 3
months from entry/intake. They receive *Hold on, for each other* with automatic
feedback after the first follow-up measurement, three months after the start of
the intervention for the experimental condition. Participants are involved in
the study for 12 months. There are four measurement points.
Intervention
The online psychological intervention is based on behavioural therapy
(Acceptance and Commitment therapy (ACT)), mindfulness and self-compassion.
There are 6 modules (plus one additional module depending on the stage of
disease) which can be worked through in 6-14 weeks. Participants can follow the
module at home at a time that suits their convenience. Participants receive
short informative texts, exercises on acceptance, mindfulness and
self-compassion, practical information, tips and further relevant references,
poems or inspiring messages. Besides that, participants are offered the
possibility to share their answers on some of the exercises with some other
participants (anonymously) and they can also contact participants if they want
to. Two versions of the intervention will be tested. In the experimental
condition 1 participants will receive short feedback by a counsellor once a
week. In the experimental condition 2, participants will receive automated
feedback by a virtual counsellor after finishing the exercises of the module.
Study burden and risks
No risks are expected from participation. Participants can choose for
themselves to sign up for study participation. The burden with regard to time
and mental effort are not expected to be too high. The intervention is
developed in close cooperation with partners of cancer patients and they have
commented on various paper versions of the intervention. In a previous survey
study we also asked participants about the preconditions (e.g. maximum time per
week) an intervention should meet (Köhle, Drossaert, Verdonck-de Leeuw, Van
Uden-Kraan & Bohlmeijer, in preparation) and the outcomes were taken into
account in the developing process. If the burden of participation is too high,
participants are free to refrain from the intervention and the study. They are
informed about this in the participant information letter. The questionnaire
assessment does not seem to be a very high burden. It will take approximately
30 minutes to complete T0, T1, T2 and T3. If it appears from intake that
participants have severe psychiatric problems, they will be stricktly advised
to consult a GP as soon as possible. Participation probably will have benefits
such as a decrease in psychological distress and an increase in mental health,
psychological flexibility and mindfulness.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Being partner of an cancer patient (diagnosis is longer than 3 months ago) or cancer survivor*
- Having internet access, and having an e-mail address
- Being able to speak, write and read Dutch language
- Having mild to moderate symptoms of psychological distress (>3 on the total Hospital Anxiety and Depression Scale (HADS); Zigmond & Snaith, 1983). ;* In case a cancer patient dies during the online intervention, partners are allowed to go on with the intervention if they want to.
Exclusion criteria
- Severe anxiety (score on HADS-A >= 15) and/or severe depression (score on HADS-D >= 15)
- Recently started (less than three months ago)with psychological or psychopharmacological treatment
- Not being able to spend 1-1.5 hours on the intervention every week
- Partner died because of cancer
- If diagnosis is less than 3 months ago
Design
Recruitment
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 |
|---|---|
| Other | aangemeld in het Nederlands Trial Register-- identificatienummer NTR4035 |
| CCMO | NL45159.044.13 |