The aim of the current study is to develop an internet-based cognitive intervention programme for occupationally active cancer survivors confronted with cognitive problems and to evaluate the (cost-)effectiveness of this programme.
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the accomplishment of an individually defined
work-related treatment goal (Goal Attainment Scaling).
Secondary outcome
• Neuropsychological functioning will be measured using a self-administered
online neuropsychological test battery, the Amsterdam Cognition Scan (ACS)
• Self-perceived cognitive problems will be assessed using the Cognitive
Symptom Checklist-Work, Dutch version (CSC-W DV).
• Work ability will be assessed using the first item of the Work Ability Index
(WAI),
• Work functioning among participants will be measured using the 27-item Work
Role Functioning Questionnaire (WRFQ)
• Need for recovery after a workday will be assessed using the 11-item subscale
of the questionnaire on Perception and Judgement of Work (VBBA)
• Health-Related Quality of Life will be measured using the SF-36
• Coping will be assessed with the 5-point Cognitive Emotion Regulation
Questionnaire (CERQ)
Background summary
Cognitive problems are common in non-central nervous system (CNS) cancer
survivors. These cognitive problems are perceived as an important contributor
to decline in job performance and work ability. Various interventions for
cancer-related cognitive impairment have been proposed, but effectiveness
concerning work-related outcomes has not yet been established. Effective
treatment options to alleviate the effects of cognitive decline and to improve
work ability are needed for working cancer survivors and their employers.
Study objective
The aim of the current study is to develop an internet-based cognitive
intervention programme for occupationally active cancer survivors confronted
with cognitive problems and to evaluate the (cost-)effectiveness of this
programme.
Study design
A three-armed randomized controlled trial will be conducted with six months of
follow-up, including two intervention groups (i.e., basic and extensive
cognitive rehabilitation programme) and one waitlist control group. Primary and
secondary outcomes will be measured at baseline (T0), at three months, upon
completion of the intervention (T1), and at three months post-intervention
(T2).
Intervention
The extensive arm will contain a comprehensive training programme (including
psycho-education, fatigue management, and cognitive strategy training) with
individual guidance (blended intervention). Five to eight sessions will have to
be completed in a period of 12 weeks. The basic arm will contain a brief
cognitive training programme (including psycho-education and fatigue
management) without individual guidance. Three to five sessions will have to be
completed in a period of 12 weeks.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Although chances are very scarce, there is a
possibility that patients experience serious psychological distress as a result
of the cognitive rehabilitation programme. In that case, patients will be
offered a consult with a psychologist or psychiatrist in the Antoni van
Leeuwenhoek. The total participation time (3-8 sessions a 60 minutes plus
homework a 60 minutes per session in 12 weeks; three measurement points with a
completion time of 120 minutes) can be seen as a burden. We expect that the
cognitive rehabilitation programme will improve work-related goals attainment,
cognitive problems and work-related outcomes.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
1. Working age (18 - 65 years) at the time of study entry
2. Histologically confirmed cancer (all tumour types except for brain tumours).
3. Between 12 and 42 months after diagnosis.
4. Completed primary therapy including chemotherapy, targeted agents and/or
immunotherapy. Patients who are still receiving hormonal therapy can be
included in the trial.
5. Experience cancer/cancer treatment-related cognitive problems. Both patients
with and without cognitive impairment assessed with neuropsychological tests,
formally assessed with neuropsychological tests, will be included in the study.
6. Fixed or temporary employment contract (with at least six months left of
their contract).
7. Being at work for a minimum of 12 working hours/week
Exclusion criteria
1. Psychiatric or neurological disorder that can interfere with current study
aims.
2. Lack basic proficiency in Dutch.
3. Participating in comparable studies or programmes.
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 |
|---|---|
| CCMO | NL66221.031.18 |