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ID
Source
Brief title
Health condition
Psychological symptoms, cancer-related fatigue, personalized treatment, ecological momentary assessment (EMA), cancer survivors.
Psychische klachten, vermoeidheid bij patiënten met kanker, gepersonaliseerde behandeling, EMA-metingen, overlevenden na kanker.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient functioning
Secondary outcome
- Symptom level
o Fatigue
o Depressive symptoms
o Fear of cancer recurrence
- Quality of life
- Goal attainment
- Number of therapy sessions
- Therapist time per patient
- Dropout rate
Background summary
The aim of this study is to establish whether personalized psychological treatment has added value to standard, non-personalized psychological treatment. We therefore aim to evaluate the efficacy of personalized psychological treatment on patient functioning in cancer survivors with severe, persistent depressive symptoms, fear of cancer recurrence and/or cancer-related fatigue, compared with standard, non-personalized psychological treatment. In addition, efficiency of personalized psychological care will be evaluated.
Psychological treatment will be personalized on four levels (a) treatment indication; (b) treatment form; (c) focus and content of treatment; (d) treatment duration. Efficacy of personalized psychological treatment will be evaluated in a randomized controlled trial. Primary outcome is patient functioning, secondary outcomes are level of symptom(s), quality of life, and goal attainment
The study will be carried out in the Netherlands.
Study objective
- Personalized psychological care is more efficacious than standard, non-personalized psychological treatment in improving functioning of cancer survivors.
- Personalized psychological treatment is more efficacious than standard, non-personalized psychological treatment in decreasing symptoms, improving quality of life and goal attainment (secondary outcomes).
- Personalized psychological treatment is more efficient and dropout is lower compared with standard non-personalized psychological treatment.
Study design
Self-report assessments consist of questionnaires (in the intervention group and the control group) and electronic diary measurements (EMA) (only in the intervention group).
Patients will fill out questionnaires at three time points:
- At baseline (before start of the psychological intervention, T0)
- At six months follow-up (T1).
- At twelve moth follow-up (T2).
The following questionnaires will be used at the timepoints described above:
- Patient functioning: Sickness Impact Profile-8 (SIP-8)
- Symptom level:
o Fatigue; Checklist Individual Strength (CIS-fatigue), subscale fatigue severity.
o Depressive symptoms; Beck Depression Inventory Primary Care
o Fear of cancer recurrence; Cancer Worry Scale (6-item)
- Quality of life: EORTC QLQ-C30 version 3.0.
- Goal attainment: following the Goal Attainment Scaling (GAS) procedure.
- Resilience: Resilience Scale-14
Patients in the intervention group will complete the EMA measurements at two time points:
- At baseline (after intake but before start of the psychological intervention, E0)
- After completing four to six modules (E1)
Intervention
The control group will receive standard, non-personalized psychological treatment for either fatigue, depressive symptoms or anxiety symptoms. This treatment will consist of existing evidence-based treatment protocols for depression, fear of cancer recurrence or fatigue in patients with cancer. The intervention group will receive personalized psychological treatment, in which the existing evidence-based treatment protocols for depression, fear of cancer recurrence or fatigue in patients with cancer will be tailored on four levels: (a) treatment indication; (b) treatment form; (c) focus and content of treatment; (d) treatment duration. In both groups, treatment will be provided by well-trained psychologists.
Inclusion criteria
- Be ≥ 18 years old
- Be able to speak and read Dutch
- Previously diagnosed with cancer
- Be at least six months and maximum 5 years after end of primary treatment with curative intent.
- Have no disease activity at time of inclusion in the study.
- Report either severe fatigue (Checklist Individual Strength - Fatigue, cutoff ≥ 35 subscale fatigue severity) , severe fear of cancer recurrence (6-item Cancer Worry Scale, cutoff ≥ 10) of severe depressive symptoms (Beck Depression Inventory Primary Care, cutoff ≥ 4), from which they experience functional impairments (Work and Social Adjustment Scale (W&SAS), cutoff ≥ 10).
Exclusion criteria
- Insufficient command of the Dutch language
- Currently receiving psychological or psychiatric treatment
- No informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7481 |
| NTR-old | NTR7723 |
| Other | METC AMC : KWF Kankerbestrijding, project number: 11351 |