Background
Allocation of treatment modules
Treatment format
Patients’ needs
Treatment duration
Aims of the current study
Methods/design
Study design
Recruitment
Referrals by medical professionals
Self-referrals
Participant eligibility
Inclusion criteria | |
1) | ≥ 18 years old. |
2) | Able to speak and read Dutch. |
3) | Previously diagnosed with cancer. |
4) | At least 6 months and maximum 5 years after end of primary treatment with curative intent. Patients who still receive hormonal therapy after treatment are eligible. |
5) | No disease activity at time of inclusion in the study. |
6) | Report either clinically relevant levels of fatigue (Checklist Individual Strength (CIS), cutoff ≥ 35 on the fatigue severity subscale), and/or fear of cancer recurrence (Cancer Worry Scale (CWS), cutoff ≥ 10), and/or depressive symptoms (Beck Depression Inventory Primary Care (BDI-PC), cutoff ≥ 4), from which they experience functional impairments (Work and Social Adjustment Scale (W&SAS), cutoff ≥ 10 |
Exclusion criteria | |
1) | Insufficient command of the Dutch language. |
2) | Currently receiving psychological or psychiatric treatment. |
3) | No informed consent. |
Protocol amendments
Assessment
Participant retention
Handling and storage of data and documents
Monitoring and auditing
Outcomes
Primary outcome
Secondary outcomes
Other study parameters
Randomisation, blinding, and treatment allocation
Procedure for additional treatment sites
Interventions
Standard CBT
1) | Patient is referred for participation in this trial via their treating doctor or via self-referral. |
2) | Screening, baseline assessment (T0), and randomization. |
3) | Intake interview. Following the standard protocols of the treatment for fear or cancer recurrence, fatigue, or depression, additional questionnaires need to be filled out. |
4) | Results of additional assessments as part of the standard protocol are discussed. |
5) | Start blended therapy for the symptom for which the score on the accompanying questionnaire is above the cutoff. |
6) | Patient receives the evidence-based diagnosis-specific treatment protocol. |
7) | At the end of treatment (approximately 6 months after intake), follow-up assessment (T1). |
8) | 12 months after intake, follow-up assessment (T2). |
Personalized CBT
1) | Patient is referred for participation in this trial via their treating doctor or via self-referral. |
2) | Screening, baseline assessment (T0), and randomization. |
3) | Intake interview (verification patients’ most burdensome symptom and patients’ preference for face-to-face, blended, or Internet therapy). Following the standard protocols of the treatment for fear or cancer recurrence, fatigue, or depression, additional questionnaires need to be filled out. |
4) | Start of EMA assessment during 14 consecutive days. Auto-VAR analyses to identify the most important maintaining factor on which to intervene first, besides the mandatory modules. |
5) | Results of EMA assessment and additional questionnaires are discussed. |
6) | Start treatment aimed at maintaining factors for the most burdensome symptom. |
7) | Evaluation of treatment response through measurement of symptom level and progression on individual treatment goals. The therapist discusses with the patient whether treatment continuation or treatment conclusion is indicated. If treatment continues, the second EMA assessment determines which treatment modules to add or repeat. |
8) | 6 months after intake, follow-up assessment (T1); if treatment continues additional assessment at end of treatment. |
9) | 12 months after intake, follow-up assessment (T2). |
Adherence and treatment integrity
Development process
Personalized CBT protocol
Protocol | Module | Maintaining factor(s) | Mandatory/Optional |
---|---|---|---|
Fear of cancer recurrence (FCR) | |||
Psycho-education | - | Mandatory | |
Values, goals, and actions | - | Mandatory | |
Attention training | Self-focused attention | Mandatory | |
Detached mindfulness and worry postponement | (1) Worry and rumination (2) Attempts to avoid, suppress, or minimize FCR thoughts (3) Intrusive thoughts or images about cancer recurrence | Optional | |
Metacognitions | Unhelpful beliefs about the importance, impact and control of worry | Optional | |
Threat-monitoring and avoidance | (1) Frequent self-examination (2) Avoidance behaviors | Optional | |
Evaluation and relapse prevention plan | - | Mandatory | |
Depression | |||
Psycho-education | - | Mandatory | |
Goal setting | - | Mandatory | |
Activity monitoring | Behavioral inactivity | Optional | |
Activity scheduling | |||
Behavioral activation | |||
Identifying dysfunctional thoughts | Dysfunctional cognitions | Optional | |
Changing dysfunctional thoughts (part 1) | |||
Changing dysfunctional thoughts (part 2) | |||
Relapse prevention | - | Mandatory | |
Fatigue | |||
Psycho-education and goal setting | - | Mandatory | |
Sleep-wake cycle | Deregulated sleep-wake cycle | Mandatory | |
Activity pattern | Deregulation of activity | Mandatory | |
Helping cognitions | Dysfunctional cognitions regarding fatigue | Optional | |
Fear of cancer recurrence | Fear of cancer recurrence | Optional | |
Social interactions | Low social support | Optional | |
Coping | Poor coping with cancer and cancer treatment | Optional | |
Realizing treatment goals | - | Mandatory |