(Cost-) effectiveness of online self-help training for fear of cancer recurrence in breast cancer patients.

(Cost-) effectiveness of online self-help training for fear of cancer recurrence in breast cancer patients. - CAREST

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41426

Enrollment

454

Registered

2013-12-18

Start date

2014-04-24

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

angst voor de terugkeer van kanker fear of cancer recurrence

Interventions

Participants start the training by filling out the Fear of Recurrence Inventory, after which they get feedback about their scores and a suggestion about which modules to follow. The two basic modu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female - Diagnosis of breast cancer, between one and five years ago (part A) - No signs for local/regional recurrence or metastatic disease (part A) - Capable of filling out questionnaires in Dutch (part A) - Age at disease onset at least 18 years old (part A) - Access to the internet (part B)

Exclusion criteria

Exclusion criteria: - No exclusion criteria

Design outcomes

Primary

Measure	Time frame
Primary outcome measure will be fear of cancer recurrence. Fear of cancer recurrence will be assessed with the Fear of Cancer Recurrence Inventory (FCRI). The FCRI consist of the following seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance. The severity-subscale is the first outcome measure in this study. The coping strategies- and functioning impairments-scale scores at baseline will be used in the predictor analysis.	—

Measure

Time frame

Primary outcome measure will be fear of cancer recurrence. Fear of cancer recurrence will be assessed with the Fear of Cancer Recurrence Inventory (FCRI). The FCRI consist of the following seven subscales: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance. The severity-subscale is the first outcome measure in this study. The coping strategies- and functioning impairments-scale scores at baseline will be used in the predictor analysis.

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Secondary

Measure	Time frame
Secondary outcomes will be healthcare costs and psychological distress. Healthcare costs will be assessed with the Medical Consumption Questionnaire (MCQ) and the EuroQol-5D (EQ-5D). Psychological distress will be assessed with the Fear of Cancer Recurrence Inventory (FCRI). Other study parameters: Baseline level of fear of recurrence severity, psychological distress, level of functioning impairment, and coping strategies will be assessed with the Fear of Cancer Recurrence Inventory (FCRI). Psychosocial problems and risk factors will be assessed with the Psychosocial Distress Questionnaire-Breast Cancer (PDQ-BC). The PDQ-BC consists of nine subscales: trait anxiety, social support, state anxiety, depressive symptoms, social problems, physical problems, body image, financial problems, and sexual problems. Self-efficacy will be assessed with an assembled questionnaire.	—

Measure

Time frame

Secondary outcomes will be healthcare costs and psychological distress. Healthcare costs will be assessed with the Medical Consumption Questionnaire (MCQ) and the EuroQol-5D (EQ-5D). Psychological distress will be assessed with the Fear of Cancer Recurrence Inventory (FCRI). Other study parameters: Baseline level of fear of recurrence severity, psychological distress, level of functioning impairment, and coping strategies will be assessed with the Fear of Cancer Recurrence Inventory (FCRI). Psychosocial problems and risk factors will be assessed with the Psychosocial Distress Questionnaire-Breast Cancer (PDQ-BC). The PDQ-BC consists of nine subscales: trait anxiety, social support, state anxiety, depressive symptoms, social problems, physical problems, body image, financial problems, and sexual problems. Self-efficacy will be assessed with an assembled questionnaire.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)