Coping with fear of cancer recurrence (CARE-pilot): Acceptance and commitment therapy (ACT) versus cognitive behavioural therapy (CBT) for fear of cancer recurrence (FCR) in cancer survivors and their spouses: a 2-arm randomized controlled feasibility trial

Coping with fear of cancer recurrence (CARE-pilot): Acceptance and commitment therapy (ACT) versus cognitive behavioural therapy (CBT) for fear of cancer recurrence (FCR) in cancer survivors and their spouses: a 2-arm randomized controlled feasibility trial - CARE-Pilot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040815

Enrollment

128

Registered

2026-07-14

Start date

2027-03-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

fear of cancer recurrence

Interventions

Group 1: The ACT couples intervention comprises six sessions, consisting of four couples’ sessions and two individual sessions for cancer survivors and their partners. The first and last sessions are

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - fluent in German - able to take part in the 6-week intervention (one session per week) - written informed consent - living in a relationship or marriage (homosexual, heterosexual or diverse) Inclusion criteria for patients/survivors: - Cancer survivors (male/female/diverse) with any type of cancer - Having completed primary treatment (excluding endocrine therapy, which may still be ongoing) - Less than five years since initial diagnosis - FCR (FoP-Q-SF total score = 34) or FCR of the partner (FoP-Q-SF/P total score = 34) Inclusion criteria for relatives: - Partner (male/female/other) of a cancer survivor - FCR (FoP-Q-SF/P total score = 34) or FCR of the patient (FoP-Q-SF total score = 34)

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients: - Metastasis Exclusion criteria for patients and relatives: - Both the patient and their partner have low FCR (FoP-Q-SF total score < 34 and FoP-Q-SF/P total score < 34) - Individuals who have participated in an ACT, CBT or mindfulness-based psychosocial intervention within the last two years - Severe psychiatric disorders and suicidal ideation

Design outcomes

Primary

Measure	Time frame
Feasibility: retention rate, recruitment rate Preliminary effectiveness of the intervention: self-reported FCR as measured by the Fear of Progression Questionnaire for patients (FoP-Q-SF) and their partners (FoP-Q-SF/P) in week 6 (T1).	—

Secondary

Measure	Time frame
Feasibility: Consent to randomisation, refusal rate, compliance with questionnaire completion, satisfaction with the intervention, adherence to the protocol and drop-outs. Preliminary efficacy, operationalised via: • Quality of life (Short Form Health Survey, SF-12) • Depression (Personal Health Questionnaire, Depression Module, PHQ-9) • Anxiety (Generalised Anxiety Disorder Scale-7, GAD-7) • Distress (National Comprehensive Cancer Network Distress Thermometer, NCCN-DT) • Psychological flexibility (CompACT-8)	—

Measure

Time frame

Feasibility: Consent to randomisation, refusal rate, compliance with questionnaire completion, satisfaction with the intervention, adherence to the protocol and drop-outs. Preliminary efficacy, operationalised via: • Quality of life (Short Form Health Survey, SF-12) • Depression (Personal Health Questionnaire, Depression Module, PHQ-9) • Anxiety (Generalised Anxiety Disorder Scale-7, GAD-7) • Distress (National Comprehensive Cancer Network Distress Thermometer, NCCN-DT) • Psychological flexibility (CompACT-8)

—

Countries

Germany

Contacts

Public ContactChristina Sauer

Universitätsmedizin Frankfurt

c.sauer@med.uni-frankfurt.de+49 69 6301 84904

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026