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Fear of Cancer RecurrenceCARE-PilotNCT07749560

Acceptance and Commitment Therapy (ACT) Versus Cognitive Behavioural Therapy (CBT) for Fear of Cancer Recurrence (FCR) in Cancer Survivors and Their Spouses

A study testing ACT couple intervention and CBT couple intervention in people with Fear of Cancer Recurrence and Cancer Survivorship, run by University Center of Tumor Diseases, Frankfurt University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Fear of cancer recurrence (FCR) is one of the most significant psychological burdens faced by cancer survivors. FCR describes the fear, worry, or concern relating to the possibility that cancer will come back or progress, and is associated with reduced quality of life as well as other psychological symptoms. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ACT couple intervention and CBT couple intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 1 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients
  • cancer survivors (male/female/diverse) with any cancer entity
  • after completed primary treatment (not including endocrine treatment, which can be ongoing)
  • < five years after primary diagnosis
  • FCR (FoP-Q-SF total score ≥ 34) or spouses' FCR (FoP-Q-SF/P total score ≥ 34)
  • living in a partnership or marriage (homo- or heterosexual, divers)
Show all 14Show fewer
  • Spouses
  • male/female/diverse spouse of a cancer survivor
  • FCR (FoP-Q-SF/P total score ≥ 34) or patients' FCR (FoP-Q-SF total score ≥ 34)
  • Patients and spouses:
  • age ≥18 years
  • fluency in the German language
  • able to participate in the 6-week intervention (one session per week)
  • written informed consent

Who cannot join

  • Patients:
  • metastatic disease
  • Patients and spouses:
  • both patient and spouse show low FCR (FoP-Q-SF total score < 34 or FoP-Q-SF/P total score < 34)
  • individuals who previously (last 2 years) participated in an ACT-, CBT-, or mindfulness-based psychosocial intervention (psycho-oncological or psychotherapeutic interventions)
  • severe psychiatric disorders and suicidality

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Christina Sauer, PD Dr. contact

049 69 6301 84904

c.sauer@med.uni-frankfurt.de

Gregor Weissflog, Dr. contact

gregor.weissflog@medizin.uni-leipzig.de

About this study

Official title: 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

Fear of cancer recurrence (FCR) is one of the most significant psychological burdens faced by cancer survivors. FCR describes the fear, worry, or concern relating to the possibility that cancer will come back or progress, and is associated with reduced quality of life as well as other psychological symptoms. Approximately 60% of cancer survivors suffer from FCR, 20% of whom suffer from severe FCR. Relatives are also burdened by FCR, which in turn negatively affects the dyadic relationship as well as the survivors' quality of life. However, to date, there is a lack of evidence-based psycho-oncological couple interventions that focus on patients'/survivors' and spouses' FCR. Meta-analyses indicate the efficacy of mindfulness- and acceptance-based approaches such as acceptance and commitment therapy (ACT) for reducing FCR. In contrast to traditional Cognitive Behavioral Therapy (CBT) approaches, which, for instance, aim to change thoughts and feelings by cognitive restructuring, ACT aims to increase psychological flexibility and promotes a more detached, acceptance-based attitude toward thoughts and feelings, as well as a value-based life orientation. However, the empirical evidence for ACT in relation to FCR still needs to be investigated more thoroughly.

This study, coping with fear of cancer recurrence (CARE-pilot), addresses these research gaps and aims to test the feasibility and preliminary efficacy of a manualized ACT couple intervention for outpatient cancer survivors (defined as cancer patients who completed primary treatment and were diagnosed < 5 years ago) and their spouses. Sixty-four couples in which either survivor, spouse or both have elevated FCR will be randomized to either the ACT couple intervention (IG) or the traditional CBT couple intervention (active control group, CG). The IG and CG interventions consist of six psychotherapy sessions (four couple sessions and two individual sessions), the content of which is intensified in online modules between sessions (blended care). The primary endpoint of the feasibility study is the retention rate and achievement of recruitment targets. Using standardized measurements, changes in FCR, quality of life (primary endpoint of preliminary efficacy), and other psychosocial variables will be assessed at post-intervention and 3 months after the end of the intervention.

The feasibility study represents the first step in evaluating the feasibility and the practicality of the couple interventions. The CARE-Pilot study aims to evaluate the feasibility and preliminary efficacy of an ACT-based couple intervention in reducing FCR, compared to a CBT-based couple intervention, in couples navigating cancer survivorship.

Read the detailed description

Introduction: Fear of cancer recurrence (FCR) is one of the most significant psychological burdens faced by cancer survivors and their romantic partners. However, to date, there is a lack of evidence-based psycho-oncological couple interventions that focus on patients'/survivors' and spouses' FCR. Therefore, this multicenter feasibility trial aims to test the feasibility and preliminary efficacy of a manualized ACT couple intervention for outpatient cancer survivors and their spouses compared with a CBT couple intervention.

Methods and analysis: This is a prospective, multicenter, randomized, controlled pilot trial comparing an ACT couple intervention with a CBT couple intervention. The sample will consist out of adult cancer survivors with a confirmed ICD-10 diagnosis of any cancer site after completed primary oncological treatment and their intimate partners. Time since diagnosis of survivors is <5 years. Survivors and/or their partner will suffer from elevated FCR. The investigators aim to include n = 64 dyads within two German comprehensive cancer centers.

ACT and CBT couple intervention will be delivered by clinical psychologists face-to-face or per video sessions, consisting of six sessions (four couple sessions, two individual sessions). For both trial conditions, online content (e.g. exercises or readings) will be available to deepen session content.

Primary outcomes will be feasibility parameters (retention and recruiting rate) and preliminary efficacy (FCR of survivors and partners). Secondary outcomes will be further feasibility variables (satisfaction with the intervention, treatment fidelity) as well as psychological parameters (e.g. QoL, psychological burden), and dyadic and somatic parameters (e.g. dyadic coping, symptom interference). Explorative outcomes are ACT-based (e.g. psychological flexibility, acceptance, value-based living). The feasibility study represents the first step in evaluating the feasibility and the practicality of the couple interventions in preparation of a full power multicenter RCT. Due to its dyadic approach, our ACT couple intervention has the potential to expand the range of psychological treatment options with ecological valid treatment for reducing FCR.

Being tested
ACT couple intervention, CBT couple intervention
Keywords
fear of cancer recurrence, FCR, cancer, cancer survivors, Acceptance and Commitment Therapy, Cognitive Behavioral Therapy, psycho-oncology, ACT, CBT, couple intervention, spouses
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT couple interventionBehavioural

    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 held face-to-face and last 90 minutes. For the other sessions, couples can choose between face-to-face sessions or video-based sessions via a video conferencing tool. These sessions last 60 minutes. All ACT flexibility skills are covered. In addition, couples are given access to an online platform (CoupleACT). Through this platform, participants receive ACT-specific audio files, homework assignments and written material to help them consolidate the content covered in the sessions.

  • CBT couple interventionBehavioural

    CBT: six sessions, comprising four couples' sessions and two individual sessions for cancer survivors and their partners. The first and last sessions are held face-to-face and last 90 minutes. For the other sessions, couples can choose between face-to-face sessions or video-based sessions via a video conferencing tool. These sessions last 60 minutes. The CBT couples intervention is based on an evaluated group therapy manual (Waadt et al., 2011). It has been adapted for the couples' context and includes, amongst other things, behavioural analysis (SORK), psychoeducation, exposure, cognitive restructuring and mindfulness training. In addition, couples are given access to an online platform (CoupleCare). Through this platform, participants receive CBT-specific audio files, homework assignments and written material to reinforce the content covered in the

Study groups in NCT07749560
Study groupRoleWhat they receive
ACT-couple intervention for FCRExperimentalACT couple intervention for FCR, including 4 couple sessions and 2 single sessions for patients and spouses + access to a digital intervention
Receives: Behavioral: ACT couple intervention
CBT-couple intervention for FCRActive comparatorCBT couple intervention for FCR, including four couple sessions and two single sessions for patients and spouses + access to a digital intervention
Receives: Behavioral: CBT couple intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fear of Progression Questionnaire (FoP-Q-SF) and partner version (FoP-Q-SF/P)

    We will assess FCR with the 12-item short form of the Fear of Progression Questionnaire (FoP-Q-SF), which is highly reliable and valid to assess FCR (68, 69). Also a validated partner version exists (FoP-Q-SF/P) which shows high reliability. (Primary outcome for preliminary efficacy).

    Response scale: 1-5, min. 12, max. 60. Higher scores = worse outcome (higher fear of progression); score ≥ 34 = clincial cut-off.

    Measured: From screening to three months follow up

  2. feasibility outcomes: retention and recruiting rate

    Measured: screening to up to seven weeks (post-intervention)

Secondary outcomes (5)
  1. Short-Form Health Survey (SF-12), Physical (PCS) and Mental (MCS) Component

    Health-related quality of life (HRQoL), 12 items; norm-based 0-100 scoring Min. = 0, max = 100. Higher scores = better outcome (better health-related quality of life)

    Measured: baseline to three-months follow-up

  2. Personal Health Questionnaire, depression module (PHQ-9)

    Assessment of depressive symptoms with 9 items, 4-point Likert scale (0-3), Min = 0; max = 27; higher scores = worse outcome (higher depression severity)

    Measured: baseline to three-months follow-up

  3. Generalized Anxiety Disorder scale (GAD-7)

    Assessment of anxiety symptoms with 7 items; 4-point Likert scale (0-3). Min = 0; max = 21. Higher scores = worse outcome (higher anxiety severity)

    Measured: baseline to three-months follow-up

  4. National Comprehensive Cancer Network (NCCN) Distress Thermometer

    Assessment of distress with a single item, visual analogue scale (0-10). Min = 0; max = 10. Higher scores = worse outcome (higher distress).

    Measured: baseline to three-months follow-up

  5. Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)

    Assessment of psychological flexibility with 8 items, 7-point Likert scale (0-6). Min = 0; max = 48. Higher scores = better outcome (higher psychological flexibility)

    Measured: baseline to three-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749560
Sponsor's protocol ID
569352800
Other IDs
2025-2311-prospective study
Acronym
CARE-Pilot
Status last verified
Aug 2026
First submitted
23 Jul 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ACT couple intervention and CBT couple intervention in people with Fear of Cancer Recurrence and Cancer Survivorship, run by University Center of Tumor Diseases, Frankfurt University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christina Sauer, PD Dr. (049 69 6301 84904, c.sauer@med.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of Progression Questionnaire (FoP-Q-SF) and partner version (FoP-Q-SF/P) (time frame: From screening to three months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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