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

NCT07749560 | Not Yet Recruiting DMC

• 2 other identifiers: 5693528002025-2311-prospective study
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Fear of Cancer Recurrence; Cancer Survivorship

Keywords

fear of cancer recurrence; FCR; cancer; cancer survivors; Acceptance and Commitment Therapy; Cognitive Behavioral Therapy; psycho-oncology; ACT; CBT; couple intervention; spouses

Outcome Measures

Primary Outcomes (2)

• 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.

  From screening to three months follow up

• feasibility outcomes: retention and recruiting rate

  screening to up to seven weeks (post-intervention)

Secondary Outcomes (5)

• Short-Form Health Survey (SF-12), Physical (PCS) and Mental (MCS) Component

  baseline to three-months follow-up

• Personal Health Questionnaire, depression module (PHQ-9)

  baseline to three-months follow-up

• Generalized Anxiety Disorder scale (GAD-7)

  baseline to three-months follow-up

• National Comprehensive Cancer Network (NCCN) Distress Thermometer

  baseline to three-months follow-up

• Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)

  baseline to three-months follow-up

Other Outcomes (6)

• Cognitive Fusion Questionnaire (CFQ)

  baseline to three-months follow-up

• German version of the Peace, acceptance and equanimity in cancer experience (PEACE)

  baseline to three-months follow-up

• Valuing Questionnaire

  baseline to three-months follow-up

Study Arms (2)

ACT-couple intervention for FCR

EXPERIMENTAL

ACT couple intervention for FCR, including 4 couple sessions and 2 single sessions for patients and spouses + access to a digital intervention

Behavioral: ACT couple intervention

CBT-couple intervention for FCR

ACTIVE COMPARATOR

CBT couple intervention for FCR, including four couple sessions and two single sessions for patients and spouses + access to a digital intervention

Behavioral: CBT couple intervention

Interventions

ACT couple intervention BEHAVIORAL

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.

ACT-couple intervention for FCR

CBT couple intervention BEHAVIORAL

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

CBT-couple intervention for FCR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Center of Tumor Diseases, Frankfurt University Hospital: lead
• Universitätsklinikum Leipzig: collaborator

MeSH Terms

Conditions

Neoplasms

Study Officials

• Christina Sauer, PD Dr.

  Frankfurt University Hospital

  PRINCIPAL INVESTIGATOR

• Gregor Weissflog, Dr.

  Leipzig University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-08