An interventional study of ACT couple intervention and CBT couple intervention in Fear of Cancer Recurrence and Cancer Survivorship, sponsored by University Center of Tumor Diseases, Frankfurt University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by University Center of Tumor Diseases, Frankfurt University Hospital · Not applicable, Interventional, and Treatment
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.
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.
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Patients
Spouses
Patients and spouses:
Exclusion Criteria:
Patients:
- metastatic disease
Patients and spouses:
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, including four couple sessions and two single sessions for patients and spouses + access to a digital intervention
Behavioral: CBT couple intervention
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: 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
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.
Time frame: From screening to three months follow up
feasibility outcomes: retention and recruiting rate
Time frame: screening to up to seven weeks (post-intervention)
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)
Time frame: baseline to three-months follow-up
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)
Time frame: baseline to three-months follow-up
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)
Time frame: baseline to three-months follow-up
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).
Time frame: baseline to three-months follow-up
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)
Time frame: baseline to three-months follow-up
Cognitive Fusion Questionnaire (CFQ)
Assessment of Cognitive fusion with 7 items, 7-point Likert scale (1-7). Min. = 7, max = 49. Higher scores = worse outcome (higher cognitive fusion)
Time frame: baseline to three-months follow-up
German version of the Peace, acceptance and equanimity in cancer experience (PEACE)
Assessment of two subscales: 1. acceptance of illness with 5 items, 4-point Likert (1-4), min = 5; max = 20. Higher scores = better outcome (higher peaceful acceptance) 2. Struggle with Illness with 7 items, 4-point Likert (1-4), min = 7; max = 28. Higher scores = worse outcome (higher struggle with illness)
Time frame: baseline to three-months follow-up
Valuing Questionnaire
Assessment of valued living with two subscales: 1. Values-consistent living (progress) with 5 items, 7-point Likert scale (0-6), min. = 0, max. = 30. Higher scores = better outcome (higher enactment of values) 2. Values-inconsistent living (obstruction) with 5 items, 7-point Likert scale (0-6) min.= 0, max = 30. Higher scores = worse outcome (higher interference with valued living)
Time frame: baseline to three-months follow-up
Dyadic Coping Inventory (DCI)
Dyadic coping with 35 items (of 37), 5-point Likert scale (1-5). Min. = 35; max. = 175. Higher scores = better outcome (better dyadic coping)
Time frame: baseline to three-months follow-up
German version of the M.D. Anderson Symptom Inventory (MDASI-G)
Assessment of two subscales: 1. Symptom severity with 13 items, 0-10. Min. = 0, max. = 130. Higher scores = worse outcome (more severe symptoms) 2. Symptom interference with daily life with 6 items, 0-10, min.= 0, max. = 60. Higher scores = worse outcome (higher interference)
Time frame: baseline to three-months follow-up
Brief Fatigue Inventory (BFI)
Assessment of fatigue with 9 items (0-10), Min. = 0, max = 90. Higher scores = higher fatigue
Time frame: Baseline to three-months follow-up
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