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NCT Number: NCT07749560

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

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.

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Key information

Conditions

Fear of Cancer Recurrence Cancer Survivorship Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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

Primary outcomes

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

    Time frame: From screening to three months follow up

    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.

  2. feasibility outcomes: retention and recruiting rate

    Time frame: screening to up to seven weeks (post-intervention)

Secondary outcomes

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

    Time frame: baseline to three-months follow-up

    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)

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

    Time frame: baseline to three-months follow-up

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

  3. Generalized Anxiety Disorder scale (GAD-7)

    Time frame: baseline to three-months follow-up

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

  4. National Comprehensive Cancer Network (NCCN) Distress Thermometer

    Time frame: baseline to three-months follow-up

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

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

    Time frame: baseline to three-months follow-up

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

Other outcomes

  1. Cognitive Fusion Questionnaire (CFQ)

    Time frame: baseline to three-months follow-up

    Assessment of Cognitive fusion with 7 items, 7-point Likert scale (1-7). Min. = 7, max = 49. Higher scores = worse outcome (higher cognitive fusion)

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

    Time frame: baseline to three-months follow-up

    Assessment of two subscales:

    • acceptance of illness with 5 items, 4-point Likert (1-4), min = 5; max = 20. Higher scores = better outcome (higher peaceful acceptance)
    • Struggle with Illness with 7 items, 4-point Likert (1-4), min = 7; max = 28. Higher scores = worse outcome (higher struggle with illness)

  3. Valuing Questionnaire

    Time frame: baseline to three-months follow-up

    Assessment of valued living with two subscales:

    • 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)
    • 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)

  4. Dyadic Coping Inventory (DCI)

    Time frame: baseline to three-months follow-up

    Dyadic coping with 35 items (of 37), 5-point Likert scale (1-5). Min. = 35; max. = 175. Higher scores = better outcome (better dyadic coping)

  5. German version of the M.D. Anderson Symptom Inventory (MDASI-G)

    Time frame: baseline to three-months follow-up

    Assessment of two subscales:

    • Symptom severity with 13 items, 0-10. Min. = 0, max. = 130. Higher scores = worse outcome (more severe symptoms)
    • Symptom interference with daily life with 6 items, 0-10, min.= 0, max. = 60. Higher scores = worse outcome (higher interference)

  6. Brief Fatigue Inventory (BFI)

    Time frame: Baseline to three-months follow-up

    Assessment of fatigue with 9 items (0-10), Min. = 0, max = 90. Higher scores = higher fatigue

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Sauer, PD Dr.

CONTACT

[email protected]

049 69 6301 84904

Gregor Weissflog, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Center of Tumor Diseases, Frankfurt University Hospital

Other

Collaborators

  • Universitätsklinikum Leipzig

Registry information

Official study 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

Acronym: CARE-Pilot

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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