Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

5. august 2026 opdateret af: PD Dr. Christina Sauer, University Center of Tumor Diseases, Frankfurt University Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

128

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ACT-couple intervention for FCR
ACT couple intervention for FCR, including 4 couple sessions and 2 single sessions for patients and spouses + access to a digital 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.
Aktiv komparator: CBT-couple intervention for FCR
CBT couple intervention for FCR, including four couple sessions and two single sessions for patients and spouses + access to a digital intervention
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fear of Progression Questionnaire (FoP-Q-SF) and partner version (FoP-Q-SF/P)
Tidsramme: 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.

From screening to three months follow up
feasibility outcomes: retention and recruiting rate
Tidsramme: screening to up to seven weeks (post-intervention)
screening to up to seven weeks (post-intervention)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Short-Form Health Survey (SF-12), Physical (PCS) and Mental (MCS) Component
Tidsramme: 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)
baseline to three-months follow-up
Personal Health Questionnaire, depression module (PHQ-9)
Tidsramme: 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)
baseline to three-months follow-up
Generalized Anxiety Disorder scale (GAD-7)
Tidsramme: 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)
baseline to three-months follow-up
National Comprehensive Cancer Network (NCCN) Distress Thermometer
Tidsramme: 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).
baseline to three-months follow-up
Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)
Tidsramme: 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)
baseline to three-months follow-up

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive Fusion Questionnaire (CFQ)
Tidsramme: 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)
baseline to three-months follow-up
German version of the Peace, acceptance and equanimity in cancer experience (PEACE)
Tidsramme: baseline to three-months follow-up

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)
baseline to three-months follow-up
Valuing Questionnaire
Tidsramme: baseline to three-months follow-up

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)
baseline to three-months follow-up
Dyadic Coping Inventory (DCI)
Tidsramme: 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)
baseline to three-months follow-up
German version of the M.D. Anderson Symptom Inventory (MDASI-G)
Tidsramme: baseline to three-months follow-up

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)
baseline to three-months follow-up
Brief Fatigue Inventory (BFI)
Tidsramme: Baseline to three-months follow-up
Assessment of fatigue with 9 items (0-10), Min. = 0, max = 90. Higher scores = higher fatigue
Baseline to three-months follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Christina Sauer, PD Dr., Frankfurt University Hospital
  • Ledende efterforsker: Gregor Weissflog, Dr., Leipzig University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. november 2028

Studieafslutning (Anslået)

1. juli 2029

Datoer for studieregistrering

Først indsendt

23. juli 2026

Først indsendt, der opfyldte QC-kriterier

5. august 2026

Først opslået (Faktiske)

6. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 569352800
  • 2025-2311-prospective study (Anden identifikator: ethics committee approval number)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .