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Completed

NCT Number: NCT04137575

ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence

The primary aim of this randomized controlled trial is to evaluate the effect of ConquerFear-Group (CF-G), compared with a control condition (CC), on Fear of Cancer Recurrence (FCR). Secondary aims are to explore the effect of CF-G on emotion regulation and additional psychological outcomes, and to explore mediating effects of emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion. In addition, treatment expectancy, participation in other treatments after completion of the intervention of the study and demographic and clinical variables will be explored as moderators.

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Key information

Conditions

Fear of Cancer Recurrence Behavior Breast Cancer Female Breast Diseases Breast Neoplasms Emotional Regulation Neoplasms Neoplasms by Site Self-Control Skin Diseases Skin and Connective Tissue Diseases Social Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, Denmark

About this study

A randomized controlled trial testing the efficacy of ConquerFear-Group (CF-G) on breast cancer survivors with clinical levels of Fear of Cancer Recurrence (FCR), compared with a control condition (CC), will be conducted.

The aims are to:

  • Evaluate the efficacy of CF-G on FCR,
  • Explore the effects on the secondary outcomes of emotion regulation, general distress, health-related QoL, survivors' unmet needs, mindfulness, metacognitions, intervention satisfaction, negative effects of intervention, and sleep.
  • Explore emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion will be explored as possible mediators.*
  • Explore treatment expectancy, participation in other treatments after completion of the CF-G or the CC and demographic and clinical variables as possible moderators.

Primary hypothesis:

CF-G will yield larger reductions in FCR than CC at post treatment, and the effect will be maintained through the follow-up period.

Secondary hypotheses:

CF-G will demonstrate a larger improvement in measures of emotion regulation than CC following the intervention period.

Changes in emotion regulation during treatment will mediate the effect of CF-G on FCR.* Changes in metacognitions during treatment will mediate the effect of CF-G on FCR.* CF-G will yield larger reductions in general distress, health-related QoL, survivors' unmet needs than CC, and CF-G will yield larger improvements in metacognitions, mindfulness, and sleep than CC following the intervention period.

*The prerequesties for conducting for mediation analysis were not fulfilled. Consequently, these analyses were abandoned. Data can be obtained upon request.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible patients have a confirmed past diagnosis of stage 1-3 breast cancer,
  • have been treated with curative intent,
  • have completed all hospital-based adjuvant treatments 3 months to 5 years prior to study entry,
  • are disease free,
  • scores in the clinical range (≥22) on the Short Form of the Fear of Cancer Recurrence Inventory (FCRI-SF),
  • are able to read and write Danish,
  • are over the age of 18 years, and
  • are able to give informed consent.

Exclusion criteria

  • self-reported current major depression,
  • currently receiving psychological treatment from a therapist not involved in the study,
  • self-reported active psychotic illness or other severe psychiatric conditions.

Treatment and study plan

ConquerFear-Group

Behavioral

The intervention consist of one 1½-hour individual session in which a psychologist will conduct an oral psychological assessment, and five 2-hour group sessions. The key goals of the intervention are to: a) teach strategies for controlling worry and excessive threat monitoring; b) modify underlying unhelpful beliefs about worry; c) develop appropriate monitoring and screening behaviors; d) educate about follow-up care and empirically-supported behavioral change (e.g., weight loss, exercise, etc.) to improve overall survival; e) address existential changes brought about by a cancer diagnosis; f) promote goal-setting. Each session is accompanied by home-based practice of skills learned in session and home reading to consolidate skill acquisition. Four trained psychologists (MSc) will perform the therapy. The intervention will be delivered on Zoom, a secure online platform.

Relaxation Training

Behavioral

The control group will receive one 1½-hour individual session and participate in five 2-hour group sessions. Patients will receive guided progressive muscle relaxation training. The intervention will be delivered on Zoom, a secure online platform.

Primary outcomes

  1. Fear of cancer recurrence

    Time frame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after baseline, 1 week post intervention, 3- and 6-months follow-up

    Changes in fear of cancer recurrence will be measured with the 42-item Fear of Cancer Recurrence Inventory at baseline, 1 week post intervention, 3- and 6-months follow-up, and session-by-session with the 9-item Fear of Cancer Recurrence Inventory-Short Form

Secondary outcomes

  1. Emotion regulation

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in emotion regulation will be assessed with the Difficulties in Emotion Regulation Questionnaire

  2. General distress 1

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in general distress will be measured with the Impact of Event Scale-Revised Questionnaire

  3. General distress

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in general distress will be measured with the Depression, Anxiety, Stress Scale-21 Questionnaire

  4. Health-related quality-of-life

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in health-related quality-of-life will be measured with the European Organization for Research and Treatment of Cancer QLQ-C30 Questionnaire

  5. Health-related quality-of-life

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in health-related quality-of-life will be measured with EuroQol-5 Domain Questionnaire

  6. Survivors' unmet needs

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in survivors' unmet needs will be measured with the Survivors' Unmet Need Survey - 8 item Information Sub-Scale Questionnaire

  7. Fear of cancer recurrence

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in fear of cancer recurrence will be measured with the Concerns About Recurrence Questionnaire

  8. Metacognitions

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in metacognitions will be measured with the Metacognitions Questionnaire-30

  9. Mindfulness

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in mindfulness will be measured with the Five Facet Mindfulness Questionnaire

  10. Sleep

    Time frame: Baseline, one week post intervention, 3- and 6-months follow-up

    Changes in sleep will be measured with the Insomnia Severity Index

  11. Negative effects of intervention

    Time frame: One week post intervention, 3- and 6-months follow-up

    Negative effects of the intervention will be assessed with one question about negative effects of the intervention experienced by the participants (narrative response)

  12. Negative effects of intervention

    Time frame: One week post intervention, 3- and 6-months follow-up

    Negative effects of the intervention will be measured with the Negative effects Questionnaire - hopelessness and failure subscales

  13. Intervention satisfaction

    Time frame: One week post intervention, 3- and 6-months follow-up

    Intervention satisfaction will be measured with three questions regarding satisfaction with the treatment

Other outcomes

  1. Moderator: Background information about the participants

    Time frame: Assessed at baseline only

    Background information about the participants will be assessed with a questionnaire regarding demongraphic information as possible moderators

  2. Moderator: Clinical data

    Time frame: Collected from patients records

    Clinical data will be explored as possible moderators

  3. Moderator: Treatment expectancy

    Time frame: Assessed at baseline only

    Treatment expectancy will be measured with the Credibility/Expectancy questionnaire as a possible moderator

  4. Participation in other psychological, medical or complementary and alternative treatments for FCR after completion of the interventions of the present study

    Time frame: Assessed at 3- and 6-months follow-up

    Two questions regarding participation in other psychological, medical or complementary and alternative treatments for FCR after completion of the interventions of the present study will be assessed as a possible moderator

  5. Mediator: Emotion regulation

    Time frame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.

    Changes in emotion regulation will be measured with the Brooding - Rumination and Reflection Scale

  6. Mediator: Emotion regulation

    Time frame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.

    Changes in emotion regulation will be measured with the Penn State Worry Questionnaire

  7. Mediator: Emotion regulation

    Time frame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.

    Changes in emotion regulation will be measured with the Experience Questionnaire

  8. Mediator: Metacognitions

    Time frame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.

    Changes in metacognitions will be measured with the Metacognitions Questionnaire-30

  9. Mediator: Working alliance

    Time frame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.

    Changes in working alliance will be measured with the Working Alliance Inventory Revised Short Form

  10. Mediator: Patient adherence

    Time frame: Assessed 3, 4, 5, and 6 weeks after baseline.

    Changes in patient adherence will be assessed with a diary of home exercise completion

  11. Mediator: Group cohesion

    Time frame: Assessed 2, 3, 4, 5, and 6 weeks after baseline.

    Changes in group cohesion will be assessed with the Therapeutic Factors Inventory Cohesiveness Scale

  12. Mediator: Level of physical relaxation/calmness

    Time frame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.

    Single question to asses level of physical relaxation before and after each session

  13. Mediator: Level of mental calmness

    Time frame: Assessed 1, 2, 3, 4, 5, and 6 weeks after baseline.

    Single question to asses level of mental calmness before and after each session

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

A Randomized Controlled Trial of ConquerFear: A Group-Based Psychological Intervention for Fear of Cancer Recurrence in Cancer Survivors

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2019
Registry last updated
Jun 21, 2024

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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