Cognitive Behavioral Therapy for Fear of Recurrence

Overseen By Jason Luke, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Suicidal ideation, Delusions, Hallucinations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who feel anxious or depressed about stopping their cancer immunotherapy by using cognitive behavioral therapy, a type of talk therapy. The research focuses on reducing fear of cancer recurrence, improving mood, and enhancing quality of life. Participants should have completed immunotherapy for cancer, speak English fluently, and not experience active suicidal thoughts or severe mental health symptoms like delusions. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance emotional well-being for cancer survivors.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Cognitive Behavioral Therapy is safe for reducing fear of recurrence?

Research has shown that Cognitive Behavioral Therapy (CBT) is a safe and well-accepted treatment. Studies indicate that it effectively helps individuals manage anxiety, stress, and depression. CBT changes negative thoughts that influence feelings and actions. It ranks as a top treatment for many mental health issues. With no known serious side effects, CBT is a dependable choice for improving mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for fear of cancer recurrence focus on medication for anxiety or general counseling. However, Cognitive Behavioral Therapy (CBT) is unique because it specifically targets the thoughts and behaviors contributing to this fear. Researchers are excited about this approach because CBT helps patients develop practical skills to manage and reduce their distress, potentially leading to lasting improvements in their quality of life. Unlike medication, which can have side effects, CBT empowers patients through structured sessions that foster self-awareness and resilience without additional drugs.

What evidence suggests that cognitive behavioral therapy is effective for reducing fear of recurrence?

Research has shown that cognitive behavioral therapy (CBT) effectively improves mental health in cancer survivors. Studies have found that CBT significantly reduces the fear of cancer recurrence and symptoms of depression and anxiety. It ranks as a top treatment for various mental health issues, including cancer-related stress. CBT changes negative thoughts and behaviors, aiding individuals in better managing their emotions. Overall, it is considered a first-choice treatment for reducing emotional distress and enhancing the quality of life for cancer patients.

In this trial, participants will be randomized to receive either CBT or join a cessation of treatment arm, where they will stop their immunotherapy. ^{2 3 6 7 8}

Who Is on the Research Team?

Jason Luke, MD

Principal Investigator

Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 21 or older who have been treated with immunotherapy for cancer and are now dealing with distress about stopping the treatment. It's not suitable for individuals experiencing delusions, hallucinations, or active thoughts of suicide.

Inclusion Criteria

I am 21 years old or older.

I have cancer and have been treated with immunotherapy.

Fluent in English

Exclusion Criteria

You have false beliefs or see or hear things that aren't there.

I am currently having thoughts about harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive-behavioral therapy via telemedicine to reduce distress associated with stopping immunotherapy

3 months

Telemedicine sessions

Follow-up

Participants are monitored for changes in fear of recurrence, quality of life, anxiety, and depressive symptoms

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy

Trial Overview The study tests whether cognitive behavioral therapy can help reduce fear of cancer recurrence, depression, anxiety, and improve overall quality of life after patients stop their immunotherapy treatments.

How Is the Trial Designed?

Group I: Cessation of treatment Experimental Treatment 1 Intervention

If the patient is randomized to this arm, they will be asked to stop their immunotherapy

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Mindfulness-Based Cognitive Therapy (MBCT) is proposed as a promising intervention for addressing fear of cancer recurrence (FCR) in survivors, based on its effectiveness in reducing health anxiety.

The paper presents a case study of a young adult breast cancer survivor who underwent an adapted MBCT protocol, demonstrating its feasibility and acceptability, while highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theoretical Rationale and Case Illustration of Mindfulness-Based Cognitive Therapy for Fear of Cancer Recurrence. Luberto, CM., Hall, DL., Chad-Friedman, E., et al.[2023]

A study involving 91 breast cancer survivors showed that group-based Acceptance and Commitment Therapy (ACT) significantly reduced fear of cancer recurrence (FCR) compared to survivorship education and enhanced usual care, with improvements noted at multiple time points after the intervention.

ACT also led to significant reductions in anxiety, depression, and avoidant coping, indicating its broader benefits for psychological well-being in cancer survivors, making it a promising intervention that should be further tested in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for breast cancer survivors with fear of cancer recurrence: A 3-arm pilot randomized controlled trial. Johns, SA., Stutz, PV., Talib, TL., et al.[2021]

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.

Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]

Dialectical behavior therapy (DBT) is an effective, evidence-based treatment specifically designed for borderline personality disorder (BPD), particularly benefiting parasuicidal women, but also showing promise for those with substance use disorders and binge-eating disorder.

DBT incorporates unique elements such as a focus on emotions, a dialectical philosophy, and mindfulness techniques, which differentiate it from other cognitive-behavioral therapies and are essential for its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy: current indications and unique elements. Chapman, AL.[2021]

A clinical curriculum for teaching Dialectical Behavior Therapy (DBT) to psychiatry residents was developed, with 87% of participants incorporating DBT into their practice after training, indicating its effectiveness in preparing them to treat borderline personality disorder (BPD) and self-harm behaviors.

Residents who underwent the year-long DBT clinical training showed significant improvements in their ability to apply DBT techniques, enhancing their confidence and willingness to treat patients with BPD, which suggests that structured training can effectively equip future psychiatrists with essential skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Dialectical Behavior Therapy to Psychiatry Residents: The Columbia Psychiatry Residency DBT Curriculum. Brodsky, BS., Cabaniss, DL., Arbuckle, M., et al.[2022]

The article reviews various psychotherapies known as the third wave of cognitive behavioral therapies, including DBT, ACT, and MBCT, highlighting their unique approaches to mental health treatment.

It summarizes existing studies on the efficacy of these therapies, indicating that they offer valuable alternatives for individuals seeking psychological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The third wave of cognitive-behavioural psychotherapies: concepts and efficacy]. Kahl, KG., Winter, L., Schweiger, U., et al.[2018]

The SWORD-study aims to evaluate the effectiveness of cognitive behaviour therapy (CBT) in reducing fear of cancer recurrence (FCR) among 104 high fearful cancer survivors, with assessments occurring at multiple time points over 15 months.

If successful, this study could provide an evidence-based therapeutic option for managing high FCR, which affects over one third of cancer survivors and is linked to negative health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol of the SWORD-study: a randomised controlled trial comparing combined online and face-to-face cognitive behaviour therapy versus treatment as usual in managing fear of cancer recurrence. van de Wal, MA., Gielissen, MF., Servaes, P., et al.[2022]

The three-session acceptance-based cognitive behavioral therapy (CBT-ACT) significantly improved sleep efficiency, insomnia severity, and worry in 28 patients with advanced cancer compared to a waitlist control group.

Participants in the CBT-ACT group also experienced notable reductions in depression and emotional distress, indicating that this intervention effectively addresses multiple psychological symptoms associated with advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of a symptom cluster intervention in advanced cancer. Wells-Di Gregorio, SM., Marks, DR., DeCola, J., et al.[2019]

Cognitive behavior therapy (CBT) effectively reduced clinical fear of cancer recurrence (FCR) in a breast cancer survivor, with the severity of FCR decreasing to a non-clinical level after seven therapy sessions and one follow-up call.

The patient's perceived control over FCR improved during therapy and remained elevated at 6 and 12 months post-therapy, indicating lasting benefits of CBT for managing FCR in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavior Therapy for Fear of Cancer Recurrence: A Case Study. van de Wal, M., Servaes, P., Berry, R., et al.[2019]

In a study involving 271 distressed breast cancer survivors, those who participated in their preferred program (Mindfulness-based cancer recovery or supportive-expressive therapy) showed greater improvements in quality of life and spiritual well-being, highlighting the importance of patient preferences in treatment outcomes.

Women with higher psychological distress at the start of the study benefited more from receiving their preferred intervention, suggesting that aligning treatment options with patient preferences can enhance the effectiveness of psycho-oncological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring mind-body therapies to individual needs: patients' program preference and psychological traits as moderators of the effects of mindfulness-based cancer recovery and supportive-expressive therapy in distressed breast cancer survivors. Carlson, LE., Tamagawa, R., Stephen, J., et al.[2015]

Mindfulness-based cognitive therapy (MBCT) significantly reduced fear of cancer recurrence (FCR) in ovarian cancer survivors after an 8-week program, with participants showing a decrease in FCR scores from an average of 71.03 to 63.00.

While anxiety levels also decreased during the study, the reduction in FCR was not maintained at the 6-month follow-up, indicating the need for further research to confirm the long-term efficacy of MBCT for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for Fear of Recurrence in Ovarian Cancer Survivors (FROCS): a single-arm, open-label, pilot study. Cohen, PA., Musiello, T., Jeffares, S., et al.[2022]

The CAREST trial, involving 262 female breast cancer survivors, found that an online self-help training based on cognitive behavioral therapy did not significantly reduce fear of cancer recurrence compared to usual care.

The study suggests that adding professional support to online interventions may be necessary to effectively address fear of cancer recurrence in survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No effect of CBT-based online self-help training to reduce fear of cancer recurrence: First results of the CAREST multicenter randomized controlled trial. van Helmondt, SJ., van der Lee, ML., van Woezik, RAM., et al.[2020]

Mindfulness-based cognitive therapy (MBCT) is as effective as maintenance antidepressant medication in preventing relapse in patients with major depressive disorder who have achieved remission, based on a study of 160 patients followed for 18 months.

For patients with unstable remission, both MBCT and maintenance treatment significantly reduced the risk of relapse by 73% compared to placebo, emphasizing the need for ongoing treatment in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Segal, ZV., Bieling, P., Young, T., et al.[2021]

Citations

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The efficacy of cognitive behavioral therapy for cancer Cognitive behavioral therapy (CBT) is one of the most recognized psychological interventions to improve the overall quality of life of cancer survivors.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... CBTs currently hold status as research-supported or evidence-based treatments for depressive disorders (APA, 2021; NICE, 2022) and are suggested as first-line ...

3. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1253266/full

a systematic review and meta-analysis of randomized ... Cognitive-behavioral therapy (CBT) has been widely recognized as the primary psychotherapy intervention for addressing various mental disorders, ...

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Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.

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Cognitive behavioral therapy for reducing fear ... - BMC Cancer Cognitive behavioral therapy for reducing fear of cancer recurrence (FCR) among breast cancer survivors: a systematic review of the literature.

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Cognitive-Behavioral Treatments for Anxiety and Stress ... CBT is an effective, gold-standard treatment for anxiety and stress-related disorders. CBT uses specific techniques to target unhelpful thoughts, feelings, and ...

7. en.wikipedia.org en.wikipedia.org/wiki/Cognitive_behavioral_therapy

Cognitive behavioral therapy Cognitive behavioral therapy (CBT) is a form of psychotherapy that aims to reduce symptoms of various mental health conditions, primarily depression, ...

8. anxietyinstitute.com anxietyinstitute.com/services/therapy-types/

Understanding Therapy Names: CBT, DBT, ACT, and More Cognitive behavioral therapy (CBT) is a structured, evidence-based approach that focuses on identifying and changing negative thought patterns that contribute ...