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

Trial Summary

What is the purpose of this trial?

The study includes participants experiencing distress with regard to stopping immunotherapy and will utilize cognitive-behavioral therapy to reduce fear of recurrence, depression, and anxiety and improve quality of life.

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 data supports the effectiveness of this treatment for fear of recurrence?

Research shows that cognitive behavioral therapy (CBT) can effectively reduce fear of cancer recurrence (FCR) in cancer survivors, as seen in a case study where a breast cancer survivor experienced a significant decrease in FCR severity after CBT sessions. Additionally, mindfulness-based cognitive therapy (MBCT) has been shown to reduce health anxiety, which is related to FCR, suggesting its potential usefulness for this condition. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy safe for humans?

Cognitive Behavioral Therapy (CBT) and its variations like Mindfulness-Based Cognitive Therapy (MBCT) and Dialectical Behavior Therapy (DBT) are generally considered safe for humans. They are evidence-based treatments used for various conditions, including depression and borderline personality disorder, and have been shown to be effective without significant safety concerns. ^{3 6 7 8 9}

How is Cognitive Behavioral Therapy unique for treating fear of cancer recurrence?

Cognitive Behavioral Therapy (CBT) for fear of cancer recurrence is unique because it can be delivered both online and face-to-face, making it more accessible. Additionally, it incorporates mindfulness techniques to help manage health anxiety, which is not commonly included in other treatments for this condition. ^{4 10 11 12 13}

Research Team

Jason Luke, MD

Principal Investigator

Hillman Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of a symptom cluster intervention in advanced cancer. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavior Therapy for Fear of Cancer Recurrence: A Case Study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Theoretical Rationale and Case Illustration of Mindfulness-Based Cognitive Therapy for Fear of Cancer Recurrence. [2023]

5. United States 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. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Teaching Dialectical Behavior Therapy to Psychiatry Residents: The Columbia Psychiatry Residency DBT Curriculum. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[The third wave of cognitive-behavioural psychotherapies: concepts and efficacy]. [2018]

10. England 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. [2022]

11. Germany 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. [2022]

12. United States 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. [2021]

13. England 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. [2020]