Group Cognitive Behavioral Therapy for Cancer Distress

Overseen By Deanna Hofschulte

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Psychotic symptoms, Neurological condition, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how group sessions using cognitive behavioral therapy can help cancer patients manage stress. The goal is to determine if these sessions can reduce the emotional and social impacts of cancer-related stress. The trial includes two groups: one will attend five therapy sessions, while the other will not. Both groups will complete questionnaires over a year. Suitable participants have been diagnosed with cancer, completed treatment in the past year, or are planning treatment, and experience moderate distress in daily life. As an unphased trial, this study offers a unique opportunity to contribute to understanding stress management in cancer care.

Will I have to stop taking my current medications?

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 cancer patients?

Research has shown that cognitive behavioral stress management (CBSM) is generally safe and well-tolerated by patients. Studies have found that CBSM effectively lowers stress and anxiety in cancer patients. For instance, one study reported that patients who participated in CBSM felt more relaxed and positive, while their anxiety levels decreased. These studies reported no major harmful side effects, suggesting that CBSM is a safe way to manage stress in cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Group Cognitive Behavioral Therapy for cancer distress because it offers a new approach to psychological support for cancer patients. Unlike standard treatments that may focus on medication or individual therapy sessions, this method uses group sessions to address emotional distress, allowing patients to share experiences and coping strategies in a supportive environment. This group setting not only helps in reducing feelings of isolation but also leverages peer support, which can enhance emotional resilience and improve overall mental well-being. Additionally, the structured nature of Cognitive Behavioral Therapy (CBT) is designed to help patients develop practical skills for managing distress, potentially leading to more sustained improvements in their mental health.

What evidence suggests that cognitive behavioral therapy might be an effective treatment for cancer distress?

Research shows that Cognitive Behavioral Stress Management (CBSM) helps cancer patients by reducing stress and improving mood. Studies have found that CBSM lowers anxiety and increases feelings of relaxation and positivity. One study discovered that CBSM also helps control stress hormones, potentially boosting overall well-being. Another clinical trial showed that using a CBSM app significantly improved the quality of life for cancer patients. In this trial, participants in Group I participated in five CBSM group sessions, while those in Group II did not receive CBSM. These findings suggest that CBSM effectively manages the mental stress associated with cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

Shawna L. Ehlers, Ph.D., L.P.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults over 18 with any type of cancer who have been treated within the last year or are planning treatment, and expect to live more than a year. They must be feeling moderately distressed, as shown by a specific stress test score or doctor's opinion, but able to participate in group therapy.

Inclusion Criteria

I have received cancer treatment in the last year or am planning to.

You have provided written consent to participate in research.

You have experienced moderately distressing events, as indicated by an Impact of Event Scale-Revised (IES-R) score of 14 or higher, or a clinical judgement.

Exclusion Criteria

Inability to actively participate in and learn from group therapy (e.g., psychotic symptoms, neurological condition, personality pathology) as determined by clinical judgment in clinical consultation (Individual therapy or alternative group therapy will be offered)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in Group I participate in five CBCSM group sessions. Both groups complete questionnaires throughout the trial.

5 weeks

5 visits (in-person or virtual)

Follow-up

Participants are monitored for psychological distress, depression, anxiety, post-traumatic stress, self-efficacy, and post-traumatic growth at 1, 3, 6, and 12 months.

12 months

4 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavior Therapy

Trial Overview The study examines if group sessions using cognitive behavioral therapy specifically designed for cancer-related stress can help reduce emotional distress in cancer patients. It focuses on teaching skills to manage the psychological impact of living with cancer.

How Is the Trial Designed?

Group I: Group I (CBCSM) Experimental Treatment 2 Interventions

Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

Group II: Group II (no CBCSM) Active Control 1 Intervention

Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

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

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders
• Post-traumatic stress disorder

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Group cognitive behavioral therapy (CBT) significantly improved the quality of life and reduced depression, anxiety, and stress in 32 women with breast cancer who had undergone mastectomy and chemotherapy, compared to a control group.

Despite the positive effects on overall emotional well-being, the intervention did not significantly reduce death anxiety, indicating that some mental health aspects may require more tailored approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a group cognitive behavioral therapy on the quality of life and emotional disturbance of women with breast cancer. Jelvehzadeh, F., Dogaheh, ER., Bernstein, C., et al.[2021]

Cognitive Behaviour Therapy (CBT) has proven effective for various psychological disorders, and there is increasing interest in its application for cancer patients, although it has not been extensively tested in this population.

This paper outlines a structured 12-session CBT program specifically designed for cancer patient groups, addressing the need for tailored interventions in psycho-oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of a group Cognitive Behaviour Therapy programme with cancer patients. Edelman, S., Kidman, AD.[2018]

The study successfully adapted and implemented group-delivered cognitive behavioral therapy for cancer distress (CBT-C) as a billable clinical service, demonstrating its acceptability and feasibility among cancer care stakeholders, with 40% of eligible patients enrolling in the program.

Despite geographic distance being a significant barrier to enrollment, 98% of participants who completed the program reported they would recommend CBT-C to others, indicating high patient satisfaction and potential for positive outcomes in distress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Implementation of Best-Evidence Cancer Distress Management: Truly Comprehensive Cancer Care. Ehlers, SL., Gudenkauf, LM., Kacel, EL., et al.[2023]

Cancer patients frequently experience distress, and the National Comprehensive Cancer Network now recommends routine evaluation and treatment of this distress as part of their care.

Structured individual and group psychosocial interventions have been shown to effectively reduce distress in cancer patients, but further research is needed to identify which specific interventions work best for different patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group and individual treatment strategies for distress in cancer patients. Clark, MM., Bostwick, JM., Rummans, TA.[2013]

The group cognitive behavioural therapy (GCBT) program, which lasted 8 weeks, helped seven newly diagnosed women with cancer learn skills to better cope with their emotional distress by challenging problems and using cognitive and behavioral techniques.

Participants valued the opportunity to share feelings and receive social support from peers, suggesting that incorporating these elements into GCBT could enhance its effectiveness for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy with cancer patients: the views of women participants on a short-term intervention. Bottomley, A.[2019]

Group cognitive behavioural therapy (CBT) has been shown to effectively address significant and long-term psychosocial problems in cancer patients, including those with advanced disease.

The article emphasizes the importance of time-limited interventions and provides guidance for health workers on how to implement group CBT techniques to support emotionally distressed cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group cognitive behavioural therapy: an intervention for cancer patients. Bottomley, A.[2019]

A study involving 22 Spanish-speaking advanced cancer patients revealed six new themes related to their experiences in meaning-centered group psychotherapy (MCGP), highlighting the importance of addressing specific cultural and emotional needs.

The most common issues identified were 'threat' and 'uncertainty,' suggesting that these factors significantly impact the well-being of Spanish-speaking patients and should be integrated into future adaptations of MCGP for Latin American populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological aspects of meaning-centered group psychotherapy: Spanish experience. Fraguell, C., Limonero, JT., Gil, F.[2019]

A study involving 60 breast cancer patients found that both cognitive-behavioral therapy (CBT) psychoeducational sessions and a self-managed informative guide improved psychological distress and quality of life after two months.

While both interventions were effective in reducing anxiety and distress, there were no significant differences in outcomes between the two groups, suggesting that self-managed resources can be as beneficial as structured therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Cognitive-Behavioral Approach and Psychoeducational Intervention in Breast Cancer Management: A Prospective Randomized Clinical Trial. Ardizzone, A., Bavetta, D., Garo, ML., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2722111/

COGNITIVE BEHAVIORAL STRESS MANAGEMENT ... Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part i: Sleep and psychological effects. J Clin ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12554254/

Cognitive Behavioral Stress Management Effects on ... Cognitive Behavioral Stress Management (CBSM) has shown efficacy at reducing distress and modulating neuroendocrine functioning, but it is ...

3. journals.lww.com journals.lww.com/cancernursingonline/fulltext/2020/05000/the_effects_of_cognitive_behavioral_stress.6.aspx

The Effects of Cognitive-Behavioral Stress Management for... The results showed that CBSM can increase Measure of Current Status relaxation scores, benefit finding, and positive affect and decrease serum cortisol, anxiety ...

4. ascopubs.org ascopubs.org/doi/10.1200/OP.23.00210

Effects of a Cognitive Behavioral Digital Therapeutic on ... Results from a clinical trial of a new cognitive behavioral stress management (CBSM) app show a significant benefit for patients with cancer ...

5. psycnet.apa.org psycnet.apa.org/record/2025-49982-001

Cognitive behavioral digital therapeutic effects on distress and ... Cognitive behavioral digital therapeutic effects on distress and quality of life in patients with cancer: National randomized controlled trial. Citation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

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.

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06628-3

Effects of cognitive behavioral therapy on resilience among ... This study provided moderately strong evidence that CBT is a valuable tool for enhancing resilience among cancer patients.