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

Trial Summary

What is the purpose of this trial?

This clinical trial tests how well cognitive behavioral cancer stress management (CBCSM) group sessions work to decrease psychological distress in cancer patients. CBCSM teaches patients how to recognize and reduce the impacts of cancer associated stress on the biological, psychological, and social life domains.

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy (CBT) for cancer distress?

Research shows that group cognitive behavioral therapy (CBT) can effectively help cancer patients manage emotional distress, with studies indicating improved patient satisfaction and outcomes. CBT has been successful in treating various psychological disorders, and its application in cancer care has shown promise in reducing distress and enhancing well-being. ^{1 2 3 4 5}

Is group cognitive behavioral therapy safe for cancer patients?

Group cognitive behavioral therapy (CBT) is generally considered safe for cancer patients, as it has been used to help manage emotional distress without reported safety concerns. It is a well-established method for treating psychological issues in various conditions, and studies have shown patient satisfaction and improved outcomes. ^{1 2 5 6 7}

How is group cognitive behavioral therapy (CBT) unique for treating cancer distress?

Group cognitive behavioral therapy (CBT) is unique for treating cancer distress because it focuses on teaching patients skills to challenge and solve problems, improve coping, and provide social support, which are not typically addressed in standard cancer care. It is also the first distress treatment linked to survival benefits in clinical trials, making it a novel approach in psycho-oncology. ^{1 2 5 7 8}

Research Team

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

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Description of a group Cognitive Behaviour Therapy programme with cancer patients. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Group and individual treatment strategies for distress in cancer patients. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Psychological aspects of meaning-centered group psychotherapy: Spanish experience. [2019]

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

Real-World Implementation of Best-Evidence Cancer Distress Management: Truly Comprehensive Cancer Care. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of the Cognitive-Behavioral Approach and Psychoeducational Intervention in Breast Cancer Management: A Prospective Randomized Clinical Trial. [2023]

7. Germany 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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