Psychotherapy for Cancer Distress

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Psychotic behavior, Suicidal ideation, others

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: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of psychotherapy called accelerated resolution therapy to determine if it can reduce distress and trauma in people with cancer. Already used for depression and stress disorders, researchers aim to assess its specific benefits for cancer-related emotional challenges. The therapy involves weekly sessions lasting 60-90 minutes for up to five weeks. Individuals who have undergone cancer treatments like chemotherapy or radiation in the past three years, or who have metastatic cancer and experience significant distress, may be suitable for this study. Participants should be comfortable using web conferencing or traveling to the Mayo Clinic for sessions. As an unphased trial, this study provides a unique opportunity to explore new therapeutic options for emotional support during cancer recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on psychotherapy, so it's likely you can continue your medications, but you should confirm with the trial coordinators.

What prior data suggests that this psychotherapy is safe for cancer patients?

Research has shown that therapies like accelerated resolution therapy (ART) are generally safe. Studies have found that these therapies can improve emotional well-being and reduce distress without major side effects. For instance, a review of psychological treatments in cancer care found that they often lead to a better quality of life and less psychological distress. ART is already used to help with depression, trauma, and stress-related disorders, indicating it is well-tolerated.

No specific negative effects of ART have been widely reported in cancer care. As ART is a type of talk therapy and not a medication, the risks are generally lower compared to drug treatments. Participants in similar therapies have experienced improved emotional well-being without significant negative effects. Overall, ART appears to be a safe and promising option for reducing cancer-related trauma and distress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about psychotherapy for cancer distress because it offers a supportive care approach that focuses on emotional and psychological well-being, something traditional medical treatments for cancer often overlook. Unlike standard treatments that primarily target the physical symptoms of cancer, this psychotherapy treatment, specifically ART (Accelerated Resolution Therapy), involves guided sessions that can help patients process and manage their distress in a short time frame of just five weeks. This technique aims to provide relief from the emotional burden of cancer by helping patients reframe distressing thoughts and experiences, potentially leading to improved mental health and overall quality of life.

What evidence suggests that accelerated resolution therapy is effective for cancer distress?

Research has shown that accelerated resolution therapy, a type of talk therapy, can help reduce distress and trauma. In this trial, participants will undergo accelerated resolution therapy as part of the supportive care arm. Studies on similar therapies have found improvements in emotional well-being and quality of life for cancer patients. Specifically, patients reported feeling less anxious, less depressed, and less tired after receiving this kind of therapy. This suggests that accelerated resolution therapy might effectively reduce distress and trauma related to cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Cindy Tofthagen, Ph.D., R.N.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for cancer patients who've had treatments like chemotherapy or bone marrow transplant within the last 3 years, or have metastatic cancer. They must be experiencing some trauma and distress related to their condition, as shown by specific questionnaire scores. Participants should not have suicidal thoughts or psychotic behavior and must be able to use web conferencing software or travel to Mayo Clinic.

Inclusion Criteria

I've had cancer treatment or have metastatic cancer in the last 3 years.

A minimum score of 3 on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)

A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants undergo accelerated resolution therapy (ART) over 60-90 minutes once a week for up to 5 sessions

6 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psychotherapy

Trial Overview The study is testing Accelerated Resolution Therapy (ART), a type of psychotherapy aimed at reducing psychological trauma and distress in cancer patients. The therapy's effectiveness will be measured through questionnaires before and after treatment sessions.

How Is the Trial Designed?

Group I: Supportive care (ART) Experimental Treatment 2 Interventions

Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.

Psychotherapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Psychotherapy for:

• Mental health disorders
• Substance use disorders

Approved in United States as Psychotherapy for:

• Mental health disorders
• Substance use disorders
• Pain management

Approved in Canada as Psychotherapy for:

• Mental health disorders
• Substance use disorders

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11857804/

Review of Psychological Interventions in Oncology Across all studies, enhanced emotional well-being, reduced psychological distress, and an improved quality of life were the expected outcomes, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12035791/

Effectiveness of Managing Cancer and Living Meaningfully ... CALM therapy has demonstrated positive effects on psychological distress, anxiety, depression, cancer‐related fatigue, sleep disturbance, and quality of life.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.e24169

Effectiveness of brief-focused cognitive behavioral therapy ... Results suggest that B-CBT-P is statistically and clinically effective to improve the emotive and relational sphere of oncological patients.

4. psychiatryinvestigation.org psychiatryinvestigation.org/m/journal/view.php?doi=10.30773/pi.2023.0357

Characteristics and Effectiveness of Individual Psychotherapy This review reports the characteristics and effectiveness of individual psychotherapeutic interventions for patients receiving palliative and end-of-life care.

5. nature.com nature.com/articles/s41598-024-63431-y

Psychological intervention improves quality of life in ... Psychological interventions did not result in significant differences in the improvement of overall survival (OS) (a) and recurrence-free ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11368479/

The Impact of Cancer on Mental Health and the Importance ... 30% of patients may experience cancer-related psychological disorders, including anxiety, depression, and post-traumatic stress.

7. mdpi.com mdpi.com/2072-6694/16/16/2827

Mental Health Challenges in Cancer Patients: A Cross ... Prior research assessing psychological distress in cancer patients has revealed diverse prevalence rates, which varied between 5.0% and 49.0% ...

8. jmir.org jmir.org/2024/1/e51949/

Digital Therapeutic (Mika) Targeting Distress in Patients ... The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress ...