Mindset Intervention for Cancer

Overseen By Sean R Zion

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe depression, Bipolar, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how mindsets affect cancer treatment outcomes and overall well-being. Participants will either engage in a mindset intervention involving short films and reflection activities or continue with their usual treatment. The trial focuses on patients newly diagnosed with certain types of cancer (breast, lung, gastrointestinal, or lymphoma) who haven't received prior therapy. It will assess both physical and mental health changes during treatment. The researchers hope to show that a positive mindset can improve health and recovery for cancer patients.

As an unphased trial, it offers a unique opportunity to explore the impact of mindset on health, potentially enhancing the treatment experience.

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. It seems that there are no restrictions on other investigational agents, but it's best to discuss your specific medications with the trial coordinators.

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

Research has shown that mindset interventions are generally safe for people. In past studies, participants experienced better overall health, including improvements in physical, social, and emotional well-being. No major negative effects were reported from these interventions. One study found that participants felt more positive about their cancer and their bodies after participating. This suggests that the mindset treatment is well-tolerated and might even enhance quality of life during cancer treatment.

In summary, current evidence supports the safety of mindset interventions, with positive effects on health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for cancer, which often involves medication, surgery, or radiation therapy, the Mindset Intervention takes a completely different approach by focusing on psychological and emotional support. This intervention is unique because it uses a series of short films accompanied by reflection activities to help patients potentially shift their mindset towards their diagnosis and treatment journey. Researchers are excited about this approach because it explores how altering a patient's mindset might improve their overall well-being and treatment experience, offering a non-invasive complement to traditional therapies.

What evidence suggests that this mindset intervention is effective for cancer patients?

Research has shown that mindset activities can positively affect people with cancer. In past studies, patients who participated in these activities reported feeling better about cancer and their bodies. These activities have improved overall quality of life, including physical, social, emotional, and daily well-being. They also help patients handle treatment better. In this trial, participants in the Mindset Intervention arm will engage in these activities, which include watching brief films and completing reflection exercises. While mindset activities don't directly treat cancer, they can help patients feel better and manage their treatment more effectively. ^{2 3 4 6 7}

Who Is on the Research Team?

Alia Crum, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with a new diagnosis of lung, breast, GI/colorectal cancer or lymphoma and treatment aimed at curing it. They must be able to consent and undergo systemic treatment involving 4-12 infusions. Excluded are those with major health issues reducing life expectancy, active severe mental health diagnoses, pregnant/nursing women, HIV-positive individuals or previous cancer treatments.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent document

I have undergone at least one round of systemic therapy.

I have not received any treatment for cancer before.

Exclusion Criteria

I am HIV-positive.

I do not have severe heart or kidney disease that would shorten my life.

Pregnant / nursing patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mindset intervention including watching films and reflection activities, or treatment as usual

6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and biomarkers

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindset
• Reflection activities

Trial Overview The study tests how mindsets affect health outcomes in cancer patients. It involves reflection activities designed to promote beneficial views about cancer and the body's role during recovery. Participants will be randomly assigned to either these mindset interventions or their usual care without the added activities.

How Is the Trial Designed?

Group I: Mindset Intervention Experimental Treatment 2 Interventions

Mindset Intervention will include watching three brief \~10-25 minute films and respond to a number of short reflection activities after viewing the films.

Group II: Treatment As Usual (TAU) Active Control 1 Intervention

TAU Control Arm will complete the same assessments as those participants in the Mindset Intervention Arm, but will not view the short films or complete the corresponding response activities.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37529924/

A randomized controlled feasibility and efficacy trial - PubMed Results: Patients in the CMI group reported significant (p < 0.001) improvements in adaptive mindsets about cancer and the body over time.

2. med.stanford.edu med.stanford.edu/news/insights/2023/08/can-altering-cancer-mindsets-change-physical-outcomes.html

Can altering cancer 'mindsets' change physical outcomes? Researchers found that a mindset intervention could improve the self-reported overall quality of life for adults undergoing cancer treatment.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pon.6194

Changing cancer mindsets: A randomized controlled ... A brief mindset-focused digital intervention was effective at improving physical, social, emotional, and functional HRQoL, increasing adaptive coping behaviors,

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7059887/

Targeting Mindsets, Not Just Tumors - PMC Precise, targeted psychological interventions aimed at shifting patient mindsets have the potential to transform supportive care in oncology.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06705218

Study Details | NCT06705218 | Exploring Mindsets, Beliefs ... In our prior research, we showed that a 2.5-hour digital MINDSET intervention significantly improves whole patient health (physical, social, and emotional ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06705218

Study Details | NCT06705218 | Exploring Mindsets, Beliefs ... In our prior research, we showed that a 2.5-hour digital MINDSET intervention significantly improves whole patient health (physical, social, and emotional ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0889159125002806

Can catastrophes be opportunities? A randomized clinical ... As hypothesized, the results demonstrate that a brief mindset intervention effectively reduced both CRP and depressive symptom levels two years after the ...