Improving health and wellbeing in cancer patients through mindset interventions
Leveraging Mindsets to Improve Health and Wellbeing in Cancer Patients
This study tests whether a short mindset training can help newly diagnosed cancer patients feel better and improve their treatment outcomes alongside their usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04020029 on ClinicalTrials.gov |
What this trial studies
This study investigates how mindsets affect treatment outcomes and overall well-being in newly diagnosed cancer patients. It involves a randomized, single-blind design where participants will receive a brief mindset intervention alongside their usual treatment. The study will assess mindsets at multiple time points, from diagnosis to six weeks post-treatment, to evaluate the impact on physical and psychological health. By focusing on patients undergoing curative treatment for specific cancers, the research aims to contribute to the understanding of psychosocial interventions in oncology.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older, fluent in English, newly diagnosed with specific types of cancer, and undergoing curative treatment.
Not a fit: Patients with cognitive impairments or those who have received prior cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the psychological and physical health outcomes for cancer patients during treatment.
How similar studies have performed: While there is existing literature on psychosocial interventions, this study represents a novel approach by focusing specifically on mindset interventions in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * We will only recruit patients ≥ 18 years who are fluent in English and are without cognitive impairment. We have no gender, race, or ethnicity restrictions. Diagnosis of cancer (breast, lung, GI or colorectal, or lymphoma) and treatment given with curative intent. * Patients diagnosed with lung cancer, breast cancer, GI/Colorectal cancer, or Lymphoma to be treated with curative intent will be eligible for this study. * Participants will be recruited if they are receiving at least one course of systemic treatment. As we are recruiting participants near the point of diagnosis, we will target individuals who have not received prior therapy for cancer. * Neither ECOG or Karnofsky Performance Status will be employed * Ability to understand and willingness to sign a written informed consent document is required for participation in this study. * Treatment plan includes course of systemic treatment involving no less than 4 and no more than 12 infusions. Exclusion Criteria: * Surgical procedures, if applicable, must take place either before the initiation of systemic treatment or after the last infusion. * There are no restrictions regarding the use of other investigational agents; however, use of any investigational agents will be recorded. * No active major mental health diagnoses including severe depression, severe anxiety, bipolar / manic depressive disorder, post-traumatic stress disorder, schizophrenia, or any psychotic disorder. Patients with mild depression or anxiety, or depression or anxiety that is well managed with treatment, will not be excluded * Pregnant / nursing patients will not be excluded from the study * Patients with a previous diagnosis of cancer (cancer survivors) will be excluded from this study. Cancer survivors may already have preconceived notions about the nature of a cancer diagnosis and the course of treatment, and therefore may not respond to our intervention in the same way as individuals who are encountering a cancer diagnosis for the first time. * Patients who are HIV-positive will not be excluded. * Patients who have major comorbidities that would substantially reduce life expectancy despite successful cancer treatment (i.e., comorbid end stage heart disease or kidney disease) will be excluded from this study.
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Alia Crum, PhD — Stanford University
- Study coordinator: Sean R Zion
- Email: szion@stanford.edu
- Phone: 650-725-2418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.