Clinical trial NCT04020029: Leveraging Mindsets to Improve Health and Wellbeing in Patients With Cancer
Official title: Leveraging Mindsets to Improve Health and Wellbeing in Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-07-15
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary Objectives:

Mindsets have been rigorously studied in the domains of development, education, and more recently, in health and disease. However, there are no large-scale longitudinal studies of the mindsets held by cancer patients and how they may affect treatment outcomes, physical health, and psychological well-being. This randomized, single-blind, treatment-as-usual (TAU) control study aims to assess (1) mindsets at four time points spanning from the point of diagnosis to six weeks post-treatment to patients who are newly diagnosed with cancer and undergoing treatment with curative intent, and (2) the impact of a brief but targeted mindset intervention to help instill more useful mindsets about the nature of cancer and the role of the body on patient reported measures of physical and psychological health. This study aims to add to the existing literature on psychosocial interventions for cancer patients and survivors while addressing the substantial time and cost limitations of traditional interventions. It also contributes to the body of research indicating that mindsets play an important role in both health and wellbeing.

Secondary Objectives:

This study has two secondary objectives. First, we aim to determine the impact of patient mindsets on measures of treatment (treatment efficacy and treatment related adverse events) and psychosocial health (stress, coping, mood, emotions). Second, we aim to understand the relationship between patient mindsets and biomarkers of immune and inflammatory processes in patients undergoing cancer treatment


Eligibility 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.

Primary outcomes:
measure: Quality of Life Survey
timeFrame: 6 weeks
Secondary outcomes:
measure: Measuring mindsets
timeFrame: 6 weeks
measure: Fear of Cancer Recurrence
timeFrame: 6 weeks
measure: Biomarker Analyses
timeFrame: 6 weeks
measure: Measuring stress with cancer
timeFrame: 6 weeks
measure: Measuring coping with cancer
timeFrame: 6 weeks
measure: Measuring affect with cancer
timeFrame: 6 weeks
measure: Measuring emotional regulation with cancer
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Alia Crum, PhD
role: PRINCIPAL_INVESTIGATOR
References: