360 Participants Needed

Mindset Intervention for Cancer

SR
Overseen BySean R Zion
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Research Team

AC

Alia Crum, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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.
See 3 more

Exclusion Criteria

I am HIV-positive.
I do not have severe heart or kidney disease that would shorten my life.
Pregnant / nursing patients
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindset InterventionExperimental Treatment2 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 Control1 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.

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security