Leveraging Mindsets to Improve Health and Wellbeing in Patients With Cancer

NCT ID: NCT04020029

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2026-12-31

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

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mindset Intervention

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 Type: EXPERIMENTAL

Mindset

Intervention Type: OTHER

Mindset Intervention will include watching three brief \~10-25 minute films

Reflection activities

Intervention Type: OTHER

Reflection activity include exercises to internalize the message

Treatment As Usual (TAU)

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.

Group Type: ACTIVE_COMPARATOR

Reflection activities

Intervention Type: OTHER

Reflection activity include exercises to internalize the message

Interventions

Mindset

Mindset Intervention will include watching three brief \~10-25 minute films

Intervention Type: OTHER

Reflection activities

Reflection activity include exercises to internalize the message

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alia Crum

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alia Crum, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

NCI-2020-00541

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-43605

Identifier Type: -

Identifier Source: org_study_id

NCT03910283

Identifier Type: -

Identifier Source: nct_alias