Leveraging Mindsets to Improve Health and Wellbeing in Patients With Cancer

NCT04020029 | Withdrawn

• 2 other identifiers: IRB-43605NCI-2020-00541
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Quality of Life Survey

  Quality of life will be assessed using the Functional Assessment of Cancer Therapy (FACT-G), a widely used patient reported health outcome measure. The FACT-G consists of 27 questions. Each question is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores on the FACT-G indicate better quality of life. Questions fall into four subscales measuring four domains of quality of life: physical wellbeing (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), and functional well-being (7-questions).

  6 weeks

Secondary Outcomes (7)

• Measuring mindsets

  6 weeks

• Fear of Cancer Recurrence

  6 weeks

• Biomarker Analyses

  6 weeks

• Measuring stress with cancer

  6 weeks

• Measuring coping with cancer

  6 weeks

Study Arms (2)

Mindset Intervention

EXPERIMENTAL

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

Other: Mindset; Other: Reflection activities

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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.

Other: Reflection activities

Interventions

Mindset OTHER

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

Mindset Intervention

Reflection activities OTHER

Reflection activity include exercises to internalize the message

Mindset Intervention; Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Stress Mindset Measure

Study Officials

• Alia Crum, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: May 5, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)