CancerNCT04020029
Leveraging Mindsets to Improve Health and Wellbeing in Patients With Cancer
A study testing Mindset and Reflection activities in people with Cancer, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Mindset and Reflection activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Mindsets to Improve Health and Wellbeing in Cancer Patients
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.
Read more
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
- Being tested
- Mindset, Reflection activities
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindsetOther
Mindset Intervention will include watching three brief ~10-25 minute films
Reflection activitiesOther
Reflection activity include exercises to internalize the message
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Reflection activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (7)
Measuring mindsets
Patient mindsets will be measured using the Illness Mindset Inventory (IMI). The IMI is a 20-item measure of mindsets about chronic illness. The Cancer version of the IMI consists of two subscales: mindsets about the nature of cancer and mindsets about the role of the body. Each item is rated on a 6 point Likert scale ranging from strongly disagree (1) to strongly agree (6).
Measured: 6 weeks
Fear of Cancer Recurrence
Fear of Cancer Recurrence will be measured using the Cancer Worry Scale (CWS). The CWS is a 6-item measure that assesses worry about the risk of developing cancer in cancer survivors. All items use a 4-point scale of frequency, ranging from 1 (not at all) to 4 (almost all the time). The CWS will be measured at only one time-point (CP-7), 6 weeks after the completion of treatment
Measured: 6 weeks
Biomarker Analyses
Blood samples will be analyzed for the following biomarkers of interest.
- C-reactive protein (CRP)
- -6 / Interleukin (IL) IL-8
- Tumor necrosis factor-alpha (TNF-a)
Measured: 6 weeks
Measuring stress with cancer
Stress will be measured using the Perceived Stress Scale (PSS). This 10-item measure is the most commonly used measure of perceptions of stress.
Measured: 6 weeks
Measuring coping with cancer
Coping will be measured using the Cancer Behavior Inventory (CBI). The CBI is a 27-item measure of self-efficacy for coping with cancer.
Measured: 6 weeks
Measuring affect with cancer
Affect will be measured using the Positive and Negative Affect Scale (PANAS). The PANAS is a 20 item scale measuring positive and negative affect.
Measured: 6 weeks
Measuring emotional regulation with cancer
Emotion Regulation will be measured using the Emotion Regulation Questionnaire (ERQ). The ERQ is a 10-item self-report scale designed to measure use of strategies to alter emotion: reappraisal of cognitions and suppression of expressions.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start5 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Study was never run due to Covid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia Crum, Stanford University
- Investigators
- Alia Crum, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020029
- Sponsor's protocol ID
- IRB-43605
- Other IDs
- NCI-2020-00541
- Status last verified
- Dec 2025
- First submitted
- 11 Jul 2019
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Mindsets to Improve Health and Wellbeing in Cancer Patients
- ClinicalTrials.gov ID
- NCT04020029
- Acronym / sponsor ID
- IRB-43605
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never run due to Covid
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindset Intervention | Experimental | Other: Mindset, Other: Reflection activitiesMindset Intervention will include watching three brief ~10-25 minute films and respond to a number of short reflection activities after viewing the films. |
| Treatment As Usual (TAU) | Active comparator | Other: Reflection activitiesTAU 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindsetMindset Intervention will include watching three brief ~10-25 minute films | Other | Mindset Intervention |
| Reflection activitiesReflection activity include exercises to internalize the message | Other | Mindset Intervention, Treatment As Usual (TAU) |
Primary outcome
Quality of Life Survey
Time frame: 6 weeks
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).
7 secondary outcomes
Measuring mindsets
Time frame: 6 weeks
Fear of Cancer Recurrence
Time frame: 6 weeks
Biomarker Analyses
Time frame: 6 weeks
Measuring stress with cancer
Time frame: 6 weeks
Measuring coping with cancer
Time frame: 6 weeks
Measuring affect with cancer
Time frame: 6 weeks
Measuring emotional regulation with cancer
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alia Crum, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindset and Reflection activities in people with Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Survey (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.