Lymphoma, Large B-Cell, Diffuse Clinical Trial
Official title:
Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer
Mindsets are lenses or frames of mind that orient individuals to a particular set of
expectations and associations. This study aims to leverage specific and empirically supported
mindsets (i.e., 'cancer is manageable' and 'the body is capable') to reduce distress and
improve physical health and psychological wellbeing in patients with cancer being treated
with curative intent. This intervention will take the form of several brief documentary style
film segments which feature both cancer survivors and experts in the fields of Oncology,
Psychology, and Psychiatry.
Although no mindset-targeted interventions have been studied in cancer patients to date,
other psychosocial interventions have demonstrated efficacy in treating emotional distress
and improving quality of life in this population. However, compared with these standard
interventions, mindset interventions need not be lengthy, complex, or costly to yield major
effects. Thus, this project aims to lay the groundwork for future scalable and efficient
interventions that can meaningfully reduce distress and improve health and wellbeing in this
population.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with lung cancer (small cell, non-small cell), breast cancer (any), GI/Colorectal cancer (colon, rectal), or Lymphoma (Hodgkins, Low Grade, Diffuse Large B-Cell, Mantle Cell, T-Cell) to be treated with curative intent. - Receiving at least one course of systemic treatment. - Age = 18 years who are fluent in English and are without cognitive impairment. - Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: - Failure to meet any of the inclusion criteria. - Surgical procedures, if applicable, must take place either before the initiation of systemic treatment or after the last infusion. - 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 not be included in this study. - 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 . - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. — View Citation
Crum A, Zuckerman B. Changing Mindsets to Enhance Treatment Effectiveness. JAMA. 2017 May 23;317(20):2063-2064. doi: 10.1001/jama.2017.4545. — View Citation
Crum AJ, Akinola M, Martin A, Fath S. The role of stress mindset in shaping cognitive, emotional, and physiological responses to challenging and threatening stress. Anxiety Stress Coping. 2017 Jul;30(4):379-395. doi: 10.1080/10615806.2016.1275585. Epub 2017 Jan 25. — View Citation
Crum AJ, Corbin WR, Brownell KD, Salovey P. Mind over milkshakes: mindsets, not just nutrients, determine ghrelin response. Health Psychol. 2011 Jul;30(4):424-9; discussion 430-1. doi: 10.1037/a0023467. — View Citation
Crum AJ, Leibowitz KA, Verghese A. Making mindset matter. BMJ. 2017 Feb 15;356:j674. doi: 10.1136/bmj.j674. Erratum in: BMJ. 2017 Nov 15;359:j5308. — View Citation
Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25. — View Citation
Faller H, Schuler M, Richard M, Heckl U, Weis J, Küffner R. Effects of psycho-oncologic interventions on emotional distress and quality of life in adult patients with cancer: systematic review and meta-analysis. J Clin Oncol. 2013 Feb 20;31(6):782-93. doi: 10.1200/JCO.2011.40.8922. Epub 2013 Jan 14. Review. — View Citation
Rehse B, Pukrop R. Effects of psychosocial interventions on quality of life in adult cancer patients: meta analysis of 37 published controlled outcome studies. Patient Educ Couns. 2003 Jun;50(2):179-86. — View Citation
Walton, G. M. (2014). The new science of wise psychological interventions. Current Directions in Psychological Science, 23(1), 73-82.
Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. — View Citation
Zahrt OH, Crum AJ. Perceived physical activity and mortality: Evidence from three nationally representative U.S. samples. Health Psychol. 2017 Nov;36(11):1017-1025. doi: 10.1037/hea0000531. Epub 2017 Jul 20. — View Citation
Zion SR, Crum AJ. Mindsets Matter: A New Framework for Harnessing the Placebo Effect in Modern Medicine. Int Rev Neurobiol. 2018;138:137-160. doi: 10.1016/bs.irn.2018.02.002. Epub 2018 Mar 20. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in FACT-G Total Score | The Functional Assessment of Cancer Therapy - General (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). For participant within each group, the change in FACT-G total score will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. Our primary outcome measure is the difference in slopes between groups. |
Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) | |
Secondary | Change in Patient Mindsets | Change in Patient Mindsets Mindsets will be measured using The Illness Mindset Inventory (IMI). The IMI is a 20-item measure of mindsets about chronic illnesses. The inventory has two sub-scales: mindsets about the nature of cancer and mindsets about the role of the body. Each item is rated on a scale from 1 (strongly disagree) - 6 (strongly agree), with higher scores indicating greater agreement with the respective mindsets. For participant within each group, the change in IMI subscores will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups. |
Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) | |
Secondary | Fear of Cancer Recurrence | Fear of cancer recurrence will be measured using the Cancer Worry Scale (CWS). The CWS is the gold-standard for measuring fear of cancer recurrence. The scale consists of 6 items that respondents report on a 4-point scale of frequency, ranging from 1 (not at all) to 4 (almost all the time), with higher scores indicating more worry. We will compare the mean total score on the CWS between patients assigned to the intervention arm and those assigned to the TAU control arm. This outcome will be measured once, at follow up. |
Post-treatment (6 weeks after the completion of treatment) | |
Secondary | Change in Body Vigilance | Body Vigilance will be measured using the Body Vigilance Scale (BVS). The BVS is a 4 item scale, assessing the degree of attentional focus, perceived sensitivity to change in bodily sensations, the average amount of time spent attending to bodily sensations, and a rating for 15 sensations individually. Items are rated on an 11 point Likert-like scale ranging from 0 (Not at all like me) to 10 (Extremely like me), with higher values indicating higher degree of body vigilance, which can be maladaptive in patients with chronic illnesses. For participants within each group, the change in BVS total score will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups. |
Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) | |
Secondary | Change in Self-Efficacy: Cancer Behavior Inventory | Self-efficacy for coping with cancer will be measured using the Cancer Behavior Inventory (CBI). The CBI is a 27-item measure of self-efficacy for coping with cancer. Items are rated on a 9 point Likert scale from 1 (not at all confident) - 9 (totally confident). Mean scores can be calculated for each of the factors, which include: Maintaining Activity/Independence, Seeking & Understanding Medical Information, Emotion Regulation, Coping With Side Effects, Acceptance/Positive Attitude, Seeking Social Support, and Spiritual Coping. A total score can be calculated by finding the sum of subscale scores. Higher scores indicate greater self-efficacy, which can be beneficial for patients with chronic illnesses. For participants within each group, the change in CBI total score will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups. |
Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) | |
Secondary | Change in Emotion Regulation Strategies | Emotion Regulation will be measured using The Emotion Regulation Questionnaire (ERQ). This 10-item self-report scale designed to measure use of strategies to alter emotion: reappraisal of cognitions and suppression of expressions. Items are rated on a Likert scale from 1 (strongly disagree) - 7 (strongly agree), with higher scores indicating greater use of the respective regulation strategy (reappraisal and suppression). For participants within each group, the change in ERQ sub-scores for reappraisal and suppression will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups for each of the two strategies. |
Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) | |
Secondary | Change in Affect (Mood) | Affect will be measured using the Positive and Negative Affect Scale (PANAS). The PANAS is a 20 item scale measuring positive and negative affect. Participants are asked to rank, based on a 5-point Likert scale, the extent to which they have felt each item from 1 (vey slightly or not at all) to 5 (extremely) over the past week. The scale yields sub-scores for positive affect and negative affect. Higher scores on each subscale represent more frequent positive affect or negative affect, respectively. For participants within each group, the change in PANAS sub-score for positive affect and negative affect will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups for each of the two types of affect. |
Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) | |
Secondary | Change in Perception of Stress | Stress will be measured using The Perceived Stress Scale (PSS). The PSS is a 10-item measure asks respondents to report on the frequency with which they have experienced levels of stress in the past month. Items are rated on a Likert Scale from 0 (Never) - 4 (Very Often). The scale yields one total score. A higher score on the PSS indicates greater perceived stress. For participants within each group, the change in PSS total score will be calculated at each of the four timepoints to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups. |
Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) | |
Secondary | Change in Symptom Related Distress | Symptom related distress will be measured by the Rotterdam Symptom Checklist (RSCL). The RSCL is a widely accepted symptom measurement instrument for patients with cancer. It covers four domains: physical symptom distress, psychological distress, activity level, and overall global life quality. Items are rated on a 4 point Likert Scale, ranging from 1 (not at all) - 4 (very much). Each sub-scale will be analyzed separately. Higher scores on the physical and psychological sub-scales indicate greater distress (a worse outcome), whereas higher scores on activity and life quality sub-scales indicate a better outcome. For participants within each group, the change in RSCL total score for will be calculated at each of the four timepoints for each sub-scale to calculate a time course trajectory of change (slope) for each group. This outcome measures the difference in slopes between groups for each of the four sub-scales of the RSCL. |
Pre-treatment (week 0), Early Treatment (week 2), Late Treatment (week 6), Post Treatment (6 weeks after the completion of treatment) |
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