Stress Management for Lung Cancer Patients
(SCAN Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hackensack Meridian Health
Disqualifiers: Cognitive impairment, Psychiatric illness, Hospice, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This is a behavioral trial study to pilot test a stress management intervention for people with cancer who are undergoing routine cancer scans. The study will involve two pilot testing phases. Initial feasibility will be determined in an Open Trial phase, to inform any needed revisions to the intervention and/or protocol prior to a Pilot Randomized Controlled Trial phase. The Open Trial phase is an unblinded, single-site, single-arm open trial (n=10). The Pilot randomized clinical trial (RCT) phase is an unblinded, single-site, feasibility pilot randomized controlled trial (n=50).
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Adapted Stress Management Program, Adapted Stress Management Program, Cognitive Behavioral Stress Management, Mindfulness-Based Stress Reduction, Enhanced Usual Care, Duphalac, Kristalose for lung cancer patients?
Research shows that Mindfulness-Based Stress Reduction (MBSR) can help improve quality of life and reduce psychological distress in cancer patients, including those with lung cancer. Studies have found that MBSR can lead to better emotional control, less anxiety, and improved coping skills, making it a potentially beneficial complementary therapy for lung cancer patients.12345
Is stress management safe for lung cancer patients?
How is the Adapted Stress Management Program treatment different for lung cancer patients?
The Adapted Stress Management Program is unique because it combines mindfulness-based stress reduction (MBSR) and cognitive-behavioral stress management (CBSM) to help lung cancer patients manage stress, anxiety, and depression, potentially improving their quality of life. Unlike standard treatments that focus solely on physical symptoms, this program addresses psychological well-being, which is crucial for patients with high distress levels.34589
Eligibility Criteria
This trial is for lung cancer patients awaiting scan results. Participants should be willing to undergo a stress management program or receive enhanced usual care. Specific eligibility details are not provided, but typically include factors like age, health status, and prior treatments.Inclusion Criteria
I can take care of myself and am up and about more than half of my waking hours.
Comfortable speaking, reading, and writing English without an interpreter
I am 18 years old or older.
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Exclusion Criteria
Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)
I need an interpreter for my medical appointments.
Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis)
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Open Trial
Participants undergo an unblinded, single-site, single-arm open trial to field test the stress management program
2 weeks
3 visits (virtual)
Pilot Randomized Controlled Trial
A small RCT is conducted to test the intervention's feasibility and acceptability
4 weeks
3 visits (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 month
Treatment Details
Interventions
- Adapted Stress Management Program (Behavioral Intervention)
- Enhanced Usual Care (Behavioral Intervention)
Trial OverviewThe study tests a new stress management intervention against enhanced usual care in two phases: an initial Open Trial with 10 people to refine the program, followed by a Pilot Randomized Controlled Trial with 50 people to assess feasibility.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Adapted Stress Management ProgramExperimental Treatment1 Intervention
The behavioral intervention consists of 3 brief coaching sessions delivered by a trained research interventionist (at baseline/orientation, pre-scan, and post-scan time points) and program modules consisting of psychoeducation and stress management skill activities/practice. They will also be provided with a list of mental health resources and crisis line information for use if needed.
Group II: Enhanced Usual CareActive Control1 Intervention
Those randomized to enhanced usual care in the pilot RCT (n=25) will receive a resource list, tablet for study assessments, and reminder calls, but will not receive the program modules. They will also be provided with a list of mental health resources and crisis line information for use if needed.
Adapted Stress Management Program is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Adapted Stress Management Program for:
- Stress management for cancer patients undergoing routine cancer scans
🇨🇦 Approved in Canada as Cognitive Behavioral Stress Management for:
- Stress management for cancer survivors
- Anxiety and depression in cancer patients
🇪🇺 Approved in European Union as Mindfulness-Based Stress Reduction for:
- Stress management for cancer patients
- Anxiety and depression in cancer survivors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Amanda KhoudaryHackensack, NJ
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Who Is Running the Clinical Trial?
Hackensack Meridian HealthLead Sponsor
National Cancer Institute (NCI)Collaborator
References
The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial. [2022]The aim of this study was determine the effectiveness of a mindfulness-based stress-reduction (MBSR) program on quality of life (QOL) and psychosocial outcomes in women with early-stage breast cancer, using a three-arm randomized controlled clinical trial (RCT). This RCT consisting of 172 women, aged 20-65 with stage I or II breast cancer consisted of the 8-week MBSR, which was compared to a nutrition education program (NEP) and usual supportive care (UC). Follow-up was performed at three post-intervention points: 4 months, 1, and 2 years. Standardized, validated self-administered questionnaires were adopted to assess psychosocial variables. Statistical analysis included descriptive and regression analyses incorporating both intention-to-treat and post hoc multivariable approaches of the 163 women with complete data at baseline, those who were randomized to MBSR experienced a significant improvement in the primary measures of QOL and coping outcomes compared to the NEP, UC, or both, including the spirituality subscale of the FACT-B as well as dealing with illness scale increases in active behavioral coping and active cognitive coping. Secondary outcome improvements resulting in significant between-group contrasts favoring the MBSR group at 4 months included meaningfulness, depression, paranoid ideation, hostility, anxiety, unhappiness, and emotional control. Results tended to decline at 12 months and even more at 24 months, though at all times, they were as robust in women with lower expectation of effect as in those with higher expectation. The MBSR intervention appears to benefit psychosocial adjustment in cancer patients, over and above the effects of usual care or a credible control condition. The universality of effects across levels of expectation indicates a potential to utilize this stress reduction approach as complementary therapy in oncologic practice.
The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. [2020]Research on the use of mindfulness-based stress reduction and related mindfulness-based interventions (MBIs) in cancer care has proliferated over the past decade. MBIs have aimed to facilitate physical and emotional adjustment to life with cancer through the cultivation and practice of mindfulness (ie, purposeful, nonjudgmental, moment-to-moment awareness). This descriptive review highlights three categories of outcomes that have been evaluated in MBI research with cancer patients - namely, symptom reduction, positive psychological growth, and biological outcomes. We also examine the clinical relevance of each targeted outcome, while describing recently published original studies to highlight novel applications of MBIs tailored to individuals with cancer. Accumulating evidence suggests that participation in a MBI contributes to reductions in psychological distress, sleep disturbance, and fatigue, and promotes personal growth in areas such as quality of life and spirituality. MBIs may also influence markers of immune function, hypothalamic-pituitary-adrenal axis regulation, and autonomic nervous system activity, though it remains unclear whether these biological changes translate to clinically important health benefits. We conclude by discussing methodological limitations of the extant literature, and implications of matching MBIs to the needs and preferences of cancer patients. Overall, the growing popularity of MBIs in cancer care must be balanced against scientific evidence for their impact on specific clinical outcomes.
The Impact of Mindfulness-Based Stress Reduction (MBSR) on Psychological Outcomes and Quality of Life in Patients With Lung Cancer: A Meta-Analysis. [2022]The impact of the mindfulness-based stress reduction (MBSR) program on psychological outcomes and quality of life (QoL) in lung cancer patients remains unclear. This meta-analysis aimed to evaluate the effectiveness of the MBSR program on psychological states and QoL in lung cancer patients.
Audio recordings of mindfulness-based stress reduction training to improve cancer patients' mood and quality of life--a pilot feasibility study. [2022]Mindfulness-based stress reduction (MBSR), typically taught in eight weekly classes, helps patients cope with illness, including cancer. Current research is almost exclusively based on post-treatment class attendance. Research suggests that short courses and alternative delivery techniques may also be beneficial. This pilot study assessed whether it would be feasible for cancer patients receiving chemotherapy to listen to MBSR audio recordings individually during treatment and at home and evaluate whether the intervention shows preliminary evidence of efficacy to improve patients' mood and quality of life (QoL).
Mindfulness-based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial. [2022]Lung cancer patients report among the highest distress rates of all cancer patients. Partners report similar distress rates. The present study examined the effectiveness of additional mindfulness-based stress reduction (care as usual [CAU] + MBSR) versus solely CAU to reduce psychological distress in lung cancer patients and/or their partners.
Use and helpfulness of self-administered stress management therapy in patients undergoing cancer chemotherapy in community clinical settings. [2013]The purpose of this multicenter longitudinal randomized controlled trial was to examine the efficacy of self-administered stress management training (SSMT) in improving quality of life and reducing psychological distress among patients receiving cancer chemotherapy. Participants were randomized to SSMT (n = 111) or usual psychosocial care only (n = 109). Mixed linear modeling demonstrated no significant improvements in primary outcome measures; however, participants assigned to SSMT reported using significantly more relaxation techniques (p
Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. [2023]Cancer diagnosis and treatment constitute profoundly stressful experiences involving unique and common challenges that generate uncertainty, fear, and emotional distress. Individuals with cancer must cope with multiple stressors, from the point of diagnosis through surgical and adjuvant treatments and into survivorship, that require substantial psychological and physiological adaptation. This can take a toll on quality of life and well-being and may also promote cellular and molecular changes that can exacerbate physical symptoms and facilitate tumor growth and metastasis, thereby contributing to negative long-term health outcomes. Since modifying responses tostressors might improve psychological and physiological adaptation, quality of life, and clinical health outcomes, several randomized controlled trials have tested interventions that aim to facilitate stress management. We review evidence for the effects of stress management interventions on psychological and physiological adaptation and health outcomes in cancer patients and survivors and summarize emerging research in the field to address unanswered questions.
Anxiety, depression, and quality of life in postoperative non-small cell lung cancer patients under the intervention of cognitive-behavioral stress management. [2023]Cognitive-behavioral stress management (CBSM) is a psychotherapy that helps patients cognize and manage stress to improve mental health and quality of life. This study aimed to explore the influence of CBSM on anxiety, depression, and quality of life in non-small cell lung cancer (NSCLC) patients.
Effectiveness of Mindfulness-Based Stress Reduction Therapy on the Quality of Life of Patients with Lung Cancer. [2023]Lung cancer is one of the most common and life-threatening cancers in men around the world. Therefore, it is important to pay particular attention to the psychological status of patients with lung cancer due to their greater vulnerability during treatment. This study aimed to evaluate the effectiveness of mindfulness-based stress reduction therapy on the quality of life of patients with lung cancer.