Stress Management for Lung Cancer Patients

(SCAN Trial)

Overseen By Amanda Khoudary, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Cognitive impairment, Psychiatric illness, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

60 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is stress management safe for lung cancer patients?

Research on stress management techniques like Mindfulness-Based Stress Reduction (MBSR) for cancer patients, including those with lung cancer, suggests these methods are generally safe and can help improve mood and quality of life. ^{3 4 5 6 7}

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. ^{3 4 5 8 9}

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).

Research Team

Heather Derry-Vick, PhD

Principal Investigator

Hackensack Meridian Health

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

My lung cancer is at stage IV or is extensive stage small cell.

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)

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
• Enhanced Usual Care

Trial Overview The 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

Group I: Adapted Stress Management Program Experimental Treatment 1 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 Care Active Control 1 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

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study involving 172 women with early-stage breast cancer, an 8-week mindfulness-based stress-reduction (MBSR) program significantly improved quality of life and coping strategies compared to a nutrition education program and usual supportive care.

The benefits of MBSR included reductions in depression, anxiety, and emotional distress, although these improvements tended to decline over time, suggesting that MBSR could be a valuable complementary therapy in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial. Henderson, VP., Clemow, L., Massion, AO., et al.[2022]

Mindfulness-based interventions (MBIs) have been shown to significantly reduce psychological distress, sleep disturbances, and fatigue in cancer patients, while also promoting personal growth in quality of life and spirituality.

There is emerging evidence that MBIs may positively influence biological markers related to immune function and stress regulation, although it is still uncertain if these changes lead to meaningful health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. Rouleau, CR., Garland, SN., Carlson, LE.[2020]

The mindfulness-based stress reduction (MBSR) program significantly reduced cancer-related fatigue and negative psychological states in lung cancer patients, based on a meta-analysis of 17 studies involving 1,680 patients.

MBSR also improved positive psychological states and quality of sleep, suggesting it could be an effective part of rehabilitation for lung cancer patients, although its overall impact on quality of life showed only a trend toward significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Mindfulness-Based Stress Reduction (MBSR) on Psychological Outcomes and Quality of Life in Patients With Lung Cancer: A Meta-Analysis. Tian, X., Yi, LJ., Liang, CS., et al.[2022]

A pilot study involving 23 cancer patients undergoing chemotherapy showed that listening to mindfulness-based stress reduction (MBSR) audio recordings improved mood and quality of life, with anxiety and depression scores decreasing significantly from an average of 18.3 to 12.2 over 3 months.

The study demonstrated that this individual audio intervention is feasible, as 87% of participants completed the protocol, suggesting that further research with larger clinical trials is warranted to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audio recordings of mindfulness-based stress reduction training to improve cancer patients' mood and quality of life--a pilot feasibility study. Altschuler, A., Rosenbaum, E., Gordon, P., et al.[2022]

Lung cancer patients who participated in an 8-week mindfulness-based stress reduction (MBSR) program alongside standard care reported significantly lower psychological distress compared to those receiving standard care alone, with a moderate effect size (d = 0.69).

The MBSR intervention also led to improvements in quality of life, mindfulness skills, self-compassion, and reduced rumination in patients, although partners did not show similar benefits, likely due to their focus on the patients' well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial. Schellekens, MPJ., van den Hurk, DGM., Prins, JB., et al.[2022]

In a multicenter trial with 220 cancer patients undergoing chemotherapy, self-administered stress management training (SSMT) did not show significant improvements in overall quality of life or psychological distress compared to usual care.

However, participants in the SSMT group reported using more relaxation techniques and showed better emotional adjustment, indicating that SSMT can be beneficial for emotional well-being in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and helpfulness of self-administered stress management therapy in patients undergoing cancer chemotherapy in community clinical settings. Aguado Loi, CX., Taylor, TR., McMillan, S., et al.[2013]

Cancer patients experience significant stress that can negatively impact their quality of life and may even promote tumor growth and metastasis, highlighting the importance of effective stress management.

Randomized controlled trials have shown that stress management interventions can improve psychological and physiological adaptation, potentially leading to better health outcomes for cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. Antoni, MH., Moreno, PI., Penedo, FJ.[2023]

Cognitive-behavioral stress management (CBSM) significantly reduced anxiety and depression levels in 172 non-small cell lung cancer patients over a 10-week intervention, with improvements observed at both 3 and 6 months post-treatment.

Patients receiving CBSM reported enhanced quality of life, with increased global health status and function scores, particularly benefiting those with baseline depression or undergoing additional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety, depression, and quality of life in postoperative non-small cell lung cancer patients under the intervention of cognitive-behavioral stress management. Wang, F., Zhang, S., Song, B., et al.[2023]

A study involving 30 lung cancer patients showed that mindfulness-based stress reduction therapy significantly improved their quality of life after eight sessions, compared to a control group that received no intervention (P<0.001).

The results suggest that incorporating psychological support, like mindfulness therapy, can be beneficial for lung cancer patients, highlighting the importance of addressing mental health during medical treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness-Based Stress Reduction Therapy on the Quality of Life of Patients with Lung Cancer. Aminnasab, A., Hatami, M., Ahadi, H.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Mindfulness-Based Stress Reduction (MBSR) on Psychological Outcomes and Quality of Life in Patients With Lung Cancer: A Meta-Analysis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Audio recordings of mindfulness-based stress reduction training to improve cancer patients' mood and quality of life--a pilot feasibility study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Use and helpfulness of self-administered stress management therapy in patients undergoing cancer chemotherapy in community clinical settings. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Stress Management Interventions to Facilitate Psychological and Physiological Adaptation and Optimal Health Outcomes in Cancer Patients and Survivors. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Anxiety, depression, and quality of life in postoperative non-small cell lung cancer patients under the intervention of cognitive-behavioral stress management. [2023]

9. Iran pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness-Based Stress Reduction Therapy on the Quality of Life of Patients with Lung Cancer. [2023]