Stress and Communication Skills Training for Cancer

Recruiting in New York (>99 mi)

Overseen By Kelly Trevino, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antipsychotics, Substance use treatments

Disqualifiers: Schizophrenia, Substance use, Bipolar, Hospice, others

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

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on communication and emotional support, so it's unlikely that medication changes are required, but you should confirm with the study team.

What data supports the effectiveness of the treatment Weekly 45 minute Sessions for Stress and Communication Skills Training for Cancer?

Research shows that communication skills training for healthcare professionals can help reduce psychological stress in cancer patients by improving how healthcare providers communicate and support them. This suggests that similar training sessions could be beneficial for patients directly, potentially helping them manage stress better. ^{1 2 3 4 5}

Is communication skills training safe for humans?

The research does not provide specific safety data for communication skills training, but it is generally considered safe as it involves learning and practicing communication techniques. ^{1 2 3 6 7}

How does the Stress and Communication Skills Training treatment for cancer differ from other treatments?

This treatment is unique because it combines stress management with communication skills training, focusing on improving psychological well-being and communication between patients and healthcare professionals, which is not typically addressed by standard cancer treatments that focus more on physical symptoms. ^{2 3 8 9 10}

What is the purpose of this trial?

This study will test an intervention to improve patients' and their caregivers' ability to manage difficult emotions and communicate about the patient's illness. There will be two versions of the intervention used for this study: a culturally tailored version for Latinx participants refined during Phase 1 of this study, and a version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. We will use the culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants. This culturally sensitive intervention has the potential to reduce Latino/a patient and caregiver distress and improve patient and caregiver quality of life, shared understanding of the patient's illness, and patients' and caregivers' ability to discuss, identify, and document patients' treatment preferences. The intervention is designed to minimize burden to patients, caregivers, and healthcare institutions to allow for easy integration into clinical practice.

Research Team

Kelly Trevino, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for Latino/a patients with advanced cancer and their caregivers, who are fluent in English or Spanish, reside in New York, and can communicate by phone. Patients must have discussed prognosis with their oncologist and not be receiving hospice care. Caregivers need to provide support without pay and have experience working with advanced cancer patients.

Inclusion Criteria

Has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) who is willing and able to participate in the study

For Patients:

Self-identifies as Latino/a

Exclusion Criteria

As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder

For Patients

Both dyad members respond "b" or "d" on the item in Appendix K, "How would you describe your/the patient"s health status: a) Relatively healthy, b) Relatively healthy and terminally ill, c) Seriously ill but not terminally ill, or d) Seriously and terminally ill" and respond "months" on the item "When you think about your/the patient's life expectancy, do you think in terms of months or years."

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants and their caregivers receive a culturally tailored or non-tailored intervention to improve communication and manage emotions related to cancer

8 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants and caregivers are monitored for improvements in communication and emotional management

4 weeks

Treatment Details

Interventions

• Weekly 45 minute Sessions

Trial Overview The study tests a stress management and communication skills intervention tailored for Latinx individuals versus a non-tailored version. Participants will attend weekly 45-minute sessions designed to improve emotional handling, quality of life, understanding of illness, and treatment preferences discussions.

Participant Groups

Group I: Patients Experimental Treatment 1 Intervention

Latino/a advanced cancer patients

Group II: Caregivers Experimental Treatment 1 Intervention

Caregivers of Latino/a advanced cancer patients

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a 12-week study involving 80 cancer patients, relaxation training did not show significant differences in anxiety, depression, or psychiatric morbidity compared to a control group at the start, but both groups reported increased symptoms over time, especially in women.

Female patients in the control group consistently reported higher levels of anxiety and depression at 6 and 12 weeks, indicating that relaxation training may not have effectively mitigated emotional distress in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled study of relaxation training. Bindemann, S., Soukop, M., Kaye, SB.[2019]

The SMART (Stress Management and Resiliency Training) program significantly improved resilience, reduced perceived stress and anxiety, and enhanced quality of life in 25 women with breast cancer over a 12-week period, compared to a control group.

The intervention, which included group training sessions and follow-up calls, was found to be feasible and effective, indicating that brief resilience training can be beneficial for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Loprinzi, CE., Prasad, K., Schroeder, DR., et al.[2022]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of communication skills training on nurses' detection of patients' distress and related factors after cancer diagnosis: a randomized study. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Communication skills training for healthcare professionals working with people who have cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Communication skills training for healthcare professionals working with people who have cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of a 105 hours psychological training program on attitudes, communication skills and occupational stress in oncology: a randomised study. [2022]

5. Scotland pubmed.ncbi.nlm.nih.gov

Communication skills of health-care professionals working in oncology--can they be improved? [2019]

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

The state of the science for communication training in pediatric oncology: A systematic review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effective communication skills are the key to good cancer care. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Randomised controlled study of relaxation training. [2019]

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

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. [2022]

10. 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]