Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:November 15, 2018
End Date:September 30, 2020
Contact:Kathrin Milbury
Email:kmilbury@mdanderson.org
Phone:713-745-2868

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Online Psychosocial Intervention for Women With Lung Cancer Undergoing Treatment

This trial studies how well online psychosocial intervention works in improving social
well-being and support in women who are undergoing treatment for stage I-IV non-small cell
lung cancer. Psychosocial intervention techniques, such as mindfulness, compassion, and
emotional processing, may improve distress and help patients manage symptoms related to
non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. Examine the feasibility (primary outcome) of the BREATHE intervention in women with lung
cancer (LC).

SECONDARY OBJECTIVES:

I. Establish the initial intervention efficacy regarding psychological distress (secondary
outcome) and cancer symptoms (tertiary outcome) relative to an education comparison (EC)
group.

EXPLORATORY OBJECTIVES:

I. Explore potential mediation (e.g., mindfulness, compassion, inflammatory processes) and
moderation (e.g., demographic and medical factors) of the intervention effects.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (PSYCHOLOGICAL): Patients participate in 5 psychological sessions and complete
training on mindfulness, compassion, emotional processing, social support, generating
positive emotions, and proactive coping strategies once a week for up to 5 weeks. Patients
also complete questionnaires over 35 minutes and participate in video-based group sessions
weekly for 5 weeks.

GROUP II (EDUCATIONAL): Patients participate in 5 information sessions and receive education
on lung cancer, symptom management, communication, and practicing self-care once a week for
up to 5 weeks. Patients also complete questionnaires and participate in group sessions as in
group I.

After completion of study intervention, patients are followed up at 1 week and at 3 months.

Inclusion Criteria:

- Women diagnosed with stage I-IV non-small cell lung cancer within 3 months of
diagnosis at the time of recruitment and receiving any type of treatment at the time
of recruitment. For women with metastatic disease, disease must be stable (without
disease progression based on patients' latest imaging impressions) per treating
oncologist

- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Have access to the internet

- Able to read, write and speak English

Exclusion Criteria:

- Major psychiatric or cognitive deficits that would impede the completion of
self-report instruments as deemed by the clinical team

- Regular (self-defined) participation in psychotherapy or a formal cancer support group
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Kathrin Milbury
Phone: 713-745-2868
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mi
from
Houston, TX
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