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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Kathrin Milbury
Phone: 713-745-2868

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Supportive care

Lead Organization

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Kathrin Milbury

Trial IDs

Primary ID 2018-0501
Secondary IDs NCI-2018-02113
Clinicaltrials.gov ID NCT03731585