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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02113 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0501 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (psychological intervention) | Experimental | 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. |
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| Group II (educational intervention) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Participate in psychological sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| BREATHE intervention in women with Lung Cancer determined successful by overall accrual | Overall accrual assessed by ≥ 50% of eligible patients consent (i.e., approach 140 to achieve 70 that consent). | Up to 3 months |
| BREATHE intervention in women with Lung Cancer determined successful by attrition | Attrition assessed by ≥ 71% of enrolled patients (≥ 50 patients) complete T1 and T2 assessments; | Up to 3 months |
| BREATHE intervention in women with Lung Cancer determined successful by adherence | Adherence assessed by ≥ 75% of all practice sessions are attended in each arm. | Up to 3 months |
| BREATHE intervention in women with Lung Cancer determined successful by acceptability | Acceptability assessed by ≥ 75% of participants indicating that the program is useful and enjoyable in each arm. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy regarding psychological distress: CES-D | The study will examine preliminary evidence of intervention efficacy. Will calculate effect sizes for between-group comparisons based on the primary efficacy endpoint of Center for Epidemiologic Studies Depression Scale (CES-D), a 20-item self-report measure focusing on the affective component of depression. Answers range from: almost never (less than 1 day), sometimes (1 to 2 days), often (3 to 4 days), almost always (5 to 7 days). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathrin Milbury | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34663123 | Derived | Milbury K, Kroll J, Chen A, Antonoff MB, Snyder S, Higgins H, Yang CC, Li Y, Bruera E. Pilot Randomized Controlled Trial in Women With Non-Small Cell Lung Cancer to Assess the Feasibility of Delivering Group-Based Psychosocial Care via Videoconference. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211052520. doi: 10.1177/15347354211052520. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Educational Intervention | Other | Participate in educational sessions |
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| Questionnaire Administration | Other | Ancillary studies |
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| Support Group Therapy | Procedure | Participate in group sessions |
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| Up to 3 months |
| Efficacy regarding cancer symptoms: IES | The study will examine preliminary evidence of intervention efficacy. Will calculate effect sizes for between-group comparisons based on the primary efficacy endpoint of Impact of Event Scale (IES) measured at T2 using analysis of covariance (ANCOVA). IES scale answers range from NOT AT ALL, RARELY, SOMETIMES, OFTEN. | Up to 3 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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