Non-Small Cell Lung CarcinomaNCT03731585
Online Psychosocial Intervention in Improving Social Well-Being and Support in Women With Stage I-IV Non-small Cell Lung Cancer Undergoing Treatment
A study testing Behavioral Intervention, Educational Intervention and Questionnaire Administration in people with Non-Small Cell Lung Carcinoma and Stage I Lung Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non-Small Cell Lung Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8
- What is being tested?
- Behavioral Intervention, Educational Intervention and Questionnaire Administration
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the feasibility (primary outcome) of the BREATHE intervention in women with lung cancer (LC).
SECONDARY OBJECTIVES:
- Establish the initial intervention efficacy regarding psychological distress (secondary outcome) and cancer symptoms (tertiary outcome) relative to an education comparison (EC) group.
EXPLORATORY OBJECTIVES:
- 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.
- Conditions
- Non-Small Cell Lung Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8
- Being tested
- Behavioral Intervention, Educational Intervention, Questionnaire Administration, Support Group Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in psychological sessions
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Participate in educational sessions
Questionnaire AdministrationOther
Ancillary studies
Support Group TherapyProcedure or surgery
Participate in group sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Intervention; Other: Questionnaire Administration; Procedure: Support Group Therapy |
| 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. Receives: Other: Educational Intervention; Other: Questionnaire Administration; Procedure: Support Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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;
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Secondary outcomes (2)
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).
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start15 Nov 2018
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731585
- Sponsor's protocol ID
- 2018-0501
- Other IDs
- NCI-2018-02113, 2018-0501
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2018
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34663123