치료 중인 I-IV기 비소세포폐암 여성의 사회적 웰빙 개선 및 지원을 위한 온라인 심리사회적 개입
치료를 받고 있는 폐암 여성을 위한 온라인 심리사회적 개입
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group I (psychological intervention)
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. |
Ancillary studies Participate in psychological sessions
다른 이름들:
Participate in group sessions |
|
실험적: Group II (educational intervention)
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. |
Ancillary studies Participate in group sessions Participate in educational sessions
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
BREATHE intervention in women with Lung Cancer determined successful by overall accrual
기간: Up to 3 months
|
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
기간: Up to 3 months
|
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
기간: Up to 3 months
|
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
기간: Up to 3 months
|
Acceptability assessed by ≥ 75% of participants indicating that the program is useful and enjoyable in each arm. |
Up to 3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Efficacy regarding psychological distress: CES-D
기간: Up to 3 months
|
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). |
Up to 3 months
|
|
Efficacy regarding cancer symptoms: IES
기간: Up to 3 months
|
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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Kathrin Milbury, M.D. Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2018-0501
- 2018-0501 (기타 식별자: M D Anderson Cancer Center)
- NCI-2018-02113 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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