NCT02429544

Brief Summary

The goal of this behavioral research study is to compare 2 different types of residential group programs to help researchers learn if and how well these groups may help to improve physical and emotional well-being in patients with stage IV breast cancer.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

April 21, 2015

Last Update Submit

July 29, 2016

Conditions

Breast Cancer

Keywords

Breast cancerStage IV breast cancerMetastaticResidential group programsQuestionnairesSurveysEEGComputer testingSaliva testStudy diaryActigraph

Outcome Measures

Primary Outcomes (1)

  • Compliance in Residential Retreat Program

    Participant compliance with assessments monitored as well as participation in all aspects of the intervention program. Intervention deemed feasible if ≥ 60% of enrolled couples complete all assessments and attend the assigned retreat.

    3 months

Study Arms (3)

Experimental Support Group (ESG) - Residential Program

EXPERIMENTAL

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver. Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits. Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Behavioral: Residential ProgramBehavioral: QuestionnairesDevice: Electroencephalogram (EEG)Other: Saliva TestingBehavioral: Study Diary plus Actigraph

Standard Support Group (SSG) - Residential Program

EXPERIMENTAL

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver. Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits. Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Behavioral: Residential ProgramBehavioral: QuestionnairesDevice: Electroencephalogram (EEG)Other: Saliva TestingBehavioral: Study Diary plus Actigraph

Standard of Care Group (SOC) - No Residential Program

OTHER

Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits. Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Behavioral: QuestionnairesDevice: Electroencephalogram (EEG)Other: Saliva TestingBehavioral: Study Diary plus Actigraph

Interventions

Residential ProgramBEHAVIORAL

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.

Also known as: Retreat
Experimental Support Group (ESG) - Residential ProgramStandard Support Group (SSG) - Residential Program
QuestionnairesBEHAVIORAL

Questionnaires completed about mood, sleep, fatigue, how participant has been feeling, and their general quality of life at baseline visit, 1 month after baseline, 7 days after residential program ends, and again about 3 months later.

Also known as: Survey
Experimental Support Group (ESG) - Residential ProgramStandard Support Group (SSG) - Residential ProgramStandard of Care Group (SOC) - No Residential Program
Electroencephalogram (EEG)DEVICE

EEG performed at baseline with simultaneous computer testing consisting of 3 tests to check attention, short-term memory, and levels of emotions. EEG repeated 7 days after the residential program ends, and then again about 3 months later.

Experimental Support Group (ESG) - Residential ProgramStandard Support Group (SSG) - Residential ProgramStandard of Care Group (SOC) - No Residential Program
Saliva TestingOTHER

Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. Saliva testing repeated 7 days after the residential program ends, and then again about 3 months later.

Experimental Support Group (ESG) - Residential ProgramStandard Support Group (SSG) - Residential ProgramStandard of Care Group (SOC) - No Residential Program
Study Diary plus ActigraphBEHAVIORAL

For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Experimental Support Group (ESG) - Residential ProgramStandard Support Group (SSG) - Residential ProgramStandard of Care Group (SOC) - No Residential Program

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 50 and over initially diagnosed with breast cancer by histological tissue diagnosis in 2003 or later.
  • Currently Stage IV (metastatic) breast cancer on the basis of definitive imaging or biopsy with stable disease (scans within the past 2 months).
  • ECOG (Eastern Cooperative Group) Performance Score of 0 or 1.
  • Able to participate occasionally in mildly strenuous physical effort.
  • Able to read, speak, and write in English or ability to provide consent or understand questionnaires.
  • Able to be accompanied by their spouse or significant other partner/friend (spouse, significant other, partner, or friend.
  • Able to travel to the retreat site.
  • Must be right handed.
  • Patients must have had a contrast-enhanced computerized tomographic (CT) scan of the chest and abdomen within 2 months of study entry and be willing to have a follow up scan within 2 months of the completion of the retreat.
  • (CAREGIVERS ONLY) Must be primary caregiver of the patient.
  • (CAREGIVERS ONLY) Able to read, speak, and write in English.
  • (CAREGIVERS ONLY) Able to attend the last two days of the retreat with patient.

You may not qualify if:

  • Significant co-morbidities (e.g., diabetes, cardiac disease, or other condition that in the opinion of the primary physician or investigators would limit participation in the intervention groups) that would preclude study participation.
  • Evidence of disease progression that would necessitate a treatment in the next 2 weeks.
  • Need for intravenous therapy more frequently than every 3 weeks or inability to time intravenous therapy treatment before and after the study.
  • Currently in treatment for a major psychiatric disorder
  • Clinical history of severe psychiatric disorders.
  • Currently receiving chemotherapy.
  • (CAREGIVERS ONLY) Must be an adult (\>=18 years old).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Surveys and QuestionnairesElectroencephalography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthDiagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Lorenzo Cohen, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 29, 2015

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Last Updated

August 1, 2016

Record last verified: 2016-07