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Effects of a Group Residential Retreat on Cancer Outcomes

NCT02429544 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-08-01

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Residential Program

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

BEHAVIORAL

Questionnaires

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.

DEVICE

Electroencephalogram (EEG)

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.

OTHER

Saliva Testing

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.

BEHAVIORAL

Study Diary plus Actigraph

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lorenzo Cohen, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429544 on ClinicalTrials.gov