Self-management Interventions for Advanced Breast Cancer

NCT ID: NCT01927081

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-11-20

Brief Summary

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The purpose of this research study is to evaluate whether self-management discussion groups are helpful for women with advanced breast cancer who are experiencing pain. The study is looking at the usefulness of two different types of discussion groups, one of which also includes gentle exercise.

Detailed Description

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Conditions

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Advanced Breast Cancer Stage IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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discussion group

Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain

Group Type ACTIVE_COMPARATOR

discussion group

Intervention Type BEHAVIORAL

Participants engage in discussions regarding issues related to coping with advanced cancer and pain

discussion group + exercise

Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain and learn gentle exercise and breathing techniques

Group Type ACTIVE_COMPARATOR

discussion group

Intervention Type BEHAVIORAL

Participants engage in discussions regarding issues related to coping with advanced cancer and pain

gentle exercise

Intervention Type BEHAVIORAL

Patients learn gentle exercise and breathing techniques

Interventions

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discussion group

Participants engage in discussions regarding issues related to coping with advanced cancer and pain

Intervention Type BEHAVIORAL

gentle exercise

Patients learn gentle exercise and breathing techniques

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Stage IV breast cancer or recurrent metatastic breast cancer
* receiving care at Duke Cancer Institute,
* life expectancy ≥9 months as estimated by the treating oncologist,
* speak and read English,
* be at least age 18
* be able to travel to the Duke Cancer Institute

Exclusion Criteria

* cognitive impairment as assessed by the 6-item Mini-mental Status Exam,
* Karnofsky Performance Rating of \<60 as rated by the oncology provider, an ECOG rating of 0-2
* treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 months,
* currently engaged in yoga practice ≥ 1 day per week
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Porter, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Carson JW, Carson KM, Olsen MK, Sanders L, Porter LS. Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial. BMC Complement Altern Med. 2017 Mar 13;17(1):153. doi: 10.1186/s12906-017-1672-9.

Reference Type DERIVED
PMID: 28288595 (View on PubMed)

Other Identifiers

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Pro00044446

Identifier Type: -

Identifier Source: org_study_id

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