NCT01927081

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

August 16, 2013

Last Update Submit

October 8, 2018

Conditions

Advanced Breast Cancer Stage IV

Outcome Measures

Primary Outcomes (2)

  • Feasibility

    Feasibility will be indicated by our ability to meet accrual goals, and by at least 70% of patients attending ≥4 of 8 sessions and providing post-test assessments

    36 months

  • Acceptability

    Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview

    36 months

Secondary Outcomes (5)

  • Change in pain

    study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months

  • Change in fatigue

    study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months

  • Change in sleep disturbance

    study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months

  • Change in Psychological distress

    study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months

  • Change in functional capacity

    study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months

Study Arms (2)

discussion group

ACTIVE COMPARATOR

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

Behavioral: discussion group

discussion group + exercise

ACTIVE COMPARATOR

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

Behavioral: discussion groupBehavioral: gentle exercise

Interventions

discussion groupBEHAVIORAL

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

discussion groupdiscussion group + exercise
gentle exerciseBEHAVIORAL

Patients learn gentle exercise and breathing techniques

discussion group + exercise

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Related Publications (1)

  • 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.

    PMID: 28288595DERIVED

Study Officials

  • Laura Porter, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2013

First Posted

August 22, 2013

Study Start

September 1, 2014

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

US(1)