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Self-management Interventions for Advanced Breast Cancer

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Duke University

Status

Completed

Conditions

Advanced Breast Cancer Stage IV

Treatments

Behavioral: discussion group
Behavioral: gentle exercise

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01927081
Pro00044446

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

65 participants in 2 patient groups

discussion group
Active Comparator group
Description:
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain
Treatment:
Behavioral: discussion group
discussion group + exercise
Active Comparator group
Description:
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
Treatment:
Behavioral: discussion group
Behavioral: gentle exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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