Advanced Breast Cancer Stage IVNCT01927081
Self-management Interventions for Advanced Breast Cancer
A study testing discussion group and gentle exercise in people with Advanced Breast Cancer Stage IV, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer Stage IV
- What is being tested?
- discussion group and gentle exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 20 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27708
About this study
Official title: Self-management Interventions for Pain in Advanced Breast Cancer
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.
- Conditions
- Advanced Breast Cancer Stage IV
- Being tested
- discussion group, gentle exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discussion groupBehavioural
Participants engage in discussions regarding issues related to coping with advanced cancer and pain
gentle exerciseBehavioural
Patients learn gentle exercise and breathing techniques
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: discussion group; Behavioral: gentle exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Acceptability
Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview
Measured: 36 months
Secondary outcomes (5)
Change in pain
pain intensity as assessed by the Brief Pain Inventory
Measured: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in fatigue
Fatigue as assessed by the Brief Fatigue Inventory
Measured: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in sleep disturbance
Sleep disturbance as assessed by the Pittsburgh Sleep Quality Index
Measured: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in Psychological distress
Anxiety and depression assessed using the Hospital Anxiety and Depression Scale
Measured: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in functional capacity
Functional capacity assessed using a 6-minute walk test
Measured: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startSep 2014
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Laura Porter, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927081
- Sponsor's protocol ID
- Pro00044446
- Status last verified
- Oct 2018
- First submitted
- 16 Aug 2013
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28288595
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management Interventions for Pain in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01927081
- Acronym / sponsor ID
- Pro00044446
- Conditions
- Advanced Breast Cancer Stage IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2014
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 22 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| discussion group | Active comparator | Behavioral: discussion groupEight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain |
| discussion group + exercise | Active comparator | Behavioral: discussion group, Behavioral: gentle exerciseEight 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| discussion groupParticipants engage in discussions regarding issues related to coping with advanced cancer and pain | Behavioural | discussion group, discussion group + exercise |
| gentle exercisePatients learn gentle exercise and breathing techniques | Behavioural | discussion group + exercise |
Primary outcome
Feasibility
Time frame: 36 months
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
Acceptability
Time frame: 36 months
Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview
5 secondary outcomes
Change in pain
Time frame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in fatigue
Time frame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in sleep disturbance
Time frame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in Psychological distress
Time frame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Change in functional capacity
Time frame: study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 28288595Carson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Porter, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing discussion group and gentle exercise in people with Advanced Breast Cancer Stage IV, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01927081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.