Breast CancerNCT02148575
Integrating Palliative Care Into Self-Management of Breast Cancer
A study testing Self-Management Group and Symptom Management Group in people with Breast Cancer, run by Yale University at 2 sites in United States.
Trial summary
The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Self-Management Group and Symptom Management Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Jan 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
- Over the age of 21
- Stage I-IV breast cancer
- Live in the State of Connecticut
- Speak English
- Receiving any kind of treatment for breast cancer
- Prognosis of at least 6 months
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Yale School of Nursing
West Haven, Connecticut, 06516
About this study
The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.
- Conditions
- Breast Cancer
- Being tested
- Self-Management Group, Symptom Management Group
- Keywords
- Palliative Care, Self-management, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management GroupBehavioural
Symptom Management GroupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Self-Management Group | Experimental | Managing Cancer Care: A Personal Guide (MCC) is a set of magazine-format, printed modules that includes information about key self-management topics, worksheets, "conversation starters", and targeted links to local and internet resources, among other features. Receives: Behavioral: Self-Management Group |
| Symptom Management Group | Active comparator | Participants in the Symptom Management Group will be given a symptom management toolkit that provides information on the most commonly experienced symptoms and side effects of cancer treatment, including fatigue, nausea, and sleep problems, among others. Each chapter includes information on when and why the symptom may occur, how the symptom can be managed, and when to call a provider. Receives: Behavioral: Symptom Management Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Care Options Test
Measured: 1 month
Knowledge of Care Options Test
Measured: 3 months
Knowledge of Care Options Test
Measured: baseline
Secondary outcomes (22)
Control Preferences Scale
Measured: 1 month
Medical Communication Competence Scale
Measured: 1 month
Measurement of Transitions Scale
Measured: 1 month
Chronic Disease Self-Efficacy Scale
Measured: 1 month
Hospital Anxiety and Depression Scale
Measured: 1 month
Uncertainty in Illness Scale
Measured: 1 month
Health Care Utilization Form
Measured: 3 months
Goals of Care Conversations Form
Measured: 1 month
Control Preferences Scale
Measured: 3 months
Medical Communication Competence Scale
Measured: 3 months
Measurement of Transitions Scale
Measured: 3 months
Chronic Disease Self-Efficacy Scale
Measured: 3 months
Hospital Anxiety and Depression Scale
Measured: 3 months
Uncertainty in Illness Scale
Measured: 3 months
Goals of Care Conversations Form
Measured: 3 months
Control Preferences Scale
Measured: baseline
Medical Communication Competence Scale
Measured: baseline
Measurement of Transitions Scale
Measured: baseline
Chronic Disease Self-Efficacy Scale
Measured: baseline
Hospital Anxiety and Depression Scale
Measured: baseline
Uncertainty in Illness Scale
Measured: baseline
Goals of Care Conversations Form
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2016
- Study completionJan 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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Yale 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dena Schulman-Green, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148575
- Sponsor's protocol ID
- 1307012400
- Status last verified
- Jun 2016
- First submitted
- 21 May 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Schulman-Green D, Linsky S, Jeon S, Kapo J, Blatt L, Chagpar A. Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2016 May;48:133-8. doi: 10.1016/j.cct.2016.04.009. Epub 2016 Apr 20.
PubMed 27107680
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Palliative Care Into Self-Management of Breast Cancer
- ClinicalTrials.gov ID
- NCT02148575
- Acronym / sponsor ID
- 1307012400
- Conditions
- Breast Cancer
- Keywords
- Palliative Care, Self-management, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 May 2014 (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 study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Management Group | Experimental | Behavioral: Self-Management GroupManaging Cancer Care: A Personal Guide (MCC) is a set of magazine-format, printed modules that includes information about key self-management topics, worksheets, "conversation starters", and targeted links to local and internet resources, among other features. |
| Symptom Management Group | Active comparator | Behavioral: Symptom Management GroupParticipants in the Symptom Management Group will be given a symptom management toolkit that provides information on the most commonly experienced symptoms and side effects of cancer treatment, including fatigue, nausea, and sleep problems, among others. Each chapter includes information on when and why the symptom may occur, how the symptom can be managed, and when to call a provider. |
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)
- Over the age of 21
- Stage I-IV breast cancer
- Live in the State of Connecticut
- Speak English
- Receiving any kind of treatment for breast cancer
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Self-Management Group | Behavioural | Self-Management Group |
| Symptom Management Group | Behavioural | Symptom Management Group |
Primary outcome
Knowledge of Care Options Test
Time frame: 1 month
Knowledge of Care Options Test
Time frame: 3 months
Knowledge of Care Options Test
Time frame: baseline
22 secondary outcomes
Control Preferences Scale
Time frame: 1 month
Medical Communication Competence Scale
Time frame: 1 month
Measurement of Transitions Scale
Time frame: 1 month
Chronic Disease Self-Efficacy Scale
Time frame: 1 month
Hospital Anxiety and Depression Scale
Time frame: 1 month
Uncertainty in Illness Scale
Time frame: 1 month
Health Care Utilization Form
Time frame: 3 months
Goals of Care Conversations Form
Time frame: 1 month
Control Preferences Scale
Time frame: 3 months
Medical Communication Competence Scale
Time frame: 3 months
Measurement of Transitions Scale
Time frame: 3 months
Chronic Disease Self-Efficacy Scale
Time frame: 3 months
Hospital Anxiety and Depression Scale
Time frame: 3 months
Uncertainty in Illness Scale
Time frame: 3 months
Goals of Care Conversations Form
Time frame: 3 months
Control Preferences Scale
Time frame: baseline
Medical Communication Competence Scale
Time frame: baseline
Measurement of Transitions Scale
Time frame: baseline
Chronic Disease Self-Efficacy Scale
Time frame: baseline
Hospital Anxiety and Depression Scale
Time frame: baseline
Uncertainty in Illness Scale
Time frame: baseline
Goals of Care Conversations Form
Time frame: baseline
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 26 Apr 2017.
- Derived from this study: PubMed 27107680Schulman-Green D, Linsky S, Jeon S, Kapo J, Blatt L, Chagpar A. Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2016 May;48:133-8. doi: 10.1016/j.cct.2016.04.009. Epub 2016 Apr 20.
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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.
Dena Schulman-Green, PhD principal investigator
Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Group and Symptom Management Group in people with Breast Cancer, run by Yale University at 2 sites 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 0 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 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Knowledge of Care Options Test (time frame: 1 month). The study lists 3 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 NCT02148575, 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 26 Apr 2017.