- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01184066
The Attitudes, Communication, Treatment and Support Intervention to Reduce Breast Cancer Treatment Disparity (ACTS)
August 28, 2018 updated by: Margaret Quinn Rosenzweig, University of Pittsburgh
The ACTS Intervention to Reduce Breast Cancer Treatment Disparity
The ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime, intensive psycho-educational intervention using a race-matched breast cancer survivor interventionist to: address Attitudes, including perceptions and stressors, that may impact adherence to clinical visits and treatment; encourage and model patient Communication with health care providers regarding physical and emotional needs, with attention to race-discordant situations; and provide tailored, understandable information about Treatment and its rationale.
The Support component is threaded throughout the intervention via the presence of a race-matched breast cancer survivor and supportive video messages from the black community.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The 5-year survival after a first diagnosis of breast cancer is 13% lower in black than in white American women, an alarming disparity that cannot be explained by stage of disease at presentation.
Nonadherence to breast cancer treatment and treatment delays from diagnosis to initiation of treatment may be among the reasons for worse breast cancer outcomes in black women.
This recognition is critical because it suggests that breast cancer survival disparity can be decreased through clinical interventions that increase adherence to chemotherapy.
The ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime, intensive psycho-educational intervention using a race-matched breast cancer survivor interventionist to: address Attitudes, including perceptions and stressors, that may impact adherence to clinical visits and treatment; encourage and model patient Communication with health care providers regarding physical and emotional needs, with attention to race-discordant situations; and provide tailored, understandable information about Treatment and its rationale.
The Support component is threaded throughout the intervention via the presence of a race-matched breast cancer survivor and supportive video messages from the black community.
This study is a randomized controlled trial that will test the efficacy of the ACTS Intervention vs. Usual Care on the primary outcomes of adherence to recommended breast cancer chemotherapy.
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- University of Pittsburgh
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Pittsburgh, Pennsylvania, United States, 15224
- West Penn Allegheny Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- African American, as determined by patient self report on their demographic form completed at first medical oncology visit
- Female
- Age 18 or older
- Diagnosed with invasive breast cancer
- Recommended (prescribed) chemotherapy by participating medical oncologists
Exclusion Criteria:
- Impaired cognition, as determined by a score of less than 22 on the Mini Mental Status Exam
- An inability to understand English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACTS Intervention
The intervention arm are the women who received the ACTS Intervention.
It is a 45 minute intervention provided by a breast cancer survivor.
The intervention includes a discussion of the patient's attitudes towards chemotherapy, communication strategies with providers, the recommended treatment in accordance with tumor size and tumor characteristics
|
ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime intensive 45 minute intervention delivered by a black breast cancer survivor and utilizing video, graphics, teaching tools, and supportive testimony to encourage chemotherapy adherence.
|
Active Comparator: Usual Care
This group receives care as usual.
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Usual Care will consist of standard therapy education by a registered nurse in the treatment center.
Education and support from clinicians are offered as needed throughout the course of cancer treatment at all participating medical oncology clinics.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to recommended breast cancer chemotherapy at the treatment midpoint.
Time Frame: Midpoint of the recommented chemotherapy treatment regimen.
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Midpoint chemotherapy adherence was measured by recording the chemotherapy dose received/chemotherapy dose prescribed at the treatment midpoint via medical record review for each participant in both the ACTS Intervention and Usual Care groups.
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Midpoint of the recommented chemotherapy treatment regimen.
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Adherence to recommended breast cancer chemotherapy at the treatment endpoint.
Time Frame: Endpoint of the recommented chemotherapy treatment regimen.
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Endpoint chemotherapy adherence was measured by recording the chemotherapy dose received/chemotherapy dose prescribed at the treatment endpoint via medical record review for each participant in both the ACTS Intervention and Usual Care groups.
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Endpoint of the recommented chemotherapy treatment regimen.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Support ISEL-12
Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
|
Social Support will be assessed with the Interpersonal Support Evaluation List (ISEL-12), the shortened general population form.
The ISEL was designed to assess the perceived availability of four separate functions of social support as well as providing an overall support measure.
The items which comprise the ISEL fall into four 10-item subscales listed as tangible, appraisal, self esteem and belonging.
Scoring is based on a 5 point Likert scale test-retest data reveal correlations between .77-.86 Cronbach alpha = .86
|
baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
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Symptom Incidence
Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
|
Symptom Occurrence and Severity Measure: The McCorkle Symptom Distress Scale (SDS) was developed in 1977 based on interviews with patients about their symptom experiences.
Scores range from 1 to 5 on a Likert-type scale with 5 indicating most severe.157
Total symptom distress can be obtained as the unweighted sum of 13 items.
If an item is scored as 3 or above it is considered to indicate serious distress.
A cumulative score of 25 or more indicates moderate distress and any score above 33 indicates severe distress necessitating immediate intervention.149
The SDS can be administered as paper questionnaire.
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baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
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Symptom Distress
Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
|
Symptom Occurrence and Severity Measure: The McCorkle Symptom Distress Scale (SDS) was developed in 1977 based on interviews with patients about their symptom experiences.
Scores range from 1 to 5 on a Likert-type scale with 5 indicating most severe.157
Total symptom distress can be obtained as the unweighted sum of 13 items.
If an item is scored as 3 or above it is considered to indicate serious distress.
A cumulative score of 25 or more indicates moderate distress and any score above 33 indicates severe distress necessitating immediate intervention.149
The SDS can be administered as paper questionnaire.
|
baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
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Communication of Symptoms. The Symptom Severity and Symptoms Reporting Checklist
Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
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Twenty two symptoms are assessed.
If present, the patient is then asked if they reported the symptom to their doctor or nurse and if they received recommendations made by the health care team.
The psychometrics for this instrument are not established.
This instrument measures a key component of the ACTS Intervention, the ability to communicate distress to health care professionals.
Scoring is dichotomous (yes/no) for experiencing the symptom and yes/no spoke with physician or nurse about that symptom.
Total score is number of symptoms reported over number of symptoms total.
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baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
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Quality of Life-FACT Functional Assessment of Cancer Therapy
Time Frame: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
|
The Functional Assessment of Cancer Therapy is a 27- item self-report Likert scale questionnaire comprising four subscales-physical well being, social well being, functional well-being, and emotional well-being The FACT is designed to measure health-related quality of life for individuals with cancer.147
Each item is rated from on a scale of zero to four with zero equal to "not at all" and four equal to "very much."
This questionnaire requires 5-7 minutes to complete.
It has been determined appropriate for use in clinical oncology settings and shown to have good validity and reliability.148
In initial psychometric evaluation, the mean score for the FACT- G was 82.05 (SD 15.86)
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baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Margaret Q Rosenzweig, PhD,FNP-C, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
August 11, 2010
First Submitted That Met QC Criteria
August 17, 2010
First Posted (Estimate)
August 18, 2010
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 706367
- RSGT-09-150-01 CPHPS (Other Grant/Funding Number: American Cancer Society)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Overall study results will be published.
Individual participant data will not be made available due to privacy issues.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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