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Breast CancerACTSNCT01184066

The Attitudes, Communication, Treatment and Support Intervention to Reduce Breast Cancer Treatment Disparity

A study testing ACTS Intervention in people with Breast Cancer, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
ACTS Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
2 sitesUnited States
Study dates
Jan 2010to Dec 2015
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Impaired cognition, as determined by a score of less than 22 on the Mini Mental Status Exam
  • An inability to understand English

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • West Penn Allegheny Health System

    Pittsburgh, Pennsylvania, 15224

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
ACTS Intervention, Usual Care
Keywords
Chemotherapy, Patient Adherence, African Americans, Cancer Survivor, Decision Making, Communication, Quality of Life, Social Support, Patient Education
Medical subject headings
Breast Neoplasms, Patient Compliance, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTS InterventionBehavioural

    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.

  • Usual CareBehavioural

    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.

Study groups in NCT01184066
Study groupRoleWhat they receive
ACTS InterventionExperimentalThe 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
Receives: Behavioral: ACTS Intervention
Usual CareActive comparatorThis group receives care as usual.
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to recommended breast cancer chemotherapy at the treatment midpoint.

    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.

    Measured: Midpoint of the recommented chemotherapy treatment regimen.

  2. Adherence to recommended breast cancer chemotherapy at the treatment endpoint.

    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.

    Measured: Endpoint of the recommented chemotherapy treatment regimen.

Secondary outcomes (5)

  1. Social Support ISEL-12

    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

    Measured: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

  2. Symptom Incidence

    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.

    Measured: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

  3. Symptom Distress

    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.

    Measured: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

  4. Communication of Symptoms. The Symptom Severity and Symptoms Reporting Checklist

    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.

    Measured: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

  5. Quality of Life-FACT Functional Assessment of Cancer Therapy

    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)

    Measured: baseline (0 weeks), midpoint (6 or 12 weeks), and endpoint (12 or 24 weeks) of recommended chemotherapy regimen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01184066
Sponsor's protocol ID
706367
Other IDs
RSGT-09-150-01 CPHPS
Acronym
ACTS
Status last verified
Aug 2018
First submitted
11 Aug 2010
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Overall study results will be published. Individual participant data will not be made available due to privacy issues.

Questions about this trial

What is this clinical trial studying?

A study testing ACTS Intervention in people with Breast Cancer, run by University of Pittsburgh 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 5 inclusion and 2 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 31 Aug 2018. 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?

Adherence to recommended breast cancer chemotherapy at the treatment midpoint. (time frame: Midpoint of the recommented chemotherapy treatment regimen.). 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 NCT01184066.

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 31 Aug 2018.

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