Breast CarcinomaNCT04022772
Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer
A study testing Best Practice, Medical Chart Review and Quality-of-Life Assessment in people with Breast Carcinoma and Breast Ductal Carcinoma In Situ, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
- What is being tested?
- Best Practice, Medical Chart Review and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2019to 27 Jul 2023
- 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
- Age 18 years and older
- Able to read, speak and consent in English.
- Individuals with a diagnosis of:
- First time diagnosis of invasive breast cancer,
- Ductal carcinoma in situ (DCIS),
- Recurrent breast cancer off all therapy prior to recurrence
- Currently starting or undergoing active treatment
- Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.
Who cannot join
- Male patients (due to the small number of male breast cancer patients treated annually).
- Individuals for whom there is documentation of inability to provide consent in the medical record.
- Patients who were previously enrolled on protocol 2016-0761.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Cohort Study of the Effect of an eHealth Support Program on Patient Reported Outcomes of Women With Breast Cancer
This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving chemotherapy. Participating in the PACK Health coaching program may improve quality of life, decrease hospital admissions and improve overall health.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the effect of an eHealth coaching program on the self-reported global health of women with breast cancer, as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale version (v.) 1.2.
SECONDARY OBJECTIVES:
- To evaluate the effect of an eHealth coaching program on the symptom experience of women with breast cancer as measured by the MD Anderson Symptom Inventory-Breast (MDASI-Br).
II. To evaluate the effect of an eHealth coaching program on physical and mental health of women diagnosed with breast cancer as measured by the subscales of the PROMIS Global Health Scale v 1.2.
III. To evaluate the effect of an eHealth coaching program on the symptom experience and global health outcomes of women by:
IIIa. Disease stage. IIIb. Active treatment type (i.e. surgery, radiation, chemotherapy, hormonal therapy, immunotherapy or a combination of these methodologies).
IIIc. Time since diagnosis. IV. To evaluate the effect of an eHealth coaching program on the frequency of emergency room visits and hospital admissions for patients receiving treatment in the ambulatory setting.
- To evaluate the relationship between financial toxicity, as measured by the Consumer Score for Financial Toxicity (COST), and quality of life, as measured by the Functional Assessment of Quality of Life-Breast (FACT-B).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients participate in PACK Health program consisting of weekly contact with an assigned health coach via text message, phone call, and email for 3 months. After 3 months, patients continue to be contacted by the health coach at least once monthly for an additional 3 months.
GROUP II: Patients receive standard of care support services over 6 months.
- Conditions
- Breast Carcinoma, Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Recurrent Breast Carcinoma
- Being tested
- Best Practice, Medical Chart Review, Quality-of-Life Assessment, Questionnaire Administration, Supportive Care
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Participate in PACK Health program
| Study group | Role | What they receive |
|---|---|---|
| GROUP I (PACK Health program) | Experimental | Patients participate in PACK Health program consisting of weekly contact with an assigned health coach via text message, phone call, and email for 3 months. After 3 months, patients continue to be contacted by the health coach at least once monthly for an additional 3 months. Receives: Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Supportive Care |
| GROUP II (standard of care) | Active comparator | Patients receive standard of care support services over 6 months. Receives: Other: Best Practice; Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcomes on global physical and mental health
Measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale version (v.)1.2. PROMIS v1.2 raw scores will be converted to PROMIS v1.2 t-scores prior to any analyses. Because t scores can only be calculated if a participant answers all 10 items, multiple imputation techniques will be used to estimate the values for missing items. Prior to conducting multiple imputation, the data will first be examined to determine whether missing data are missing completely at random (MCAR), missing at random (MAR) or missing not at random (MNAR). Models will be created separately for physical and mental health. Testing will be 2-sided and conducted with a 0.05 level of statistical significance yielding a family wise Type I error rate of 0.10.
Measured: Up to 6 months
Secondary outcomes (1)
Rate of emergency room visits and hospital admissions
A generalized linear mixed model using a log link function will be used to model the rate of emergency room visits and hospital admissions by intervention and time. The number of emergency room visits and hospital admissions will be recorded for each subject from day 1 through day 180 and summarized to correspond to inventory assessment periods.
Measured: From day 1 to day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start31 Jul 2019
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eileen Hacker, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022772
- Sponsor's protocol ID
- 2018-0473
- Other IDs
- NCI-2019-03897, 2018-0473
- Status last verified
- Aug 2023
- First submitted
- 15 Jul 2019
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Whisenant M, Williams LA, Dains JE, Brassil KJ, Fellman B, Urbauer DL, Isaac T, Shelton V, Burton BS, Hacker E. The Effect of a Digital Health Coaching Program on Patient-Reported and Healthcare Utilization Outcomes of Women With Breast Cancer. Oncol Nurs Forum. 2026 Jan 5;53(1):1-14. doi: 10.1188/26.ONF.e26535242.
PubMed 41586740
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Cohort Study of the Effect of an eHealth Support Program on Patient Reported Outcomes of Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04022772
- Acronym / sponsor ID
- 2018-0473
- Conditions
- Breast Carcinoma, Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Recurrent Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 17 Jul 2019 (actual)
- 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.
This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving chemotherapy. Participating in the PACK Health coaching program may improve quality of life, decrease hospital admissions and improve overall health.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the effect of an eHealth coaching program on the self-reported global health of women with breast cancer, as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale version (v.) 1.2.
SECONDARY OBJECTIVES:
- To evaluate the effect of an eHealth coaching program on the symptom experience of women with breast cancer as measured by the MD Anderson Symptom Inventory-Breast (MDASI-Br).
II. To evaluate the effect of an eHealth coaching program on physical and mental health of women diagnosed with breast cancer as measured by the subscales of the PROMIS Global Health Scale v 1.2.
III. To evaluate the effect of an eHealth coaching program on the symptom experience and global health outcomes of women by:
IIIa. Disease stage. IIIb. Active treatment type (i.e. surgery, radiation, chemotherapy, hormonal therapy, immunotherapy or a combination of these methodologies).
IIIc. Time since diagnosis. IV. To evaluate the effect of an eHealth coaching program on the frequency of emergency room visits and hospital admissions for patients receiving treatment in the ambulatory setting.
- To evaluate the relationship between financial toxicity, as measured by the Consumer Score for Financial Toxicity (COST), and quality of life, as measured by the Functional Assessment of Quality of Life-Breast (FACT-B).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients participate in PACK Health program consisting of weekly contact with an assigned health coach via text message, phone call, and email for 3 months. After 3 months, patients continue to be contacted by the health coach at least once monthly for an additional 3 months.
GROUP II: Patients receive standard of care support services over 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP I (PACK Health program) | Experimental | Other: Medical Chart Review, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Supportive CarePatients participate in PACK Health program consisting of weekly contact with an assigned health coach via text message, phone call, and email for 3 months. After 3 months, patients continue to be contacted by the health coach at least once monthly for an additional 3 months. |
| GROUP II (standard of care) | Active comparator | Other: Best Practice, Other: Medical Chart Review, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive standard of care support services over 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years and older
- Able to read, speak and consent in English.
- Individuals with a diagnosis of:
- Currently starting or undergoing active treatment
- Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.
Key exclusion criteria (3 listed)
- Male patients (due to the small number of male breast cancer patients treated annually).
- Individuals for whom there is documentation of inability to provide consent in the medical record.
- Patients who were previously enrolled on protocol 2016-0761.
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | GROUP II (standard of care) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | GROUP I (PACK Health program), GROUP II (standard of care) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | GROUP I (PACK Health program), GROUP II (standard of care) |
| Questionnaire AdministrationAncillary studies | Other | GROUP I (PACK Health program), GROUP II (standard of care) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveParticipate in PACK Health program | Procedure or surgery | GROUP I (PACK Health program) |
Primary outcome
Patient reported outcomes on global physical and mental health
Time frame: Up to 6 months
Measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale version (v.)1.2. PROMIS v1.2 raw scores will be converted to PROMIS v1.2 t-scores prior to any analyses. Because t scores can only be calculated if a participant answers all 10 items, multiple imputation techniques will be used to estimate the values for missing items. Prior to conducting multiple imputation, the data will first be examined to determine whether missing data are missing completely at random (MCAR), missing at random (MAR) or missing not at random (MNAR). Models will be created separately for physical and mental health. Testing will be 2-sided and conducted with a 0.05 level of statistical significance yielding a family wise Type I error rate of 0.10.
1 secondary outcome
Rate of emergency room visits and hospital admissions
Time frame: From day 1 to day 180
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 7 Aug 2023.
- Derived from this study: PubMed 41586740Whisenant M, Williams LA, Dains JE, Brassil KJ, Fellman B, Urbauer DL, Isaac T, Shelton V, Burton BS, Hacker E. The Effect of a Digital Health Coaching Program on Patient-Reported and Healthcare Utilization Outcomes of Women With Breast Cancer. Oncol Nurs Forum. 2026 Jan 5;53(1):1-14. doi: 10.1188/26.ONF.e26535242.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Eileen Hacker, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Medical Chart Review and Quality-of-Life Assessment in people with Breast Carcinoma and Breast Ductal Carcinoma In Situ, run by M.D. Anderson Cancer Center 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 8 inclusion and 3 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 7 Aug 2023. 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?
Patient reported outcomes on global physical and mental health (time frame: Up to 6 months). 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 NCT04022772, 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 7 Aug 2023.