Breast CancerNCT03465813
Reducing Distress and Depressive-symptoms in Rural Women
A study testing CaringGuidance After Breast Cancer Diagnosis in people with Breast Cancer and Psychological Adjustment, run by University of Nebraska at 1 site in United States.
Trial summary
Approximately 30% of U.S. breast cancer survivors experience significant cancer-related distress ranging from adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. Read more about this study
- Who is it for?
- Ages 19 to 85 years, women only
- Conditions the study is for
- Breast Cancer, Psychological Adjustment
- What is being tested?
- CaringGuidance After Breast Cancer Diagnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2017to 30 May 2019
- 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 19 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- experiencing their first, stage 0 - IIIA breast cancer diagnosis (either clinical or definitive early stage at enrollment), and be 19 to 85 years of age,
- enroll < 3 months post-diagnosis (as soon as possible after diagnosis is desirable),
- reside in a non-metro county of the United States according to the USDA Rural-Urban Continuum Codes (6 -9) (RUCC) or at a rural zip-code by the USDA Rural Urban Commuting Area (RUCA) codes (4.0, 4.2, 5.0, 5.2, 6.0, 6.1, 7.0, 7.2-4, 8.0, 8.2-4, 9.0-2, 10.0, 10.2-6)
- be able to read and write in English since the CaringGuidance™ program is in English,
- have regular access (e.g. home or work) to high speed/satellite broadband Internet on desk/laptop or wireless iPad, Android or iPhone throughout the 3 months of the study,*
- have an email address at which to receive CaringGuidance™ prompts,
- have a Baseline Distress Thermometer score of > 4, or an Impact of Events Scale score of > 9, or Center for Epidemiological Studies Depression Scale score of > 16 (i.e. clinically meaningful thresholds).
- Able to comprehend and provide informed consent
Who cannot join
- Men and women with recurrent or advanced breast cancer
- Those mentally or physically unable to read the consent form or other study materials and/or participate in the consent and engagement with the CaringGuidance program. Women who have been hospitalized for mental health issues or substance abuse in the past year are ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Oncology Clinics
Omaha, Nebraska, 68131
About this study
Official title: Reducing Distress and Depressive-symptoms in Rural Women Using CaringGuidance™-After Breast Cancer Diagnosis: Randomized Controlled Pilot Study
Approximately 30% of U.S. breast cancer survivors experience significant cancer-related distress ranging from adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. For rural cancer survivors, lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. However, these barriers may be overcome by a new Internet-based psychoeducational program designed for newly diagnosed women; CaringGuidance™- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding and provide supportive tools to prevent/manage distress and depressive-symptoms. This pilot study will determine preliminary efficacy of the CaringGuidance™ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer.
Read the detailed description
Of the 3.1 million U.S. breast cancer survivors, approximately 30% experience significant cancer-related distress ranging from sub-threshold to diagnosable adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. Rural cancer survivors report poorer mental health than urban survivors. Lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. These barriers may be overcome by a new Internet-based, psychoeducational program designed for newly diagnosed women; CaringGuidance™- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding, and provide supportive tools to prevent/manage distress and depressive-symptoms.
The aims of this pilot study are to determine preliminary efficacy of the CaringGuidance™ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer, and trial measures and methods, prior to a fully powered randomized controlled clinical trial.
Sixty rural women, will be randomized to 3 months of self-guided CaringGuidance™ program access with usual care or usual care alone. Both groups complete monthly standard psychosocial measures, daily activity/symptom logs and receive a monthly call. Program engagement/dose will be measured by the CaringGuidance™ internal data system. Descriptive and inferential statistics will characterize the sample and determine differences between groups at monthly intervals and overall. Variability of outcome variables will also be assessed to determine usefulness.
- Conditions
- Breast Cancer, Psychological Adjustment
- Being tested
- CaringGuidance After Breast Cancer Diagnosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaringGuidance After Breast Cancer DiagnosisBehavioural
CaringGuidance After Breast Cancer Diagnosis, psychoeducational, Internet-accessible program
| Study group | Role | What they receive |
|---|---|---|
| CaringGuidance Intervention | Experimental | Three months of web-based CaringGuidance psychoeducational program use, independently on home computer in addition to usual care. Receives: Behavioral: CaringGuidance After Breast Cancer Diagnosis |
| Usual Care | No intervention | Three months of care as usual from subjects' clinics and community as the subject chooses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in distress at 1, 2, and 3 months
self-report of psychological distress
Measured: at baseline and months 1, 2, and 3
change from baseline in depressive-symptoms at 1, 2, and 3 months
self-report of depressive-symptoms
Measured: at baseline and months 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start19 Jul 2017
- Primary completion11 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Sponsor
- Investigators
- Robin M Lally, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465813
- Sponsor's protocol ID
- 0140-17-EP
- Status last verified
- Sep 2023
- First submitted
- 28 Feb 2018
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Distress and Depressive-symptoms in Rural Women Using CaringGuidance™-After Breast Cancer Diagnosis: Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03465813
- Acronym / sponsor ID
- 0140-17-EP
- Conditions
- Breast Cancer, Psychological Adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 11 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 14 Mar 2018 (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.
Approximately 30% of U.S. breast cancer survivors experience significant cancer-related distress ranging from adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. For rural cancer survivors, lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. However, these barriers may be overcome by a new Internet-based psychoeducational program designed for newly diagnosed women; CaringGuidance™- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding and provide supportive tools to prevent/manage distress and depressive-symptoms. This pilot study will determine preliminary efficacy of the CaringGuidance™ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer.
Detailed description
Of the 3.1 million U.S. breast cancer survivors, approximately 30% experience significant cancer-related distress ranging from sub-threshold to diagnosable adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. Rural cancer survivors report poorer mental health than urban survivors. Lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. These barriers may be overcome by a new Internet-based, psychoeducational program designed for newly diagnosed women; CaringGuidance™- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding, and provide supportive tools to prevent/manage distress and depressive-symptoms.
The aims of this pilot study are to determine preliminary efficacy of the CaringGuidance™ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer, and trial measures and methods, prior to a fully powered randomized controlled clinical trial.
Sixty rural women, will be randomized to 3 months of self-guided CaringGuidance™ program access with usual care or usual care alone. Both groups complete monthly standard psychosocial measures, daily activity/symptom logs and receive a monthly call. Program engagement/dose will be measured by the CaringGuidance™ internal data system. Descriptive and inferential statistics will characterize the sample and determine differences between groups at monthly intervals and overall. Variability of outcome variables will also be assessed to determine usefulness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CaringGuidance Intervention | Experimental | Behavioral: CaringGuidance After Breast Cancer DiagnosisThree months of web-based CaringGuidance psychoeducational program use, independently on home computer in addition to usual care. |
| Usual Care | No intervention | –Three months of care as usual from subjects' clinics and community as the subject chooses. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- experiencing their first, stage 0 - IIIA breast cancer diagnosis (either clinical or definitive early stage at enrollment), and be 19 to 85 years of age,
- enroll < 3 months post-diagnosis (as soon as possible after diagnosis is desirable),
- reside in a non-metro county of the United States according to the USDA Rural-Urban Continuum Codes (6 -9) (RUCC) or at a rural zip-code by the USDA Rural Urban Commuting Area (RUCA) codes (4.0, 4.2, 5.0, 5.2, 6.0, 6.1, 7.0, 7.2-4, 8.0, 8.2-4, 9.0-2, 10.0, 10.2-6)
- be able to read and write in English since the CaringGuidance™ program is in English,
- have regular access (e.g. home or work) to high speed/satellite broadband Internet on desk/laptop or wireless iPad, Android or iPhone throughout the 3 months of the study,*
Key exclusion criteria (2 listed)
- Men and women with recurrent or advanced breast cancer
- Those mentally or physically unable to read the consent form or other study materials and/or participate in the consent and engagement with the CaringGuidance program. Women who have been hospitalized for mental health issues or substance abuse in the past year are ineligible.
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 |
|---|---|---|
| CaringGuidance After Breast Cancer DiagnosisCaringGuidance After Breast Cancer Diagnosis, psychoeducational, Internet-accessible program | Behavioural | CaringGuidance Intervention |
Primary outcome
change from baseline in distress at 1, 2, and 3 months
Time frame: at baseline and months 1, 2, and 3
self-report of psychological distress
change from baseline in depressive-symptoms at 1, 2, and 3 months
Time frame: at baseline and months 1, 2, and 3
self-report of depressive-symptoms
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 25 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Robin M Lally, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaringGuidance After Breast Cancer Diagnosis in people with Breast Cancer and Psychological Adjustment, run by University of Nebraska 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 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 25 Sep 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?
change from baseline in distress at 1, 2, and 3 months (time frame: at baseline and months 1, 2, and 3). 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?
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 25 Sep 2023.