Breast CancerNCT02783755
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities
A study testing Device: smartphone in people with Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is two-fold. First, the investigator will develop a low-literacy Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basic smartphone… 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?
- Device: smartphone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 30 Jun 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
- diagnosis of breast cancer within the last three years
- being >21 years old,
- having a life expectancy of at least 12 months,
- having 1 clinical pain ratings of >3 gathered as part of their routine clinic visits
Who cannot join
- metastases to the brain,
- presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff,
- current or past (<6 months) engagement in PCST for cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities.
The purpose of this study is two-fold. First, the investigator will develop a low-literacy Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basic smartphone components with the assistance of experts in the field. Next, an iterative development design using focus groups with women who have breast cancer and pain accrued from medically underserved areas will be used to refine the developed mPCST protocol and basic smart phone components. The protocol-designed to reduce cancer pain and disability in patients with low literacy in medically underserved areas-will be delivered via tele-video conferencing sessions in the community clinic. The smartphone tools (e.g., simple text messages, images, and preloaded intervention content) will allow the intervention to extend into the patients' homes. The second study purpose is to pilot test the feasibility, acceptability, and efficacy of the developed protocol. The investigator will also obtain an estimate of the effect size of the developed protocol to decrease pain. Focus group data will be managed and evaluated in a systematic format using a grounded theory approach. Data analyses for the pilot testing period of the study will be assessed by examining accrual, attrition, and adherence to the intervention. Simple t-tests will be used to examine pre- to post-intervention differences in pain and the other outcomes of interest. There are minimal risk or safety issues related to this study.
- Conditions
- Breast Cancer
- Being tested
- Device: smartphone
- Keywords
- pain, coping, mhealth, Breast cancer
- Medical subject headings
- Breast Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: smartphoneBehavioural
Coping Skills Training for pain will be delivered to participants using video-conferencing
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health Pain Coping Skills Training (mPCST) | Experimental | Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms). Receives: Behavioral: Device: smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity will be assessed with the Brief Pain Inventory (BPI).
Measured: Baseline and post intervention, approximately 60 minutes
Change in pain Interference will be assessed with the Brief Pain Inventory (BPI)
Measured: Baseline and Post Intervention, approximately 60 minutes
Secondary outcomes (6)
Change in self-efficacy for pain control will be assessed with the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale.
Measured: Baseline and Post Intervention, approximately 60 minutes
Change in pain catastrophizing will be assessed with the Coping Strategies Questionnaire.
Measured: Baseline and Post Intervention, approximately 60 minutes
Change in Depressive Symptoms:(PROMIS )four-item Depression Scale, a self-report measure of depressive symptoms.
Measured: Baseline and Post Intervention, approximately 60 minutes
Change in fatigue
The Patient Reported Outcomes Measurement Information System (PROMIS) four-item Fatigue Scale is a self-report measure of fatigue symptoms.
Measured: Baseline and Post Intervention, approximately 60 minutes
Change in mPCST Acceptability, as measured by participants' engagement
Patient acceptability of mPCST will be assessed with the Client Satisfaction Questionnaire 10-item version that rates items from 1 = low acceptability and 4 = high acceptability
Measured: Sessions 2,3,4 and 5
change in Health-Related Quality of Life
The Functional Assessment of Cancer Therapy- General (FACT-G) will be used to assess participants' health-related quality of life. The FACT-G is a 7-item self-report measure that provides participants with a variety of symptoms and concerns.
Measured: Baseline and Post Intervention, approximately 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completion30 Jun 2017
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 Duke 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara J Somers, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783755
- Sponsor's protocol ID
- Pro00065621
- Status last verified
- Aug 2019
- First submitted
- 24 May 2016
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities.
- ClinicalTrials.gov ID
- NCT02783755
- Acronym / sponsor ID
- Pro00065621
- Conditions
- Breast Cancer
- Keywords
- pain, coping, mhealth, Breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 26 May 2016 (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 two-fold. First, the investigator will develop a low-literacy Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basic smartphone components with the assistance of experts in the field. Next, an iterative development design using focus groups with women who have breast cancer and pain accrued from medically underserved areas will be used to refine the developed mPCST protocol and basic smart phone components. The protocol-designed to reduce cancer pain and disability in patients with low literacy in medically underserved areas-will be delivered via tele-video conferencing sessions in the community clinic. The smartphone tools (e.g., simple text messages, images, and preloaded intervention content) will allow the intervention to extend into the patients' homes. The second study purpose is to pilot test the feasibility, acceptability, and efficacy of the developed protocol. The investigator will also obtain an estimate of the effect size of the developed protocol to decrease pain. Focus group data will be managed and evaluated in a systematic format using a grounded theory approach. Data analyses for the pilot testing period of the study will be assessed by examining accrual, attrition, and adherence to the intervention. Simple t-tests will be used to examine pre- to post-intervention differences in pain and the other outcomes of interest. There are minimal risk or safety issues related to this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Pain Coping Skills Training (mPCST) | Experimental | Behavioral: Device: smartphoneMobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms). |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of breast cancer within the last three years
- being >21 years old,
- having a life expectancy of at least 12 months,
- having 1 clinical pain ratings of >3 gathered as part of their routine clinic visits
Key exclusion criteria (3 listed)
- metastases to the brain,
- presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff,
- current or past (<6 months) engagement in PCST for cancer.
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 |
|---|---|---|
| Device: smartphoneCoping Skills Training for pain will be delivered to participants using video-conferencing | Behavioural | Mobile Health Pain Coping Skills Training (mPCST) |
Primary outcome
Change in pain severity will be assessed with the Brief Pain Inventory (BPI).
Time frame: Baseline and post intervention, approximately 60 minutes
Change in pain Interference will be assessed with the Brief Pain Inventory (BPI)
Time frame: Baseline and Post Intervention, approximately 60 minutes
6 secondary outcomes
Change in self-efficacy for pain control will be assessed with the self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale.
Time frame: Baseline and Post Intervention, approximately 60 minutes
Change in pain catastrophizing will be assessed with the Coping Strategies Questionnaire.
Time frame: Baseline and Post Intervention, approximately 60 minutes
Change in Depressive Symptoms:(PROMIS )four-item Depression Scale, a self-report measure of depressive symptoms.
Time frame: Baseline and Post Intervention, approximately 60 minutes
Change in fatigue
Time frame: Baseline and Post Intervention, approximately 60 minutes
Change in mPCST Acceptability, as measured by participants' engagement
Time frame: Sessions 2,3,4 and 5
change in Health-Related Quality of Life
Time frame: Baseline and Post Intervention, approximately 60 minutes
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 19 Aug 2019.
- 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.
Tamara J Somers, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: smartphone in people with Breast Cancer, run by Duke University 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 4 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 19 Aug 2019. 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 in pain severity will be assessed with the Brief Pain Inventory (BPI). (time frame: Baseline and post intervention, approximately 60 minutes). 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 19 Aug 2019.