Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06085313
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-10-02
Brief Title:
Cancer Pain Management Using a Web-based Intervention
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Cancer Pain Management A Technology-Based Intervention for Asian American Breast Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAI
Brief Summary:
This study is funded by the HEAL Initiative httpshealnihgov Based on Preliminary Studies PSs the research team developed and pilot-tested an evidence-based Web App-based information and coachingsupport program for cancer pain management CAPA that was culturally tailored to Asian American breast cancer survivors using multiple unique features However CAPA rarely considered depressive symptoms accompanying pain in its design or components and PSs indicated the necessity of further individualization of the intervention components of CAPA due to diversities in the needs of ABD The purpose of the proposed 2-phase study is to further develop CAPA with additional components for ABD and the individual optimization functionality CAI and to test the efficacy of CAI in improving cancer pain experience of ABD The specific aims are to a develop and evaluate CAI through an expert review and a usability test R61 phase b determine whether the intervention group that uses CAI and usual care will show significantly greater improvements than the active control group that uses CAPA and usual care in primary outcomes cancer pain management and cancer pain experience including depressive symptoms from baseline to post 1-month and post 3-months c identify theory-based variables attitudes self-efficacy perceived barriers and social influences that mediate the intervention effects of CAI on the primary outcomes and d determine whether the effects of CAI on the primary outcomes are moderated by selected background disease genetic and situational factors This study is guided by the Banduras Theory and the stress and coping framework by Lazarus and Folkman The R61 phase includes a the intervention development process b a usability test among 15 ABD 15 family members and 15 community gatekeepers and c an expert review among 10 experts in oncology The R33 phase adopts a randomized repeated measures control group design among 300 ABD Long-term goals are a to extend and test CAI in various healthcare settings with diverse subgroups of ABD b examine the costeffectiveness sustainability and scalability of CAI in the settings and c translate CAI into health care for ABD
Detailed Description:
Due to advances in early detection and treatment breast cancer survivors represent nearly 70 of the 56 million female cancer survivors in the US These women usually have some combination of surgery radiation or chemotherapy which can result in significant chronic pain Indeed the prevalence of pain is much higher in breast cancer survivors compared to survivors of other kinds of cancer Pain occurs in 2560 of breast cancer survivors and about half report moderate to severe pain Chronic pain decreases survivors quality of life and daily functioning and increases their fatigue depression anxiety and sleep disruption
Racialethnic minorities are high-risk groups for inadequate pain management Racialethnic minority patients in the US tend to present with a later-stage disease than non-minority patients and their pain is more likely to be undertreated Specifically Asian Americans reportedly shoulder unnecessary burden of pain because they rarely complain delay seeking help and rarely ask necessary information or support due to cultural values beliefs and language barriers Because of their cultural stigma attached to breast cancer fear of addiction to pain medication and stoicism toward pain they tend to unnecessarily tolerate pain that they could easily manage with currently existing regimen including pharmacologic and non-pharmacologic strategies
Especially Asian American breast cancer survivors with depressive symptoms ABD are more likely to suffer from inadequate pain management due to their depression eg not motivated enough to seek for help stigma attached to depression and pain could also worsen their depressive symptoms Indeed depression is a common co-morbidity in breast cancer survivors A systematic literature review indicated that Asian American breast cancer survivors had moderate to high levels of depressive symptoms anxiety and post-traumatic stress symptoms In another study among 1400 Chinese breast cancer survivors about 26 had mild to severe depression and 13 fulfilled the criteria of clinical depression Furthermore as mentioned above the recent opioid crisis has exacerbated their fear of addiction and reluctance to seek help The Coronavirus Disease 2019 COVID19 pandemic with Anti-Asian incidents has also placed an additional dimension of stress to this population
Despite systematic efforts to provide adequate cancer pain management researchers continue to find barriers including patients beliefs and misconceptions meanings of cancer pain expectations about pain relief miscommunication lack of social support inadequate training of healthcare providers and deficiencies within the healthcare infrastructure eg insurance coverage Among these this study focuses on those at the individual and interpersonal levels of influence by the National Institute of Minority Health and Health Disparity NIMHD Research Framework as the first step
Technology-based programs could be a solution to fill this gap in care for the survivors in communities Mainly because of easy access eg no transportation required 24-hour access and low cost once the system is developed technology-based programs are more effective in providing information and coachingsupport than conventional program Researchers also indicated their effectiveness in approaching isolated marginalized people with stigmatized conditions and underserved populations in communities These marginalized groups report greater interest in e-health than their more affluent counterparts In Preliminary Studies PSs Asian Americans preferred technology-based programs to traditional programs due to its high accessibility and anonymity Furthermore Internet use by Asian Americans is greater than that of any other racialethnic group and over 93 of women are internet users
Despite the strengths of technology-based programs few technology-based interventions are available for breast cancer survivors especially in pain and depressive symptom management Little is known about the efficacy of culturally tailored technology-based interventions in improving pain and symptom experience of racialethnic minority cancer survivors especially ABD Only eight programs were identified in an extensive literature review Two targeted individuals One program had four face-to-face group sessions Two programs combined face-to-face meetings with individual telephone counseling One used a telephone conference approach Two programs came from our own research team one aimed to enhance general breast cancer survivorship experience eg needs for help by providing Web-based information and coachingsupport TICAA and the other was CAPA that is the basis for CAI CAPA has multiple unique features based on the actual data from PSs which are rarely incorporated into technology-based interventions Also CAPA is the only existing technology-based program for cancer pain management that is culturally tailored to Asian American breast cancer survivors However CAPA rarely considers depressive symptoms accompanying pain in its design or components and PSs indicated the necessity of further individualization of its components due to diversities in the needs of ABD For instance individual ABD selectively used only the specific online educational modules and resources that they were interested in
CAI will offer the following features that have rarely been used in existing programs First CAI incorporates survivors own cultural attitudes deep tailoring based on the actual data from PSs and uses multiple languages surface tailoring Indeed cultural tailoring is essential in providing information and coachingsupport for ABD because of their unique cultural heritage eg Confucianism stigma attached to breast cancer and depression stoicism to pain The use of multiple languages is also essential in providing information and coaching support to ABD who may not otherwise understand the material and instructions they are given The feedback from community gatekeepers and ABD will be continuously incorporated into CAI as a part of the continuous cultural tailoring process The impact of deep and surface tailoring will be differentiated in the dose-response analysis process see Fidelity
Second the individual optimization functionality that will be developed in R61 Phase is unique because it allows further individualization of the intervention components for individual users through a machine-learning method Genetic Algorithm Through this functionality CAI can deliver the most relevant and effective information and coachingsupport to each participant Because there exist diversities in ABDs needs for pain and depressive symptom management even within the same sub-ethnic group this individualization is necessary in PSs ABD selectively used only those components that they were interested in
Third CAI is unique in incorporating both group interpersonal level of influence and individual individual level of influence coachingsupport by culturally matched bilingual healthcare providers There exist added benefits to protocols that include both group and individual coachingsupport Culturally matched bilingual interventionists could also ensure efficacy in coachingsupport limit the potential for harmful communications provide reliable and objective informationresources moderate and monitor liability or risk management issues and nurture a positive group culture in culturally appropriate and sensitive ways
Fourth peer support through a social media function interpersonal level of influence is rarely used in existing programs While social media as a health tool is understudied findings indicate its effectiveness in providing information and coachingsupport to breast cancer survivors including racialethnic minorities
Finally few existing programs incorporated existing evidence-based educational content from scientific authorities Yet the accuracy and credibility of information provided by technology-based programs are important aspects that the users are mostly concerned about
In summary this study will fill the gap in existing pain management programs for Asian American breast cancer survivors especially for ABD and fundamentally enhance the methodologyparadigm related to culturally tailored technology-based programs to reduce health disparities in cancer pain experience among racialethnic minority cancer survivors The design and methods of the program could be easily extended to other sub-ethnic or racialethnic groups
Racialethnic minorities are high-risk groups for inadequate pain management Racialethnic minority patients in the US tend to present with a later-stage disease than non-minority patients and their pain is more likely to be undertreated Specifically Asian Americans reportedly shoulder unnecessary burden of pain because they rarely complain delay seeking help and rarely ask necessary information or support due to cultural values beliefs and language barriers Because of their cultural stigma attached to breast cancer fear of addiction to pain medication and stoicism toward pain they tend to unnecessarily tolerate pain that they could easily manage with currently existing regimen including pharmacologic and non-pharmacologic strategies
Especially Asian American breast cancer survivors with depressive symptoms ABD are more likely to suffer from inadequate pain management due to their depression eg not motivated enough to seek for help stigma attached to depression and pain could also worsen their depressive symptoms Indeed depression is a common co-morbidity in breast cancer survivors A systematic literature review indicated that Asian American breast cancer survivors had moderate to high levels of depressive symptoms anxiety and post-traumatic stress symptoms In another study among 1400 Chinese breast cancer survivors about 26 had mild to severe depression and 13 fulfilled the criteria of clinical depression Furthermore as mentioned above the recent opioid crisis has exacerbated their fear of addiction and reluctance to seek help The Coronavirus Disease 2019 COVID19 pandemic with Anti-Asian incidents has also placed an additional dimension of stress to this population
Despite systematic efforts to provide adequate cancer pain management researchers continue to find barriers including patients beliefs and misconceptions meanings of cancer pain expectations about pain relief miscommunication lack of social support inadequate training of healthcare providers and deficiencies within the healthcare infrastructure eg insurance coverage Among these this study focuses on those at the individual and interpersonal levels of influence by the National Institute of Minority Health and Health Disparity NIMHD Research Framework as the first step
Technology-based programs could be a solution to fill this gap in care for the survivors in communities Mainly because of easy access eg no transportation required 24-hour access and low cost once the system is developed technology-based programs are more effective in providing information and coachingsupport than conventional program Researchers also indicated their effectiveness in approaching isolated marginalized people with stigmatized conditions and underserved populations in communities These marginalized groups report greater interest in e-health than their more affluent counterparts In Preliminary Studies PSs Asian Americans preferred technology-based programs to traditional programs due to its high accessibility and anonymity Furthermore Internet use by Asian Americans is greater than that of any other racialethnic group and over 93 of women are internet users
Despite the strengths of technology-based programs few technology-based interventions are available for breast cancer survivors especially in pain and depressive symptom management Little is known about the efficacy of culturally tailored technology-based interventions in improving pain and symptom experience of racialethnic minority cancer survivors especially ABD Only eight programs were identified in an extensive literature review Two targeted individuals One program had four face-to-face group sessions Two programs combined face-to-face meetings with individual telephone counseling One used a telephone conference approach Two programs came from our own research team one aimed to enhance general breast cancer survivorship experience eg needs for help by providing Web-based information and coachingsupport TICAA and the other was CAPA that is the basis for CAI CAPA has multiple unique features based on the actual data from PSs which are rarely incorporated into technology-based interventions Also CAPA is the only existing technology-based program for cancer pain management that is culturally tailored to Asian American breast cancer survivors However CAPA rarely considers depressive symptoms accompanying pain in its design or components and PSs indicated the necessity of further individualization of its components due to diversities in the needs of ABD For instance individual ABD selectively used only the specific online educational modules and resources that they were interested in
CAI will offer the following features that have rarely been used in existing programs First CAI incorporates survivors own cultural attitudes deep tailoring based on the actual data from PSs and uses multiple languages surface tailoring Indeed cultural tailoring is essential in providing information and coachingsupport for ABD because of their unique cultural heritage eg Confucianism stigma attached to breast cancer and depression stoicism to pain The use of multiple languages is also essential in providing information and coaching support to ABD who may not otherwise understand the material and instructions they are given The feedback from community gatekeepers and ABD will be continuously incorporated into CAI as a part of the continuous cultural tailoring process The impact of deep and surface tailoring will be differentiated in the dose-response analysis process see Fidelity
Second the individual optimization functionality that will be developed in R61 Phase is unique because it allows further individualization of the intervention components for individual users through a machine-learning method Genetic Algorithm Through this functionality CAI can deliver the most relevant and effective information and coachingsupport to each participant Because there exist diversities in ABDs needs for pain and depressive symptom management even within the same sub-ethnic group this individualization is necessary in PSs ABD selectively used only those components that they were interested in
Third CAI is unique in incorporating both group interpersonal level of influence and individual individual level of influence coachingsupport by culturally matched bilingual healthcare providers There exist added benefits to protocols that include both group and individual coachingsupport Culturally matched bilingual interventionists could also ensure efficacy in coachingsupport limit the potential for harmful communications provide reliable and objective informationresources moderate and monitor liability or risk management issues and nurture a positive group culture in culturally appropriate and sensitive ways
Fourth peer support through a social media function interpersonal level of influence is rarely used in existing programs While social media as a health tool is understudied findings indicate its effectiveness in providing information and coachingsupport to breast cancer survivors including racialethnic minorities
Finally few existing programs incorporated existing evidence-based educational content from scientific authorities Yet the accuracy and credibility of information provided by technology-based programs are important aspects that the users are mostly concerned about
In summary this study will fill the gap in existing pain management programs for Asian American breast cancer survivors especially for ABD and fundamentally enhance the methodologyparadigm related to culturally tailored technology-based programs to reduce health disparities in cancer pain experience among racialethnic minority cancer survivors The design and methods of the program could be easily extended to other sub-ethnic or racialethnic groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None