Clinical trial NCT06085313: Cancer Pain Management Using a Web-based Intervention
Official title: Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of Breast
Depressive Symptoms
Cancer Pain
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is funded by the HEAL Initiative (https://heal.nih.gov/). Based on Preliminary Studies (PSs), the research team developed and pilot-tested an evidence-based Web App-based information and coaching/support 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 Bandura's 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 5.6 million female cancer survivors in the U.S. 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 25%\~60% 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.

Racial/ethnic minorities are high-risk groups for inadequate pain management. Racial/ethnic minority patients in the U.S. 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 (e.g., 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 1,400 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 (e.g., 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 (e.g., no transportation required, 24-hour access) and low cost (once the system is developed), technology-based programs are more effective in providing information and coaching/support 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 racial/ethnic 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 racial/ethnic 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 (e.g., needs for help) by providing Web-based information and coaching/support (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 coaching/support for ABD because of their unique cultural heritage (e.g., 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 coaching/support to each participant. Because there exist diversities in ABD's 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) coaching/support by culturally matched bilingual healthcare providers. There exist added benefits to protocols that include both group and individual coaching/support. Culturally matched bilingual interventionists could also ensure efficacy in coaching/support, limit the potential for harmful communications, provide reliable and objective information/resources, 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 coaching/support to breast cancer survivors including racial/ethnic 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 methodology/paradigm related to culturally tailored technology-based programs to reduce health disparities in cancer pain experience among racial/ethnic minority cancer survivors. The design and methods of the program could be easily extended to other sub-ethnic or racial/ethnic groups.

Eligibility criteria: Inclusion Criteria:

* women aged 18 years and older who identify as Chinese, Korean, or Japanese;
* have had a breast cancer diagnosis in the past;
* can read and write English, Mandarin (simplified or traditional), Korean, or Japanese;
* have access to the internet through computers or mobile devices (mobile phones and tablets);
* have experienced cancer pain during the past week (at least 1 on a scale from 0 to 5 \[no symptom=0, mild symptom that does not bother=1, somewhat bothering symptom=2, moderate symptom=3, severe symptom=4, and worst possible symptom=5\]);
* have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire) which is equivalent to the cut-point of minimal to moderate depression.

Exclusion Criteria:

* less than 18 years old because their cancer experience would be different from that of adults.
* Those who are in treatment or not in treatment, but who were diagnosed with breast cancer within the past five years, will be excluded.
* Those who participated in the PI's pilot studies will be excluded.
* The participants of R33 phase will exclude those in active depression treatment regardless of their level of depression.
* Those without Internet access will be excluded, but those with Internet access through community/group computers will be included.

Primary outcomes:
measure: Cancer Pain Management (CPM)
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Activity monitoring device (Fitbit) as a tool for digital pain biomarkers
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Memorial Symptom Assessment Scale-Short Form (MSAS-SF)
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B)
timeFrame: Pretest, Post 1-month, Post 3-months
Secondary outcomes:
measure: Questions on Attitudes and Perceived Barriers
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Cancer Behavior Inventory (CBI)
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Questions on Social Influence
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Disease Factors
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Genetic factors
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Social Readjustment Rating Scale (SRRS)
timeFrame: Pretest, Post 1-month, Post 3-months
measure: Acculturation Stress Scale (ASS)
timeFrame: pretest, Post 1-month, Post 3-months
measure: Personal Resources Questionnaire (PRQ-2000)
timeFrame: pretest, Post 1-month, Post 3-months
measure: Discrimination Scale (DS)
timeFrame: pretest, Post 1-month, Post 3-months
measure: Perceived Isolation Scale (PIS)
timeFrame: pretest, Post 1-month, Post 3-months
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Eun Ok Im
role: PRINCIPAL_INVESTIGATOR
References: