Trial Title:
Cancer Pain Management Using a Web-based Intervention
NCT ID:
NCT06085313
Condition:
Cancer of Breast
Depressive Symptoms
Cancer Pain
Conditions: Official terms:
Breast Neoplasms
Cancer Pain
Depression
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
CAI
Description:
Web App-based information and coaching/support program for cancer pain management with
additional components for the individual optimization functionality
Arm group label:
CAI: Web App-based, individualized coaching and support program for cancer pain
Intervention type:
Behavioral
Intervention name:
CAPA
Description:
Web App-based information and coaching/support program for cancer pain management
Arm group label:
CAPA: Web App-based information and coaching/support program for cancer pain
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas at Austin
Address:
City:
Austin
Zip:
78712
Country:
United States
Status:
Recruiting
Contact:
Last name:
Wonshik Chee
Phone:
512-232-2142
Email:
cai.help@austin.utexas.edu
Start date:
February 20, 2024
Completion date:
August 31, 2027
Lead sponsor:
Agency:
University of Texas at Austin
Agency class:
Other
Source:
University of Texas at Austin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06085313
