Cancer Pain Management Using a Web-based Intervention

Description

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.

Conditions

Cancer of Breast, Depressive Symptoms, Cancer Pain

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Cancer Pain Management: A Technology-Based Intervention for Asian American Breast Cancer Survivors

Cancer Pain Management Using a Web-based Intervention

Condition
Cancer of Breast
Intervention / Treatment

-

Contacts and Locations

Austin

The University of Texas at Austin, Austin, Texas, United States, 78712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas at Austin,

Eun Ok Im, PRINCIPAL_INVESTIGATOR, The University of Texas at Austin

Study Record Dates

2027-08-31