Cancer Pain Management Using a Web-based Intervention

NCT06085313 | Recruiting

• 1 other identifier: STUDY00004807
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Breast; Depressive Symptoms; Cancer Pain

Outcome Measures

Primary Outcomes (6)

• Cancer Pain Management (CPM)

  1 yes/no question on if cancer pain is managed. If yes, additional questions on cancer pain management (types \[e.g., acetaminophen, NSAIDs, opioid, massage, acupuncture, acupressure, etc.\] and frequency of management \& how much relief). If no, what are the reasons.

  Pretest, Post 1-month, Post 3-months

• Brief Pain Inventory-Short Form (BPI-SF)

  15 items: (a) a global yes or no item asking for a comparison of pain with other minor aches/pains; (b) 4 items (0\~10) for the sensory component; (c) 1 item for pain medications; (d) a numerical scale rating the effectiveness of pain relief; (e) 7 items (0\~10) for a reactive dimension; and (f) a body diagram for location of pain. The BPI-SF pain scores are determined by adding 4 items on the intensity of pain and 7 items on the interference of pain (0\~110; no pain to extreme pain).

  Pretest, Post 1-month, Post 3-months

• Activity monitoring device (Fitbit) as a tool for digital pain biomarkers

  * Records continuous, automatic, wrist-based resting heart rates, total steps and time (physical activity), and non-walking activities (e.g., swim duration and pool lengths). * Has an auto sleep tracking function and records the duration of sleep, sleep stage, and number of times waking. Data on the time asleep and number of wakes will be measured and the time asleep (the overall tracked time - the time awake/restless) will be calculated. * The data on resting heart rates, total steps and time (physical activity), and time asleep will be used for data analyses to address the specific aims.

  Pretest, Post 1-month, Post 3-months

• Memorial Symptom Assessment Scale-Short Form (MSAS-SF)

  * 26 items on symptoms experienced during the past 7 days. * Rated on a 5-point (0-4) Likert scale; (0=no symptom to 4=very much). * Includes the Global Distress Index (4 psychologic and 6 physical symptoms), the physical symptom distress score (12 items), the psychologic symptom distress score (6 items), the total symptom distress, and the number of total symptoms. * Determines the MSAS-SF scores by adding the ratings for distress of 26 symptoms.

  Pretest, Post 1-month, Post 3-months

• Center for Epidemiologic Studies Depression Scale (CES-D)

  * Measures the frequency of depressive symptoms in the past week. * 20 items on the level of depression (range=0\~60). All items are summed to calculate depressive symptoms score

  Pretest, Post 1-month, Post 3-months

• Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B)

  * 44-items to measure multidimensional quality of life in patients with breast cancer. * Consists of the FACT-General plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to quality of life. * 7 domains: physical well-being, social/family well-being, emotional well-being, functional well-being, relationship with doctor, BCS, and additional concerns. * On a 5-point Likert scale (0=not at all\~4=very much), indicating a range of non to extreme interference. All items are summed to obtain a total score (FACT-B score).

  Pretest, Post 1-month, Post 3-months

Secondary Outcomes (10)

• Questions on Attitudes and Perceived Barriers

  Pretest, Post 1-month, Post 3-months

• Cancer Behavior Inventory (CBI)

  Pretest, Post 1-month, Post 3-months

• Questions on Social Influence

  Pretest, Post 1-month, Post 3-months

• Disease Factors

  Pretest, Post 1-month, Post 3-months

• Genetic factors

  Pretest, Post 1-month, Post 3-months

Study Arms (2)

CAI: Web App-based, individualized coaching and support program for cancer pain

EXPERIMENTAL

Web App-based information and coaching/support program for cancer pain management with the individual optimization functionality

Behavioral: CAI

CAPA: Web App-based information and coaching/support program for cancer pain

ACTIVE COMPARATOR

Web App-based information and coaching/support program for cancer pain management

Behavioral: CAPA

Interventions

CAI BEHAVIORAL

Web App-based information and coaching/support program for cancer pain management with additional components for the individual optimization functionality

CAI: Web App-based, individualized coaching and support program for cancer pain

CAPA BEHAVIORAL

Web App-based information and coaching/support program for cancer pain management

CAPA: Web App-based information and coaching/support program for cancer pain

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Depression; Cancer Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eun Ok Im

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wonshik Chee

CONTACT

512-232-2142; cai.help@austin.utexas.edu

OVPR

CONTACT

512-471-2877; research@utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 16, 2023
• Study Start: February 20, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)