Cancer Pain Management Using a Web-based Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Texas at Austin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CAI
BehavioralWeb App-based information and coaching/support program for cancer pain management with additional components for the individual optimization functionality
CAPA
BehavioralWeb App-based information and coaching/support program for cancer pain management
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: CAI: Web App-based, individualized coaching and support program for cancer painExperimental treatment 1 intervention
Group B: CAPA: Web App-based information and coaching/support program for cancer painActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pretest, Post 1-month, Post 3-months2
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).
Time frame
Pretest, Post 1-month, Post 3-months3
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.
Time frame
Pretest, Post 1-month, Post 3-months4
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.
Time frame
Pretest, Post 1-month, Post 3-monthsSecondary outcomes
1
Questions on Attitudes and Perceived Barriers
6 items on attitudes (bipolar \[-3 to +3\] scales), 16 items on perceived barriers (4-point Likert scales). By summing the items in each subscale, the attitude and perceived barriers scores will be calculated.
Time frame
Pretest, Post 1-month, Post 3-months2
Cancer Behavior Inventory (CBI)
* A measure of self-efficacy for coping with cancer. * 27-items (9-point scale) on how confident to accomplish certain behaviors (not at all=1, to totally confident=9). By summing the items, the self-efficacy scores will be calculated.
Time frame
Pretest, Post 1-month, Post 3-months3
Questions on Social Influence
Data from 3 items measured on 7-point Likert scales will be summed to calculated the social influence scores.
Time frame
Pretest, Post 1-month, Post 3-months4
Disease Factors
7 questions on disease factors, including general health, diagnosis of breast cancer, length of time since diagnosis, cancer type (if known), stage of cancer, diagnosed clinical depression and medical treatments, and medication. Used in PSs 1-4, \& 5 without any issues.
Time frame
Pretest, Post 1-month, Post 3-monthsSponsors and contacts
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Source ClinicalTrials.gov