Clinical trial NCT04175639: mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients
Official title: mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: cancer
pain
fatigue
distress
coping
mHealth
symptom management
physical disability
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy of a mobile health (mHealth) behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients in medically underserved areas has not been investigated. The long-term goal of this work is to use mHealth technologies to facilitate wide-spread implementation of an efficacious behavioral cancer pain intervention - a non-pharmacological approach to pain management. The proposed project's objective is to demonstrate the efficacy of an innovative mobile health Pain Coping Skills Training (mPCST-Community) designed to meet the needs of breast cancer patients with pain in medically underserved areas. mPCST-Community addresses intervention barriers for patients in medically underserved areas as it is delivered with video-conferencing in the patients' community based oncology clinic by a remote therapist, is extended to the patients' home environment using simple mHealth technology, and is low-literacy adapted. The central hypothesis is that mPCST-Community will result in decreased pain compared to a mHealth education attention control group (mHealth-Ed). The rationale of this proposal is that if mPCST-Community is shown to be efficacious it will rapidly increase intervention access for individuals who receive their oncology care in medically underserved areas and ultimately reduce pain-related suffering. Guided by strong preliminary data, a randomized controlled trial will be used to pursue three specific aims: 1) Test the extent to which the mPCST-Community intervention reduces pain, fatigue, disability, and distress, 2) Examine self-efficacy and pain catastrophizing as mediators through which the mPCST-Community leads to reductions in pain, fatigue, disability, and distress, and 3) To evaluate the cost-effectiveness of mPCST-Community. For Aim 1, based on the study team's extensive work demonstrating the efficacy of in-person pain coping skills training protocols and pilot work showing promise for mPCST-Community, it is expected that mPCST-Community will lead to decreased pain as well as fatigue, disability, and distress compared to mHealth-Ed. For Aim 2, it is expected that the effects of mPCST-Community will be mediated by increased self-efficacy for pain control and decreased pain catastrophizing. For Aim 3, it is expected that mPCST-Community will demonstrate cost-effectiveness as assessed by all-cause medical resource use, participant and therapist time, and health utilities as well as successful overall accrual, high subject retention, and high intervention adherence.

Detailed description: Guided by extensive prior work, the investigators have designed an innovative mHealth behavioral pain coping skills training (PCST) intervention to reduce pain and disability in cancer patients in medically underserved areas (mPCST-Community). Our prior work has tested PCST protocols through in-person sessions at major medical centers where resources and literacy levels are relatively high. mPCST-Community is different and innovative; it uses mHealth technology (e.g., videoconferencing) to decrease access barriers for patients in medically underserved areas. The protocol is brief (4 sessions) and delivered in the community clinic by a remote well-trained pain therapist. Importantly, this protocol has been carefully adapted for low literacy patients.Beverly Thorn, PhD, a nationally recognized expert in strategies for adapting pain coping interventions to low literacy, medically underserved patients, was instrumental in developing the mPCST-Community protocol. mPCST-Community extends to the patient's daily life through use of a simple mobile application that provides low literacy text/audio protocol summaries, relaxation audio, daily assessment and personalized feedback, and coping messaging.

The investigators propose a randomized controlled trial (RCT) to test the efficacy of the developed mPCST-Community protocol in breast cancer patients with pain receiving cancer care in medically underserved areas (N=180). The investigators have done careful and extensive pilot work to prepare for the proposed trial. Our pilot work (Journal of Psychosocial Oncology) was conducted in breast cancer patients with pain in three medically underserved rural community clinics. First, focus group data (3 groups; n=19) were used to further refine the adapted protocol. Second, the mPCST-Community protocol was evaluated in a single-arm trial with 20 patients. The invesitgators found high feasibility (i.e., recruitment met), low attrition and high adherence (90% completion), and high acceptability. Importantly, impressive and positive pre- to post-intervention changes were found for pain severity (t=-2.52, p=0.01,gav=0.62; 30% change), pain interference (t=-2.62,p=0.01, gav=0.62), and self-efficacy for pain management (t=3.57, p=0.0004, gav=0.98; 30% change).8Study specific aims are:

Aim 1:Test the extent to which mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress. Hypothesis:mPCST-Community will lead to decreases in these pain-related outcomes compared to a Health-Ed control condition.

Aim 2:Examine mediators through which mPCST-Community leads to benefits. Hypothesis:The effects of mPCST-Community on pain severity, pain interference, fatigue, physical disability, and psychological distress will be mediated by increased self-efficacy for pain management and decreased pain catastrophizing.

Aim 3:Evaluate the cost and cost-effectiveness of mPCST-Community. Hypothesis: mPCST-Community will be cost-saving or cost effective in terms of its incremental cost per quality-adjusted life-year from a societal perspective, inclusive of healthcare, intervention and patient-time costs. Its sustainability will be further demonstrated by documenting successful accrual, retention, and protocol adherence.

Eligibility criteria: Inclusion Criteria:

1. women with a diagnosis of any breast cancer within the last three years
2. being \>18 years old
3. having a life expectancy of \>12 months
4. report experiencing pain on at least 10 days in the last month and rate their pain in the past week as a 4 or greater on a 0-10 scale. The combination of these items assess patients level of persistent pain (in the last month) and pain severity with an accurate recall period (i.e., last week; \>4).

Exclusion Criteria:

1. cognitive impairment as indicated by a baseline Folstein Mini-Mental Status Examination of \<2588
2. brain metastases
3. presence of a severe psychiatric condition or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or medical/study staff interactions, or 4) current or past (\<6 months) engagement in PCST for cancer.

Primary outcomes:
measure: Change in pain severity
timeFrame: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
measure: Change in Pain Interference
timeFrame: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
measure: Change in fatigue
timeFrame: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
measure: Change in Physical Disability
timeFrame: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
Secondary outcomes:
measure: Change in Self-Efficacy for pain control
timeFrame: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
measure: Change in Pain Catastrophizing
timeFrame: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
measure: Cost-Effectiveness
timeFrame: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Tamara J Somers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: