Trial Outcomes & Findings for mHealth Behavioral Cancer Pain Intervention for Medically Underserved Patients (NCT NCT04175639)
NCT ID: NCT04175639
Last Updated: 2025-12-09
Results Overview
Pain Severity will be assessed using the Brief Pain Inventory (BPI) by asking patients about pain on a scale of 0 = no pain to 10 = pain as bad as you can imagine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
Baseline, post-intervention (up to 10 weeks), 3 months, 6 months
Results posted on
2025-12-09
Participant Flow
Three consented participants were lost to follow-up or withdrawn prior to completing the baseline assessment and were not randomized.
Participant milestones
| Measure |
Mobile Health Pain Coping Skills Training (mPCST)
Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).
Mobile Health Pain Coping Skills Training (mPCST): Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
|
mHealth-Education (mHealth-Ed)
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
87
|
|
Overall Study
COMPLETED
|
79
|
83
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
mHealth Behavioral Cancer Pain Intervention for Medically Underserved Patients
Baseline characteristics by cohort
| Measure |
Mobile Health Pain Coping Skills Training (mPCST)
n=90 Participants
Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).
Mobile Health Pain Coping Skills Training (mPCST): Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
|
mHealth-Education (mHealth-Ed)
n=87 Participants
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=518 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=4 Participants
|
61 Participants
n=50 Participants
|
115 Participants
n=518 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=4 Participants
|
26 Participants
n=50 Participants
|
62 Participants
n=518 Participants
|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
59.6 years
STANDARD_DEVIATION 11.4 • n=50 Participants
|
60.3 years
STANDARD_DEVIATION 12.0 • n=518 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=4 Participants
|
87 Participants
n=50 Participants
|
177 Participants
n=518 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=518 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=4 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=518 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=4 Participants
|
81 Participants
n=50 Participants
|
166 Participants
n=518 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=4 Participants
|
5 Participants
n=50 Participants
|
8 Participants
n=518 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=4 Participants
|
6 Participants
n=50 Participants
|
15 Participants
n=518 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=518 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=518 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=4 Participants
|
27 Participants
n=50 Participants
|
51 Participants
n=518 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=4 Participants
|
51 Participants
n=50 Participants
|
104 Participants
n=518 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=518 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=4 Participants
|
3 Participants
n=50 Participants
|
5 Participants
n=518 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-intervention (up to 10 weeks), 3 months, 6 monthsPopulation: Participants with data collected.
Pain Severity will be assessed using the Brief Pain Inventory (BPI) by asking patients about pain on a scale of 0 = no pain to 10 = pain as bad as you can imagine.
Outcome measures
| Measure |
Mobile Health Pain Coping Skills Training (mPCST)
n=72 Participants
Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).
Mobile Health Pain Coping Skills Training (mPCST): Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
|
mHealth-Education (mHealth-Ed)
n=77 Participants
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
|
|---|---|---|
|
Pain Severity as Measured by the Brief Pain Inventory (BPI)
Baseline
|
4.71 score on a scale
Standard Deviation 2.05
|
4.51 score on a scale
Standard Deviation 1.84
|
|
Pain Severity as Measured by the Brief Pain Inventory (BPI)
Post-intervention
|
3.52 score on a scale
Standard Deviation 2.04
|
4.69 score on a scale
Standard Deviation 2.32
|
|
Pain Severity as Measured by the Brief Pain Inventory (BPI)
3 months
|
3.59 score on a scale
Standard Deviation 2.37
|
4.15 score on a scale
Standard Deviation 2.40
|
|
Pain Severity as Measured by the Brief Pain Inventory (BPI)
6 months
|
3.16 score on a scale
Standard Deviation 2.12
|
4.13 score on a scale
Standard Deviation 2.58
|
PRIMARY outcome
Timeframe: Baseline, post-intervention (up to 10 weeks), 3 months, 6 monthsPopulation: Participants with data collected.
Pain Interference will be assessed by asking how much pain has interfered with seven daily activities including general activity, walking, work, mood, enjoyment of life, relations with other and sleep within the last 7 days on a scale of 0 = does not interfere to 10 = completely interferes. Reported as the mean score for the seven items.
Outcome measures
| Measure |
Mobile Health Pain Coping Skills Training (mPCST)
n=72 Participants
Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).
Mobile Health Pain Coping Skills Training (mPCST): Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
|
mHealth-Education (mHealth-Ed)
n=77 Participants
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
|
|---|---|---|
|
Pain Interference as Measured by the Brief Pain Inventory (BPI)
Baseline
|
4.64 score on a scale
Standard Deviation 2.56
|
4.76 score on a scale
Standard Deviation 2.30
|
|
Pain Interference as Measured by the Brief Pain Inventory (BPI)
Post-intervention
|
3.28 score on a scale
Standard Deviation 2.34
|
4.79 score on a scale
Standard Deviation 2.55
|
|
Pain Interference as Measured by the Brief Pain Inventory (BPI)
3 months
|
3.22 score on a scale
Standard Deviation 2.47
|
4.11 score on a scale
Standard Deviation 2.60
|
|
Pain Interference as Measured by the Brief Pain Inventory (BPI)
6 months
|
2.92 score on a scale
Standard Deviation 2.49
|
4.04 score on a scale
Standard Deviation 2.90
|
PRIMARY outcome
Timeframe: Baseline, post-intervention (up to 10 weeks), 3 months, 6 monthsPopulation: Participants with data collected.
The Patient Reported Outcomes Measurement Information System (PROMIS) six-item Fatigue Scale is a self-report measure of fatigue symptoms. Items ask patients to evaluate symptoms from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities. Reported as a T-score with a range of 0 to 100, with a mean score of 50 and a standard deviation of 10. A higher score indicates greater fatigue.
Outcome measures
| Measure |
Mobile Health Pain Coping Skills Training (mPCST)
n=72 Participants
Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).
Mobile Health Pain Coping Skills Training (mPCST): Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
|
mHealth-Education (mHealth-Ed)
n=77 Participants
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
|
|---|---|---|
|
Change in Fatigue
Baseline
|
60.60 T-score
Standard Deviation 7.67
|
60.59 T-score
Standard Deviation 7.33
|
|
Change in Fatigue
Post-intervention
|
56.38 T-score
Standard Deviation 8.12
|
58.95 T-score
Standard Deviation 7.36
|
|
Change in Fatigue
3 months
|
56.34 T-score
Standard Deviation 8.38
|
58.02 T-score
Standard Deviation 7.83
|
|
Change in Fatigue
6 months
|
54.25 T-score
Standard Deviation 8.97
|
58.52 T-score
Standard Deviation 7.86
|
PRIMARY outcome
Timeframe: Baseline, post-intervention (up to 10 weeks), 3 months, 6 monthsPopulation: Participants with data collected.
Physical disability will be assessed using 4-item form Patient Care Monitor (PCM) scale. The four items ask about patients' ability to run, do light physical work or fun activities, do hard physical work or fun activities, and ability to function normally in the last 7 days (0 = not a problem to 10 = as bad as possible). Reported as the mean score for the four items.
Outcome measures
| Measure |
Mobile Health Pain Coping Skills Training (mPCST)
n=72 Participants
Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).
Mobile Health Pain Coping Skills Training (mPCST): Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
|
mHealth-Education (mHealth-Ed)
n=77 Participants
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
|
|---|---|---|
|
Physical Disability as Measured by the Patient Care Monitor (PCM)
Baseline
|
5.56 score on a scale
Standard Deviation 2.45
|
5.87 score on a scale
Standard Deviation 2.23
|
|
Physical Disability as Measured by the Patient Care Monitor (PCM)
Post-intervention
|
4.62 score on a scale
Standard Deviation 2.40
|
5.64 score on a scale
Standard Deviation 2.30
|
|
Physical Disability as Measured by the Patient Care Monitor (PCM)
3 months
|
4.66 score on a scale
Standard Deviation 2.67
|
5.29 score on a scale
Standard Deviation 2.43
|
|
Physical Disability as Measured by the Patient Care Monitor (PCM)
6 months
|
4.20 score on a scale
Standard Deviation 2.77
|
5.31 score on a scale
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (up to 10 weeks), 3 months, 6 monthsPopulation: Participants with data collected.
The self-efficacy for pain management will be assessed using 5-item Chronic Pain Self-Efficacy scale. This sub-scale contains 5 items that inquire about patients' certainty about degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication. These items will be answered on a scale of 10 = very uncertain to 100 = very certain scale and averaged.
Outcome measures
| Measure |
Mobile Health Pain Coping Skills Training (mPCST)
n=72 Participants
Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).
Mobile Health Pain Coping Skills Training (mPCST): Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
|
mHealth-Education (mHealth-Ed)
n=77 Participants
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
|
|---|---|---|
|
Self-Efficacy for Pain Control as Measured by the Chronic Pain Self-Efficacy Scale
Baseline
|
54.69 score on a scale
Standard Deviation 17.79
|
56.09 score on a scale
Standard Deviation 18.09
|
|
Self-Efficacy for Pain Control as Measured by the Chronic Pain Self-Efficacy Scale
Post-intervention
|
64.46 score on a scale
Standard Deviation 20.42
|
55.12 score on a scale
Standard Deviation 18.64
|
|
Self-Efficacy for Pain Control as Measured by the Chronic Pain Self-Efficacy Scale
3 months
|
65.27 score on a scale
Standard Deviation 21.58
|
56.60 score on a scale
Standard Deviation 18.97
|
|
Self-Efficacy for Pain Control as Measured by the Chronic Pain Self-Efficacy Scale
6 months
|
66.03 score on a scale
Standard Deviation 23.17
|
58.49 score on a scale
Standard Deviation 23.52
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (up to 10 weeks), 3 months, 6 monthsPopulation: Participants with data collected.
Pain catastrophizing will be assessed with the 6-item pain catastrophizing sub-scale of the Coping Strategies Questionnaire. These items ask about patients' tendency to catastrophize when faced with pain and are answered on a scale of 0 = never to 6 = always and averaged.
Outcome measures
| Measure |
Mobile Health Pain Coping Skills Training (mPCST)
n=72 Participants
Mobile Health Pain Coping Skills Training (mPCST) protocol for breast cancer survivors with persistent pain that will produce significant improvements in pain, pain disability, fatigue, physical disability, and adherence to post-treatment lifestyle recommendations that are impacted by pain (i.e., daily activity, self-monitoring of symptoms).
Mobile Health Pain Coping Skills Training (mPCST): Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
|
mHealth-Education (mHealth-Ed)
n=77 Participants
mHealth-Education (mHealth- Ed): Participating in mHealth will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic with a nurse about cancer care.
|
|---|---|---|
|
Pain Catastrophizing as Measured by the Coping Strategies Questionnaire
6 months
|
1.00 score on a scale
Standard Deviation 1.12
|
1.60 score on a scale
Standard Deviation 1.18
|
|
Pain Catastrophizing as Measured by the Coping Strategies Questionnaire
Baseline
|
1.67 score on a scale
Standard Deviation 1.41
|
1.83 score on a scale
Standard Deviation 1.13
|
|
Pain Catastrophizing as Measured by the Coping Strategies Questionnaire
Post-intervention
|
1.22 score on a scale
Standard Deviation 1.05
|
1.60 score on a scale
Standard Deviation 1.03
|
|
Pain Catastrophizing as Measured by the Coping Strategies Questionnaire
3 months
|
1.12 score on a scale
Standard Deviation 1.06
|
1.53 score on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each timeWe will create a composite cost variable based on patient time, medical resource use, productivity, and the EQ-5D.The EQ-5D is a measure of health status that can be linked to population-based preference weights is widely used in economic evaluations. It is short, assessing 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The respondent indicates no problems, some problems, or severe problems in each dimension.
Outcome measures
Outcome data not reported
Adverse Events
Mobile Health Pain Coping Skills Training (mPCST)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
mHealth-Education (mHealth-Ed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place