mHealth Behavioral Cancer Pain Intervention for Medically Underserved Patients

Browse trials for

• Breast Neoplasms 12,547
• Neoplasms 9,371
• Pain 2,226
• Fatigue 1,863

Keywords

• cancer
• pain
• fatigue
• distress
• coping
• mHealth
• symptom management
• physical disability

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 180 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Study arms

• Experimental
  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).

  Behavioral: Mobile Health Pain Coping Skills Training (mPCST)

• No intervention
  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.

Interventions

• BehavioralMobile 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.

Primary outcomes

1. Pain Severity as Measured by the Brief Pain Inventory (BPI)

   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.

   Time frame: Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

2. Pain Interference as Measured by the Brief Pain Inventory (BPI)

   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.

   Time frame: Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

3. Change in Fatigue

   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.

   Time frame: Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

4. Physical Disability as Measured by the Patient Care Monitor (PCM)

   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.

   Time frame: Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

Secondary outcomes

1. Self-Efficacy for Pain Control as Measured by the Chronic Pain Self-Efficacy Scale

   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.

   Time frame: Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

2. Pain Catastrophizing as Measured by the Coping Strategies Questionnaire

   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.

   Time frame: Baseline, post-intervention (up to 10 weeks), 3 months, 6 months

3. Cost-Effectiveness

   We 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.

   Time frame: Baseline, post intervention(up to 10 weeks or however long the intervention lasts), 3-month and 6- month: approximately 25 minutes each time

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Jan 27, 2025
• Informed consent form · May 1, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No