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Mobile Pain Coping Skills TrainingNCT02266017

Mobile Pain Coping Skills Training for Cancer Pain

A study testing Pain Coping Skills Training in people with Mobile Pain Coping Skills Training and In Person Pain Coping Skills Training, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pain in cancer patients is estimated to be as high as 90% and results in physical and psychological disability. Behavioral interventions that increase patients' confidence in their ability to manage their pain have been shown to be beneficial. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pain Coping Skills Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteUnited States
Study dates
6 Oct 2014to 21 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy of 6 or more months
  • Clinical pain rating of 3/10
  • Primary diagnosis of breast, lung, prostate, or colorectal cancer in last year

Who cannot join

  • Cognitive impairment
  • Metastases to brain
  • Treatment for serious psychological disorder in last 6 months
  • Current or past engagement in pain coping skills training for cancer pain

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke Cancer Institute

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: An Accessible Mobile Health Behavioral Intervention For Cancer Pain

Pain in cancer patients is estimated to be as high as 90% and results in physical and psychological disability. Behavioral interventions that increase patients' confidence in their ability to manage their pain have been shown to be beneficial. Behavioral interventions for cancer pain teach patients how their thoughts and feelings can influence their pain and specific strategies (e.g., relaxation) for decreasing cancer pain. However, despite guidelines recommending such interventions be used in the care of cancer patients with pain, they are not routinely used. A critical barrier to the use of behavioral interventions is that patients have difficulties attending appointments which are typically offered at the medical center during normal business hours. Mobile health (mHealth) technologies provide new opportunities to decrease such barriers. The investigators have developed a new mHealth approach that may increase the use of behavioral cancer pain interventions and ultimately lead to greater use of interventions that can decrease pain and disability.

The investigators propose to test an approach that uses mHealth technologies to deliver a behavioral cancer pain intervention to patients in their home using a tablet computer (e.g., iPad) and video-conferencing (e.g., Skype). The investigators will randomly assign 160 cancer patients with breast, lung, prostate, or colorectal cancer pain to receive either mHealth Pain Coping Skills Training system (mPCST) or to receive a traditional in-person pain coping skills training intervention protocol (PCST-trad) at the medical center. The investigators will test whether the mPCST is more accessible to patients than PCST-trad. The investigators expect that mPCST, compared to PCST-trad, will: a) be more feasible meaning that more patients will complete it in a timely manner; b) create less burden meaning it is easier for patients physically, emotionally, and financially to participate; c) increase engagement meaning that patients will practice skills more and have more understanding of the material; and d) be more overall acceptable to patients. the investigators also expect that patients who find this intervention more feasible, less burdensome, more engaging, and more acceptable will be more likely to experience decreased pain, physical disability, and psychological disability, and increased confidence in their ability to manage their pain.

The investigators' goal is to use mHealth technologies to facilitate wide-spread use of behavioral cancer pain interventions. Increased use of mHealth behavioral cancer pain interventions will particularly benefit patients living far from medical centers (e.g., rural), experiencing cancer-related physical challenges, and facing other practical barriers (e.g., transportation, work) to in-person interventions. These outcomes could lead to future work evidencing that mHealth behavioral interventions could be applied to other areas of quality of life in cancer patients (e.g., fatigue) and/or in other samples of patients with persistent pain (e.g., arthritis).

Being tested
Pain Coping Skills Training
Keywords
pain, coping, mhealth, cancer
Medical subject headings
Pain, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Coping Skills TrainingBehavioural

Study groups in NCT02266017
Study groupRoleWhat they receive
Mobile Pain Coping Skills TrainingExperimentalCoping Skills Training for pain will be delivered to participants using video-conferencing via a tablet computer.
Receives: Behavioral: Pain Coping Skills Training
In person Pain Coping Skills TrainingActive comparatorParticipants will be provided with an in-person pain coping skills training intervention
Receives: Behavioral: Pain Coping Skills Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pain

    Brief Pain Inventory

    Measured: Pre Study Intervention, Post Study Intervention & 3-month follow-up after post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2014 (estimated)
  2. Study start6 Oct 2014
  3. Primary completion21 Mar 2018
  4. Study completion21 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02266017
Sponsor's protocol ID
Pro00054792
Other IDs
Research Scholars Grant
Status last verified
Aug 2023
First submitted
2 Sep 2014
Last updated
7 Aug 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Pain Coping Skills Training in people with Mobile Pain Coping Skills Training and In Person Pain Coping Skills Training, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain (time frame: Pre Study Intervention, Post Study Intervention & 3-month follow-up after post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.

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