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Advanced CancerNCT03207360

Pain Coping Skills and Meaning-Centered Intervention

A study testing Pain Coping Skills in people with Advanced Cancer and Pain, 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

The proposed study seeks to develop and test a novel psychosocial pain management intervention for patients with advanced cancer. It is hypothesized that the intervention will demonstrate feasibility, acceptability, and preliminary efficacy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Pain
What is being tested?
Pain Coping Skills
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
17 Nov 2017to 11 Feb 2020
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

  • Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis
  • At least moderate pain (pain score >/= 4) at recruitment
  • Clinically elevated distress (NCCN Distress Thermometer >/= 3) at recruitment
  • Eastern Cooperative Oncology Group (ECOG) </= 2 at recruitment
  • Ability to speak and read English

Who cannot join

  • Brain tumor diagnosis
  • Significant cognitive impairment
  • Serious mental illness that would interfere with engagement in the intervention (e.g., schizophrenia)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Pain Coping Skills Training and Meaning-Centered Intervention for Cancer Pain

The proposed study seeks to develop and test a novel psychosocial pain management intervention for patients with advanced cancer. It is hypothesized that the intervention will demonstrate feasibility, acceptability, and preliminary efficacy. The first aim is to develop a combined pain coping skills training and meaning-centered psychotherapy intervention. The second aim is to test the intervention's feasibility and acceptability as well as preliminary efficacy for improving primary outcomes (i.e., pain, pain interference, and meaning in life) and secondary outcomes. Two efficacious, theory-driven interventions will be integrated to address pain management by teaching pain coping skills with a novel emphasis on enhancing a sense of meaning in life. Participants will be patients with advanced cancer and moderate-to-severe pain. The study will be conducted in two phases. Phase I of the study will be intervention development. The intervention content will be guided by theory and mentoring from a team of leading experts in pain management and meaning-centered psychotherapy. Initial intervention content will be further informed by interviews with patients with advanced cancer. Content will then be refined through an iterative patient testing process. Phase II of the study will be a single-arm pilot trial testing the intervention. The intervention will be delivered in-person and consist of four, 45-to-60 minute therapy sessions delivered using videoconferencing technology. Study measures will be collected at baseline (0 weeks), immediately post-intervention (5 weeks), and 4-weeks post-intervention (9 weeks).

Read the detailed description

Effective pain management is a major healthcare concern for patients with advanced cancer. Compared to patients with early-stage disease, those with advanced cancer report higher levels of pain and greater functional impairment related to pain. There is a critical need for psychosocial pain management interventions that are specifically designed to address the suffering of patients with advanced cancer. The proposed study seeks to develop and assess the feasibility, acceptability, and preliminary efficacy of a novel integration of pain coping skills training and meaning-centered psychotherapy for patients with advanced cancer and moderate-to-severe pain.

Being tested
Pain Coping Skills
Medical subject headings
Pain

What participants receive

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

  • Pain Coping SkillsBehavioural

    Also called Meaning-Centered Psychotherapy

    Participants will be trained in pain coping skills and meaning-centered psychotherapy. The intervention will consist of 4 weekly videoconference-delivered sessions that will last between 45 and 60 minutes.

Study groups in NCT03207360
Study groupRoleWhat they receive
Pain Coping SkillsExperimentalNot described
Receives: Behavioral: Pain Coping Skills

What is being measured

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

  1. Feasibility as measured by study accrual

    Treatment feasibility will be shown by meeting targeted study accrual (N = 30 for single-arm trial) in the 24-month study period.

    Measured: 5 weeks (immediately post-intervention)

  2. Feasibility as measured by study attrition

    Treatment feasibility will be shown by no more than 30% study attrition. Attrition will be defined as not completing the post-intervention assessment.

    Measured: 5 weeks (immediately post-intervention)

  3. Acceptability as measured by the Client Satisfaction Questionnaire eight-item version (CSQ)

    Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol (mean score of 7) on the CSQ.

    Measured: 5 weeks (immediately post-intervention)

  4. Acceptability as measured by engagement

    Acceptability will be indicated by reported practice of the skills and ideas from the intervention in at least 75% of the sessions.

    Measured: 3 weeks, 4 weeks, and 5 weeks (sessions 2, 3, and 4)

  5. Change in pain and pain interference

    Pain and pain interference will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF).

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

  6. Change in meaning in life

    Meaning in life (i.e., purpose, coherence, and significance) and overall spiritual well-being will be measured using the 12-item Functional Assessment of Cancer Therapy - Spiritual Well-Being scale (FACIT-Sp).

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

Secondary outcomes (8)

  1. Change in self-efficacy for pain management

    Self-efficacy for pain management will be measured using the five-item self-efficacy for pain management subscale of the Chronic Pain Self-Efficacy Scale.

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

  2. Change in anxiety

    Anxiety will be measured using the seven-item version of the Generalized Anxiety Disorders scale (GAD-7).

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

  3. Change in depressive symptoms

    Depressive symptoms will be measured using the eight-item version of the Patient Health Questionnaire (PHQ-8).

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

  4. Change in hopelessness

    Hopelessness will be measured using the eight-item Hopelessness Assessment in Illness Questionnaire.

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

  5. Change in fatigue

    Fatigue will be assessed using the four-item Fatigue Symptom Inventory (FSI).

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

  6. Change in health-related quality of life

    Health-related quality of life will be assessed using the 16-item version of the McGill Quality of Life Questionnaire.

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

  7. Change in performance status

    Performance status will be assessed using the one-item self-report version of the Karnofsky Performance Rating Scale.

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks post-intervention)

  8. Change in meaningfulness in life despite pain

    Meaningfulness in life despite pain will be measured using the five-item Pain Solutions Questionnaire - Meaningfulness in Life Despite Pain subscale.

    Measured: 0 weeks, 5 weeks, and 9 weeks (baseline, immediately post-intervention, 4-weeks 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 posted2 Jul 2017
  2. Study start17 Nov 2017
  3. Primary completion11 Feb 2020
  4. Study completion11 Feb 2020

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
Not applicable
Intervention model
Single group
Model description
Single group assignment
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03207360
Sponsor's protocol ID
Pro00083582
Other IDs
130526-PF-17-054-01-PCSM
Status last verified
Jan 2020
First submitted
30 Jun 2017
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Winger JG, Ramos K, Kelleher SA, Somers TJ, Steinhauser KE, Porter LS, Kamal AH, Breitbart WS, Keefe FJ. Meaning-Centered Pain Coping Skills Training: A Pilot Feasibility Trial of a Psychosocial Pain Management Intervention for Patients with Advanced Cancer. J Palliat Med. 2022 Jan;25(1):60-69. doi: 10.1089/jpm.2021.0081. Epub 2021 Aug 12.

    PubMed 34388037

Questions about this trial

What is this clinical trial studying?

A study testing Pain Coping Skills in people with Advanced Cancer and Pain, 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 5 inclusion and 3 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 13 Feb 2020. 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?

Feasibility as measured by study accrual (time frame: 5 weeks (immediately post-intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03207360, which also lists 1 linked publication.

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 13 Feb 2020.

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Pain Coping Skills and Meaning-Centered Intervention | AzTrials