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Advanced CancerNCT02430467

Caregiver-Guided Pain Management Training in Palliative Care

A study testing Caregiver-guided pain management training (CG-PMT) and Enhanced treatment-as-usual (TAU) in people with Advanced Cancer, 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 purpose of this study is to develop more effective ways to help patients and their caregivers cope with cancer pain. The investigators are looking at the usefulness of a Caregiver-Guided Pain Management Training Intervention versus Pain Education. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Caregiver-guided pain management training (CG-PMT) and Enhanced treatment-as-usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
1 siteUnited States
Study dates
Jul 2015to 4 Oct 2019
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

Patient Inclusion Criteria:

  1. clinical diagnosis Stage 4 solid or hematologic malignancy and nonresectable Stage 3 gastrointestinal (GI) cancer
  2. life expectancy of < 1 month
  3. worst pain in the past 2 weeks greater than or equal to 4 on the 0-10 pain scale,
  4. have an identified caregiver who is also willing to participate,
  5. at least 18 years old, 6) fluent in English.

Caregiver Inclusion Criteria:

  1. at least 18 years old
  2. fluent in English

Patient Exclusion Criteria:

  1. Palliative Performance Scale rating <40,
  2. current external radiation therapy for reduction of pain
  3. unable to provide informed consent or complete study procedures as determined by clinical or study staff.

Caregiver Exclusion Criteria:

  1. unable to provide informed consent or complete study procedures as determined by clinical or study staff.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

The purpose of this study is to develop more effective ways to help patients and their caregivers cope with cancer pain. The investigators are looking at the usefulness of a Caregiver-Guided Pain Management Training Intervention versus Pain Education.

Read the detailed description

The primary aim of this study is to test the efficacy for the Caregiver-Guided Pain Management Training intervention to improve the caregiver's self-efficacy for helping the patient manage pain. Secondary aims include testing the effectiveness of the CG-PMT intervention to improve patient pain severity, patient self-efficacy for pain management and patient psychological distress, as well as short-term caregiver adjustment and caregiver adjustment following the patient's death.

In this multi-site study, 236 dyads (patients with cancer pain and their family caregivers) will be randomized to either a Caregiver-Guided Pain Management Training protocol or to an Enhanced Treatment-as-Usual control condition. Dyads in the Caregiver-Guided Pain Management condition will receive three one-hour sessions conducted via videoconference. Dyads in the Enhanced Treatment-as-Usual condition will receive educational material about cancer pain and its management but will not receive any study-related treatment sessions. Assessments will be conducted with patients and caregivers before and after treatment, and with caregivers 3 months and 6 months following the patient's death. The primary hypothesis to be tested is that caregivers who receive the intervention will report significantly higher levels of self-efficacy for helping the patient manage pain than caregivers in the control condition. Secondary aims will focus on (a) improvements in short-term caregiver adjustment as well as caregiver adjustment following the patient's death, and (b) patient pain severity, self-efficacy for pain management, and psychological distress.

Conditions
Advanced Cancer
Being tested
Caregiver-guided pain management training (CG-PMT), Enhanced treatment-as-usual (TAU)

What participants receive

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

  • Caregiver-guided pain management training (CG-PMT)Behavioural

    Patient-caregiver dyads in the CG-PM arm of the study will receive 3 50-minute sessions via Skype with a masters-level therapist over a 3-week period. The intervention integrates educational information about cancer pain and its management with a behavioral training program to teach patients and caregivers pain coping skills including relaxation, imagery, and activity pacing, and to teach caregivers how to guide and coach the patient in the practice and application of these pain control techniques.

  • Enhanced treatment-as-usual (TAU)Behavioural

    Patient-caregiver dyads in the Enhanced TAU condition will receive the same educational video and booklet on cancer pain and its management that is used as part of the CG-PMT intervention. They will also receive iPads with icons linked to reputable websites that provide educational information on cancer including cancer pain (e.g., ACS, NCI) and will be encouraged to utilize them for information and support. However, they will not meet with a study interventionist nor receive any training in behavioral pain coping skills.

Study groups in NCT02430467
Study groupRoleWhat they receive
Caregiver-guided pain management training protocol (CG-PMT)Active comparatorPatient-caregiver dyads in the CG-PM arm of the study will receive 3 50-minute sessions via Skype with a masters-level therapist over a 3-week period. The intervention integrates educational information about cancer pain and its management with a behavioral training program to teach patients and caregivers pain coping skills including relaxation, imagery, and activity pacing, and to teach caregivers how to guide and coach the patient in the practice and application of these pain control techniques
Receives: Behavioral: Caregiver-guided pain management training (CG-PMT)
Enhanced treatment-as-usual (TAU)Active comparatorPatient-caregiver dyads in the Enhanced TAU condition will receive the same educational video and booklet on cancer pain and its management that is used as part of the CG-PMT intervention. They will also receive iPads with icons linked to reputable websites that provide educational information on cancer including cancer pain (e.g., ACS, NCI) and will be encouraged to utilize them for information and support. However, they will not meet with a study interventionist nor receive any training in behavioral pain coping skills.
Receives: Behavioral: Enhanced treatment-as-usual (TAU)

What is being measured

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

  1. Change in caregiver self-efficacy for helping the patient manage pain

    Caregiver Self-Efficacy Scale

    Measured: baseline, post-intervention (3 weeks)

Secondary outcomes (9)

  1. Change in caregiver strain

    Caregiver Strain Index

    Measured: baseline, following intervention (3 weeks)

  2. Change in caregiver satisfaction

    Caregiving Satisfaction Scale

    Measured: baseline, following intervention (3 weeks)

  3. Change in caregiver psychological distress

    Center for Epidemiology Studies Short Depression Scale

    Measured: baseline, following intervention (3 weeks)

  4. Change in caregiver psychological distress

    Trait Anxiety Scale

    Measured: following death of patient (3 mos & 6 mos)

  5. Change in caregiver health behaviors

    Self-Administered Comorbidity Questionnaire

    Measured: following death of patient (3 mos & 6 mos)

  6. Change in caregiver global health rating

    Global health rating

    Measured: following death of patient (3 mos & 6 mos)

  7. Change in patient pain

    Brief Pain Inventory

    Measured: baseline, post-intervention (3 weeks)

  8. Change in patient self-efficacy

    Patient Self-Efficacy Scale

    Measured: baseline, post-intervention (3 weeks)

  9. Change in patient psychological distress

    Hospital Anxiety and Depression Scale

    Measured: baseline, post-intervention (3 weeks)

Timeline

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

  1. First posted30 Apr 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion1 Nov 2018
  4. Study completion4 Oct 2019

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02430467
Sponsor's protocol ID
Pro00057512
Other IDs
1R01NR015348-01
Status last verified
Aug 2023
First submitted
24 Apr 2015
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Porter LS, Steel JL, Fairclough DL, LeBlanc TW, Bull J, Hanson LC, Fischer S, Keefe FJ. Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial. Palliat Med. 2021 May;35(5):952-961. doi: 10.1177/02692163211004216. Epub 2021 Mar 29.

    PubMed 33775175

  • Porter LS, Samsa G, Steel JL, Hanson LC, LeBlanc TW, Bull J, Fischer S, Keefe FJ. Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study. Clin Trials. 2019 Jun;16(3):263-272. doi: 10.1177/1740774519829695. Epub 2019 Feb 19.

    PubMed 30782014

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver-guided pain management training (CG-PMT) and Enhanced treatment-as-usual (TAU) in people with Advanced Cancer, 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?

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 25 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 caregiver self-efficacy for helping the patient manage pain (time frame: baseline, post-intervention (3 weeks)). 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 NCT02430467, which also lists 2 linked publications.

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 25 Aug 2023.

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