Chronic Cancer Pain Management Program (ICMP)

February 29, 2024 updated by: Karen Zhang, Hamilton Health Sciences Corporation

Evaluating an Online Interprofessional Chronic Pain Management Group for Survivors of Breast Cancer: A Feasibility Study of a Randomized Controlled Trial

The goal of this research study is to evaluate an online inter-professional pain management program for survivors of breast cancer.

The main questions it aims to answer:

  1. whether this treatment will help address the pain management concerns of patients,
  2. whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT).

Participants will be asked to attend a 6-week online pain management group sessions (1h/week). Participants will also be asked to fill out questionnaires before and after the program completion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Survivors of breast cancer often experience chronic pain that is undertreated and gets in the way of their functioning, relationships, mental health, and quality of life. There is little research on the best ways of treating chronic pain in cancer that make good use of all the expertise offered by different health care providers such as nurses, psychologists, and physiotherapists. In addition, little is known about how to offer such a service in an online format.

This study aims to pilot an online interprofessional pain management program for survivors of breast cancer. The investigators would like to know whether this treatment will help address the pain management concerns of patients, and whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT).

Participants in the study will attend a 6-week online pain management program (I-Can-Manage-Pain after cancer) that will cover the topics of understanding cancer pain, exercises to manage pain and psychological strategies to cope with pain. Questionnaires will be administered before and after the program to assess their satisfaction and changes in outcomes related to pain, quality of life, confidence to manage their pain, and use of health care services. The feasibility of implementing the study and the program will be pre-determined by an acceptability criteria for patient recruitment, completion of questionnaires, participation in the online sessions, and satisfaction with the pain management program.

It is hoped that study findings will help inform the development of treatment programs to improve post-treatment pain management and the quality of life of survivors of breast cancer patients.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Karen Zhang, PHD
  • Phone Number: 65126 905.521.2100
  • Email: zhangka@HHSC.CA

Study Contact Backup

  • Name: Silva Darrouj, HBSc
  • Phone Number: 905-961-9973
  • Email: darrouj@hhsc.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:
        • Contact:
          • Dr. Karen Zhang, PHD
          • Phone Number: 65126 905.521.2100
          • Email: zhangka@HHSC.CA
        • Principal Investigator:
          • Karen Zhang, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. diagnosis of Stage 1-3 breast cancer;
  2. had surgical excision at least 3 months ago;
  3. completed neoadjuvant/adjuvant chemotherapy and/or radiation treatment at least 4 months ago;
  4. within 5 years post active cancer treatment;
  5. persistent pain within the last 3 months that is bothersome;
  6. medical clearance to participate in the intervention
  7. over 18 years of age;
  8. verbal fluency in English;
  9. have access to internet and technology to participate in the online program. Patients currently receiving adjuvant endocrine therapy or molecularly targeted therapies or who have completed these therapies within the last 5 years are eligible to participate.

Exclusion Criteria:

  • Participants will be excluded from the study if they:

    1. demonstrate significant cognitive impairment as determined by the clinical judgment of the provider;
    2. have a pre-existing non-cancer pain condition,
    3. have severe emotional distress that interferes with group participation as determined by scores above 15 on the Patient Health Questionnaire-9.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancer Pain Management Group
Participants in the study will attend a 6-week online pain management program (I-Can-Manage-Pain after cancer) that will cover the topics of understanding cancer pain, exercises to manage pain and psychological strategies to cope with pain. Questionnaires will be administered before and after the program
Behavioral: I-Can-Manage-Pain after cancer (Pain Management Program)
6-week online interprofessional cancer pain management program (I-Can-Manage-Pain after cancer) for survivors of breast cancer. The program will cover the topics of understanding cancer pain, exercises to manage pain and psychological strategies to cope with pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Interference.
Time Frame: 6 weeks
This construct will be measured using the 6-item Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Scale. (PIS) The PIS uses a 5-point rating scale to determine the degree to which an individual perceives their pain symptoms to interfere with their physical, mental and social functioning. Sum of raw scores will be translated to a T-score using a conversion table. A T-score of 50 with a standard deviation of 10 is the average for the general population based on United States Data. The minimally important difference20 for the PIS scores among pain samples ranges from 2 to 3 T-score points.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity.
Time Frame: 6 weeks
The three-item PROMIS Pain Intensity-Short Form measures the severity of pain over a course of 7 days. Scores on this scale range from 3-15. Higher scores indicate higher pain intensity
6 weeks
Pain Catastrophizing;
Time Frame: 6 weeks
Catastrophizing is the anticipation of negative pain experience and will be measured using the 13-item Pain Catastrophizing Scale. The scores on this scale range from 0-52 and higher scores indicate higher tendency for pain catastrophizing
6 weeks
Psychological Distress (depression, anxiety, stress)
Time Frame: 6 weeks
Will be assessed by degree of depression, anxiety, stress. The 21-item Depression, Anxiety and Stress Scale (DASS-21) will be used to measure mood, anxiety and stress symptoms over the past week. Higher scores on the three subscales of depression, anxiety and stress indicate higher emotional distress.
6 weeks
Psychological Distress (Fear of Cancer recurrence)
Time Frame: 6 weeks
Fear of cancer recurrence will be assessed using the 6-item Cancer Worry Scale (CWS). Score of 14 or above indicates high levels of fear of recurrence
6 weeks
Self-Efficacy
Time Frame: 6 weeks
Will be assessed using the brief version of the cancer behavior inventory (CBI-B). The CBI is a 12-item measure examines the degree to which an individual feels confident in self-managing their cancer. This measure shows good internal consistency. Higher scores indicator greater confidence in self-managing cancer.
6 weeks
Healthcare Utilization
Time Frame: 6 weeks
Will be assessed using the Health Service Utilization Questionnaire. This questionnaire assesses health care facility visits, procedures obtained and support services used. Higher numbers indicates more usage of healthcare services
6 weeks
Patient Satisfaction
Time Frame: 6 weeks
Items 12-14 on the Patient Satisfaction Survey will be used to measure the extent to which patients understood the survey questions, and their satisfaction with the survey length
6 weeks
Trial adherence and fidelity
Time Frame: 12 months
Percentage of participants completing the trial questionnaire and the intervention program.
12 months
Trial Feasibility (ability to recruit patients)
Time Frame: 12 months
ability to recruit patients will be assessed using the trial screening and recruitment log. A recruitment of 1-2 participants per week is considered sufficient.
12 months
Patients' satisfaction with the intervention.
Time Frame: 12 months
patients' satisfaction with the intervention will be measured using the patients' satisfaction survey (PSS). Scores on items 1-4 and 10-14 of PSS range between 1-5. Higher scores on items 1-4 and 10-14 indicates higher satisfaction. Other items will be analyzed qualitatively.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

McMaster University

Investigators

  • Principal Investigator: Karen Zhang, PHD, Hamilton Health Sciences Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2024

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on I-Can-Manage-Pain after cancer (Pain Management Program)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe