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ICMP: Chronic Cancer Pain Management Program

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06101849
Collaborator
McMaster University (Other)
30
Enrollment
1
Arm
8.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: I-Can-Manage-Pain after cancer (Pain Management Program)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A pre-post study design.A pre-post study design.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating an Online Interprofessional Chronic Pain Management Group for Survivors of Breast Cancer: A Feasibility Study of a Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jul 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pain Interference. [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.

Secondary Outcome Measures

  1. Pain intensity. [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

  2. Pain Catastrophizing; [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

  3. Psychological Distress (depression, anxiety, stress) [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.

  4. Psychological Distress (Fear of Cancer recurrence) [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

  5. Self-Efficacy [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. Healthcare Utilization [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

  7. Patient Satisfaction [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

  8. Trial adherence and fidelity [12 months]

    Percentage of participants completing the trial questionnaire and the intervention program.

  9. Trial Feasibility (ability to recruit patients) [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.

  10. Patients' satisfaction with the intervention. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hamilton Health Sciences Corporation
  • McMaster University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Karen Zhang, Clinical, Health and Rehabilitation Psychologist, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT06101849
Other Study ID Numbers:
  • 16187
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karen Zhang, Clinical, Health and Rehabilitation Psychologist, Hamilton Health Sciences Corporation
Pain
Breast Cancer
Cancer Pain
Pain Management
psycho-oncology
Psychology
quality of life
Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms, Second Primary
Cancer Pain

Study Results

No Results Posted as of Oct 26, 2023