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Trial Title:
Chronic Cancer Pain Management Program
NCT ID:
NCT06101849
Condition:
Breast Cancer
Cancer, Treatment-Related
Pain Cancer
Conditions: Official terms:
Breast Neoplasms
Neoplasms, Second Primary
Cancer Pain
Conditions: Keywords:
Pain
Breast Cancer
Cancer Pain
Pain Management
psycho-oncology
Psychology
quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
A pre-post study design.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
I-Can-Manage-Pain after cancer (Pain Management Program)
Description:
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
Arm group label:
Cancer Pain Management Group
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Juravinski Cancer Centre
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Silva Darrouj, HBSc
Phone:
905-961-9973
Email:
darrouj@hhsc.ca
Contact backup:
Last name:
Dr. Karen Zhang, PHD
Phone:
905.521.2100
Phone ext:
65126
Email:
zhangka@HHSC.CA
Investigator:
Last name:
Karen Zhang, PHD
Email:
Principal Investigator
Start date:
January 3, 2024
Completion date:
July 30, 2024
Lead sponsor:
Agency:
Hamilton Health Sciences Corporation
Agency class:
Other
Collaborator:
Agency:
McMaster University
Agency class:
Other
Source:
Hamilton Health Sciences Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06101849
