Life After Breast Cancer - Impact of a Life Coach (Lifecoach)
Primary Purpose
Survivorship, Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group life-coaching
Individual life-coaching
Sponsored by
About this trial
This is an interventional supportive care trial for Survivorship focused on measuring Breast Cancer Survivorship, Post-traumatic Growth, Quality of Life, Fear of Recurrence, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- have been diagnosed with stage I, II, or III breast cancer;
- are female breast cancer patients over the age of 18;
- have completed anti-cancer treatment via surgery and/or chemotherapy and /or radiation therapy at the McGill University Health Centre Breast Clinic;
- are fluent in written and spoken English or French;
- are alert and oriented and capable of giving informed consent;
- have an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).
Exclusion Criteria:
- have a recurrence of breast cancer;
- are diagnosed with a second cancer;
- are diagnosed with stage IV breast cancer due to their worse prognosis; and 4) have an active psychiatric diagnosis that would render adherence to the study problematic.
Sites / Locations
- Cedar's Breast Clinic, Royal Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Arm 1 - Group and Individual
Arm 2 - Group only
Arm 3 - Routine care
Arm Description
Participants in this experimental Arm 1 will receive the 3 group sessions followed by 4 to 5 individual coaching sessions via phone calls that last 60 minutes each.
Arm 2 will receive only the first 3 Life coach sessions (group session).
Arm 3 will receive routine care by the Breast clinic team for the entire course of the study.
Outcomes
Primary Outcome Measures
Change from baseline Post-traumatic growth (PTG) assessed by the Post-Traumatic Growth Inventory (PTGI)
The PTGI consists of 21 items, the response scale is a 6-point Likert scale asking respondents the degree to which changes occurred in their lives as a result of the crisis, where 0 represented "I did not experience this change" and 5 represented "I experienced this change to a very great degree". The PTGI is composed of 5 subscales, with 5 items measuring the construct New Possibilities, 7 items measuring the construct Relating to Others, 4 items measuring the construct Personal Strength, 3 items measuring the construct Appreciation of Life and 2 items measuring the construct Spiritual Change. The scores are summed to provide an overall measure of post-traumatic growth ranging from 0 - 105 where higher scores indicate more reported growth.
Secondary Outcome Measures
Change from baseline Fear of cancer recurrence (FCR) assessed by the Cancer Worry Scale (CWS)
The CWS is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The six items are rated on a 4-point Likert scale ranging from 1 ("never") to 4 ("almost always"). Possible scores range from 6 to 24 with higher scores indicating more worry.
Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference
The PROPr is a 31-item instrument assessing eight domains (29 items) (i.e., anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities, and pain intensity), and Cognitive Function Abilities (2 items). Raw scores generated for each domain are transformed into T scores; higher PROMIS T scores indicate greater endorsement of the construct being assessed.
Full Information
NCT ID
NCT05020561
First Posted
August 12, 2021
Last Updated
August 19, 2021
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Quebec Breast Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05020561
Brief Title
Life After Breast Cancer - Impact of a Life Coach
Acronym
Lifecoach
Official Title
Adjustment to Life After Breast Cancer Treatment: Can a Life-Coach Make a Difference
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Quebec Breast Cancer Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of our intervention are to
Ease the transition between cancer treatment and active life, and
Allow breast cancer survivors to take control of their lives.
The primary objective of this study is to:
1) Determine whether individual life coaching (i.e., individualized guidance that helps to put resources into action) can significantly improve quality of life and post-traumatic growth among women who have been recently treated with breast cancer.
It is hypothesized that:
Participants who receive both "group coaching sessions" and "individualized coaching sessions" will report greater post-traumatic growth and quality of life, and less fear of cancer recurrence when compared to the breast cancer survivors who received only the group coaching sessions or usual care.
Participants who receive only the group coaching sessions will report greater post-traumatic growth and quality of life, and lesser fear of cancer recurrence when compared to the participants who receive usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survivorship, Breast Cancer
Keywords
Breast Cancer Survivorship, Post-traumatic Growth, Quality of Life, Fear of Recurrence, Randomized controlled trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 - Group and Individual
Arm Type
Experimental
Arm Description
Participants in this experimental Arm 1 will receive the 3 group sessions followed by 4 to 5 individual coaching sessions via phone calls that last 60 minutes each.
Arm Title
Arm 2 - Group only
Arm Type
Experimental
Arm Description
Arm 2 will receive only the first 3 Life coach sessions (group session).
Arm Title
Arm 3 - Routine care
Arm Type
No Intervention
Arm Description
Arm 3 will receive routine care by the Breast clinic team for the entire course of the study.
Intervention Type
Behavioral
Intervention Name(s)
Group life-coaching
Intervention Description
Group coaching sessions will be focusing on providing material and tools that guide the participants in the transition from cancer treatment to survivorship. All activities of the group session will be following the "After Cancer Passport" document.
Intervention Type
Behavioral
Intervention Name(s)
Individual life-coaching
Intervention Description
In the individual coaching sessions, the life-coach will provide guidances that help the participants to put tools into actions. All activities are outlined in the After Cancer Passport. Participants will use their Passport for each individual coaching session to outline their objectives and indicators of success. The life coach will also assign activities, such as self-reflection, for the participants to complete between each session.
Primary Outcome Measure Information:
Title
Change from baseline Post-traumatic growth (PTG) assessed by the Post-Traumatic Growth Inventory (PTGI)
Description
The PTGI consists of 21 items, the response scale is a 6-point Likert scale asking respondents the degree to which changes occurred in their lives as a result of the crisis, where 0 represented "I did not experience this change" and 5 represented "I experienced this change to a very great degree". The PTGI is composed of 5 subscales, with 5 items measuring the construct New Possibilities, 7 items measuring the construct Relating to Others, 4 items measuring the construct Personal Strength, 3 items measuring the construct Appreciation of Life and 2 items measuring the construct Spiritual Change. The scores are summed to provide an overall measure of post-traumatic growth ranging from 0 - 105 where higher scores indicate more reported growth.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline Fear of cancer recurrence (FCR) assessed by the Cancer Worry Scale (CWS)
Description
The CWS is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The six items are rated on a 4-point Likert scale ranging from 1 ("never") to 4 ("almost always"). Possible scores range from 6 to 24 with higher scores indicating more worry.
Time Frame
12 months
Title
Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference
Description
The PROPr is a 31-item instrument assessing eight domains (29 items) (i.e., anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, ability to participate in social roles and activities, and pain intensity), and Cognitive Function Abilities (2 items). Raw scores generated for each domain are transformed into T scores; higher PROMIS T scores indicate greater endorsement of the construct being assessed.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
have been diagnosed with stage I, II, or III breast cancer;
are female breast cancer patients over the age of 18;
have completed anti-cancer treatment via surgery and/or chemotherapy and /or radiation therapy at the McGill University Health Centre Breast Clinic;
are fluent in written and spoken English or French;
are alert and oriented and capable of giving informed consent;
have an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).
Exclusion Criteria:
have a recurrence of breast cancer;
are diagnosed with a second cancer;
are diagnosed with stage IV breast cancer due to their worse prognosis; and 4) have an active psychiatric diagnosis that would render adherence to the study problematic.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarkis Meterissian, M.D.
Phone
514-934-1934
Email
sarkis.meterissian.med@ssss.gouv.qc.ca
Facility Information:
Facility Name
Cedar's Breast Clinic, Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarkis Meterissian, Dr.
Phone
514-934-1934
Ext
36631
Email
sarkis.meterissian@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Sarkis Meterissian, DR
First Name & Middle Initial & Last Name & Degree
Virginia Lee, PhD
First Name & Middle Initial & Last Name & Degree
Christine Maheu, PhD
First Name & Middle Initial & Last Name & Degree
Sophie Blondin, MA
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
will be submitted to the International Journal of Clinical Trials (IJCT) in November 2022
Learn more about this trial
Life After Breast Cancer - Impact of a Life Coach
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