Skip to main content
Clinical Trials/NCT05020561
NCT05020561
Unknown
Not Applicable

Adjustment to Life After Breast Cancer Treatment: Can a Life-Coach Make a Difference

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country120 target enrollmentSeptember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Survivorship
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment
120
Locations
1
Primary Endpoint
Change from baseline Post-traumatic growth (PTG) assessed by the Post-Traumatic Growth Inventory (PTGI)
Last Updated
4 years ago

Overview

Brief Summary

The objectives of our intervention are to

  1. Ease the transition between cancer treatment and active life, and
  2. 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:

  1. 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.
  2. 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.
Registry
clinicaltrials.gov
Start Date
September 15, 2021
End Date
September 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible Party
Principal Investigator
Principal Investigator

Dr. Sarkis Meterissian

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Outcomes

Primary Outcomes

Change from baseline Post-traumatic growth (PTG) assessed by the Post-Traumatic Growth Inventory (PTGI)

Time Frame: 12 months

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 Outcomes

  • Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference(12 months)
  • Change from baseline Fear of cancer recurrence (FCR) assessed by the Cancer Worry Scale (CWS)(12 months)

Study Sites (1)

Loading locations...

Similar Trials