Life After Breast Cancer - Impact of a Life Coach

Breast Cancer Clinical Trial

— Lifecoach  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05020561
• Other study ID #: 2022-7735
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Sarkis Meterissian, M.D.
• Phone: 514-934-1934
• Email: sarkis.meterissian.med[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. have been diagnosed with stage I, II, or III breast cancer;

2. are female breast cancer patients over the age of 18;

3. have completed anti-cancer treatment via surgery and/or chemotherapy and /or radiation therapy at the McGill University Health Centre Breast Clinic;

4. are fluent in written and spoken English or French;

5. are alert and oriented and capable of giving informed consent;

6. have an Internet connection at home that supports participation in coaching sessions via videoconferencing (zoom).

Exclusion Criteria:

1. have a recurrence of breast cancer;

2. are diagnosed with a second cancer;

3. 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Survivorship

Intervention

Behavioral:
• Group life-coaching
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.
• Individual life-coaching
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.

Locations

Country	Name	City	State
Canada	Cedar's Breast Clinic, Royal Victoria Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Quebec Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months