Clinical trial NCT05020561: Life After Breast Cancer - Impact of a Life Coach
Official title: Adjustment to Life After Breast Cancer Treatment: Can a Life-Coach Make a Difference
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Survivorship
Breast Cancer
Keywords: Breast Cancer Survivorship
Post-traumatic Growth
Quality of Life
Fear of Recurrence
Randomized controlled trial
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Quebec Breast Cancer Foundation
First posted: 2021-08-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Post-traumatic growth (PTG) assessed by the Post-Traumatic Growth Inventory (PTGI)
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline Fear of cancer recurrence (FCR) assessed by the Cancer Worry Scale (CWS)
timeFrame: 12 months
measure: Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference
timeFrame: 12 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Cedar's Breast Clinic, Royal Victoria Hospital
state: Quebec
Study officials:
References: