NCT05020561

Brief Summary

The objectives of our intervention are to

  1. 1.Ease the transition between cancer treatment and active life, and
  2. 2.Allow breast cancer survivors to take control of their lives.
  3. 3.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.
  4. 4.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

August 12, 2021

Last Update Submit

August 19, 2021

Conditions

Keywords

Breast Cancer SurvivorshipPost-traumatic GrowthQuality of LifeFear of RecurrenceRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline Fear of cancer recurrence (FCR) assessed by the Cancer Worry Scale (CWS)

    12 months

  • Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference

    12 months

Study Arms (3)

Arm 1 - Group and Individual

EXPERIMENTAL

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.

Behavioral: Group life-coachingBehavioral: Individual life-coaching

Arm 2 - Group only

EXPERIMENTAL

Arm 2 will receive only the first 3 Life coach sessions (group session).

Behavioral: Group life-coaching

Arm 3 - Routine care

NO INTERVENTION

Arm 3 will receive routine care by the Breast clinic team for the entire course of the study.

Interventions

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.

Arm 1 - Group and IndividualArm 2 - Group only

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.

Arm 1 - Group and Individual

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedar's Breast Clinic, Royal Victoria Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

  • Tock WL, Maheu C, Blondin S, Lee V, Neuman S, Meterissian S. The Effect of Life Coaching on Post-Traumatic Growth and Well-Being in Breast Cancer Survivors: A Randomized Controlled Trial. Psychooncology. 2025 Oct;34(10):e70295. doi: 10.1002/pon.70295.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 25, 2021

Study Start

September 15, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
will be submitted to the International Journal of Clinical Trials (IJCT) in November 2022

Locations