SurvivorshipLifecoachNCT05020561
Life After Breast Cancer - Impact of a Life Coach
A study testing Group life-coaching and Individual life-coaching in people with Survivorship and Breast Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Survivorship, Breast Cancer
- What is being tested?
- Group life-coaching and Individual life-coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cedar's Breast Clinic, Royal Victoria Hospital
Montreal, Quebec, H3G 1A4
Sarkis Meterissian, Dr., 514-934-1934 ext. 36631, sarkis.meterissian@muhc.mcgill.ca
Sarkis Meterissian, DR
About this study
Official title: Adjustment to Life After Breast Cancer Treatment: Can a Life-Coach Make a Difference
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.
Read more
The primary objective of this study is to:
- 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.
- Conditions
- Survivorship, Breast Cancer
- Being tested
- Group life-coaching, Individual life-coaching
- Keywords
- Breast Cancer Survivorship, Post-traumatic Growth, Quality of Life, Fear of Recurrence, Randomized controlled trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group life-coachingBehavioural
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-coachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group life-coaching; Behavioral: Individual life-coaching |
| Arm 2 - Group only | Experimental | Arm 2 will receive only the first 3 Life coach sessions (group session). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Breast Cancer Foundation
- Responsible party
- Principal investigator, Dr. Sarkis Meterissian, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020561
- Sponsor's protocol ID
- 2022-7735
- Acronym
- Lifecoach
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 41068064
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustment to Life After Breast Cancer Treatment: Can a Life-Coach Make a Difference
- ClinicalTrials.gov ID
- NCT05020561
- Acronym / sponsor ID
- Lifecoach / 2022-7735
- Conditions
- Survivorship, Breast Cancer
- Keywords
- Breast Cancer Survivorship, Post-traumatic Growth, Quality of Life, Fear of Recurrence, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Quebec Breast Cancer Foundation
- Study start
- 15 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Group and Individual | Experimental | Behavioral: Group life-coaching, Behavioral: Individual life-coachingParticipants 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 - Group only | Experimental | Behavioral: Group life-coachingArm 2 will receive only the first 3 Life coach sessions (group session). |
| Arm 3 - Routine care | No intervention | –Arm 3 will receive routine care by the Breast clinic team for the entire course of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group life-coachingGroup 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. | Behavioural | Arm 1 - Group and Individual, Arm 2 - Group only |
| Individual life-coachingIn 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. | Behavioural | Arm 1 - Group and Individual |
Primary outcome
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.
2 secondary outcomes
Change from baseline Fear of cancer recurrence (FCR) assessed by the Cancer Worry Scale (CWS)
Time frame: 12 months
Change from baseline Quality of life (QoL) assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 41068064Tock 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group life-coaching and Individual life-coaching in people with Survivorship and Breast Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarkis Meterissian, M.D. (514-934-1934, sarkis.meterissian.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Post-traumatic growth (PTG) assessed by the Post-Traumatic Growth Inventory (PTGI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.