Peer Support Group for Adolescent and Young Adult (AYA) Allogeneic Stem Cell Transplant Recipients

December 31, 2025 updated by: Samantha Mayo, University Health Network, Toronto

Peer Support Group for AYA Allogeneic Stem Cell Transplant Recipients

Allogeneic Haemopoietic Stem Cell Transplant (Allo-HSCT) is a potentially curative option for patients with both malignant and non-malignant hematological disorders. There appears to be unique experiences that adolescents and young adults (AYA) face when undergoing transplant. There is literature to suggest that peer support for young adults is associated with improvements in mental health including greater happiness, self-esteem and effective coping, as well as reductions in depression, loneliness and anxiety.

Our primary objective is to determine the feasibility and acceptability of an AYA peer support program for patients undergoing Allo-HSCT. Our secondary objective is to explore the impact of the AYA peer support program on sense of support/connectivity, anxiety, and depression.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-39 years of age
  • >3 months post Allo-HSCT
  • any malignant /non-malignant indication for Allo-HSCT

Exclusion Criteria:

- Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peer Support
The intervention will be a monthly online AYA peer support group (1 hour) that will run for six months via Microsoft Teams.
Behavioral: Peer Support

The intervention will be a monthly online AYA peer support group (1 hour) that will run for six months via Microsoft Teams.

In an effort to evaluate a patient-driven "real-world" intervention, the support group has been designed with the following features: 1) participants will be asked to commit for a six month period, but are able to miss sessions if necessary; and, 2) each session will be facilitated by a Nurse Practitioner and Social Worker from the Allo-HSCT program, but the topics of discussion will be determined by the AYA participants present at each session. Participants in the group will then be invited to share their thoughts and experiences about these topics, with as much information as they feel comfortable.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention Measure (FIM)
Time Frame: at 6 months
The Feasibility of Intervention Measure (FIM) revised to evaluated the AYA peer support program comprises 4-items regarding the respondent's perceptions of the feasibility of the intervention. Responses range from 1 (completely disagree) to 5 (completely agree). Scale value is computed by averaging responses and ranges from 1-5. Higher values indicate greater feasibility of the intervention.
at 6 months
Acceptability of Intervention Measure (AIM)
Time Frame: at 6 months
The Acceptability of Intervention Measure (AIM) revised to evaluated the AYA peer support program comprises 4-items regarding the respondent's perceptions of the acceptability of the intervention. Responses range from 1 (completely disagree) to 5 (completely agree). Scale value is computed by averaging responses and ranges from 1-5. Higher values indicate greater acceptability of the intervention.
at 6 months
Intervention Appropriateness Measure (IAM)
Time Frame: at 6 months
The Intervention Appropriate Measure (IAM) revised to evaluated the AYA peer support program comprises 4-items regarding the respondent's perceptions of the appropriateness of the intervention. Responses range from 1 (completely disagree) to 5 (completely agree). Scale value is computed by averaging responses and ranges from 1-5. Higher values indicate greater appropriateness of the intervention.
at 6 months
Post-intervention Qualitative interviews
Time Frame: at 6 months
Post-intervention qualitative interviews with participants will also explore their perceptions of the feasibility and acceptability of the intervention, including suggestions for improvement of the intervention. These semi-structured interviews will also help explore participant's opinions related to program length, time, usefulness, and delivery.
at 6 months
Intervention usage
Time Frame: at 6 months
Intervention usage (i.e. proportion of sessions attended by each participant) will be calculated based on attendance lists for each session collected by the session facilitators. Reasons for non-attendance or early drop-out from a session will be collected, but this is optional for participants.
at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social Connectedness
Time Frame: Baseline, 3 months, and 6 months
The Social Connectedness Scale is a measure of one's sense of belonging or connectedness between the self and other people, including friends and society. It comprises 20-items about one's view of themselves, rated from 1 (strongly disagree) to 6 (strongly agree). Scores are calculated by summing responses to the 20 items. Possible scores range from 20-120, with higher scores indicating better social connectedness.
Baseline, 3 months, and 6 months
Anxiety
Time Frame: Baseline, 3 months, and 6 months
GAD-7 (Generalized Anxiety Disorder screener) is a measure of anxiety. It comprises 7-items about one's bother with anxiety symptoms, rated from 0 (not at all) to 3 (nearly every day). Scores are calculated by summing responses to the 7 items. Possible scores range from 0-21, with higher scores indicating worse anxiety.
Baseline, 3 months, and 6 months
Depressive Symptoms
Time Frame: Baseline, 3 months, and 6 months
PHQ-9 (Patient Health Questionnaire -9) is a measure of depressive symptoms. It comprises 9-items about one's bother with depressive symptoms, rated from 0 (not at all) to 3 (nearly every day). Scores are calculated by summing responses to the 9 items. Possible scores range from 0-27, with higher scores indicating worse depressive symptoms.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Samantha Mayo, RN PhD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-5959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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