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

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: Completed
• Conditions: Leukemia; Cancer; Stem Cell Transplant
• Intervention / Treatment: Behavioral: Peer Support

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure (FIM)	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)	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)	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	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	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

Outcome Measure	Measure Description	Time Frame
Social Connectedness	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	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	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

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Samantha Mayo, RN PhD, University Health Network, Toronto

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
• Lee, R. M., Robbins, S. B., & Hill, C. E. (1995). Measuring Belongingness: The Social Connectedness and the Social Assurance Scales. Journal of Counseling Psychology, 42(2), 232-241. https://doi.org/10.1037/0022-0167.42.2.232

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): February 7, 2025
• Study Completion (Actual): February 7, 2025

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: peer support; adolescents and young adults
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms; Leukemia
• Other Study ID 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