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

NCT06704243 | Completed

• 1 other identifier: 23-5959
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Leukemia; Stem Cell Transplant

Keywords

peer support; adolescents and young adults

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Social Connectedness

  Baseline, 3 months, and 6 months

• Anxiety

  Baseline, 3 months, and 6 months

• Depressive Symptoms

  Baseline, 3 months, and 6 months

Study Arms (1)

Peer Support

EXPERIMENTAL

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

Interventions

Peer Support BEHAVIORAL

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.

Peer Support

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- Non-English speaking

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (4)

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Neoplasms; Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Samantha Mayo, RN PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 26, 2024
• Study Start: May 24, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)