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Completed

NCT Number: NCT06704243

Peer Support Group for Adolescent and Young Adult (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.

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Key information

Conditions

Cancer Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type Stem Cell Transplant

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Peer Support Group for AYA Allogeneic Stem Cell Transplant Recipients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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