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CancerNCT06704243

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

A study testing Peer Support in people with Cancer and Leukemia, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Cancer, Leukemia, Stem Cell Transplant
What is being tested?
Peer Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteCanada
Study dates
24 May 2024to 7 Feb 2025
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 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • Non-English speaking

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Being tested
Peer Support
Keywords
peer support, adolescents and young adults
Medical subject headings
Neoplasms, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer SupportBehavioural

    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.

Study groups in NCT06704243
Study groupRoleWhat they receive
Peer SupportExperimentalThe intervention will be a monthly online AYA peer support group (1 hour) that will run for six months via Microsoft Teams.
Receives: Behavioral: Peer Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 6 months

  2. 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.

    Measured: at 6 months

  3. 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.

    Measured: at 6 months

  4. 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.

    Measured: at 6 months

  5. 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.

    Measured: at 6 months

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, 3 months, and 6 months

  2. 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.

    Measured: Baseline, 3 months, and 6 months

  3. 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.

    Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start24 May 2024
  3. Primary completion7 Feb 2025
  4. Study completion7 Feb 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06704243
Sponsor's protocol ID
23-5959
Status last verified
Dec 2025
First submitted
25 Oct 2024
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16717171

  • 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.

    PubMed 28851459

  • 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.

    PubMed 11556941

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Peer Support in people with Cancer and Leukemia, run by University Health Network, Toronto 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jan 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Intervention Measure (FIM) (time frame: at 6 months). The study lists 5 primary outcomes in all. 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 NCT06704243, which also lists 4 linked publications.

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 6 Jan 2026.

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