CancerNCT07116018
Psychoeducation for AlloHCT Caregivers
A study testing Psychoeducation in people with Cancer and Caregivers, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Background: Caregivers of patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for hematological malignancies face significant challenges that can impact their well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Caregivers, Stem Cell Transplant
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 21 May 2025to 23 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be caregiver for an adult patient diagnosed with hematological malignancy who is scheduled to receive allogeneic stem cell transplant.
- Are recruited and consented to participate in the caregiver study during the patient's pre-transplant screening phase for allogeneic stem cell transplant.
- Will provide care for the patient from the day of allogeneic stem cell transplant up to 100 days post- transplant.
- Are willing to begin the study intervention no earlier than 0-day post-transplant and not later than 2-weeks post-transplant.
Who cannot join
- Less than 18 years of age
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
Canada1 site
Princess Margaret Cancer Centre, University Health Network
Toronto, Ontario, M5G 2M9
About this study
Official title: Feasibility Testing of an Adapted Psychoeducational Intervention for Caregivers of Patients Undergoing Allogeneic Stem Cell Transplant for Hematological Malignancy
Background: Caregivers of patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for hematological malignancies face significant challenges that can impact their well-being. This study aims to evaluate the feasibility and acceptability of an adapted psychoeducational intervention(PEI) designed to support these caregivers.
Methods: This study will recruit caregivers of alloHCT patients. Participants will be enrolled during pre-transplant clinic visits, typically 2-4 weeks before the scheduled transplant. The intervention consists of eight sessions over 12 weeks, delivered via Microsoft Teams by a nurse facilitator. In the adapted PEI, participants will learn stress management, coping strategies, energy management, goal-setting, communication skills, and support resource access through interactive exercises. Data Collection: Participants will complete questionnaires at three time points: pre-intervention, one month post-transplant, and three months post-transplant. The final assessment will include additional questions about feasibility, acceptability and the initial efficacy of the adapted PEI.
Read more
Outcomes: The primary outcomes will be the feasibility and acceptability of the adapted psychoeducational intervention (PEI). Secondary outcomes will include initial efficacy of the adapted PEI on caregiver outcomes such as depression, anxiety, satisfaction with caregiving and quality of life.
Significance: This research aims to assess the feasibility, acceptability and initial efficacy of implementing the adapted PEI for alloHCT caregivers. If found feasible and acceptable, this intervention could potentially improve caregivers' ability to manage caregiving stressors and pave the way for larger-scale randomized studies and implementation.
- Conditions
- Cancer, Caregivers, Stem Cell Transplant, Psychoeduction, Coping
- Being tested
- Psychoeducation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
The intervention comprises 8 individual psychoeducational sessions over 12 weeks, as an adaptation of the Psychoeducation, Paced Respiration, and Relaxation (PEPRR) (Laudenslager et al., 2015). The adaptation in the current study involves delivery by a trained nurse and omission of the biofeedback component.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational intervention | Experimental | The intervention will be psychoeducational program, comprising a series of 8 individual sessions over a 12 week period. The intervention is a manualized, adapted version of the Psychoeducation, Paced Respiration, and Relaxation (PEPRR) intervention (Laudenslager et al. 2015). Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure (FIM)
The Feasibility of Intervention Measure (FIM) revised to evaluated the psychoeducation 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: 3 months
Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) revised to evaluated the psychoeducation 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: 3 months
Intervention Appropriateness Measure (IAM)
The Intervention Appropriate Measure (IAM) revised to evaluated the psychoeducation 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: 3 months
Secondary outcomes (5)
Perceived Stress
Perceived Stress Scale (PSS)
Measured: Baseline, 1 month, 3 months
Depression
Centre for Epidemiological Studies- Depression (CES-D) scale
Measured: Baseline, 1 month, 3 months
Caregiver Quality of Life
Caregiver Quality of Life Index- Cancer Scale
Measured: Baseline, 1 month, 3 months
Satisfaction with Life
Satisfaction with Life Scale
Measured: Baseline, 1 month, 3 months
Anxiety
State-Trait Anxiety Inventory (STAI)
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start21 May 2025
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Mayo, University Health Network, Toronto
- Investigators
- Samantha Mayo, RN, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116018
- Sponsor's protocol ID
- 24-5539
- Status last verified
- Jun 2026
- First submitted
- 4 Aug 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laudenslager ML, Simoneau TL, Kilbourn K, Natvig C, Philips S, Spradley J, Benitez P, McSweeney P, Mikulich-Gilbertson SK. A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: effects on distress. Bone Marrow Transplant. 2015 Aug;50(8):1110-8. doi: 10.1038/bmt.2015.104. Epub 2015 May 11.
PubMed 25961767
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of an Adapted Psychoeducational Intervention for Caregivers of Patients Undergoing Allogeneic Stem Cell Transplant for Hematological Malignancy
- ClinicalTrials.gov ID
- NCT07116018
- Acronym / sponsor ID
- 24-5539
- Conditions
- Cancer, Caregivers, Stem Cell Transplant, Psychoeduction, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Caregivers of patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for hematological malignancies face significant challenges that can impact their well-being. This study aims to evaluate the feasibility and acceptability of an adapted psychoeducational intervention(PEI) designed to support these caregivers.
Methods: This study will recruit caregivers of alloHCT patients. Participants will be enrolled during pre-transplant clinic visits, typically 2-4 weeks before the scheduled transplant. The intervention consists of eight sessions over 12 weeks, delivered via Microsoft Teams by a nurse facilitator. In the adapted PEI, participants will learn stress management, coping strategies, energy management, goal-setting, communication skills, and support resource access through interactive exercises. Data Collection: Participants will complete questionnaires at three time points: pre-intervention, one month post-transplant, and three months post-transplant. The final assessment will include additional questions about feasibility, acceptability and the initial efficacy of the adapted PEI.
Outcomes: The primary outcomes will be the feasibility and acceptability of the adapted psychoeducational intervention (PEI). Secondary outcomes will include initial efficacy of the adapted PEI on caregiver outcomes such as depression, anxiety, satisfaction with caregiving and quality of life.
Significance: This research aims to assess the feasibility, acceptability and initial efficacy of implementing the adapted PEI for alloHCT caregivers. If found feasible and acceptable, this intervention could potentially improve caregivers' ability to manage caregiving stressors and pave the way for larger-scale randomized studies and implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational intervention | Experimental | Behavioral: PsychoeducationThe intervention will be psychoeducational program, comprising a series of 8 individual sessions over a 12 week period. The intervention is a manualized, adapted version of the Psychoeducation, Paced Respiration, and Relaxation (PEPRR) intervention (Laudenslager et al. 2015). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be caregiver for an adult patient diagnosed with hematological malignancy who is scheduled to receive allogeneic stem cell transplant.
- Are recruited and consented to participate in the caregiver study during the patient's pre-transplant screening phase for allogeneic stem cell transplant.
- Will provide care for the patient from the day of allogeneic stem cell transplant up to 100 days post- transplant.
- Are willing to begin the study intervention no earlier than 0-day post-transplant and not later than 2-weeks post-transplant.
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationThe intervention comprises 8 individual psychoeducational sessions over 12 weeks, as an adaptation of the Psychoeducation, Paced Respiration, and Relaxation (PEPRR) (Laudenslager et al., 2015). The adaptation in the current study involves delivery by a trained nurse and omission of the biofeedback component. | Behavioural | Psychoeducational intervention |
Primary outcome
Feasibility of Intervention Measure (FIM)
Time frame: 3 months
The Feasibility of Intervention Measure (FIM) revised to evaluated the psychoeducation 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.
Acceptability of Intervention Measure (AIM)
Time frame: 3 months
The Acceptability of Intervention Measure (AIM) revised to evaluated the psychoeducation 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.
Intervention Appropriateness Measure (IAM)
Time frame: 3 months
The Intervention Appropriate Measure (IAM) revised to evaluated the psychoeducation 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.
5 secondary outcomes
Perceived Stress
Time frame: Baseline, 1 month, 3 months
Depression
Time frame: Baseline, 1 month, 3 months
Caregiver Quality of Life
Time frame: Baseline, 1 month, 3 months
Satisfaction with Life
Time frame: Baseline, 1 month, 3 months
Anxiety
Time frame: Baseline, 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 25961767Laudenslager ML, Simoneau TL, Kilbourn K, Natvig C, Philips S, Spradley J, Benitez P, McSweeney P, Mikulich-Gilbertson SK. A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: effects on distress. Bone Marrow Transplant. 2015 Aug;50(8):1110-8. doi: 10.1038/bmt.2015.104. Epub 2015 May 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Mayo, RN, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Cancer and Caregivers, 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 4 inclusion and 2 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 15 Jun 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: 3 months). The study lists 3 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 NCT07116018, which also lists 1 linked publication.
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 15 Jun 2026.