Cancer, Caregivers, Coping, Psychoeduction, Stem Cell Transplant
Conditions
Brief summary
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.
Interventions
BEHAVIORALPsychoeducation
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.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Less than 18 years of age * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure (FIM) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | Baseline, 1 month, 3 months | Perceived Stress Scale (PSS) |
| Depression | Baseline, 1 month, 3 months | Centre for Epidemiological Studies- Depression (CES-D) scale |
| Caregiver Quality of Life | Baseline, 1 month, 3 months | Caregiver Quality of Life Index- Cancer Scale |
| Satisfaction with Life | Baseline, 1 month, 3 months | Satisfaction with Life Scale |
| Anxiety | Baseline, 1 month, 3 months | State-Trait Anxiety Inventory (STAI) |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORSamantha Mayo, RN, PhD
University Health Network, Toronto
Outcome results
None listed