Hematologic Malignancy Clinical Trial
— PATH-COfficial title:
Randomized Controlled Trial of a Positive Psychology Based Intervention (PATH-C) for Caregivers of Hematopoietic Stem Cell Transplant Survivors
The goal of this randomized clinical trial is to evaluate whether a positive psychology intervention (PATH-C) can improve psychological well-being, quality of life, and physical activity in caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult caregivers (aged 18 years and older) of patients undergoing allogeneic or autologous HSCT at Dana-Farber Cancer Institute for a hematologic malignancy. - A relative or a friend who either lives with the patient or has in-person contact with them at least twice per week and is identified as the primary caregiver for HSCT. - Ability to speak English and able to complete questionnaires with minimal assistance of an interpreter as this is a feasibility trial of the PATH-C intervention which is currently only available in English. Exclusion Criteria: - Caregivers of patients undergoing HSCT for benign hematologic conditions. - Caregivers with acute or unstable psychiatric conditions which the treating transplant clinician believes prohibits informed consent or compliance with study procedures. - Cognitive deficits impeding a caregiver's ability to provide informed consent or participate adequately in the study assessed via a commonly used 6-item cognitive assessment with the Brief Interview for Mental Status (BIMS) screening tool that is sensitive and specific for screening for cognitive impairment in research participants. |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | American Society of Hematology, Dana-Farber Cancer Institute, Robert Wood Johnson Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Optimism | Compare optimism using the 10-item Life Orientation Test-Revised (LOT-R) between the two groups.
The LOT-R ranges from 0 to 24, with higher scores indicating greater optimism. |
Up to 20 weeks (+/- 28 days) | |
Other | Positive Affect | Compare positive affect using the 15-item Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Short Form between the two groups.
The PROMIS Positive Affect Short Form ranges from 15 to 75, with higher scores indicating greater positive affect. |
Up to 20 weeks (+/- 28 days) | |
Other | Life Satisfaction | Compare life satisfaction using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction Questionnaire between the two groups.
The PROMIS General Life Satisfaction Questionnaire ranges from 10 to 60, with higher scores indicating greater satisfaction with life. |
Up to 20 weeks (+/- 28 days) | |
Other | Gratitude | Compare gratitude using the 6-item Gratitude Questionnaire between the two groups.
The Gratitude Questionnaire ranges from 6 to 42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life. |
Up to 20 weeks (+/- 28 days) | |
Other | Flourishing | Compare flourishing using the 8-item Flourishing Scale between the two groups.
The Flourishing Scale ranges from 8 to 56, with higher scores indicating having more psychological resources and strengths. |
Up to 20 weeks (+/- 28 days) | |
Other | Self-Efficacy | Compare self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between the two groups.
The CASE-t ranges from 0 to 170, with higher scores indicating greater self-efficacy. |
Up to 20 weeks (+/- 28 days) | |
Other | Perceived Coping Skills | Compare coping skills using the Measure of Current Status (MOCS-A) between the two groups.
The MOCS-A ranges from 0 to 52, with higher scores indicating having more coping skills. |
Up to 20 weeks (+/- 28 days) | |
Other | Stress Resilience | Compare stress resilience using the 6-item Brief Resilience Scale (BRS) between the two groups.
The BRS ranges from 6 to 30, with higher scores indicating greater stress resilience. |
Up to 20 weeks (+/- 28 days) | |
Other | Locus of Control | Compare locus of control using the Multidimensional Health Locus of Control (MHLC) scale, Form A between the two groups.
The MHLC Form A ranges from 6 to 36 for each locus of control category (internal, powerful others, or chance), and higher scores suggest greater belief in each category as the source of health locus of control. |
Up to 20 weeks (+/- 28 days) | |
Primary | PATH-C Intervention Feasibility | PATH-C Intervention Feasibility is defined as >60% of eligible participants enrolling in the study and >60% of enrolled participants who start the intervention completing at least 6/9 intervention sessions. | Up to 10 weeks | |
Secondary | PATH-C Intervention Acceptability | Acceptability will be measured using weekly ratings of the ease and utility of each exercise (0=very difficult/not helpful; 10=very easy/very helpful) and will use a threshold of a mean combined score of 7.0/10.0. | Up to 10 weeks | |
Secondary | Physical activity longitudinally based on ActiGraph GT3X+ accelerometer | Compare physical activity levels using the ActiGraph GT3X+ accelerometer between the two groups.
Greater steps/day and lower sedentary leisure time indicate greater physical activity. |
Up to 20 weeks (+/- 28 days) | |
Secondary | Caregiver Quality of Life based on the CarGOQOL | Compare caregiver quality of life using the 29-item CareGiver Oncology Quality of Life questionnaire (CarGOQOL) between the two groups.
Higher scores on the CarGOQOL (normalized score range, 1-100) indicate better quality of life. |
Up to 20 weeks (+/- 28 days) | |
Secondary | Anxiety Symptoms based on the HADS-Anxiety Subscale | Compare anxiety symptoms using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale between the two groups.
The HADS-A subscale ranges from 0-21, with higher scores indicating worse anxiety symptoms. |
Up to 20 weeks (+/- 28 days) | |
Secondary | Depression Symptoms based on the HADS-Depression Subscale | Compare depression symptoms using the 7-item Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale between the two groups.
The HADS-D subscale ranges from 0-21, with higher scores indicating worse depression symptoms. |
Up to 20 weeks (+/- 28 days) | |
Secondary | Caregiving Burden based not the Caregiver Reaction Assessment (CRA) | Compare caregiving burden using the 24-item Caregiver Reaction Assessment (CRA) between the two groups.
The CRA ranges from 24 to 120, with higher scores indicating greater caregiving burden. |
Up to 20 weeks (+/- 28 days) |
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