University of Pittsburgh Medical Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Location status: Recruiting
Location contact
Donna Posluszny, PhD
CONTACT
Donna Posluszny, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07107165
Adherence to the medical regimen after stem cell transplant is challenging for both patients and their family caregivers. The investigators propose a randomized clinical trial testing two brief psychosocial interventions to determine if either improves patient and family caregiver psychosocial and health-related outcomes.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15232, United States
Location status: Recruiting
Donna Posluszny, PhD
CONTACT
Donna Posluszny, PhD
PRINCIPAL_INVESTIGATOR
The investigators propose a randomized controlled trial testing two brief, 4 session psychosocial interventions to help patients and family caregivers better manage the time period after hospital discharge from stem cell transplant. Patients and family caregivers will be randomized to either the skill learning intervention (n=52 patient-family caregiver dyads) or to the supportive care intervention (n=52 patient-family caregiver dyads). The intervention will be conducted via live video conferencing. Patients and family caregivers will complete questionnaires before the intervention and at 1-, 5-, 12-, 24 weeks afterwards. The investigators will determine whether the skills learning group has improved outcomes, including adherence to the medical regimen and perceived task efficacy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
DPST consists of teaching the patient and family caregiver problem-solving skills that they can apply to help them manage the medical regimen after stem cell transplant.
Other names: DPST
Supportive Care consists of providing support to the patient and family caregiver as they manage the medical regimen after stem cell transplant
Other names: SC
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
Assess levels of adherence to the post-transplant multi-component medical regimen of 20 main tasks; each task marked as yes = 1/no=0 adherent. Tasks will be grouped and summed into categories including medication taking (3 items, range 0=low to 3 high), infection precautions (6 items; range 0=low to 6 high), catheter/port care (4 items, range 0=low to 4 = high), and lifestyle behaviors (7 items, range 0=low to 7=high). Higher scores indicate greater adherence.
Time frame: 1-, 5-, 12- and 24-weeks post intervention
Assesses perceptions of efficacy to complete tasks of the post-transplant multi-component medical regimen, 20 items rated on 1=low to 10=high scale, mean score will be used.
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
levels of immunosuppressant medication in patient's blood
Time frame: continuous over 24 weeks post-intervention
Counts of number of hospital readmissions, emergency room visits, and unplanned medical visits
Time frame: baseline and 1-,5-,12-, and 24-weeks post-intervention
Assesses symptoms of depression, 9 items rated on 4-point scale from 0=not at all to 3=nearly every day. Sum and categorical classification will be used (score 10-14=moderate; score 15 and higher =severe.
Time frame: baseline and 1-, 5-, 12-, and 24-weeks post-intervention
Assesses symptoms of anxiety, 7 items rated from 0=not at all to 3=nearly every day. Sum and category will be used (score 10-14 = moderate; score 15 or higher = severe)
Time frame: baseline and 1-, 5-, 12-, 24-weeks post-intervention
Assess relationship quality, 9 items rated from 1=not at all to 5 = often; range 9-45; sum will be used. Higher scores indicate greater relationship quality.
Time frame: 1-, 5-, 12-, and 24-weeks post-intervention
Rating of whether the patient was mostly responsible, the caregiver was mostly responsible, or the patient and caregiver had equal responsibility in making sure each task of the post-transplant multi-component medical regimen is completed. Levels of each of the three choices will be tabulated. The highest level will dictate the categorical score (patient mostly responsible; caregiver mostly responsible; patient and caregiver equally responsible).
Time frame: 1-, 5-, 12-, 24- weeks
Assesses burden in caregivers, 24 items rated on a 1=low to 5=high; range = 24-120; sum will be used.
Time frame: baseline and 1-, 5-, 12-, 24-weeks post-intervention
Assess distress specific to cancer, 35 items are rated from 0=none to 3=severe; range = 0-105; sum score will be used.
Time frame: baseline and 1-, 5-, 12-, and 24-weeks post-intervention
Assesses overall health-related quality of life and functioning, 16 items rated from 1=low to 5 = high; higher scores indicate greater health-related quality of life; sum will be used.
Time frame: 1-week post intervention
Ratings of satisfaction with the intervention, 8 items, rating scale from 1 (low) to 4 (high). Sum of ratings on each item will be used with higher scores indicating greater satisfaction.
Time frame: 1-week post intervention
assess satisfaction with telehealth services, 2 items rated on 1=low to 7=high scale range = 2-14; sum will be used.
Time frame: continuous over 24-weeks post-intervention
presence of graft failure, graft versus host disease, and survival
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
A four-item subscale of the Cancer Caregiving Tasks, Consequences of Needs scale. Items have five possible responses: always/most days = 4; mostly=3; only sometimes=2; rarely/never=1, and don't know/not relevant=0. Items are summed to make a total score; higher score indicates more attention from health care professionals.
Time frame: 1-, 5-, 12- and 24-weeks post-intervention
1 item specifying how worried are you about making a mistake or unintentionally hurting the patient while caring for him/her. Responses include 1=very worried; 2=somewhat worried; 3=only a little; 4=not at all. Lower responses indicate greater worry.
Contact information is provided by the study sponsor or research team.
University of Pittsburgh
Other
Adapting After Discharge From Allogeneic SCT: Partnering Together; Dyadic Intervention to Improve Patient-Family Caregiver Team-Based Management of the Medical Regimen After Allogeneic Hematopoietic Cell Transplantation
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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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