N/A
N=159
Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress
Hematopoietic/Lymphoid Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02037568 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Functional Assessment of Cancer Treatment - Blood/Marrow Transplant — 97.7; 98.1; 95.7; 95.8 units on a scale — p=.96
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- fPER (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Assessment of Cancer Treatment - Blood/Marrow Transplant |
97.7; 98.1; 95.7; 95.8; 101.5; 100.1 | .96 |
| PRIMARY Caregiver Distress - Principal Component Analysis |
-0.09; 0.07; 0.02; -0.06; 0.05; 0.0 | 0.007 sig |
| SECONDARY Perceived Stress Scale |
24.2; 25.5; 23.0; 22.9; 21.3; 22.4 | 0.08 |
| SECONDARY Center for Epidemiological Studies Depression Scale |
20.0; 20.5; 19.6; 18.3; 20.0; 17.8 | 0.05 |
| SECONDARY Spielberger State-Trait Anxiety Inventory |
39.6; 41.6; 38.4; 39.6; 39.2; 39.3 | 0.070 |
| SECONDARY Change in Adrenal Activity Over Time |
1.93; 2.14; 1.98; 2.18; 2.19; 2.14 | 0.96 |
| SECONDARY Change in Caregiver Telomere Length Over Time |
0.03; 0.0; 0.03; 0.0; 0.03; 0.03 | 0.74 |
| SECONDARY Change in Caregiver Telomerase Activity Over Time |
1.7; 1.7; 1.69; 1.73; 1.76; 1.71 | 0.79 |
| SECONDARY Caregiver Reaction Assessment |
10.4; 10.3; 10.8; 10.9; 10.8; 10.9 | 0.86 |
Summary
PURPOSE: As this is a randomized controlled trial, all subjects receiving stress management psychoeducation will be expected to obtain a new set of coping skills that will allow them to better deal with the stressors of caregiving for an allogeneic HSCT patient. It is expected that improving caregiver status will improve patient quality of life.
Eligibility Criteria
Inclusion Criteria
- DISEASE CHARACTERISTICS (Meets all of the following criteria):
- Patient undergoing allogeneic hematopoietic stem cell transplant (HSCT)
- Caregiver: the person in the patient's life who is primarily responsible for care decisions, emotionally invested in the patient's care, provides instrumental care such as transportation, and available if randomized to the fPER group to participate in the majority of intervention sessions
- PATIENT CHARACTERISTICS:
- Able to read and speak English
- Has telephone access
- CAREGIVER CHARACTERISTICS:
- Able to read and speak English
- Willingness to use a Smartphone
- No serious medical condition likely to influence cortisol assessment in their hair
- Alcohol consumption limited to < 2 drinks/day
- At least 18 years of age
Exclusion Criteria
- PRIOR CONCURRENT THERAPY:
- No history of a psychiatric illness unrelated to the HSCT within the past 18 months
- No steroid medications (caregiver)
Data sourced from ClinicalTrials.gov (NCT02037568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.