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Improved Outcome in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Patients by Reducing Caregiver Distress

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02037568
First Posted: January 16, 2014
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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.

Condition Intervention
Hematopoietic/Lymphoid Cancer Behavioral: fPER

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Improved Behavioral Outcome in Allogeneic Hematopoietic Stem Cell Transplant Patients by Reducing Caregiver Distress: Behavioral and Physiological Evidence

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Functional Assessment of Cancer Treatment - Blood/Marrow Transplant [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ]
    "Functional Assessment of Cancer Treatment - Blood/Marrow Transplant" (FACT-BMT) is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-148. Higher score indicates better life quality.

  • Caregiver Distress - Principal Component Analysis [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ]
    Caregiver Distress is a composite score is created from a principal component analysis (PCA). This PCA extracted the first principal component from summary variables of Center for Epidemiological Studies Depression Scale, Spielberger State and Trait Anxiety Inventory, and Perceived Stress Scale. The composite distress score has a mean of 0.0 and SD of 1.0, scale ranges from -2.06 - 3.73. Higher score indicates greater distress.


Secondary Outcome Measures:
  • Perceived Stress Scale [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ]
    The "Perceived Stress Scale" (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress.

  • Center for Epidemiological Studies Depression Scale [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ]
    "Center for Epidemiological Studies Depression" Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.

  • Spielberger State-Trait Anxiety Inventory [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ]
    The "Spielberger State and Trait Anxiety Inventory" (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).

  • Change in Adrenal Activity Over Time [ Time Frame: Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant. ]
    Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis. Because hair cortisol were not normally distributed, the data were log transformed.

  • Change in Caregiver Telomere Length Over Time [ Time Frame: Baseline (prior to transplant), 3 months and 6 months after transplant ]
    Telomere length was assessed as a measure of cellular aging in blood samples from participants. Because telomere length were not normally distributed, the data were log transformed.

  • Change in Caregiver Telomerase Activity Over Time [ Time Frame: Baseline (prior to transplant), 3 months and 6 months after transplant ]
    Telomerase activity will be assessed as a measure of the ability to reverse cellular aging processes. Because telomerase activity were not normally distributed, the data were log transformed.

  • Caregiver Reaction Assessment [ Time Frame: Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant ]
    The "Caregiver Reaction Assessment" (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.


Enrollment: 159
Study Start Date: January 2014
Study Completion Date: September 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Caregiver Self-Directed
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.
Experimental: Caregiver Intervention
Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation and Relaxation (fPER), which included one-on-one psychoeducation, and stress management intervention.
Behavioral: fPER
Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors such as coping with the "new normal."
Other Names:
  • Other Names:
  • "fone" PsychoEducation and Relaxation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037568


Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Presbyterian/St. Luke's Medical Center (PSLMC)
Denver, Colorado, United States, 80218
Sponsors and Collaborators
University of Colorado, Denver
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Mark L Laudenslager, PhD University of Colorado Denver (Anschutz Medical Campus)
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Informed Consent Form  [PDF] September 1, 2017

  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02037568     History of Changes
Other Study ID Numbers: 13-2639
First Submitted: January 14, 2014
First Posted: January 16, 2014
Results First Submitted: September 1, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by University of Colorado, Denver:
depression
stress
caregiving
anxiety
psychoeducation intervention
psycho-oncology
allogeneic hematopoietic stem cell transplant