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Stress Management Intervention for Caregivers of Patients Undergoing Bone Marrow Transplant (BMT)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00833898
First received: January 30, 2009
Last updated: November 6, 2015
Last verified: November 2015
Results First Received: June 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Hematopoietic/Lymphoid Cancer
Interventions: Device: Paced respiration as part of PEPRR
Behavioral: PEPRR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Caregivers and their patients were recruited consecutively between 11/2008 and 4/2012 during pre-transplant screening of all Allo-HSCT patients and their caregivers at a single site (Presbyterian St. Luke’s Medical Center, Denver, CO).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
149 patient-caregiver dyads were consented (298 participants) and 148 dyads were randomized. 1 dyad (2 participants) did not meet the inclusion criteria.

Reporting Groups
  Description
Caregiver Control Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
Caregiver Intervention Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.

Participant Flow:   Overall Study
    Caregiver Control     Caregiver Intervention  
STARTED     74     74  
Month 1 (Post Transplantation)     72     74  
Month 3 (Post Transplantation)     66     64  
Month 6 (Post Transplantation)     59     54  
Month 12 (Post Transplantation)     50     50  
COMPLETED     34     38  
NOT COMPLETED     40     36  
Withdrawal by Subject                 33                 27  
Lost to Follow-up                 7                 7  
Patient did not receive transplant                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Caregiver Control Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
Caregiver Intervention Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
Total Total of all reporting groups

Baseline Measures
    Caregiver Control     Caregiver Intervention     Total  
Number of Participants  
[units: participants]
  74     74     148  
Age  
[units: years]
Mean (Standard Deviation)
  54.8  (12.355)     52.2  (12.169)     53.5  (12.285)  
Gender [1]
[units: participants]
     
Female     56     56     112  
Male     17     18     35  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian (not Latino/Hispanic)     68     65     133  
Black/African-American (not Latino/Hispanic)     2     0     2  
Asian/Oriental/Pacific Islander     0     1     1  
Latino/Hispanic/Mexian-American     1     6     7  
Other     1     1     2  
Unknown or Not Reported     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     74     74     148  
Annual income [2]
[units: participants]
     
< 25,000     13     11     24  
25,000-44,999     15     14     29  
45,000-64,999     11     15     26  
> 65,000     31     29     60  
Unknown or Not Reported     4     5     9  
Relationship to patient  
[units: participants]
     
Spouse/partner     46     57     103  
Parent     19     8     27  
Other     8     8     16  
Unknown or Not Reported     1     1     2  
Employment Status (Before Caregiving)  
[units: participants]
     
Full-time     35     36     71  
Part-time     11     13     24  
Unemployed     8     7     15  
On leave     1     2     3  
Retired     16     13     29  
Unknown or Not Reported     3     3     6  
Employment Status (During Caregiving)  
[units: participants]
     
Full-time     16     19     35  
Part-time     7     10     17  
Unemployed     14     8     22  
On leave     17     19     36  
Retired     15     15     30  
Unknown or Not Reported     5     3     8  
[1] For Caregiver Control gender information, participant did not reported their gender (n = 1).
[2] Income in dollars



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

2.  Primary:   Physiological - Cortisol Awakening Response (CAR)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

3.  Secondary:   Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

4.  Secondary:   State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

5.  Secondary:   Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

6.  Secondary:   Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

7.  Secondary:   Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

8.  Secondary:   Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

9.  Secondary:   Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

10.  Secondary:   Stress as Measured by the Impact of Events Scale (IES)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

11.  Secondary:   The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

12.  Secondary:   The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

13.  Secondary:   Area Under the Curve for Salivary Cortisol (AUCc)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

14.  Secondary:   Area Under the Curve for Salivary DHEA (AUCd)   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

15.  Secondary:   Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity   [ Time Frame: Baseline (prior to transplant), 1 and 3 post transplant ]

16.  Secondary:   Plasma C-reactive Protein (CRP)   [ Time Frame: Baseline (prior to transplant) and 3 post transplant ]

17.  Secondary:   Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)   [ Time Frame: Baseline (prior to transplant) and 3 post transplant ]

18.  Secondary:   Plasma Inflammatory Marker Interleukin 6 (IL-6)   [ Time Frame: Baseline (prior to transplant) and 3 post transplant ]

19.  Secondary:   Plasma Inflammatory Marker Interleukin 4 (IL-4)   [ Time Frame: Baseline (prior to transplant) and 3 post transplant ]

20.  Secondary:   Plasma Inflammatory Marker Interleukin 10 (IL-10)   [ Time Frame: Baseline (prior to transplant) and 3 post transplant ]

21.  Secondary:   Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)   [ Time Frame: Baseline (prior to transplant) and 3 post transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark L. Laudenslager, PhD
Organization: University of Colorado Denver
phone: 303-724-9279
e-mail: biel@ucdenver.edu


Publications of Results:
Other Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00833898     History of Changes
Other Study ID Numbers: 08-0303
1R01CA126971-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: January 30, 2009
Results First Received: June 8, 2015
Last Updated: November 6, 2015
Health Authority: United States: Institutional Review Board