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

NCT02037568 | Completed Results DMC

• 1 other identifier: 13-2639
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hematopoietic/Lymphoid Cancer

Keywords

depression; stress; caregiving; anxiety; psychoeducation intervention; psycho-oncology; allogeneic hematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (2)

• Functional Assessment of Cancer Treatment - Blood/Marrow 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.

  Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant

• Caregiver Distress - Principal Component Analysis

  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.

  Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant

Secondary Outcomes (7)

• Perceived Stress Scale

  Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant

• Center for Epidemiological Studies Depression Scale

  Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant

• Spielberger State-Trait Anxiety Inventory

  Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant

• Change in Adrenal Activity Over Time

  Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant.

• Change in Caregiver Telomere Length Over Time

  Baseline (prior to transplant), 3 months and 6 months after transplant

Study Arms (2)

Caregiver Self-Directed

NO INTERVENTION

Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care; caregiver workbook.

Caregiver Intervention

EXPERIMENTAL

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

Interventions

fPER BEHAVIORAL

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."

Also known as: Other Names:, "fone" PsychoEducation and Relaxation

Caregiver Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• PRIOR CONCURRENT THERAPY:
• No history of a psychiatric illness unrelated to the HSCT within the past 18 months
• No steroid medications (caregiver)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Presbyterian/St. Luke's Medical Center (PSLMC)

Denver, Colorado, 80218, United States

Location

Related Publications (2)

• Sannes TS, Ranby KW, Yusufov M, Brewer BW, Jacobs JM, Callan S, Ulrich GR, Pensak NA, Natvig C, Laudenslager ML. More often than not, we're in sync: patient and caregiver well-being over time in stem cell transplantation. Health Qual Life Outcomes. 2022 Jan 10;20(1):6. doi: 10.1186/s12955-021-01909-3.

  PMID: 35012566 DERIVED

• Laudenslager ML, Simoneau TL, Mikulich-Gilbertson SK, Natvig C, Brewer BW, Sannes TS, Kilbourn K, Gutman J, McSweeney P. A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress. Psychooncology. 2019 Aug;28(8):1614-1623. doi: 10.1002/pon.5126. Epub 2019 May 25.

  PMID: 31127974 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Mark L. Laudenslager, PhD
• Organization: University of Colorado Denver

biel@ucdenver.edu

303-724-9277

Study Officials

• Mark L Laudenslager, PhD

  University of Colorado Denver (Anschutz Medical Campus)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 6, 2017
• Results First Posted: December 6, 2017

Record last verified: 2017-12

Locations

US (2)