Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness



Status:Completed
Conditions:Anxiety, Anxiety, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 85
Updated:7/25/2018
Start Date:December 2016
End Date:July 13, 2018

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A Randomized Controlled Trial of Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness

The proposed project is a pilot randomized control trial of the Pep-Pal (Psychoeducation and
Skills Based Intervention) versus a treatment as usual control group. A total of 120
caregivers; 40 caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), 40
caregivers of patients enrolled in phase I oncology trials, and 40 caregivers of patients
with advanced cancer (Stage IV, solid tumor) will be enrolled in this study. The
investigators do not expect different outcomes from these three groups, rather these
populations are selected to optimize recruitment within a short time frame. The caregivers
will be randomized to either treatment as usual or Pep-Pal intervention.

The proposed project is a pilot randomized control trial of the Pep-Pal intervention versus a
treatment as usual control group. A total of 120 caregivers; 40 caregivers of patients with
HSCT, 40 caregivers of patients enrolled in phase I oncology trials, and 40 caregivers of
patients with advanced cancer (Stage IV, solid tumor) will be enrolled in this study. The
investigators do not expect different outcomes from these three groups, rather these
populations are selected to optimize recruitment within a short time frame. The caregivers
will be randomized to either treatment as usual or Pep-Pal intervention. The proposed study
population is based on prior research indicating that caregivers of patients receiving HSCT,
caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with
advanced cancer experience significant distress. In addition, an initial study of caregivers
of patients receiving allogeneic-HSCT were able to benefit from a brief, cognitive behavioral
stress management treatment approach. A study examining distress in phase I oncology clinical
trial patient caregivers highlighted the need for more support for this significantly
distressed population. Furthermore, initial results of the qualitative development study for
Pep-Pal yielded support for a mobilized platform delivery of resources for caregivers to
manage distress because they acknowledged many barriers to engaging in in-person treatment to
manage distress.

Inclusion Criteria:

1. Women and men ≥ 18 years of age of any ethnicity

2. Must endorse a moderate level of anxiety (e.g. Score above an 8 on the Hospital and
Anxiety Depression Scale (HADS))

3. Speak and read in English

4. Caregiver of a patient with auto HSCT who are moving forward with bone marrow
transplant or have receive a bone marrow transplant

5. Caregiver of a patient in a Phase I Clinical Trial

6. Caregiver of a patient diagnosed with advanced cancer (stage III or stage IV)

7. No Cognitive or psychiatric conditions prohibiting participation

8. Must meet criteria for being a primary caregiver, defined as, 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 for a patient
receiving auto-HSCT, enrolled in a phase I oncology clinical trial, or of a patient
diagnosed with advanced cancer (stage IV, solid tumor).

9. Have a computer, smartphone, or tablet with internet access

Exclusion Criteria:

1. Caregivers below the age of 18

2. Score below an 8 on the Hospital and Anxiety Depression Scale (HADS)

3. Cannot speak and read in English

4. Patient does not receive a bone marrow transplant

5. Patient is not enrolled in a Phase I clinical trial

6. Patient is not diagnosed with Stage III or Stage IV cancer

7. Cognitive conditions prohibiting participation
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Nicole R Amoyal-Pensak, PhD
Phone: 301-452-7079
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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