Clinical trial NCT03002896: Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
Official title: A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress
Anxiety
Depression
Keywords: Cancer
Caregivers
Pep-pal
Pep-Pal + Treatment as Usual
Treatment as Usual
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2016-12-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed project is a pilot study of the Pep-Pal (Psychoeducation and Skills Based Intervention) versus a treatment as usual control group. A total of 60 caregivers; including caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), caregivers enrolled in Phase I clinical trials, and caregivers of patients with advanced cancer (Stage III, 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.

Detailed description: The proposed project is a pilot study of the Pep-Pal intervention versus a treatment as usual control group. A total of 60 caregivers; caregivers of patients with HSCT, caregivers of patients enrolled in phase I oncology trials, and 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Exit Interviews
timeFrame: 12 weeks
measure: Pep-Pal Self-Report sessions at 12 Weeks
timeFrame: 12 weeks
measure: Evaluation of Self-Report Caregiver reported outcomes at Baseline
timeFrame: Week 1
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
timeFrame: Week 12
Secondary outcomes:
measure: Evaluation of Self-report caregiver reported outcomes at baseline
timeFrame: Week 1
measure: Evaluation of Self-report caregiver reported outcomes at baseline
timeFrame: Week 1
measure: Evaluation of Self-report caregiver reported outcomes at baseline
timeFrame: Week 1
measure: Evaluation of Self-report caregiver reported outcomes at baseline
timeFrame: Week 1
measure: Evaluation of Self-report caregiver reported outcomes at baseline
timeFrame: Week 1
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
timeFrame: Week 12
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
timeFrame: Week 12
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
timeFrame: Week 12
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
timeFrame: Week 12
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
timeFrame: Week 12
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Nicole R Amoyal-Pensak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pensak NA, Carr AL, Jones J, Mikulich-Gilbertson SK, Kutner JS, Kilbourn K, Sannes TS, Brewer BB, Kolva E, Joshi T, Laudenslager ML. A pilot study of mobilized intervention to help caregivers of oncology patients manage distress. Psychooncology. 2021 Apr;30(4):520-528. doi: 10.1002/pon.5597. Epub 2020 Dec 2.
citation: Carr AL, Jones J, Mikulich Gilbertson S, Laudenslager ML, Kutner JS, Kilbourn K, Sannes TS, Brewer BW, Kolva E, Joshi T, Amoyal Pensak N. Impact of a Mobilized Stress Management Program (Pep-Pal) for Caregivers of Oncology Patients: Mixed-Methods Study. JMIR Cancer. 2019 May 3;5(1):e11406. doi: 10.2196/11406.