Developing a Virtual Stress Management Intervention for Spousal/Partnered Caregivers of Solid Tumor Cancer Patients.

NCT04739696 | Active Not Recruiting DMC

• 2 other identifiers: 20-2458.cc5R01CA231387-02
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized control trial will investigate the ability of an effective stress management psychoeducation program for employed caregivers to mitigate psychological distress and pathophysiology in spousal or partnered caregivers of patients' diagnosis with a solid tumor cancer of any stage. It is expected that improving caregiver status will have reduced depressive symptoms.

Conditions

Breast Cancer; Lung Cancer; Colon Cancer; Solid Tumor, Adult

Keywords

depression; stress; caregiving; anxiety; psychoeducation intervention; psycho-oncology

Outcome Measures

Primary Outcomes (1)

• Caregiver: Change in Center for Epidemiological Studies Depression Scale (CESD)

  Change in caregiver depressive symptoms. 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.

  Baseline, 3 months, 6 months, 9 months, 12 months follow up

Secondary Outcomes (12)

• Caregiver: Change in Spielberger State-Trait Anxiety Inventory (STAI)

  Baseline, 3 month, 6 month, 9 month, 12 month follow up

• Caregiver: Change in Perceived Stress Scale (PSS)

  Baseline, 3 month, 6 month, 9 month, 12 month follow up

• Caregiver: Health Care Utilization

  Baseline, 12 month follow up

• Caregiver: Change in Adrenal Activity Over Time

  Baseline, 3 month, 6 month, 9 month, 12 month follow up

• Caregiver: Change in Caregiver Telomere Length Over Time

  Baseline, 3 month, 6 month, 9 month, 12 month follow up

Study Arms (3)

Caregiver Control

NO INTERVENTION

biomarker analysis; questionnaire administration; survey administration; treatment as usual

Caregiver Intervention

EXPERIMENTAL

biomarker analysis; questionnaire administration; survey administration; PsychoEducation Paced Respiration and Relaxation (PEPRR), which includes virtual one-on-one psychoeducation and stress management intervention.

Behavioral: PEPRR

Caregiver Self-Directed

EXPERIMENTAL

biomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention.

Behavioral: Pep-Pal

Interventions

PEPRR BEHAVIORAL

Briefly presented in the following order, 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 work and caregiver stress, 5) Strategies for maintaining energy and stamina with caregiver and work demands, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs to employers and your loved ones, and 8) Getting the support they need including work accommodations and/or legal protections (e.g., Family Medical Leave Act, Americans with Disabilities Act)

Also known as: Virtual-PEPRR, PsychoEducation Paced Respiration and Relaxation

Caregiver Intervention

Pep-Pal BEHAVIORAL

Pep-Pal program consisted of 11 sessions: 1) Introduction to stress management, 2) Stress and the mind body connection, 3) How thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty, 7) Managing changing relationships and communicating needs, 8) Getting the support they need; 9) Employment related challenges and resources for working caregivers; 10) Employment session one; 11) Employment session two

Caregiver Self-Directed

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• DISEASE CHARACTERISTICS (Meets all of the following criteria):
• Patients who have a primary diagnosis of solid tumor cancer at any stage that are within 12 weeks +/- of starting treatment, which includes either infusion chemo- or immunotherapy, oral targeted agents, or both.
• PATIENT CHARACTERISTICS:
• Patients who have a primary diagnosis of soled tumor cancer at any stage that are within 12 weeks of initiating treatment.
• Patient must be spouse or partner of the caregiver for at least a year and must live with caregiver
• Must be able to read/speak English
• years of age or older
• CAREGIVER CHARACTERISTICS:
• A primary caregiver for the patient with a diagnosis of solid tumor cancer at any stage who are within 12 weeks of initiating treatment
• Spouse or partner of the patient for at least a year
• The caregiver must live with the patient
• Must be available to fully participate in an intervention (Virtual-PEPRR or PepPal) if assigned
• Must score 1 or greater on the PHQ-2 (depression) and/or GAD-2 (anxiety) during pre-screening.
• Must be employed at the time of the patient's diagnosis for a minimum of 20 hours/week with plans to remain employed and working during their patient's treatment. Caregivers that were furloughed or laid off due to Covid-19 who are actively looking for work will be included.
• Able to read and speak the English language

You may not qualify if:

• Having a serious medical condition likely to influence neuroendocrine parameters
• Chronic use of steroid medications
• If Female, pregnant or planning to become pregnant in the next year
• History of a psychiatric illness unrelated to their experience as a caregiver with the past 18 months.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colonic Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Cathy J Bradley, PhD

  University of Colorado Denver (Anschutz Medical Campus)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 5, 2021
• Study Start: February 5, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (1)