An Individualized Grief Intervention for Spouses of Cancer Patients After the Patient's Death

NCT02112084 | Completed DMC

• 2 other identifiers: 33122-DPM1P01CA138317
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals providing end-of-life caregiving to partners with terminal cancer often begin the bereavement process before the patient dies and with additional sources of stress. We know that grief for these partners can be long-term and impact virtually every aspect of their lives. This project will test the effectiveness of a new promising intervention that uses a dual process model (DPM) which focuses both on loss orientation (emotional loss and grief (referred to as LO)) and restoration orientation (learning new tasks of living that may have been the primary responsibility of the spouse who has died (referred to as RO tasks)).

Conditions

Bereavement; Death; Cancer

Outcome Measures

Primary Outcomes (1)

• DPM Coping Processes: Loss- and Restoration- Orientation and Oscillation

  Features of the DPM will be measured using the Inventory of Daily Widowed Life (IDWL) which consists of 22 Likert-format items that inquire into how much time during the past week the respondents spend on loss-orientation (e.g., "Thinking about how much I miss my spouse;" "Feeling a bond with my spouse") and restoration-oriented activities (e. g., "Finding ways to keep busy or occupied;" "Took some time away from grieving for my spouse"). At the end of the 22 IDWL items are several additional questions we developed to measure important dimensions of the oscillation between LO and RO. These features assess oscillation awareness, frequency, and control (each measured on a 5-point Likert scale) and oscillation intent is measured by an open-ended item that asks, "When I go back and forth between dealing with these two issues (grief-related emotions vs. new responsibilities, activities and time away from grieving), I usually do it because \_\_.

  up to 14 months post patient death

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care participants do not receive an intervention.

Individualized DPM

EXPERIMENTAL

Individualized DPM

Behavioral: Individualized DPM

Interventions

Individualized DPM BEHAVIORAL

The intervention includes 7 LO phone sessions and 7 RO home visits provided by trained interventionists. The primary focus of the LO phone conversations will be on grief work issues, daily functioning, and emotional support. The calls will provide an opportunity to discuss how grief could be interfering with their daily functioning, dealing with grief-related feelings- emotions they are experiencing, the frustrations associated with taking on new responsibilities while still trying to meet their own needs, critical time periods like anniversaries and holidays, unfinished business, coping strategies, including using humor, and having realistic expectations about the bereavement process. The RO home visits will be based specifically on the bereaved partners' skill and knowledge needs.

Individualized DPM

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spouse/Partner of patient with a cancer diagnosis who received hospice care in their home by one of the participating hospice programs
• Lived in the home with the patient
• English speaking and writing
• cognitively and physically able to use the phone unassisted, complete questionnaires, and participate in the DPM intervention
• Access to a telephone
• Intends to reside in an area where the intervention will be offered for the time it takes to deliver the intervention (14 weeks from the start of the intervention).

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Utah College of Nursing

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Death; Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen H Mooney, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Michael Caserta, PhD

  University of Utah

  STUDY CHAIR

• Dale Lund, PhD

  California State University, San Bernardino

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 11, 2014
• Study Start: May 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: April 30, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)