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BereavementDPMNCT02112084

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

A study testing Individualized DPM in people with Bereavement and Death, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Bereavement, Death, Cancer
What is being tested?
Individualized DPM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
1 siteUnited States
Study dates
May 2010to 30 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).
  • No Exclusion Criteria:

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah College of Nursing

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Enhancing End-of-Life and Bereavement Outcomes Among Cancer Caregivers: Individualized Dual Process Intervention for Bereaved Partners After Cancer Death

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)).

Read the detailed description

The past emphasis on only the psycho-emotional features of loss has resulted in a lack of attention to the restoration-focused adaptation. Middle-aged and older bereaved persons, including those who previously provided care for a terminally ill spouse or partner, are confronted with unfamiliar daily demands. Even though death due to a terminal illness like cancer may be anticipated, the surviving spouse/partner may be so involved in caring for the dying person and consumed by the emotional distress that accompanies it, there is little time or energy to plan for the changes, some of which are unforeseen prior to the loss. This gap in abilities suggests a need for intervention strategies that improve skills such as mastering tasks of daily living, engaging in self-care behaviors, and functioning socially as a single or uncoupled person in society. One of the major findings in our previous research was the strong association between competencies in tasks of daily living and more favorable adjustments to psycho-emotional aspects of grief.

Some tasks of daily living may have been the primary responsibility of the deceased person. If these skills are not acquired during bereavement, the health, functioning, autonomy and overall quality of life of the bereaved could be adversely affected. Furthermore, the inability to accomplish these tasks interferes with the emotion-focused energy the bereaved need to direct toward the loss itself. Effectively coping with the secondary stress associated with these new challenges reduces the emotional disruption of bereavement. As new skills are gained, the bereaved feel more confident to meet future challenges in their daily lives and some may experience personal growth as they venture into "previously uncharted territory" during a time of transformation independent of their deceased spouses/partners.

While some of the RO challenges are practical, others have health implications (some have both). Self-care behaviors are often partnered activities among couples and the partner's death frequently disrupts these behavioral patterns or interferes with the ability to engage in new ones. The importance for bereaved persons to care for themselves while still addressing the need to grieve represents another set of secondary stressors requiring RO coping strategies. Also, those who more effectively engage in self-care could conceivably be in a better position to address the negative emotional effects of the loss. An important feature of RO is the adaptation to new roles and identities and establishing new relationships and maintaining social connectedness. Older and middle aged bereaved spouses/partners prefer to maintain the meaningful relationships and activities they have had throughout their lives but they also want to learn ways to access services and programs more effectively and how to maximize opportunities to meet and socialize with others. Activities can include inexpensive entertainment and leisure options, safe places to go to socialize with others, and volunteering opportunities to help others so they can remain socially connected and function more effectively and comfortably as a single person. These activities provide potential linkages to the service network and opportunities for time away from grief itself.

The overall intent of the I-DPM intervention is to more effectively stimulate both LO and RO coping processes as well as the oscillation between them than what would otherwise occur without an exposure to such a treatment. At best the usual care hospice caregivers receive after the death of the patient is primarily LO focused as well as infrequent. We hypothesize that those who receive the I-DPM intervention will show greater improvements over time in bereavement outcomes largely because the intervention content will stimulate both LO and RO processes - the telephone support will focus primarily on LO coping while the home visits are intended to address RO issues causing the most concern for the bereaved. In our earlier work we documented that LO coping was directly related to grief, depression, bereavement coping self-efficacy, and loneliness, while RO coping was strongly associated with competencies and personal growth. RO coping, however, also was related to the aforementioned loss-oriented outcomes most likely because of the positive relationship between competencies and the psycho-emotional aspects of bereavement mentioned above and the confidence one can master new challenges along with the perception of growth that accompanies it.

To summarize, bereavement interventions that have traditionally focused on grief work and psycho-emotional outcomes have only been moderately effective, largely due to having a limited focus on emotional coping. Alternatively, an intervention that addresses RO in addition to LO as we are testing in the DPM intervention could provide a more promising solution by helping the bereaved develop skills specific to practical daily challenges as well as the emotional disruption and upset that permeate bereavement.

Being tested
Individualized DPM
Medical subject headings
Death, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized DPMBehavioural

    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.

Study groups in NCT02112084
Study groupRoleWhat they receive
Usual CareNo interventionUsual care participants do not receive an intervention.
Individualized DPMExperimentalIndividualized DPM
Receives: Behavioral: Individualized DPM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 __.

    Measured: up to 14 months post patient death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2014 (estimated)
  2. Study startMay 2010
  3. Primary completionMar 2016
  4. Study completion30 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112084
Sponsor's protocol ID
33122-DPM
Other IDs
1P01CA138317
Acronym
DPM
Status last verified
Feb 2017
First submitted
2 Apr 2014
Last updated
17 May 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Individualized DPM in people with Bereavement and Death, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DPM Coping Processes: Loss- and Restoration- Orientation and Oscillation (time frame: up to 14 months post patient death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.

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