Psychotherapy for Caregiver Burden

Recruiting at 7 trial locations

Overseen By Talia Zaider, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Lack of study understanding, Ongoing psychotherapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 7 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants will complete 1 set of questionnaires about 2 weeks before beginning their Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social support. Participants will then be assigned to receive either MCP-C or SP-C for 7 sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session of MCP-C or SP-C. It will take between 35 and 50 minutes to complete each set of questionnaires. After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires, their participation in this study will end. If participants decide not to complete all 7 sessions, they may still choose to complete the questionnaires. Participants may remain in the study and continue to receive all 7 sessions of MCP-C or SP-C even if their loved one passes away.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently engaged in regular individual psychotherapy, you may need to pause it during the trial.

What data supports the effectiveness of the treatment Meaning-Centered Psychotherapy for Caregivers (MCP-C)?

Research shows that Meaning-Centered Psychotherapy (MCP) helps improve psychological well-being and reduce distress in cancer patients, and MCP-C is being developed to help caregivers by addressing similar issues. A web-based version of MCP-C has been found to be feasible and acceptable, suggesting it could help caregivers find meaning and reduce their burden. ^{1 2 3 4 5}

Is Meaning-Centered Psychotherapy safe for caregivers?

Meaning-Centered Psychotherapy, including its versions for caregivers, has been studied for its feasibility and acceptability, suggesting it is generally safe for use in humans. ^{1 2 3 5 6}

How is Meaning-Centered Psychotherapy for Caregivers different from other treatments for caregiver burden?

Meaning-Centered Psychotherapy for Caregivers (MCP-C) is unique because it specifically targets existential distress, which is a common and critical element of caregiver burden, by helping caregivers find meaning and purpose in their role. Unlike other treatments, MCP-C is structured to address the spiritual and emotional well-being of caregivers, and it can be delivered flexibly, including through a web-based program. ^{1 2 3 5 7}

Research Team

Talia Zaider, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for caregivers experiencing stress, burnout, or burden from caring for someone with cancer. Participants should be willing to undergo psychotherapy and complete several questionnaires before and after therapy sessions.

Inclusion Criteria

Residing in New York, New Jersey, or Florida, or have the ability to complete sessions while complying with current telehealth regulations

I am 18 years old or older.

I am caring for someone with advanced cancer.

Exclusion Criteria

I don't fully understand what participating in the study involves.

I am currently in ongoing therapy that I cannot pause.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either Meaning-Centered Psychotherapy for Caregivers (MCP-C) or Supportive Psychotherapy for Caregivers (SP-C) for 7 sessions

7 weeks

7 visits (in-person)

Follow-up

Participants complete additional sets of questionnaires about 2 weeks, 6 months, and 12 months after their last session to monitor maintenance of treatment gains

12 months

3 visits (virtual)

Treatment Details

Interventions

• Meaning-Centered Psychotherapy for Caregivers
• Supportive Psychotherapy for Caregivers

Trial Overview The study compares two types of therapy: Meaning-Centered Psychotherapy (MCP-C) and standard Supportive Psychotherapy (SP-C). Caregivers will be randomly assigned to one of these therapies for seven sessions, followed by evaluations over a year.

Participant Groups

Group I: Meaning-Centered Psychotherapy for Caregivers Experimental Treatment 1 Intervention

Meaning-Centered Psychotherapy for Caregivers/MCP-C

Group II: Supportive Psychotherapy for Caregivers Active Control 1 Intervention

Supportive Psychotherapy for Caregivers/SP-C standard of care

Meaning-Centered Psychotherapy for Caregivers is already approved in United States for the following indications:

Approved in United States as MCP-C for:

• Support for caregivers of cancer patients

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

A case study involving a patient with Glioblastoma Multiforme and his caregiver showed that concurrent engagement in Meaning-Centered Psychotherapy (MCP) and Meaning-Centered Psychotherapy for Caregivers (MCP-C) led to enhanced well-being for both individuals.

Both the patient and caregiver experienced increased connectedness and improved coping with existential distress, suggesting that simultaneous participation in these therapies may provide unique benefits that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of concurrent engagement in meaning-centered psychotherapy and meaning-centered psychotherapy for cancer caregivers: A case study. Roberts, KE., Applebaum, AJ.[2023]

Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) is designed to address existential distress, a significant but often overlooked aspect of caregiver burden in those caring for patients with advanced cancer.

A case study from an initial MCP-C group revealed that participants experienced personal growth, improved self-care, and a deeper understanding of their caregiving experience, highlighting the potential benefits of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C): Rationale and Overview. Applebaum, AJ., Kulikowski, JR., Breitbart, W.[2022]

The Care for the Cancer Caregiver (CCC) Workshop, a web-based adaptation of Meaning-Centered Psychotherapy, was found to be feasible and acceptable for cancer caregivers, with 84 participants randomized to either the workshop or a waitlist control.

While no significant differences were observed between groups in most measures, caregivers in the CCC Workshop showed significant increases in benefit finding, suggesting that the program may help enhance caregivers' sense of meaning and purpose over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the cancer caregiver's journey through web-based Meaning-Centered Psychotherapy. Applebaum, AJ., Buda, KL., Schofield, E., et al.[2021]

In a study involving 170 cancer survivors, meaning-centered group psychotherapy for cancer survivors (MCGP-CS) was found to be more cost-effective than care-as-usual (CAU), with lower total costs (€4492 for MCGP-CS vs. €5304 for CAU) and higher quality-adjusted life years (QALYs) at 0.540 compared to 0.507 for CAU.

MCGP-CS had a 74% probability of being both less costly and more effective than CAU, and a 49% probability compared to supportive group psychotherapy (SGP), indicating strong evidence for its economic and therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors. van der Spek, N., Jansen, F., Holtmaat, K., et al.[2019]

The pilot study involving 30 patients with advanced cancer showed that Meaning-Centered Psychotherapy and Essential Care (MCP-EC) significantly reduced symptoms of anxiety, depression, and hopelessness, while enhancing spiritual well-being and a sense of meaning.

Patients reported high satisfaction with the MCP-EC intervention, indicating its feasibility and acceptability compared to usual psychological support, although further research with larger samples is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adaptation of meaning-centered psychotherapy integrating "essential care": A pilot study. Quílez-Bielsa, E., Barrado-Moreno, V., Lastra Del Prado, R., et al.[2022]

Meaning-centered psychotherapy (MCP) was found to significantly reduce anxiety and depression in patients with pancreatobiliary cancer after four therapy sessions, with improvements noted at a 2-month follow-up.

Patients who underwent MCP also experienced a notable enhancement in their quality of life, while those who did not receive MCP showed no significant changes, highlighting the potential effectiveness of this therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Findings on the Effectiveness of Meaning-Centered Psychotherapy in Patients with Pancreatobiliary Cancer. Ryu, JS., Choi, SW., Yun, SS., et al.[2018]

A study involving 51 cancer inpatients found that a Meaning-Centered Psychotherapy Model tailored for palliative care, especially with compassion elements, is feasible and acceptable for patients in their final weeks of life.

Patients reported that key elements like meaning, self-compassion, and legacy were particularly helpful, suggesting that these constructs can aid in coping with the dying process, although further research with larger samples is needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-centered psychotherapy integrated with elements of compassion: A pilot study to assess feasibility and utility. Gil, F., Fraguell, C., Benito, L., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

The benefits of concurrent engagement in meaning-centered psychotherapy and meaning-centered psychotherapy for cancer caregivers: A case study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C): Rationale and Overview. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Exploring the cancer caregiver's journey through web-based Meaning-Centered Psychotherapy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors. [2019]

5. England pubmed.ncbi.nlm.nih.gov

An adaptation of meaning-centered psychotherapy integrating "essential care": A pilot study. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Preliminary Findings on the Effectiveness of Meaning-Centered Psychotherapy in Patients with Pancreatobiliary Cancer. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Meaning-centered psychotherapy integrated with elements of compassion: A pilot study to assess feasibility and utility. [2019]