NCT03454295

Easing Psychosocial Burden for Informal Caregivers

Completed EARLY_PHASE1 Last updated 1 April 2024

What this trial tests

EARLY_PHASE1 trial testing Focus Group in Glioblastoma in 64 participants. Completed in 26 March 2024.

Timeline

12 February 2018

Primary endpoint
26 March 2024

26 March 2024

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	64
Start date	12 February 2018
Primary completion	26 March 2024
Estimated completion	26 March 2024
Sites	3 locations across United States

Drugs / interventions tested

• Focus Group
• Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C
• Enhanced Usual Care / EUC

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall goal of this study is to determine the best time to offer Meaning-Centered Psychotherapy (MCP), an intervention that has proven to be helpful in improving spiritual well-being and decreasing existential distress among patients with advanced cancer, to caregivers. (MCP has also been shown to be an appropriate method of attending to the palliative or comfort care needs of caregivers of patients with cancer. Studies show that the psychological burden associated with caring for a patient with advanced cancer is often greater than that experienced by the patients themselves.) The investigators would also like to find out about caregivers initial impressions of MCP-C, Meaning-Centered Psychotherapy for Cancer Caregivers, so that the intervention can be adjusted to meet the unique needs of caregivers of patients with Glioblastoma.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to help support caregivers of people with a brain or spinal cord tumour.
   Boele FW, Rooney AG, Bulbeck H, Sherwood P. · · 2019 · cited 33× · PMID 31264707 · DOI 10.1002/14651858.cd012582.pub2
2. Meaning-Centered Psychotherapy for Cancer Caregivers: A pilot trial among caregivers of patients with glioblastoma multiforme.
   Applebaum AJ, Baser RE, Roberts KE, Lynch K, et al · · 2022 · cited 20× · PMID 35852487 · DOI 10.1093/tbm/ibac043
3. A qualitative exploration of the feasibility and acceptability of Meaning-Centered Psychotherapy for Cancer Caregivers.
   Applebaum AJ, Roberts KE, Lynch K, Gebert R, et al · · 2022 · cited 18× · PMID 35078552 · DOI 10.1017/s1478951521002030
4. Benefits of supportive strategies for carers of people with high-grade glioma: a systematic review : Strategies for addressing the needs of high-grade glioma carers.
   Jones D, Pinkham MB, Wallen MP, Hart NH, et al · · 2022 · cited 8× · PMID 36282336 · DOI 10.1007/s00520-022-07419-2
5. Physical activity and glioblastoma: a paradigm shift in neuro-oncology therapy.
   Xie L, Wang F. · · 2025 · cited 1× · PMID 40809025 · DOI 10.3389/fonc.2025.1638060