Trial Outcomes & Findings for Psychological Intervention for Caregivers of Patients With Malignant Gliomas (NCT NCT03735498)

Last Updated: 2024-11-13

Results Overview

The investigators will report the percentage of eligible caregivers who agree to participate in the study of this intervention. The intervention will be deemed feasible if at least 70% (+/- 18%) of eligible caregivers are enrolled in the study.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

2 years

Results posted on

2024-11-13

Participant Flow

Subjects were recruited from the Mass General Hospital Cancer Center from February 2019 through October 2019. Interested participants were screened for eligibility using the GAD-7 tool with eligible participants having a score of 5 or greater.

Participant milestones

Participant milestones
Measure	Psychological Intervention * 6 one-hour video conference sessions with mental health provider * participants complete survey battery before and after participating in the intervention * semi-structured interviews to assess acceptability of intervention Psychological Intervention: Promote effective coping and reduce caregiving burden
Overall Study STARTED	13
Overall Study Started Intervention	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Psychological Intervention * 6 one-hour video conference sessions with mental health provider * participants complete survey battery before and after participating in the intervention * semi-structured interviews to assess acceptability of intervention Psychological Intervention: Promote effective coping and reduce caregiving burden
Overall Study Withdrawal by Subject	3
Overall Study Two participants did not complete all 6 sessions	2

Baseline Characteristics

Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psychological Intervention n=13 Participants * 6 one-hour video conference sessions with mental health provider * participants complete survey battery before and after participating in the intervention * semi-structured interviews to assess acceptability of intervention Psychological Intervention: Promote effective coping and reduce caregiving burden
Age, Continuous	55.7 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: We approached 30 potentially eligible caregivers of whom 21 provided consent to participate. Fourteen of those 21 patients met eligibility criteria based on the GAD-7 with one participant withdrawing consent prior to study enrollment. 13 of those 21 patients were able to proceed with the study.

Outcome measures

Outcome measures
Measure	Psychological Intervention n=30 Participants * 6 one-hour video conference sessions with mental health provider * participants complete survey battery before and after participating in the intervention * semi-structured interviews to assess acceptability of intervention Psychological Intervention: Promote effective coping and reduce caregiving burden
Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention	21 Participants

PRIMARY outcome

Timeframe: 2 years

Population: We evaluated the percentage of the 13 caregivers enrolled in the study that completed at least 50% of intervention sessions.

The investigators will report the percentage of eligible caregivers who participate in each session. Participation will be considered feasible if at least 70% of enrolled participants complete ≥50% of the sessions.

Outcome measures

Outcome measures
Measure	Psychological Intervention n=13 Participants * 6 one-hour video conference sessions with mental health provider * participants complete survey battery before and after participating in the intervention * semi-structured interviews to assess acceptability of intervention Psychological Intervention: Promote effective coping and reduce caregiving burden
Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session	10 Participants

Adverse Events

Psychological Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Deborah Forst

Massachusetts General Hospital

Phone: 617-724-8770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place