Malignant Glioma
Conditions
Keywords
Malignant Gliomas
Brief summary
This research study is evaluating a psychological intervention for caregivers of loved ones with malignant gliomas.
Detailed description
Caregivers of loved ones with malignant gliomas frequently experience a physical and psychological burden caring for their loved ones. The purpose of this study is to find out whether a psychological intervention can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable. The psychological intervention will take place in a series of six sessions. A trained social worker or psychologist will meet with the participant or talk with the participant over the telephone or by video conference for 45 minutes at a time to discuss the caregiver experience while developing effective skills to support the loved one as well as the participant over the course of the loved one's illness. Upon the completion of the sessions, the investigators will have a short (30-minute) exit interview to obtain the participant's feedback on the intervention. The investigators will use the feedback to improve the intervention before further testing its effectiveness in future research studies. The investigators will also ask the participant to complete questionnaires before and after their participation in the intervention to help the investigators understand the participant's coping skills, caregiving burden, mood, and understanding about the loved one's illness.
Interventions
OTHERPsychological Intervention
Promote effective coping and reduce caregiving burden
Sponsors
National Institute of Nursing Research (NINR)
Palliative Care Research Cooperative Group
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 * Identified by a patient with a malignant glioma (WHO Grade III or IV glioma) as the patient's primary caregiver * The patient is receiving care at the MGH Cancer Center * The patient was diagnosed with a malignant glioma within the past 6 months * Able to speak and read in English * Generalized Anxiety Disorder 7-item (GAD-7) score ≥5 * Participants may or may not be pregnant.
Exclusion criteria
* Deemed inappropriate for the study by the patient's clinician or the study PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention | 2 years | 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. |
| Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session | 2 years | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Two participants did not complete all 6 sessions | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Psychological Intervention |
|---|---|
| Age, Continuous | 55.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Psychological Intervention | Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention | 21 Participants |
Primary
Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session
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.
Time frame: 2 years
Population: We evaluated the percentage of the 13 caregivers enrolled in the study that completed at least 50% of intervention sessions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Psychological Intervention | Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session | 10 Participants |