Cancer
Conditions
Keywords
Cancer Care
Brief summary
This research study is evaluating the impact of a psychological intervention on the quality of life and mood of caregivers of patients undergoing stem cell transplant.
Detailed description
The purpose of this study is to find out whether a psychological intervention can make the experience of being a caregiver more manageable by improving the participant's quality of life, mood, and caregiving burden during the participant's loved one's transplant process. The psychological intervention will entail six visits with a trained clinician and will take place during the first three months of the participant's loved ones' transplant process. A trained behavioral psychologist or social worker will meet with the participant or talk with the participant over the telephone or video conference for 45 minutes at a time to discuss the participant's caregiver experience and to help the participant develop effective skills to support the participant's loved one as well as participant over the course of the transplant. The study will use a series of questionnaires to measure the participant's quality of life, mood, and overall caregiving burden. Study questionnaires will be completed in the hospital or clinic. The participant will also have the option of completing these questionnaires remotely through a secure web link, over the telephone, or in a mailed paper copy.
Interventions
OTHERCARE
Promote effective coping and reduce caregiving burden.
Standard cared administered by the hospital.
Sponsors
Massachusetts General Hospital
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult caregivers (≥18 years) of patients undergoing autologous or allogeneic HCT at MGH, and they must attend the HCT consent visit with the patient. * A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for transplant. * Ability to speak English or able to complete questionnaires with minimum assistance of an interpreter.
Exclusion criteria
• Significant uncontrolled psychiatric or other co-morbid disease, which the primary oncologist believes prohibits the ability to participate in study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention (Feasibility Description Below) | 15 months | Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Caregiver Quality of Life (QOL) as Measured by the Caregiver Oncology QOL (CarGOQOL) Questionnaire Between the Study Arms | day 60 | we will compare caregiver QOL as measured by CarGOQOL between study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL |
| Compare Caregiving Burden (CRA) Between the Study Arms | day 60 | we will compare caregiver caregiving burden as measured by Caregiver Reaction Assessment (CRA). The CRA ranges from 24-120 with higher scores indicating greater caregiving burden |
| Compare Caregiver Anxiety Using Hospital Anxiety and Depression Scale (HADS) Between the Study Arms | day 60 | We will compare caregiver anxiety use the Hospital Anxiety and Depression Scale (HADS) between the two groups. The HADS includes two subscales: depression (range 0 (no distress) to 21 (maximum distress) and anxiety (range 0 (no distress) and 21 (maximum distress)). Higher scores on HADS-Anxiety subscale indicate worse anxiety symptoms. |
| Compare Caregiver Self-efficacy Using the Cancer Self-Efficacy Scale-Transplant (CASE-t) Between the Study Arms | day 60 | We will compare caregiver self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between study groups. The scale ranges from 0 to 170 with higher scores indicate higher self efficacy. |
| Compare Perceived Coping Skills (MOCS) Between the Study Arms | day 60 | Compare caregiver coping skills using the Measure of Current Status (MOCS) between the study arms. Score ranges from 0-52, with higher scores indicating higher coping skills |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAreej El-Jawahri, MD
Massachusetts General Hospital
Participant flow
Pre-assignment details
8 caregivers who were enrolled were never randomized as they became ineligible prior to randomization with the transplant aborted.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58 years |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 85 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 47 |
| other Total, other adverse events | 0 / 45 | 0 / 47 |
| serious Total, serious adverse events | 0 / 45 | 0 / 47 |
Outcome results
None listed