Psychosocial Intervention for Blood Cancer Caregivers
(BMT-CARE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Benign hematologic condition, untreated psychiatric, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
The goal of this study is to evaluate whether a psychological intervention (BMT-CARE) is effective at improving the quality of life in caregivers and patients treated with hematopoietic cell transplant compared to usual care, and to identify critical facilitators and barriers for BMT-CARE implementation and adoption.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment BMT-CARE for blood cancer caregivers?
Is the psychosocial intervention for blood cancer caregivers safe?
How is the BMT-CARE treatment different from other treatments for blood cancer caregivers?
BMT-CARE is unique because it is a 6-session program that combines medical information with cognitive-behavioral strategies to improve the quality of life, mood, coping skills, and self-confidence of caregivers of stem cell transplant recipients, which is not typically addressed by standard medical treatments.12368
Eligibility Criteria
This trial is for caregivers of patients undergoing bone marrow transplants. Caregivers must be adults who are responsible for the patient's care during the transplant process.Inclusion Criteria
I am caring for someone undergoing a stem cell transplant for cancer.
Ability to respond to questions in English, Spanish, or with minimal assistance from an interpreter
Ability to read and respond to survey questions in English, Spanish or with minimal assistance from an interpreter
See 2 more
Exclusion Criteria
Caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent
I am a caregiver for someone having a stem cell transplant for a non-cancerous blood condition or as an outpatient.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the BMT-CARE intervention, a 6-session caregiver-directed cognitive behavioral therapy (CBT)-based psychosocial intervention, from enrollment up to 60 days post-HCT
8-10 weeks
6 sessions (in-person or virtual)
Follow-up
Participants are monitored for quality of life, healthcare utilization, and mental health resource utilization up to 180 days post-HCT
120 days
Questionnaires at baseline, and days 60, 90, and 180 post-HCT
Open-label extension (optional)
Participants may continue to receive usual care and psychosocial support as needed
Long-term
Treatment Details
Interventions
- BMT-CARE (Behavioral Intervention)
Trial OverviewThe study compares a psychological support program called BMT-CARE with usual care to see if it helps improve life quality for caregivers. It also looks at what makes BMT-CARE easy or hard to adopt.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: BMT-CAREExperimental Treatment1 Intervention
Participants randomized to BMT-CARE plus usual care will complete the following:
* Questionnaires at baseline, and days 60, 90 and 180 post HCT.
* Receive the BMT-CARE intervention from enrollment up to 60 days post-HCT. BMT-CARE is a -6-session caregiver-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that integrates HCT-related education with CBT strategies to enhance caregiver knowledge and skills.
* Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits.
Group II: Usual CareActive Control1 Intervention
Participants randomized to usual care will complete the following
* Questionnaires at baseline, and days 60, 90 and 180 post HCT.
* Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General Hospital Cancer CenterBoston, MA
Moffitt Cancer CenterTampa, FL
University of Alabama at BriminghamBirmingham, AL
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Program Evaluation of a Class Addressing Psychosocial Topics in Preparation for Hematopoietic Cell Transplantation: a Brief Report. [2023]Patients undergoing hematopoietic cell transplantation (HCT) and their caregivers can experience psychosocial complications pre-, during, and post-transplant. To meet the needs of the most patients and caregivers, a class was developed to prepare patients and caregivers to prevent and manage common psychosocial challenges. We evaluated the feasibility and acceptability of the class over a 5-month pilot period. Attendance in this class became part of standard pre-transplant care. Attendees were invited to complete a questionnaire (Likert-scale and open-ended questions) to evaluate the feasibility and acceptability of this class. Data were collected over a 5-month period. Descriptive analysis was completed. Patients (n = 41) and caregivers (n = 40) were satisfied to very satisfied with the class. Patients (80%) and caregivers (65%) reported that the class met their expectations, with several describing it as worthwhile and informative. Information relating to finances and benefits were considered most helpful, followed by emotional support resources. Patients (73%) and caregivers (93%) reported that they would recommend the class to others. This education class should be provided as early as possible to ensure that psychosocial needs are addressed. Future research initiatives include further assessing the perspectives of patients, clinicians, and other stakeholders; evaluating delivery methods; and collaborating with other centers.
Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention. [2023]In a recent trial, a 6-session intervention (BMT-CARE) integrating medical information with cognitive-behavioral strategies improved quality of life (QOL), mood, coping skills, and self-efficacy for family/friend caregivers of hematopoietic stem cell transplantation (HCT) recipients. This study examined whether improvements in coping and self-efficacy mediated the intervention effects on QOL and mood.
Psychosocial adjustment of patients and caregivers prior to allogeneic bone marrow transplantation. [2015]There are many studies that examine the psychosocial adjustment of survivors of bone marrow transplantation (BMT). On the other hand, there are relatively few studies that examine the psychosocial adjustment of patients prior to BMT, and even fewer that focus on the psychosocial adjustment of the patient's caregiver. The purpose of the present study was to assess performance status and psychosocial adjustment to illness, mood and stress response of patients and caregivers prior to admission for allogeneic BMT. Forty patients and their 39 caregivers were assessed using standardized measures. One-fourth of the patients reported clinical levels of psychosocial maladjustment on the Psychosocial Adjustment to Illness Scale and had greater adjustment problems than BMT survivors. Approximately one-third (35%) and one-quarter (23%) of the patients reported significant symptoms of intrusive and avoidance stress responses, respectively on the Impact of Events Scale. Caregivers reported more impairments in family relationships than patients, but overall reported similar distress to that of patients. Information about the pre-BMT process appears to be critical to understanding the psychosocial impact that BMT can have on patients and their caregivers.
Coping in caregivers of patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. [2023]Caregivers of patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) must cope with substantial caregiving burden, high rates of psychological distress, and diminished quality of life (QOL). However, data describing coping strategies before HSCT and the association between coping, QOL, and psychological outcomes in this population are lacking. We conducted a secondary analysis of data collected during a multisite randomized clinical trial of a supportive care intervention in HSCT recipients and their caregivers. Caregivers completed the Brief COPE, Hospital Anxiety and Depression Scale, and the Caregiver Oncology Quality of Life Questionnaire to measure coping strategies, psychological distress, and QOL, respectively. We grouped coping into 2 higher-order domains: approach-oriented (ie, emotional support and active coping) and avoidant (ie, self-blame and denial). We used the median split method to describe the distribution of coping and multivariate linear regression models to assess the relationship between coping and caregiver outcomes. We enrolled 170 caregivers, with a median (range) age of 53 (47-64) years. Most were White (87%), non-Hispanic (96%), and female (77%). Approach-oriented coping was associated with less anxiety (β = -0.210, P = .003), depression symptoms (β = -0.160, P = .009), and better QOL (β = 0.526, P = .002). In contrast, avoidant coping was associated with more anxiety (β = 0.687, P
Preliminary efficacy of a brief family intervention to prevent declining quality of life secondary to parental bone marrow transplantation. [2018]The primary purpose of this research was to develop and evaluate the efficacy and feasibility of a brief, cost-effective family-focused intervention to promote adaptive coping and quality of life throughout a parent's bone marrow transplantation (BMT). Targeted outcomes were cohesion, decreased use of avoidance coping, open communication and effective management of emotional distress. Participants included an intervention group of 31 families and 29 families in a control group who received usual care. Each family included the BMT recipient, a partner/caregiver and children 10-18 years old. The intervention included two dyadic sessions for the BMT recipient and the partner/caregiver, one individual session for the caregiver and two digital video discs (DVDs) for children. Statistical analyses indicated that the intervention had a positive impact on at least one aspect of the adaptation of each family member. Caregivers reported the most distress but benefitted least from the intervention, whereas recipients and children reported improvement in distress. Ratings of satisfaction/acceptability were high, with 97% responding that they would recommend the intervention to others. Plans for future research include increased intervention intensity for the caregiver, a larger more diverse sample and implementation over an extended period post BMT.
[Psychological problems and treatment possibilities in intensive care medicine exemplified by bone marrow transplantation]. [2015]Bone Marrow resp. Peripheral Blood Stem Cell Transplantation (BMT/PBSCT) represents the only chance of cure for many patients with haematological diseases. Treatment and convalescence place significant stress not only on patients but on partners, siblings (who are frequently donors) and medical staff. Stressors are the high risk of mortality and chronic disabilities, acute treatment side-effects and multiple psychological and social demands. This requires support during longt-term psychosocial sequelae. We present problems and possible interventions in an acute and a rehabilitative medical setting, discussing recent findings in respect of donors' motivations, social support and quality of life. Psychosocial support in BMT should be given in a process perspective systematically combining and assessing in- and outpatient interventions.
Psychological Impacts and Ways of Coping Reported by Spousal Caregivers of Hematopoietic Cell Transplant Recipients: A Qualitative Analysis. [2021]Allogeneic hematopoietic cell transplantation (HCT) is a demanding treatment with well-established medical and psychosocial sequelae. Impacts on significant others are tremendous. Using an unfiltered qualitative approach, we asked spouses (n = 15) of HCT recipients to talk about their thoughts and feelings regarding the transplantation and their role as caregiver. Recordings were transcribed and independently coded to identify recurrent patterns. Caregivers mentioned both negative and positive psychological impacts of HCT, but the number of negative impacts was greater: 164 versus 34 instances. The most frequently mentioned negative psychological impacts were anxiety/worry (30 instances), fear (20 instances), feeling overloaded/overwhelmed (19 instances), and uncertainty (17 instances). Other emergent categories were roles/responsibilities (49 instances) such as parenting, work, and treatment-related tasks, and coping strategies (55 instances). The latter included both adaptive and maladaptive strategies (75% and 25%, respectively). Despite the preponderance of negatively toned thoughts and feelings, signs of adjustment emerged, with mentions of positive psychological states, such as optimism and gratitude, and adaptive coping strategies, such as active coping, use of emotional support, and self-care. Interventions intended to facilitate adaptation to the HCT experience should involve strategies to help caregivers manage symptoms of distress and promote adaptive coping.
[Experience in psychosocial management of cancer patients undergoing bone marrow transplantation]. [2006]Psychosocial care of cancer patients undergoing bone marrow transplantation. During the last years bone marrow transplantation (BMT) has emerged as a treatment of choice especially for cancer diseases of the haemopoietic system as well as for certain solid tumours. BMT is a very invasive treatment with high dose chemotherapy and total body irradiation, which is accompanied by special psychosocial strains for the patient. Therefore psychosocial care during the acute treatment is needed. In this paper a psychosocial liaison service in a BMT unit as part of a comprehensive psychosocial care on different oncology wards of an acute clinic is presented. Based on a systematic clinical documentation of the psychosocial interventions the practice and problems of the psychosocial care are described. Apart of common problems of psychosocial liaison services known from the literature the experiences show special demands reflecting the special environment of the treatment setting. These problems are discussed with regard to the different target groups (patients, relatives, medical staff). Following the reported experiences some proposals concerning structure and integration of psychosocial care in an BMT unit are given.