HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change in quality of life as measured by comparing Neuro-QOL scores at baseline and at 3 months post-intervention in CA Participants.
研究概览
简要总结
The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-CA, to improve the quality of life and cognitive function in Service Members, Veterans and civilians who are survivors of brain cancer or a brain tumor (CA participants). This study will also assess the ability of the HOBSCOTCH-CA program to improve quality of life in caregivers of patients with brain cancer/tumor and to reduce caregiver burden. Enrolling with a Caregiver is optional for CA participants.
Investigators will compare two groups of CA participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOCTCH-CA immediately (Group 1) and another group that will receive HOBSCOTCH-CA (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total.
HOBSCOTCH-CA involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a "pre" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. CA participants are asked to do short homework assignments and keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).
详细描述
The investigators' hypothesis is that the home-based intervention (HOBSCOTCH-CA) will improve quality of life and cognitive function in Service Members, Veterans and civilians with who are survivors of brain cancer or tumor. Also, that the integration of family caregiver participation in the HOBSCOTCH-CA intervention will reduce caregiver burden and increase caregiver knowledge of their loved one's disease and the cognitive challenges they face, ultimately leading to an improvement in caregiver quality of life (QOL).
The investigators will test the hypothesis by pursuing the following specific aims:
Aim 1: Adapt the HOBSCOTCH program education module for delivery to patients with brain cancer/tumor (CA participant) and cognitive challenges.
The investigators' working hypothesis is that the existing education module of the HOBSCOTCH program can be adapted to address key knowledge areas for patients with brain cancer/tumor and their caregivers.
Aim 2: Evaluate the efficacy of the HOBSCOTCH-CA program in patients with brain cancer/tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CA Participants will be referred to the study by their providers (Oncologist) who will be made aware of the study and inclusion/
排除标准
- •. Inclusion Criteria
- •and Exclusion Criteria
- •will be confirmed by referring providers. Participants who learn about the study here and elsewhere will be instructed on how to confirm their eligibility with their provider.
- •Inclusion Criteria for CA Participant:
- •Service members, Veterans and civilians with a diagnosis of brain cancer (excluding glioblastoma)
- •Diagnosis of primary brain tumor with expected survival of 2 years or greater (e.g., low-grade glioma, oligodendroglioma, IDH mutant astrocytoma, meningioma) defined as the presence of a primary lesion on neuroimaging (CT or MRI), confirmed by histopathological examination (Note: some patients being treated for meningioma may be treated with radiotherapy without need for initial histopathologic confirmation)
- •Patients undergoing surgical and/or radiation therapy will have completed their treatment at least 3 months prior to being enrolled in trial (Note: patients receiving chemotherapy or other systemic therapy will be included)
- •Stable on all CNS acting medications for one month prior to enrollment
- •Subjective cognitive complaints
- •Literate and proficient in English
- •Internet access for the pre-session and Session 1 of the HOBSCOTCH-CA program; telephone access for sessions 2-8
- •Exclusion Criteria for CA Participant:
- •Presence of a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
- •Acute psychiatric disorder or substance abuse
- •Patients with glioblastoma (GBM)
- •Inclusion Criteria for CA Participant Caregiver:
- •Caregiver to a patient with a confirmed diagnosis of brain cancer/tumor survivor
- •CA Subject has given permission for their caregiver to participate
- •Literate and proficient in English
- •Internet access (for Pre-HOBSCOTCH and Session 1)
- •Telephone access (for Session 8)
- •Exclusion Criteria for CA Participant Caregiver:
- •Significant visual impairment precluding reading or writing
- •No reliable telephone or internet access
研究组 & 干预措施
CA Participant-Group 1
After enrollment and completion of baseline assessments, CA Participant Group 1 will receive the HOBSCOTCH-PTE intervention consisting of 1:1 sessions delivered once per week including:
- 1 pre-HOBSCOTCH Session (on webcam)
- 1 educational session (on webcam)
- 6 telephone sessions (option to do on webcam)
- 1 wrap-up session (webcam or telephone)
干预措施: HOBSCOTCH-CA (Behavioral)
CA Participant-Group 2
After a 3-month waiting period and having completed baseline and 3-month study assessments, CA Participant Group 2 will receive the HOBSCOTCH-CA intervention consisting of 1:1 sessions delivered once per week including:
- 1 pre-HOBSCOTCH Session (on webcam)
- 1 educational session (on webcam)
- 6 telephone sessions (option to do on webcam)
- 1 wrap-up session (webcam or telephone)
干预措施: HOBSCOTCH-CA (Behavioral)
CA Participant Caregiver-Group 1
After enrollment and completion of baseline assessments, CA Participant Caregiver Group 1 will receive an adapted version of HOBSCOTCH-CA alongside the CA participant by attending:
- 1 pre-HOBSCOTCH Session (on webcam)
- 1 educational session (on webcam)
- 1 wrap-up session (webcam or telephone)
干预措施: HOBSCOTCH-CA (Behavioral)
CA Participant Caregiver-Group 2
After a 3-month waiting period and having completed baseline and 3-month study assessments, CA Participant Caregiver Group 2 will receive an adapted version of HOBSCOTCH-CA alongside the CA participant by attending:
- 1 pre-HOBSCOTCH Session (on webcam)
- 1 educational session (on webcam)
- 1 wrap-up session (webcam or telephone)
干预措施: HOBSCOTCH-CA (Behavioral)
结局指标
主要结局
Change in quality of life as measured by comparing Neuro-QOL scores at baseline and at 3 months post-intervention in CA Participants.
时间窗: Baseline and 3 months post-intervention
The Neuro-QOL is a self-reported, validated assessment on health-related quality of life covering 17 domains in individuals with neurological disorders. Items are scored on a 5-point Likert scale that uses different language depending on assessment. The questions range from least (1) to most (5) based on frequency of behavior, amount of difficulty, or degree of agreement. Depending on the domain, a higher or lower score can indicate better or poorer quality of life for that domain.
Change in quality of life as measured by comparing FACT-Br scores at baseline and at 3 months post-intervention in CA Participants.
时间窗: Baseline and 3 months post-intervention
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is a validated instrument measuring general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales or domains. A 5-point Likert scale from 0 (not at all) to 4 (very much) is utilized with a higher score representing poorer or better QOL depending on the domain.
Change in subjective cognitive function as measured by comparing scores on the Cognitive Function Sub-Scale (Item Bank 2.0) of the Neuro-QOL at baseline and at 3 months post-intervention in CA Participants.
时间窗: Baseline and 3 months post-intervention
The Cognitive Function sub-scale of the Neuro-QOL is a brief validated tool developed by the NIH for use in patients with neurological disease. Scores range from 8 to 40, with a higher score indicating better reported cognitive functioning.
Change in CA Participant Caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention in Caregivers of CA Participants.
时间窗: Baseline and 3 months post-intervention
The Zarit Burden Interview is a 22-item questionnaire designed to measure the extent to which a caregiver perceives his or her level of burden as a result of caring for a person with a particular diagnosis. A 5 point Likert scale is used with a higher score indicating a greater level of perceived burden.
次要结局
- Changes in CA participants' self-efficacy as measured by comparing scores on the PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v1.0 General Self-Efficacy assessment at baseline and 3-months post-intervention.(Baseline and 3 months post-intervention)
- Changes in CA Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.(Baseline and 3 months post-intervention)
- Changes in CA participants' anxiety as measured by comparing score on the Generalized Anxiety Disorder-7 (GAD-7) at baseline and at 3-months post-intervention.(Baseline and 3 months post-intervention)
- Changes in CA participants' symptom frequency as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention.)
- Changes in CA participants' medication adherence as measured by a daily self-reported diary compared at baseline and at 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention.)
- Changes in CA participants' use of memory strategies as measured by a daily self-reported diary compared at baseline and 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention.)
- Changes in CA participants' self-reports of wellbeing as measured by comparing daily reports of well-being in a diary at baseline and at 3 months post-intervention.(Recorded daily and compared between baseline and 3 months post-intervention.)
- Engagement and Satisfaction for CA Participants as measured by analyzing study attrition and a Participant Satisfaction Survey at the end of the study.(At 6 months (end of the study).)
- Engagement and Satisfaction for CA Participants as measured by CollaboRATE post-study completion.(At 6 months (end of the study).)
- HOBSCOTCH-CA fidelity as measured by CA participant's compliance with weekly homework assignments over the 8 weekly sessions.(At the beginning of HOBSCOTCH-CA (week 1) and at the end of the intervention (week 8).)
- Changes in CA Caregiver Participants' mood as measured by comparing scores on the Patient Health Questionnaire (PHQ-9) at baseline and at 3 months post- intervention.(Baseline and 3 months post-intervention)
- Changes in CA Participant Caregiver self-reported health status as measured by comparing scores on the Short-Form Health Survey 36 (SF-36) at baseline and 3 months-post intervention.(Baseline and 3 months post-intervention)
- Changes in CA Caregiver participants' anxiety as measured by comparing scores on the Generalized Anxiety Disorder-7 (GAD-7) at baseline and at 3-months post-intervention.(Baseline and 3 months post-intervention)
- Changes in CA Participant Caregiver knowledge of relationship between their condition (brain cancer/tumor) and cognition and memory as measured by comparing scores on the HOBSCOTCH-CA Knowledge Questionnaire at baseline and at 6 months (end of study)(Baseline and at 6 months (end of study).)
- Feasibility of HOBSCOTCH-CA program for Caregivers as measured by study attrition and a Participant Satisfaction Survey.(At 6 months (end of study).)
- Sustainability of improvement on primary outcome measure of quality of life for Group 1 CA Participants by comparing scores on the Neuro-QOL at 3 months and 6 months post-intervention.(At 3 months and 6 months post-intervention)
- Sustainability of improvement on primary outcome measure of subjective cognition for Group 1 CA Participants by comparing scores on the Cognitive Function sub-scale of the Neuro-QOL at 3 months and 6 months post-intervention(At 3 months and 6 months post-intervention)
- Sustainability of improvement on primary outcome measure of quality of life for Group 1 CA Participants by comparing scores on the FACT-Br at 3 months and 6 months post-intervention.(At 3 months and 6 months post-intervention)
- Sustainability of improvement on primary outcome measure for CA Participant Caregiver by comparing scores on the Zarit Caregiver Burden at 3 months and 6 months post-intervention.(At 3 months and 6 months post-intervention)
- Changes in CA Participant knowledge of relationship between their condition and cognition and memory as measured by comparing scores on the HOBSCOTCH-CA Knowledge Questionnaire at baseline and at 6 months (end of study)(Baseline and at 6 months (at the end of the study).)
- Changes in CA Participants' objective cognition as measured by comparing scores on the Montreal Cognitive Assessment (MoCA) at baseline and at 3 months post-intervention.(Baseline and 3 months post-intervention)
- Changes in CA Participants' subjective cognition as measured by comparing scores on the Everyday Memory Questionnaire (EMQ) at baseline and at 3 months post-intervention.(Baseline and 3 months post-intervention)
- Changes in CA participants' executive function as measured by comparing scores on the self-reported Behavior Inventory of Executive Function-Adult Version (BRIEF-A) at baseline and 3-months post intervention.(Baseline and 3 months post-intervention)
研究者
Elaine T. Kiriakopoulos
Elaine T. Kiriakopoulos, MD, MPH, MSc Assistant Professor of Neurology, Geisel School of Medicine at Dartmouth Director, HOBSCOTCH Institute for Cognitive Health & Well-Being Dartmouth Hitchcock Epilepsy Center
Dartmouth-Hitchcock Medical Center