HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)
NCT ID: NCT06930846
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2025-11-03
2028-12-31
Brief Summary
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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).
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Detailed Description
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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.
The investigators' working hypothesis is that the HOBSCOTCH-CA intervention will improve quality of life (QOL) in CA participants. The investigators also expect to see improvements in subjective cognition, knowledge, self-efficacy, symptom reduction, and health outcomes.
Aim 3: Incorporate family caregivers into select components of the HOBSCOTCH-CA intervention and evaluate the effects of the HOBSCOTCH-CA intervention on the caregiver.
The investigator's working hypothesis is that family caregivers will have improvement in QOL and reduced caregiver burden and improved health status as a result of their family member with CA participating in the HOBSCOTCH-CA intervention, and by their own participation in the HOBSCOTCH-CA modules delivering disease specific education and mindfulness skill building exercises.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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)
HOBSCOTCH-CA
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-CA is an adaptation of the HOBSCOTCH program for people who are survivors of brain cancer or a brain tumor that incorporates education about the effects from brain cancer/tumor and its treatment on cognition into the education module and gives them the option of enrolling with a Caregiver. CA Participants receive all sessions of HOBSCOTCH-CA. If they enroll with a Caregiver, the Caregiver participates in the education (introductory) session and sessions 1 and 8. The HOBSCOTCH-CA Participant may invite their Caregiver to attend all sessions.
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)
HOBSCOTCH-CA
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-CA is an adaptation of the HOBSCOTCH program for people who are survivors of brain cancer or a brain tumor that incorporates education about the effects from brain cancer/tumor and its treatment on cognition into the education module and gives them the option of enrolling with a Caregiver. CA Participants receive all sessions of HOBSCOTCH-CA. If they enroll with a Caregiver, the Caregiver participates in the education (introductory) session and sessions 1 and 8. The HOBSCOTCH-CA Participant may invite their Caregiver to attend all sessions.
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)
HOBSCOTCH-CA
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-CA is an adaptation of the HOBSCOTCH program for people who are survivors of brain cancer or a brain tumor that incorporates education about the effects from brain cancer/tumor and its treatment on cognition into the education module and gives them the option of enrolling with a Caregiver. CA Participants receive all sessions of HOBSCOTCH-CA. If they enroll with a Caregiver, the Caregiver participates in the education (introductory) session and sessions 1 and 8. The HOBSCOTCH-CA Participant may invite their Caregiver to attend all sessions.
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)
HOBSCOTCH-CA
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-CA is an adaptation of the HOBSCOTCH program for people who are survivors of brain cancer or a brain tumor that incorporates education about the effects from brain cancer/tumor and its treatment on cognition into the education module and gives them the option of enrolling with a Caregiver. CA Participants receive all sessions of HOBSCOTCH-CA. If they enroll with a Caregiver, the Caregiver participates in the education (introductory) session and sessions 1 and 8. The HOBSCOTCH-CA Participant may invite their Caregiver to attend all sessions.
Interventions
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HOBSCOTCH-CA
HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH-CA is an adaptation of the HOBSCOTCH program for people who are survivors of brain cancer or a brain tumor that incorporates education about the effects from brain cancer/tumor and its treatment on cognition into the education module and gives them the option of enrolling with a Caregiver. CA Participants receive all sessions of HOBSCOTCH-CA. If they enroll with a Caregiver, the Caregiver participates in the education (introductory) session and sessions 1 and 8. The HOBSCOTCH-CA Participant may invite their Caregiver to attend all sessions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Service members, Veterans and civilians with a diagnosis of brain cancer (excluding glioblastoma)
3. 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)
4. 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)
5. Stable on all CNS acting medications for one month prior to enrollment
6. Subjective cognitive complaints
7. Literate and proficient in English
8. Internet access for the pre-session and Session 1 of the HOBSCOTCH-CA program; telephone access for sessions 2-8
1. Age 18 +
2. Caregiver to a patient with a confirmed diagnosis of brain cancer/tumor survivor
3. CA Subject has given permission for their caregiver to participate
4. Literate and proficient in English
5. Internet access (for Pre-HOBSCOTCH and Session 1)
6. Telephone access (for Session 8)
Exclusion Criteria
2. Acute psychiatric disorder or substance abuse
3. Patients with glioblastoma (GBM)
1. Significant visual impairment precluding reading or writing
2. No reliable telephone or internet access
18 Years
ALL
No
Sponsors
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Congressionally Directed Medical Research Programs
FED
Mayo Clinic
OTHER
University of North Carolina
OTHER
Dartmouth College
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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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
Principal Investigators
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Elaine T Kiriakopoulos, MD, MPH, MSc
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College
Locations
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Dartmouth-Health Lebanon
Lebanon, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY02002841
Identifier Type: -
Identifier Source: org_study_id
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