HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)

NCT06930846 | Recruiting

• 1 other identifier: STUDY02002841
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Brain Cancer; Brain Tumor; Brain Neoplasms; Primary Brain Tumor; Low-grade Glioma; Oligodendroglioma; Meningioma; Low Grade Astrocytoma; Cognitive Dysfunction; Memory Impairment; Memory Disorders; Memory Dysfunction

Keywords

Brain cancer survivor; Brain tumor survivor; Cognition; Self-management; Cognitive training; Memory disorders; Cognitive remediation; Caregiver; Caregiver burden; Mindfulness

Outcome Measures

Primary Outcomes (4)

• Change in quality of life as measured by comparing Neuro-QOL scores at baseline and at 3 months post-intervention in CA Participants.

  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.

  Baseline and 3 months post-intervention

• Change in quality of life as measured by comparing FACT-Br scores at baseline and at 3 months post-intervention in CA Participants.

  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.

  Baseline and 3 months post-intervention

• 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.

  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.

  Baseline and 3 months post-intervention

• 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.

  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.

  Baseline and 3 months post-intervention

Secondary Outcomes (23)

• 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

• 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

Study Arms (4)

CA Participant-Group 1

EXPERIMENTAL

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)

Behavioral: HOBSCOTCH-CA

CA Participant-Group 2

ACTIVE COMPARATOR

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)

Behavioral: HOBSCOTCH-CA

CA Participant Caregiver-Group 1

EXPERIMENTAL

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)

Behavioral: HOBSCOTCH-CA

CA Participant Caregiver-Group 2

ACTIVE COMPARATOR

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)

Behavioral: HOBSCOTCH-CA

Interventions

HOBSCOTCH-CA BEHAVIORAL

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.

Also known as: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)

CA Participant Caregiver-Group 1; CA Participant Caregiver-Group 2; CA Participant-Group 1; CA Participant-Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• + years
• 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
• Presence of a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)
• Acute psychiatric disorder or substance abuse
• Patients with glioblastoma (GBM)
• Age 18 +
• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Congressionally Directed Medical Research Programs: collaborator
• Mayo Clinic: collaborator
• University of North Carolina: collaborator
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Health Lebanon

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Oligodendroglioma; Meningioma; Cognitive Dysfunction; Memory Disorders; Caregiver Burden

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Elaine T Kiriakopoulos, MD, MPH, MSc

  Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah J. Kaden, BA

CONTACT

603-650-4225; sarah.j.kaden@hitchcock.org

Trina K Dawson, BA

CONTACT

603-650-4205; trina.k.dawson@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: Prospective Randomized Waitlist Control Trial

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)