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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

CA Participants will be referred to the study by their providers (Oncologist) who will be made aware of the study and inclusion/exclusion criteria. Inclusion Criteria 2.

- 5.

and Exclusion Criteria 1.

- 3.

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: 1. 18 + years. 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.Exclusion Criteria for CA Participant: 1. Presence of a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease) 2. Acute psychiatric disorder or substance abuse. 3. Patients with glioblastoma (GBM) Inclusion Criteria for CA Participant Caregiver: 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 for CA Participant Caregiver: 1. Significant visual impairment precluding reading or writing. 2. No reliable telephone or internet access

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06930846
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dartmouth-Hitchcock Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elaine T Kiriakopoulos, MD, MPH, MSc
Principal Investigator Affiliation	Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, U.S. Fed
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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. 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.

Arms & Interventions

Arms

Experimental: 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)

Active Comparator: 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)

Experimental: 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)

Active Comparator: 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)

Interventions

Behavioral: - 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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Sarah J. Kaden, BA

[email protected]

603-650-4225

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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