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

Dartmouth Health

Status: Enrolling

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

Treatments: Behavioral: HOBSCOTCH-CA

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06930846

STUDY02002841

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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125 participants in 4 patient groups

CA Participant-Group 1

Experimental group

Description:

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)

Treatment:

Behavioral: HOBSCOTCH-CA

CA Participant-Group 2

Active Comparator group

Description:

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)

Treatment:

Behavioral: HOBSCOTCH-CA

CA Participant Caregiver-Group 1

Experimental group

Description:

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)

Treatment:

Behavioral: HOBSCOTCH-CA

CA Participant Caregiver-Group 2

Active Comparator group

Description:

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)

Treatment:

Behavioral: HOBSCOTCH-CA