HOBSCOTCH-CA for Brain Cancer

(HOBSCOTCH-CA Trial)

Overseen By Trina K Dawson, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Neurodegenerative disease, Acute psychiatric disorder, Glioblastoma

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called HOBSCOTCH-CA, which aims to boost quality of life and improve cognitive function for individuals who have survived brain cancer or have a brain tumor. It also examines how this program can help reduce stress for caregivers. Participants are divided into two groups: one starts the program immediately, while the other begins after three months. The trial suits service members, veterans, and civilians diagnosed with brain cancer (excluding glioblastoma) who completed surgery or radiation therapy at least three months ago and experience cognitive issues. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance support for brain cancer survivors and their caregivers.

Will I have to stop taking my current medications?

The trial requires that participants be stable on all medications affecting the brain for at least one month before joining. This means you should not change these medications right before or during the trial.

What prior data suggests that the HOBSCOTCH-CA program is safe for brain cancer survivors and their caregivers?

Research has shown that HOBSCOTCH-CA, a home-based program, is generally safe for participants. The program incorporates problem-solving therapy and mindfulness, both low-risk activities. Participants engage in virtual sessions with a cognitive coach, eliminating the need for physical treatments. While specific data on side effects for HOBSCOTCH-CA is unavailable, similar programs are typically well-tolerated, as they do not involve medication or surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HOBSCOTCH-CA for brain cancer because it offers a unique, personalized approach to managing cognitive challenges often experienced by patients. Unlike standard treatments that focus primarily on physical symptoms, HOBSCOTCH-CA emphasizes cognitive rehabilitation through structured, one-on-one sessions. This method aims to empower patients by improving memory and attention via remote sessions, making it more accessible. Additionally, involving caregivers in the process can enhance support systems, potentially leading to better outcomes for patients.

What evidence suggests that the HOBSCOTCH-CA program is effective for improving quality of life and cognitive function in brain cancer survivors?

Research has shown that the HOBSCOTCH-CA program can enhance the quality of life and cognitive abilities of brain cancer or brain tumor survivors. This trial will evaluate the HOBSCOTCH-CA program, which teaches problem-solving skills and includes mindfulness or relaxation exercises. Participants will be divided into groups, with some receiving the intervention immediately and others after a waiting period. Studies have found that similar programs can help manage cognitive and memory issues related to brain cancer. Participants often report improvements in daily activities and mental sharpness. Additionally, caregivers who join the program frequently experience reduced stress and an improved quality of life. These early results suggest that HOBSCOTCH-CA may benefit both survivors and their caregivers. ^{1 3 4 5 6}

Who Is on the Research Team?

Elaine T Kiriakopoulos, MD, MPH, MSc

Principal Investigator

Dartmouth-Health/Dartmouth-Hitchcock, Dartmouth College

Are You a Good Fit for This Trial?

This trial is for brain cancer or tumor survivors, including Service Members, Veterans, and civilians. It's also open to caregivers but their participation is optional. Participants must be referred by their oncologists.

Inclusion Criteria

My oncologist referred me to this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention

Baseline assessments and enrollment for CA participants and optional caregivers

1 week

1 visit (virtual)

Intervention

HOBSCOTCH-CA program with 1 pre-session, 1 educational session, 6 weekly sessions, and 1 wrap-up session

8 weeks

8 visits (virtual or telephone)

Waiting Period (Group 2 only)

3-month waiting period before starting the HOBSCOTCH-CA intervention

12 weeks

Follow-up

Participants are monitored for changes in quality of life and cognitive function

3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• HOBSCOTCH-CA

Trial Overview The HOBSCOTCH-CA program aims to improve quality of life and cognitive function in brain cancer/tumor survivors through virtual coaching sessions on problem-solving therapy and mindfulness. The study compares immediate participation with a delayed start group.

How Is the Trial Designed?

Group I: CA Participant-Group 1 Experimental Treatment 1 Intervention

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)

Group II: CA Participant Caregiver-Group 1 Experimental Treatment 1 Intervention

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)

Group III: CA Participant-Group 2 Active Control 1 Intervention

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)

Group IV: CA Participant Caregiver-Group 2 Active Control 1 Intervention

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)

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Mayo Clinic, Rochester, MN

Collaborator

Trials

1

Recruited

90+

University of North Carolina Cancer Center

Collaborator

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06930846

HOBSCOTCH-CA (HOme-Based Self-management and ... 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 ...

2. trials.braintumor.org trials.braintumor.org/trials/NCT06930846

HOBSCOTCH-CA (HOme-Based Self-management and ... 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 ...

3. dartmouth-hitchcock.org dartmouth-hitchcock.org/hobscotch-institute/hobscotch-ca-program

HOme-Based Self-Management and COgnitive Training ... The HOBSCOTCH-CA program teaches people how brain cancer and cognitive problems can be related, and how to find strategies and solutions to better manage ...

4. withpower.com withpower.com/trial/phase-brain-neoplasms-6-2025-69dda

HOBSCOTCH-CA for Brain Cancer 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S147444220870111X

Interventions for cognitive deficits in adults with brain tumours Here, we review the empirical studies that have been done to treat or to prevent cognitive impairment in patients with brain tumours.

6. trialx.com trialx.com/clinical-trials/listings/307722/hobscotch-ca-home-based-self-management-and-cognitive-training-changes-lives-in-brain-cancer/

HOBSCOTCH-CA (HOme-Based Self-management and ... 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 ...