Recruiting

HOBSCOTCH-CA

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06930846

Conditions

Brain Cancer

Brain Tumor

Brain Neoplasms

Primary Brain Tumor

Low-grade Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HOBSCOTCH-CA

Study Details

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

Study ID

NCT06930846

Start date

Nov 3, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sarah J. Kaden, BA

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

Trina K Dawson, BA

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

Locations

Dartmouth-Health Lebanon

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Kathryn Giordano

603-650-4225HOBSCOTCH-CA.Research@Hitchcock.org

Sarah J. Kaden, BA

603-650-4225HOBSCOTCH-CA.Research@Hitchcock.org

Principal Investigator:

Elaine T. Kiriakopoulos, MD, MPH, MSc

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2025-11-21.