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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 + 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

• 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

• Internet access (for Pre-HOBSCOTCH and Session 1)

• Telephone access (for Session 8)

Locations
United States
New Hampshire
Dartmouth-Health Lebanon
RECRUITING
Lebanon
Contact Information
Primary
Sarah J. Kaden, BA
sarah.j.kaden@hitchcock.org
603-650-4225
Backup
Trina K Dawson, BA
trina.k.dawson@hitchcock.org
603-650-4205
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2028-12
Participants
Target number of participants: 125
Treatments
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)
Sponsors
Collaborators: Mayo Clinic, Dartmouth College, University of North Carolina, Congressionally Directed Medical Research Programs
Leads: Dartmouth-Hitchcock Medical Center

This content was sourced from clinicaltrials.gov